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The ongoing issue of gender disparities in interventional cardiology
As gender disparities persist in interventional cardiology, a new survey is shedding light on what is keeping women away from the field.
With women representing only 9% of interventional cardiologists in the United States as of 2017, researchers under the direction of the American College of Cardiology Women in Cardiology Leadership Council sought to asses the perspectives of fellows-in-training (FIT) regarding the factors influencing their cardiology subspecialty decisions.
A total of 574 FIT completed the survey, with 190 respondents anticipating pursuit of a career in interventional cardiology. The results of the survey were published online in JACC: Cardiovascular Interventions. According to the report, unlike other studies that looked at gender disparities in interventional cardiology that focused on the training (residency) or later (practicing cardiologists), this is the first to look at the time when the decision is made during general cardiology fellowship.
The goal of the survey was “to try to understand in the current realm of our millennials who are studying and are in fellowship and in training and in the trenches, what is dissuading them to be in the subspecialty of interventional cardiology,” Roxana Mehran, MD, Icahn School of Medicine at Mount Sinai, New York, and coauthor of the study, said in an interview.
Lead author Celina Yong, MD, and her colleagues wrote in their report on the survey that women “were more likely to express interest in all other cardiovascular specialties (general/clinical cardiology, advanced imaging, heart failure/transplant, adult congenital, and other), with the exception of electrophysiology (13% women vs. 87% men, P = .001).”
Researchers analyzed the 504 remaining survey responses after excluding those considering electrophysiology to get a better understanding about the influencing factors related to the decision to pursue interventional cardiology.
“Logistic regression of all demographic characteristics revealed that male sex was the most significant predictor of a career choice in interventional cardiology [odds ratio, 3.98; P less than 0.001],” the authors noted.
All respondents who intended to pursue a career in interventional cardiology had a list of 15 options to select the reasons for choosing this path. The top five, in descending order, were the opportunity to pursue hands-on procedures, personal interest in the specialty subject area, the opportunity for immediate gratification or sense of accomplishment, the thrill of treating ill patients in critical situations, and having mentors or role models the respondent identified with.
“When disaggregated by gender, there were six attributes that were significantly different between men and women in terms of reasons for pursuing” interventional cardiology, the authors stated. “Men were more likely to be driven by innovation in the field, importance of being an expert, likelihood of employment after completion of training, financial advantages, and prestige. Women were more likely to be driven by having a female mentor or role model.”
For those not pursuing a career in interventional cardiology, the top five reasons, in descending order, were an uncontrollable or unpredictable lifestyle, concern over long work hours and poor work/life balance, greater interest in another field, a desire for different type of patient contact, and wanting to have children in the next 5 years.
“There were seven attributes identified that negatively influenced IC choice differently by sex,” noted Dr. Yong, of VA Palo Alto (Calif.) Medical Center, and her colleagues. “Women were more likely to be negatively influenced by all seven of these factors compared to men (in descending order)”:
1) Greater interest in another field.
2) Little flexibility in job prospects/opportunities over a lifetime.
3) Physically demanding nature of job (e.g., wearing heavy lead).
4) Radiation exposure concerns during childbearing.
5) “Old boys club” culture.
6) Lack of female role models.
7) Gender discrimination or harassment.
Dr. Mehran said that despite some limitations, the survey results were not surprising.
“Unfortunately, surveys are very subjective,” she said. Also, one can question how biased some of these questions are. “But nonetheless, I think the result is very similar to what we had expected and have been talking about.”
She noted that the subspecialty of interventional cardiology needs to be more family friendly.
“I think we are going to lose a lot of good men also who are not choosing interventional cardiology,” she said. “There is no question that we have to think about how we can enhance and improve and pave the way for men and women, but mostly women because there are hardly any women and that’s important. The family friendly environment is very, very important in interventional cardiology.”
The patriarchal culture is another area that needs to be addressed, she said.
“I feel that, hopefully, that’s a perception and not much of a reality,” Dr. Mehran said, though she did note that there are plenty of examples where female doctors do not get shown the same level of respect their male counterparts do. She noted, for example, at scientific meetings, when a woman is on a panel and speaking, audience members can be seen tuning out, using it as opportunity to look at phones. Sometimes the women on the panels are not even referred to as “doctor.”
“I think we have to have a standard that those kinds of things will not be tolerated, that people will be called out if they didn’t do the extra work to find the best women for those important panels and leadership roles. There has to be a code of conduct that is equal and gender neutral,” she said, adding: “I think we are trying to work very hard to equalize the playing field but we have to come up with solutions.”
To that end, Dr. Mehran created a not-for-profit organization, Women As One, to tackle these gender disparities.
“We are really looking for solutions,” she said. “We will hold several think tanks with key opinion leaders, men and women, to come up with how best can academic organizations make sure that there is gender equality, good representation, and no discrimination on the basis of sex. ... We have to come up with solutions. Otherwise we just keep showing the same statistics over and over again and its not improving.”
SOURCE: JACC: Cardiovasc Interven. 2019 Jan; doi: 10.1016/j.jcin.2018.09.036
As gender disparities persist in interventional cardiology, a new survey is shedding light on what is keeping women away from the field.
With women representing only 9% of interventional cardiologists in the United States as of 2017, researchers under the direction of the American College of Cardiology Women in Cardiology Leadership Council sought to asses the perspectives of fellows-in-training (FIT) regarding the factors influencing their cardiology subspecialty decisions.
A total of 574 FIT completed the survey, with 190 respondents anticipating pursuit of a career in interventional cardiology. The results of the survey were published online in JACC: Cardiovascular Interventions. According to the report, unlike other studies that looked at gender disparities in interventional cardiology that focused on the training (residency) or later (practicing cardiologists), this is the first to look at the time when the decision is made during general cardiology fellowship.
The goal of the survey was “to try to understand in the current realm of our millennials who are studying and are in fellowship and in training and in the trenches, what is dissuading them to be in the subspecialty of interventional cardiology,” Roxana Mehran, MD, Icahn School of Medicine at Mount Sinai, New York, and coauthor of the study, said in an interview.
Lead author Celina Yong, MD, and her colleagues wrote in their report on the survey that women “were more likely to express interest in all other cardiovascular specialties (general/clinical cardiology, advanced imaging, heart failure/transplant, adult congenital, and other), with the exception of electrophysiology (13% women vs. 87% men, P = .001).”
Researchers analyzed the 504 remaining survey responses after excluding those considering electrophysiology to get a better understanding about the influencing factors related to the decision to pursue interventional cardiology.
“Logistic regression of all demographic characteristics revealed that male sex was the most significant predictor of a career choice in interventional cardiology [odds ratio, 3.98; P less than 0.001],” the authors noted.
All respondents who intended to pursue a career in interventional cardiology had a list of 15 options to select the reasons for choosing this path. The top five, in descending order, were the opportunity to pursue hands-on procedures, personal interest in the specialty subject area, the opportunity for immediate gratification or sense of accomplishment, the thrill of treating ill patients in critical situations, and having mentors or role models the respondent identified with.
“When disaggregated by gender, there were six attributes that were significantly different between men and women in terms of reasons for pursuing” interventional cardiology, the authors stated. “Men were more likely to be driven by innovation in the field, importance of being an expert, likelihood of employment after completion of training, financial advantages, and prestige. Women were more likely to be driven by having a female mentor or role model.”
For those not pursuing a career in interventional cardiology, the top five reasons, in descending order, were an uncontrollable or unpredictable lifestyle, concern over long work hours and poor work/life balance, greater interest in another field, a desire for different type of patient contact, and wanting to have children in the next 5 years.
“There were seven attributes identified that negatively influenced IC choice differently by sex,” noted Dr. Yong, of VA Palo Alto (Calif.) Medical Center, and her colleagues. “Women were more likely to be negatively influenced by all seven of these factors compared to men (in descending order)”:
1) Greater interest in another field.
2) Little flexibility in job prospects/opportunities over a lifetime.
3) Physically demanding nature of job (e.g., wearing heavy lead).
4) Radiation exposure concerns during childbearing.
5) “Old boys club” culture.
6) Lack of female role models.
7) Gender discrimination or harassment.
Dr. Mehran said that despite some limitations, the survey results were not surprising.
“Unfortunately, surveys are very subjective,” she said. Also, one can question how biased some of these questions are. “But nonetheless, I think the result is very similar to what we had expected and have been talking about.”
She noted that the subspecialty of interventional cardiology needs to be more family friendly.
“I think we are going to lose a lot of good men also who are not choosing interventional cardiology,” she said. “There is no question that we have to think about how we can enhance and improve and pave the way for men and women, but mostly women because there are hardly any women and that’s important. The family friendly environment is very, very important in interventional cardiology.”
The patriarchal culture is another area that needs to be addressed, she said.
“I feel that, hopefully, that’s a perception and not much of a reality,” Dr. Mehran said, though she did note that there are plenty of examples where female doctors do not get shown the same level of respect their male counterparts do. She noted, for example, at scientific meetings, when a woman is on a panel and speaking, audience members can be seen tuning out, using it as opportunity to look at phones. Sometimes the women on the panels are not even referred to as “doctor.”
“I think we have to have a standard that those kinds of things will not be tolerated, that people will be called out if they didn’t do the extra work to find the best women for those important panels and leadership roles. There has to be a code of conduct that is equal and gender neutral,” she said, adding: “I think we are trying to work very hard to equalize the playing field but we have to come up with solutions.”
To that end, Dr. Mehran created a not-for-profit organization, Women As One, to tackle these gender disparities.
“We are really looking for solutions,” she said. “We will hold several think tanks with key opinion leaders, men and women, to come up with how best can academic organizations make sure that there is gender equality, good representation, and no discrimination on the basis of sex. ... We have to come up with solutions. Otherwise we just keep showing the same statistics over and over again and its not improving.”
SOURCE: JACC: Cardiovasc Interven. 2019 Jan; doi: 10.1016/j.jcin.2018.09.036
As gender disparities persist in interventional cardiology, a new survey is shedding light on what is keeping women away from the field.
With women representing only 9% of interventional cardiologists in the United States as of 2017, researchers under the direction of the American College of Cardiology Women in Cardiology Leadership Council sought to asses the perspectives of fellows-in-training (FIT) regarding the factors influencing their cardiology subspecialty decisions.
A total of 574 FIT completed the survey, with 190 respondents anticipating pursuit of a career in interventional cardiology. The results of the survey were published online in JACC: Cardiovascular Interventions. According to the report, unlike other studies that looked at gender disparities in interventional cardiology that focused on the training (residency) or later (practicing cardiologists), this is the first to look at the time when the decision is made during general cardiology fellowship.
The goal of the survey was “to try to understand in the current realm of our millennials who are studying and are in fellowship and in training and in the trenches, what is dissuading them to be in the subspecialty of interventional cardiology,” Roxana Mehran, MD, Icahn School of Medicine at Mount Sinai, New York, and coauthor of the study, said in an interview.
Lead author Celina Yong, MD, and her colleagues wrote in their report on the survey that women “were more likely to express interest in all other cardiovascular specialties (general/clinical cardiology, advanced imaging, heart failure/transplant, adult congenital, and other), with the exception of electrophysiology (13% women vs. 87% men, P = .001).”
Researchers analyzed the 504 remaining survey responses after excluding those considering electrophysiology to get a better understanding about the influencing factors related to the decision to pursue interventional cardiology.
“Logistic regression of all demographic characteristics revealed that male sex was the most significant predictor of a career choice in interventional cardiology [odds ratio, 3.98; P less than 0.001],” the authors noted.
All respondents who intended to pursue a career in interventional cardiology had a list of 15 options to select the reasons for choosing this path. The top five, in descending order, were the opportunity to pursue hands-on procedures, personal interest in the specialty subject area, the opportunity for immediate gratification or sense of accomplishment, the thrill of treating ill patients in critical situations, and having mentors or role models the respondent identified with.
“When disaggregated by gender, there were six attributes that were significantly different between men and women in terms of reasons for pursuing” interventional cardiology, the authors stated. “Men were more likely to be driven by innovation in the field, importance of being an expert, likelihood of employment after completion of training, financial advantages, and prestige. Women were more likely to be driven by having a female mentor or role model.”
For those not pursuing a career in interventional cardiology, the top five reasons, in descending order, were an uncontrollable or unpredictable lifestyle, concern over long work hours and poor work/life balance, greater interest in another field, a desire for different type of patient contact, and wanting to have children in the next 5 years.
“There were seven attributes identified that negatively influenced IC choice differently by sex,” noted Dr. Yong, of VA Palo Alto (Calif.) Medical Center, and her colleagues. “Women were more likely to be negatively influenced by all seven of these factors compared to men (in descending order)”:
1) Greater interest in another field.
2) Little flexibility in job prospects/opportunities over a lifetime.
3) Physically demanding nature of job (e.g., wearing heavy lead).
4) Radiation exposure concerns during childbearing.
5) “Old boys club” culture.
6) Lack of female role models.
7) Gender discrimination or harassment.
Dr. Mehran said that despite some limitations, the survey results were not surprising.
“Unfortunately, surveys are very subjective,” she said. Also, one can question how biased some of these questions are. “But nonetheless, I think the result is very similar to what we had expected and have been talking about.”
She noted that the subspecialty of interventional cardiology needs to be more family friendly.
“I think we are going to lose a lot of good men also who are not choosing interventional cardiology,” she said. “There is no question that we have to think about how we can enhance and improve and pave the way for men and women, but mostly women because there are hardly any women and that’s important. The family friendly environment is very, very important in interventional cardiology.”
The patriarchal culture is another area that needs to be addressed, she said.
“I feel that, hopefully, that’s a perception and not much of a reality,” Dr. Mehran said, though she did note that there are plenty of examples where female doctors do not get shown the same level of respect their male counterparts do. She noted, for example, at scientific meetings, when a woman is on a panel and speaking, audience members can be seen tuning out, using it as opportunity to look at phones. Sometimes the women on the panels are not even referred to as “doctor.”
“I think we have to have a standard that those kinds of things will not be tolerated, that people will be called out if they didn’t do the extra work to find the best women for those important panels and leadership roles. There has to be a code of conduct that is equal and gender neutral,” she said, adding: “I think we are trying to work very hard to equalize the playing field but we have to come up with solutions.”
To that end, Dr. Mehran created a not-for-profit organization, Women As One, to tackle these gender disparities.
“We are really looking for solutions,” she said. “We will hold several think tanks with key opinion leaders, men and women, to come up with how best can academic organizations make sure that there is gender equality, good representation, and no discrimination on the basis of sex. ... We have to come up with solutions. Otherwise we just keep showing the same statistics over and over again and its not improving.”
SOURCE: JACC: Cardiovasc Interven. 2019 Jan; doi: 10.1016/j.jcin.2018.09.036
FROM JACC: CARDIOVASCULAR INTERVENTIONS
Key clinical point: Men are more likely to pursue a career in interventional cardiology than are women.
Major finding: Logistical regression of all demographic characteristics revealed being male was the most significant predictor of a career choice in IC .
Study details: Researchers analyzed survey responses from 574 fellows-in-training to determine the likelihood of pursuing a career in interventional cardiology.
Disclosures: The study was funded by the American College of Cardiology and the Women in Cardiology section of the ACC. The authors reported no financial disclosures.
Source: JACC: Cardiovasc Interven. 2019 Jan. doi: 10.1016/j.jcin.2018.09.036.
Device approved to treat PDA in premature infants
weighing as little as 2 pounds.
PDA is a life-threatening opening between two blood vessels leading from the heart and commonly occurs in premature infants, with about one in five infants born prematurely having a hemodynamically significant PDA. The Amplatzer Piccolo Occluder is a self-expanding, wire mesh device that is minimally invasive and is the first device approved for use in very-low-birth-weight infants.
FDA approval was based on results of the ADO II AS trial, which evaluated the device in 50 patients with PDA who were older than 3 days. In addition, the safety and efficacy of the Amplatzer Piccolo Occluder was supported by a continued access protocol involving 150 more patients.
“This approval is a potentially life-saving advance for the very smallest premature infants that will help us treat these delicate babies who might otherwise not be able to survive,” said Evan Zahn, MD, principal investigator of ADO II AS and director of the congenital heart program at Cedars-Sinai’s Smidt Heart Institute in Los Angeles.
Find the full press release on the Abbott website.
weighing as little as 2 pounds.
PDA is a life-threatening opening between two blood vessels leading from the heart and commonly occurs in premature infants, with about one in five infants born prematurely having a hemodynamically significant PDA. The Amplatzer Piccolo Occluder is a self-expanding, wire mesh device that is minimally invasive and is the first device approved for use in very-low-birth-weight infants.
FDA approval was based on results of the ADO II AS trial, which evaluated the device in 50 patients with PDA who were older than 3 days. In addition, the safety and efficacy of the Amplatzer Piccolo Occluder was supported by a continued access protocol involving 150 more patients.
“This approval is a potentially life-saving advance for the very smallest premature infants that will help us treat these delicate babies who might otherwise not be able to survive,” said Evan Zahn, MD, principal investigator of ADO II AS and director of the congenital heart program at Cedars-Sinai’s Smidt Heart Institute in Los Angeles.
Find the full press release on the Abbott website.
weighing as little as 2 pounds.
PDA is a life-threatening opening between two blood vessels leading from the heart and commonly occurs in premature infants, with about one in five infants born prematurely having a hemodynamically significant PDA. The Amplatzer Piccolo Occluder is a self-expanding, wire mesh device that is minimally invasive and is the first device approved for use in very-low-birth-weight infants.
FDA approval was based on results of the ADO II AS trial, which evaluated the device in 50 patients with PDA who were older than 3 days. In addition, the safety and efficacy of the Amplatzer Piccolo Occluder was supported by a continued access protocol involving 150 more patients.
“This approval is a potentially life-saving advance for the very smallest premature infants that will help us treat these delicate babies who might otherwise not be able to survive,” said Evan Zahn, MD, principal investigator of ADO II AS and director of the congenital heart program at Cedars-Sinai’s Smidt Heart Institute in Los Angeles.
Find the full press release on the Abbott website.
FDA: Benefits still outweigh risks from paclitaxel-coated devices for PAD
The Food and Drug Administration has issued a letter alerting health care providers that it is aware of and examining recent data on an increase in long-term mortality rates for patients receiving paclitaxel-coated balloons and paclitaxel-eluting stents for treatment of peripheral artery disease.
“Currently, the FDA believes that the benefits continue to outweigh the risks for approved paclitaxel-coated balloons and paclitaxel-eluting stents when used in accordance with their indications for use,” William Maisel, MD, MPH, chief medical officer of the Center for Devices and Radiological Health at the FDA, wrote in a letter to health care providers.
The FDA letter was in response to a recent systematic review of paclitaxel-coated balloons and stents recently published in the Journal of the American Heart Association. Konstantinos Katsanos, MD, PhD, from Patras University Hospital in Rion, Greece, and colleagues performed the systematic review and meta-analysis of 28 randomized controlled trials with 4,663 patients who received paclitaxel-coated devices in the femoral and/or popliteal arteries and found similar 1-year risk of all-cause patient mortality (2.3%; risk ratio, 1.08; 95% confidence interval, 0.72-1.61). However, there was an increased risk of all-cause mortality for patients with paclitaxel-coated devices at 2 years (7.2% vs. 3.8%; RR, 1.68; 95% CI, 1.15-2.47) and at 5 years (14.7% vs. 8.1%; RR, 1.93; 95% CI, 1.27-2.93), compared with control groups. The number needed to harm at 2 years was 29 patients (95% CI, 19-59) and 14 patients (95% CI, 9-32) at 5 years. Their meta regression analysis found a significant link between paclitaxel exposure and absolute risk of death.
“Actual causes for this serious late side effect remain unknown, and further investigations with longer-term follow-up are urgently warranted,” Dr. Katsanos and colleagues wrote in their review.
The FDA told health care providers of patients with paclitaxel-coated balloons and paclitaxel-eluting stents to continue surveillance of these patients per standard of care, to discuss the risks and benefits of PAD treatment options with patients, and to report any adverse or suspected adverse events to MedWatch.
The FDA said they are currently evaluating long-term data on paclitaxel-coated products to determine whether the devices carry an increased risk of death or other long-term risks, and noted there were several paclitaxel-coated balloons or paclitaxel-eluting stents that have either been approved or are under study in the United States.
SOURCE: Katsanos K et al. J Am Heart Assoc. 2018. doi: 10.1161/JAHA.118.011245.
The Food and Drug Administration has issued a letter alerting health care providers that it is aware of and examining recent data on an increase in long-term mortality rates for patients receiving paclitaxel-coated balloons and paclitaxel-eluting stents for treatment of peripheral artery disease.
“Currently, the FDA believes that the benefits continue to outweigh the risks for approved paclitaxel-coated balloons and paclitaxel-eluting stents when used in accordance with their indications for use,” William Maisel, MD, MPH, chief medical officer of the Center for Devices and Radiological Health at the FDA, wrote in a letter to health care providers.
The FDA letter was in response to a recent systematic review of paclitaxel-coated balloons and stents recently published in the Journal of the American Heart Association. Konstantinos Katsanos, MD, PhD, from Patras University Hospital in Rion, Greece, and colleagues performed the systematic review and meta-analysis of 28 randomized controlled trials with 4,663 patients who received paclitaxel-coated devices in the femoral and/or popliteal arteries and found similar 1-year risk of all-cause patient mortality (2.3%; risk ratio, 1.08; 95% confidence interval, 0.72-1.61). However, there was an increased risk of all-cause mortality for patients with paclitaxel-coated devices at 2 years (7.2% vs. 3.8%; RR, 1.68; 95% CI, 1.15-2.47) and at 5 years (14.7% vs. 8.1%; RR, 1.93; 95% CI, 1.27-2.93), compared with control groups. The number needed to harm at 2 years was 29 patients (95% CI, 19-59) and 14 patients (95% CI, 9-32) at 5 years. Their meta regression analysis found a significant link between paclitaxel exposure and absolute risk of death.
“Actual causes for this serious late side effect remain unknown, and further investigations with longer-term follow-up are urgently warranted,” Dr. Katsanos and colleagues wrote in their review.
The FDA told health care providers of patients with paclitaxel-coated balloons and paclitaxel-eluting stents to continue surveillance of these patients per standard of care, to discuss the risks and benefits of PAD treatment options with patients, and to report any adverse or suspected adverse events to MedWatch.
The FDA said they are currently evaluating long-term data on paclitaxel-coated products to determine whether the devices carry an increased risk of death or other long-term risks, and noted there were several paclitaxel-coated balloons or paclitaxel-eluting stents that have either been approved or are under study in the United States.
SOURCE: Katsanos K et al. J Am Heart Assoc. 2018. doi: 10.1161/JAHA.118.011245.
The Food and Drug Administration has issued a letter alerting health care providers that it is aware of and examining recent data on an increase in long-term mortality rates for patients receiving paclitaxel-coated balloons and paclitaxel-eluting stents for treatment of peripheral artery disease.
“Currently, the FDA believes that the benefits continue to outweigh the risks for approved paclitaxel-coated balloons and paclitaxel-eluting stents when used in accordance with their indications for use,” William Maisel, MD, MPH, chief medical officer of the Center for Devices and Radiological Health at the FDA, wrote in a letter to health care providers.
The FDA letter was in response to a recent systematic review of paclitaxel-coated balloons and stents recently published in the Journal of the American Heart Association. Konstantinos Katsanos, MD, PhD, from Patras University Hospital in Rion, Greece, and colleagues performed the systematic review and meta-analysis of 28 randomized controlled trials with 4,663 patients who received paclitaxel-coated devices in the femoral and/or popliteal arteries and found similar 1-year risk of all-cause patient mortality (2.3%; risk ratio, 1.08; 95% confidence interval, 0.72-1.61). However, there was an increased risk of all-cause mortality for patients with paclitaxel-coated devices at 2 years (7.2% vs. 3.8%; RR, 1.68; 95% CI, 1.15-2.47) and at 5 years (14.7% vs. 8.1%; RR, 1.93; 95% CI, 1.27-2.93), compared with control groups. The number needed to harm at 2 years was 29 patients (95% CI, 19-59) and 14 patients (95% CI, 9-32) at 5 years. Their meta regression analysis found a significant link between paclitaxel exposure and absolute risk of death.
“Actual causes for this serious late side effect remain unknown, and further investigations with longer-term follow-up are urgently warranted,” Dr. Katsanos and colleagues wrote in their review.
The FDA told health care providers of patients with paclitaxel-coated balloons and paclitaxel-eluting stents to continue surveillance of these patients per standard of care, to discuss the risks and benefits of PAD treatment options with patients, and to report any adverse or suspected adverse events to MedWatch.
The FDA said they are currently evaluating long-term data on paclitaxel-coated products to determine whether the devices carry an increased risk of death or other long-term risks, and noted there were several paclitaxel-coated balloons or paclitaxel-eluting stents that have either been approved or are under study in the United States.
SOURCE: Katsanos K et al. J Am Heart Assoc. 2018. doi: 10.1161/JAHA.118.011245.
Key clinical point: In a letter to health care providers, FDA said it was investigating data from a recent meta-analysis of increased long-term mortality risk from paclitaxel-coated balloons and paclitaxel-eluting stents for treatment of peripheral artery disease.
Major finding: All-cause mortality increased significantly after 2 years (7.2% vs. 3.8%) and 5 years (14.7% vs. 8.1%) compared with control groups.
Study details: A systematic review and meta-analysis of 28 randomized controlled trials with 4,663 patients.
Source: Katsanos K et al. J Am Heart Assoc. 2018. doi: 10.1161/JAHA.118.011245.
Getting serious about post-EVAR aortic neck dilation
CHICAGO – Clinically significant aortic neck dilation occurs in one-quarter of patients after endovascular abdominal aortic aneurysm repair and is associated with sharply increased risk for type Ia endoleak, stent migration at the proximal seal zone, continued aneurysmal sack enlargement, and even aneurysm rupture, Jason T. Lee, MD, said at a symposium on vascular surgery sponsored by Northwestern University.
He cited what he considers to be the best-quality systematic review of the literature regarding proximal neck dilation after endovascular aneurysm repair (EVAR), which was conducted by investigators at Paracelsus Medical University in Nuremberg, Germany. The data, he said, speak to the importance of trying to minimize the chances of aortic neck dilation (AND).
The review, which included 26 published studies through 2015 and nearly 10,000 EVAR patients, concluded that AND occurred in 24.6% of these patients. The investigators defined AND as more than 3 mm of dilation, which with an average neck diameter of about 30 mm in all comers, would represent a 10% aortic neck-diameter expansion. The incidence of the composite adverse outcome of type I endoleak, stent migration, and reintervention during a maximum of 9 years of follow-up was 29-fold greater in the AND group than in AND-free patients (J Endovasc Ther. 2017;24[1]:59-67).
Continuing controversy exists regarding the extent to which post-EVAR AND is a manifestation of the underlying aneurysmal process as opposed to an adverse effect caused by the outward radial force applied by the stent. That being said, there are several factors related to AND that are potentially within the vascular interventionalist’s control. Topping the list is aggressive oversizing of self-expanding stent grafts in an effort to obtain an excellent seal, according to Dr. Lee, a professor of surgery at Stanford (Calif.) University.
“The data from multiple series definitely suggests that more than 20% oversizing is correlated with a higher incidence of AND. So maybe the answer is oversizing by more like 10%-15%,” the vascular surgeon said.
Another factor contributing to AND is the overwhelming popularity of self-expanding aortic stent grafts, now utilized in 95% of all EVARS done in the United States. Balloon-expandable stent grafts require much less oversizing – less than 5% – to maintain their diameter post deployment, but they are rarely used. Indeed, the only commercially available balloon-expandable device in the United States is the TriVascular Ovation stent system, which seals the stent graft to the wall of the aorta via polyethylene glycol rather than by radial force.
Intriguingly, Italian investigators have reported that, in a multicenter series of 161 patients who underwent EVAR with the Ovation endograft, no AND occurred at CT scanning done after a minimum of 24 months of follow-up (J Vasc Surg. 2016;63[1]:8-15).
Previous studies of the implications of AND after EVAR have been limited to comparisons of early-generation devices, so Dr. Lee and his coinvestigators conducted a retrospective review of a prospective Stanford database that included 86 patients who underwent elective, uncomplicated infrarenal endovascular abdominal aortic aneurysm repairs using a variety of contemporary stent grafts. Eighty-six percent of patients experienced AND during a median radiologic follow-up of 21.9 months, with a mean 1.3-mm increase at 30 days and 3.3 mm at most recent follow-up. The degree of AND correlated with the amount of oversizing. However, AND didn’t vary significantly by device type, which included the Cook Zenith, Gore Excluder, Medtronic Endurant, and Endologix Powerlink self-expanding stent grafts (Ann Vasc Surg. 2017;43:115-20).
Aortic anatomy also plays a role in AND. Shorter necks with severe angulation have been found to pose a higher risk. Open repair, which entails much less AND than does EVAR, may make more sense in that challenging anatomic situation, according to Dr. Lee.
He reported current research funding from Cook, Gore, and Medtronic.
CHICAGO – Clinically significant aortic neck dilation occurs in one-quarter of patients after endovascular abdominal aortic aneurysm repair and is associated with sharply increased risk for type Ia endoleak, stent migration at the proximal seal zone, continued aneurysmal sack enlargement, and even aneurysm rupture, Jason T. Lee, MD, said at a symposium on vascular surgery sponsored by Northwestern University.
He cited what he considers to be the best-quality systematic review of the literature regarding proximal neck dilation after endovascular aneurysm repair (EVAR), which was conducted by investigators at Paracelsus Medical University in Nuremberg, Germany. The data, he said, speak to the importance of trying to minimize the chances of aortic neck dilation (AND).
The review, which included 26 published studies through 2015 and nearly 10,000 EVAR patients, concluded that AND occurred in 24.6% of these patients. The investigators defined AND as more than 3 mm of dilation, which with an average neck diameter of about 30 mm in all comers, would represent a 10% aortic neck-diameter expansion. The incidence of the composite adverse outcome of type I endoleak, stent migration, and reintervention during a maximum of 9 years of follow-up was 29-fold greater in the AND group than in AND-free patients (J Endovasc Ther. 2017;24[1]:59-67).
Continuing controversy exists regarding the extent to which post-EVAR AND is a manifestation of the underlying aneurysmal process as opposed to an adverse effect caused by the outward radial force applied by the stent. That being said, there are several factors related to AND that are potentially within the vascular interventionalist’s control. Topping the list is aggressive oversizing of self-expanding stent grafts in an effort to obtain an excellent seal, according to Dr. Lee, a professor of surgery at Stanford (Calif.) University.
“The data from multiple series definitely suggests that more than 20% oversizing is correlated with a higher incidence of AND. So maybe the answer is oversizing by more like 10%-15%,” the vascular surgeon said.
Another factor contributing to AND is the overwhelming popularity of self-expanding aortic stent grafts, now utilized in 95% of all EVARS done in the United States. Balloon-expandable stent grafts require much less oversizing – less than 5% – to maintain their diameter post deployment, but they are rarely used. Indeed, the only commercially available balloon-expandable device in the United States is the TriVascular Ovation stent system, which seals the stent graft to the wall of the aorta via polyethylene glycol rather than by radial force.
Intriguingly, Italian investigators have reported that, in a multicenter series of 161 patients who underwent EVAR with the Ovation endograft, no AND occurred at CT scanning done after a minimum of 24 months of follow-up (J Vasc Surg. 2016;63[1]:8-15).
Previous studies of the implications of AND after EVAR have been limited to comparisons of early-generation devices, so Dr. Lee and his coinvestigators conducted a retrospective review of a prospective Stanford database that included 86 patients who underwent elective, uncomplicated infrarenal endovascular abdominal aortic aneurysm repairs using a variety of contemporary stent grafts. Eighty-six percent of patients experienced AND during a median radiologic follow-up of 21.9 months, with a mean 1.3-mm increase at 30 days and 3.3 mm at most recent follow-up. The degree of AND correlated with the amount of oversizing. However, AND didn’t vary significantly by device type, which included the Cook Zenith, Gore Excluder, Medtronic Endurant, and Endologix Powerlink self-expanding stent grafts (Ann Vasc Surg. 2017;43:115-20).
Aortic anatomy also plays a role in AND. Shorter necks with severe angulation have been found to pose a higher risk. Open repair, which entails much less AND than does EVAR, may make more sense in that challenging anatomic situation, according to Dr. Lee.
He reported current research funding from Cook, Gore, and Medtronic.
CHICAGO – Clinically significant aortic neck dilation occurs in one-quarter of patients after endovascular abdominal aortic aneurysm repair and is associated with sharply increased risk for type Ia endoleak, stent migration at the proximal seal zone, continued aneurysmal sack enlargement, and even aneurysm rupture, Jason T. Lee, MD, said at a symposium on vascular surgery sponsored by Northwestern University.
He cited what he considers to be the best-quality systematic review of the literature regarding proximal neck dilation after endovascular aneurysm repair (EVAR), which was conducted by investigators at Paracelsus Medical University in Nuremberg, Germany. The data, he said, speak to the importance of trying to minimize the chances of aortic neck dilation (AND).
The review, which included 26 published studies through 2015 and nearly 10,000 EVAR patients, concluded that AND occurred in 24.6% of these patients. The investigators defined AND as more than 3 mm of dilation, which with an average neck diameter of about 30 mm in all comers, would represent a 10% aortic neck-diameter expansion. The incidence of the composite adverse outcome of type I endoleak, stent migration, and reintervention during a maximum of 9 years of follow-up was 29-fold greater in the AND group than in AND-free patients (J Endovasc Ther. 2017;24[1]:59-67).
Continuing controversy exists regarding the extent to which post-EVAR AND is a manifestation of the underlying aneurysmal process as opposed to an adverse effect caused by the outward radial force applied by the stent. That being said, there are several factors related to AND that are potentially within the vascular interventionalist’s control. Topping the list is aggressive oversizing of self-expanding stent grafts in an effort to obtain an excellent seal, according to Dr. Lee, a professor of surgery at Stanford (Calif.) University.
“The data from multiple series definitely suggests that more than 20% oversizing is correlated with a higher incidence of AND. So maybe the answer is oversizing by more like 10%-15%,” the vascular surgeon said.
Another factor contributing to AND is the overwhelming popularity of self-expanding aortic stent grafts, now utilized in 95% of all EVARS done in the United States. Balloon-expandable stent grafts require much less oversizing – less than 5% – to maintain their diameter post deployment, but they are rarely used. Indeed, the only commercially available balloon-expandable device in the United States is the TriVascular Ovation stent system, which seals the stent graft to the wall of the aorta via polyethylene glycol rather than by radial force.
Intriguingly, Italian investigators have reported that, in a multicenter series of 161 patients who underwent EVAR with the Ovation endograft, no AND occurred at CT scanning done after a minimum of 24 months of follow-up (J Vasc Surg. 2016;63[1]:8-15).
Previous studies of the implications of AND after EVAR have been limited to comparisons of early-generation devices, so Dr. Lee and his coinvestigators conducted a retrospective review of a prospective Stanford database that included 86 patients who underwent elective, uncomplicated infrarenal endovascular abdominal aortic aneurysm repairs using a variety of contemporary stent grafts. Eighty-six percent of patients experienced AND during a median radiologic follow-up of 21.9 months, with a mean 1.3-mm increase at 30 days and 3.3 mm at most recent follow-up. The degree of AND correlated with the amount of oversizing. However, AND didn’t vary significantly by device type, which included the Cook Zenith, Gore Excluder, Medtronic Endurant, and Endologix Powerlink self-expanding stent grafts (Ann Vasc Surg. 2017;43:115-20).
Aortic anatomy also plays a role in AND. Shorter necks with severe angulation have been found to pose a higher risk. Open repair, which entails much less AND than does EVAR, may make more sense in that challenging anatomic situation, according to Dr. Lee.
He reported current research funding from Cook, Gore, and Medtronic.
EXPERT ANALYSIS FROM THE NORTHWESTERN VASCULAR SYMPOSIUM
ATTRACT trial shouldn’t detract from pharmacomechanical thrombolysis
CHICAGO – A closer look at the landmark ATTRACT trial of pharmacomechanical catheter-directed thrombolysis for acute deep vein thrombosis (DVT) shows multiple benefits for the intervention versus standard anticoagulation alone in the subset of participants with iliofemoral DVT, Kush R. Desai, MD, said at a symposium on vascular surgery sponsored by Northwestern University.
ATTRACT, a National Institutes of Health–sponsored, phase 3, multicenter, open-label, assessor-blinded study, was the first-ever randomized trial of pharmacomechanical catheter-directed thrombolysis (PCDT) for acute DVT.
The results caused a major stir because, despite a sound therapeutic rationale for the procedure, the incidence of chronic postthrombotic syndrome (PTS) at 24 months of follow-up was 47% in the PCDT plus anticoagulation group and 48% in controls on anticoagulation alone (N Engl J Med. 2017 Dec 7;377[23]:2240-52). Since then, that overall negative trial has been one of the hottest topics in DVT.
“This is the first thing your educated patients who come to the emergency department with DVT will ask about. It’s the first thing they’ll see when they go online and type in ‘thrombolysis DVT,’ ” noted Dr. Desai, an interventional radiologist at Northwestern University, Chicago.
But the trial has several major flaws, he cautioned. And contrary to popular opinion, ATTRACT is not the death knell for PCDT. Far from it.
“I don’t think the story stops with ATTRACT. This isn’t the end for PCDT in patients with iliofemoral DVT,” he asserted.
That’s in part because 301 of the 692 participants in ATTRACT had DVT of the femoropopliteal segment. That’s a population in which Dr. Desai and other interventionalists wouldn’t have anticipated seeing a benefit for PCDT, because their risk of PTS is so low.
“We know through historical data that patients with iliofemoral DVT are much more likely to develop PTS and to have recurrent DVT, so this is probably one of the major shortcomings of the trial,” he explained. “It’s through no fault of the trial investigators, because the study was planned years ago when we just didn’t know as much about PTS as we do now.
“The way I look at it is, I don’t practice in the way that ATTRACT was designed,” Dr. Desai said. “I don’t typically lyse or get referrals for lysis or thrombectomy in patients who have isolated femoropopliteal DVT. It has to involve at least the common femoral vein and frequently goes up to the iliac vein.”
The ATTRACT investigators’ recent subanalysis of the 391 participants with iliofemoral DVT showed that, although there was no difference between the two study arms in the occurrence of PTS through the first 24 months of follow-up, PCDT led to a 35% reduction in the incidence of moderate or severe PTS – by a margin of 18% versus 28% in controls.
Patients in the PCDT arm also experienced significantly greater improvement in venous disease-specific quality of life through 24 months, and a greater reduction in leg pain and swelling at 10 and 30 days (Circulation. 2018 Dec 4. doi: 10.1161/CIRCULATIONAHA.118.037425).
And moderate to severe PTS is a key outcome, Dr. Desai continued. Multiple studies have shown that patients with PTS have a worse quality of life than those with chronic lung disease, arthritis, or diabetes. Moreover, the 5%-10% of patients with symptomatic DVT who develop the most-severe form of PTS – characterized by severe pain, chronic ulcerations, stasis dermatitis, venous claudication, and intractable edema – have a quality of life comparable with patients with cancer or heart failure.
The 1.5% incidence of major bleeding within 10 days in the PCDT group was 200% higher than in controls, but none of it was life threatening.
“This is reassuring: Nobody had intracranial hemorrhage; nobody had a GUSTO 5 bleed,” Dr. Desai said.
Another limitation of the ATTRACT trial is that all but one of the devices utilized for PCDT were used off label. They weren’t designed for venous application. Several on-label rheolytic, rotational thrombectomy, or clot aspiration devices have been approved since enrollment in ATTRACT was closed. Future randomized trials will utilize on-label devices in patients with acute iliofemoral DVT to clarify the role of PCDT.
It’s noteworthy that nearly half of ATTRACT participants developed PTS within 24 months of their DVT despite being on optimal anticoagulation. It’s a finding that underscores the need for improved therapies. That was the impetus for development of first-generation catheter-directed thrombolysis utilizing a percutaneously inserted catheter to infuse a fibrinolytic drug directly to the thrombus to dissolve it rapidly.
But that form of catheter-directed thrombolysis has major disadvantages, Dr. Desai explained: It’s a multiday procedure requiring ICU-level care and prolonged exposure to powerful lytic agents.
“This is where things have changed with PCDT,” he said. “We can now, with on-label devices, accelerate the thrombolysis time, reduce lytic exposure, and I think also reduce the bleeding risk, although that hasn’t been shown in a trial yet. PCDT also reduces the necessity for ICU-level care and prolonged hospitalization.”
Dr. Desai no longer performs multiday lytic procedures. “In fact, with the introduction of the newer on-label devices, I haven’t done a multiday unilateral limb lytic procedure in a couple years. I think we’ve gotten to the point where we don’t need to do that anymore.”
Indeed, PCDT makes recanalization possible as a single-day, single-session procedure.
Dr. Desai views the recent ATTRACT subanalysis as hypothesis generating.
“Should PCDT be the first-line treatment in all proximal DVT patients? No it should not – and that’s not what I would have advocated even before ATTRACT came out,” he explained. “It’s sort of a salvage procedure for patients with iliofemoral DVT and moderate to severe symptoms. And there are a significant number of such patients.”
Current understanding of the pathophysiology of PTS is that a nondissolved thrombus at the valve leaflets becomes inflammatory, with resultant valvular dysfunction leading to venous reflux and venous hypertension. PCDT is consistent with the open-vein hypothesis, which posits that, by eliminating thrombus much faster than achievable via anticoagulation, valve integrity is maintained and PTS is prevented.
Dr. Desai reported receiving consulting fees from AngioDynamics, Boston Scientific, Cook Medical, and Spectranetics.
CHICAGO – A closer look at the landmark ATTRACT trial of pharmacomechanical catheter-directed thrombolysis for acute deep vein thrombosis (DVT) shows multiple benefits for the intervention versus standard anticoagulation alone in the subset of participants with iliofemoral DVT, Kush R. Desai, MD, said at a symposium on vascular surgery sponsored by Northwestern University.
ATTRACT, a National Institutes of Health–sponsored, phase 3, multicenter, open-label, assessor-blinded study, was the first-ever randomized trial of pharmacomechanical catheter-directed thrombolysis (PCDT) for acute DVT.
The results caused a major stir because, despite a sound therapeutic rationale for the procedure, the incidence of chronic postthrombotic syndrome (PTS) at 24 months of follow-up was 47% in the PCDT plus anticoagulation group and 48% in controls on anticoagulation alone (N Engl J Med. 2017 Dec 7;377[23]:2240-52). Since then, that overall negative trial has been one of the hottest topics in DVT.
“This is the first thing your educated patients who come to the emergency department with DVT will ask about. It’s the first thing they’ll see when they go online and type in ‘thrombolysis DVT,’ ” noted Dr. Desai, an interventional radiologist at Northwestern University, Chicago.
But the trial has several major flaws, he cautioned. And contrary to popular opinion, ATTRACT is not the death knell for PCDT. Far from it.
“I don’t think the story stops with ATTRACT. This isn’t the end for PCDT in patients with iliofemoral DVT,” he asserted.
That’s in part because 301 of the 692 participants in ATTRACT had DVT of the femoropopliteal segment. That’s a population in which Dr. Desai and other interventionalists wouldn’t have anticipated seeing a benefit for PCDT, because their risk of PTS is so low.
“We know through historical data that patients with iliofemoral DVT are much more likely to develop PTS and to have recurrent DVT, so this is probably one of the major shortcomings of the trial,” he explained. “It’s through no fault of the trial investigators, because the study was planned years ago when we just didn’t know as much about PTS as we do now.
“The way I look at it is, I don’t practice in the way that ATTRACT was designed,” Dr. Desai said. “I don’t typically lyse or get referrals for lysis or thrombectomy in patients who have isolated femoropopliteal DVT. It has to involve at least the common femoral vein and frequently goes up to the iliac vein.”
The ATTRACT investigators’ recent subanalysis of the 391 participants with iliofemoral DVT showed that, although there was no difference between the two study arms in the occurrence of PTS through the first 24 months of follow-up, PCDT led to a 35% reduction in the incidence of moderate or severe PTS – by a margin of 18% versus 28% in controls.
Patients in the PCDT arm also experienced significantly greater improvement in venous disease-specific quality of life through 24 months, and a greater reduction in leg pain and swelling at 10 and 30 days (Circulation. 2018 Dec 4. doi: 10.1161/CIRCULATIONAHA.118.037425).
And moderate to severe PTS is a key outcome, Dr. Desai continued. Multiple studies have shown that patients with PTS have a worse quality of life than those with chronic lung disease, arthritis, or diabetes. Moreover, the 5%-10% of patients with symptomatic DVT who develop the most-severe form of PTS – characterized by severe pain, chronic ulcerations, stasis dermatitis, venous claudication, and intractable edema – have a quality of life comparable with patients with cancer or heart failure.
The 1.5% incidence of major bleeding within 10 days in the PCDT group was 200% higher than in controls, but none of it was life threatening.
“This is reassuring: Nobody had intracranial hemorrhage; nobody had a GUSTO 5 bleed,” Dr. Desai said.
Another limitation of the ATTRACT trial is that all but one of the devices utilized for PCDT were used off label. They weren’t designed for venous application. Several on-label rheolytic, rotational thrombectomy, or clot aspiration devices have been approved since enrollment in ATTRACT was closed. Future randomized trials will utilize on-label devices in patients with acute iliofemoral DVT to clarify the role of PCDT.
It’s noteworthy that nearly half of ATTRACT participants developed PTS within 24 months of their DVT despite being on optimal anticoagulation. It’s a finding that underscores the need for improved therapies. That was the impetus for development of first-generation catheter-directed thrombolysis utilizing a percutaneously inserted catheter to infuse a fibrinolytic drug directly to the thrombus to dissolve it rapidly.
But that form of catheter-directed thrombolysis has major disadvantages, Dr. Desai explained: It’s a multiday procedure requiring ICU-level care and prolonged exposure to powerful lytic agents.
“This is where things have changed with PCDT,” he said. “We can now, with on-label devices, accelerate the thrombolysis time, reduce lytic exposure, and I think also reduce the bleeding risk, although that hasn’t been shown in a trial yet. PCDT also reduces the necessity for ICU-level care and prolonged hospitalization.”
Dr. Desai no longer performs multiday lytic procedures. “In fact, with the introduction of the newer on-label devices, I haven’t done a multiday unilateral limb lytic procedure in a couple years. I think we’ve gotten to the point where we don’t need to do that anymore.”
Indeed, PCDT makes recanalization possible as a single-day, single-session procedure.
Dr. Desai views the recent ATTRACT subanalysis as hypothesis generating.
“Should PCDT be the first-line treatment in all proximal DVT patients? No it should not – and that’s not what I would have advocated even before ATTRACT came out,” he explained. “It’s sort of a salvage procedure for patients with iliofemoral DVT and moderate to severe symptoms. And there are a significant number of such patients.”
Current understanding of the pathophysiology of PTS is that a nondissolved thrombus at the valve leaflets becomes inflammatory, with resultant valvular dysfunction leading to venous reflux and venous hypertension. PCDT is consistent with the open-vein hypothesis, which posits that, by eliminating thrombus much faster than achievable via anticoagulation, valve integrity is maintained and PTS is prevented.
Dr. Desai reported receiving consulting fees from AngioDynamics, Boston Scientific, Cook Medical, and Spectranetics.
CHICAGO – A closer look at the landmark ATTRACT trial of pharmacomechanical catheter-directed thrombolysis for acute deep vein thrombosis (DVT) shows multiple benefits for the intervention versus standard anticoagulation alone in the subset of participants with iliofemoral DVT, Kush R. Desai, MD, said at a symposium on vascular surgery sponsored by Northwestern University.
ATTRACT, a National Institutes of Health–sponsored, phase 3, multicenter, open-label, assessor-blinded study, was the first-ever randomized trial of pharmacomechanical catheter-directed thrombolysis (PCDT) for acute DVT.
The results caused a major stir because, despite a sound therapeutic rationale for the procedure, the incidence of chronic postthrombotic syndrome (PTS) at 24 months of follow-up was 47% in the PCDT plus anticoagulation group and 48% in controls on anticoagulation alone (N Engl J Med. 2017 Dec 7;377[23]:2240-52). Since then, that overall negative trial has been one of the hottest topics in DVT.
“This is the first thing your educated patients who come to the emergency department with DVT will ask about. It’s the first thing they’ll see when they go online and type in ‘thrombolysis DVT,’ ” noted Dr. Desai, an interventional radiologist at Northwestern University, Chicago.
But the trial has several major flaws, he cautioned. And contrary to popular opinion, ATTRACT is not the death knell for PCDT. Far from it.
“I don’t think the story stops with ATTRACT. This isn’t the end for PCDT in patients with iliofemoral DVT,” he asserted.
That’s in part because 301 of the 692 participants in ATTRACT had DVT of the femoropopliteal segment. That’s a population in which Dr. Desai and other interventionalists wouldn’t have anticipated seeing a benefit for PCDT, because their risk of PTS is so low.
“We know through historical data that patients with iliofemoral DVT are much more likely to develop PTS and to have recurrent DVT, so this is probably one of the major shortcomings of the trial,” he explained. “It’s through no fault of the trial investigators, because the study was planned years ago when we just didn’t know as much about PTS as we do now.
“The way I look at it is, I don’t practice in the way that ATTRACT was designed,” Dr. Desai said. “I don’t typically lyse or get referrals for lysis or thrombectomy in patients who have isolated femoropopliteal DVT. It has to involve at least the common femoral vein and frequently goes up to the iliac vein.”
The ATTRACT investigators’ recent subanalysis of the 391 participants with iliofemoral DVT showed that, although there was no difference between the two study arms in the occurrence of PTS through the first 24 months of follow-up, PCDT led to a 35% reduction in the incidence of moderate or severe PTS – by a margin of 18% versus 28% in controls.
Patients in the PCDT arm also experienced significantly greater improvement in venous disease-specific quality of life through 24 months, and a greater reduction in leg pain and swelling at 10 and 30 days (Circulation. 2018 Dec 4. doi: 10.1161/CIRCULATIONAHA.118.037425).
And moderate to severe PTS is a key outcome, Dr. Desai continued. Multiple studies have shown that patients with PTS have a worse quality of life than those with chronic lung disease, arthritis, or diabetes. Moreover, the 5%-10% of patients with symptomatic DVT who develop the most-severe form of PTS – characterized by severe pain, chronic ulcerations, stasis dermatitis, venous claudication, and intractable edema – have a quality of life comparable with patients with cancer or heart failure.
The 1.5% incidence of major bleeding within 10 days in the PCDT group was 200% higher than in controls, but none of it was life threatening.
“This is reassuring: Nobody had intracranial hemorrhage; nobody had a GUSTO 5 bleed,” Dr. Desai said.
Another limitation of the ATTRACT trial is that all but one of the devices utilized for PCDT were used off label. They weren’t designed for venous application. Several on-label rheolytic, rotational thrombectomy, or clot aspiration devices have been approved since enrollment in ATTRACT was closed. Future randomized trials will utilize on-label devices in patients with acute iliofemoral DVT to clarify the role of PCDT.
It’s noteworthy that nearly half of ATTRACT participants developed PTS within 24 months of their DVT despite being on optimal anticoagulation. It’s a finding that underscores the need for improved therapies. That was the impetus for development of first-generation catheter-directed thrombolysis utilizing a percutaneously inserted catheter to infuse a fibrinolytic drug directly to the thrombus to dissolve it rapidly.
But that form of catheter-directed thrombolysis has major disadvantages, Dr. Desai explained: It’s a multiday procedure requiring ICU-level care and prolonged exposure to powerful lytic agents.
“This is where things have changed with PCDT,” he said. “We can now, with on-label devices, accelerate the thrombolysis time, reduce lytic exposure, and I think also reduce the bleeding risk, although that hasn’t been shown in a trial yet. PCDT also reduces the necessity for ICU-level care and prolonged hospitalization.”
Dr. Desai no longer performs multiday lytic procedures. “In fact, with the introduction of the newer on-label devices, I haven’t done a multiday unilateral limb lytic procedure in a couple years. I think we’ve gotten to the point where we don’t need to do that anymore.”
Indeed, PCDT makes recanalization possible as a single-day, single-session procedure.
Dr. Desai views the recent ATTRACT subanalysis as hypothesis generating.
“Should PCDT be the first-line treatment in all proximal DVT patients? No it should not – and that’s not what I would have advocated even before ATTRACT came out,” he explained. “It’s sort of a salvage procedure for patients with iliofemoral DVT and moderate to severe symptoms. And there are a significant number of such patients.”
Current understanding of the pathophysiology of PTS is that a nondissolved thrombus at the valve leaflets becomes inflammatory, with resultant valvular dysfunction leading to venous reflux and venous hypertension. PCDT is consistent with the open-vein hypothesis, which posits that, by eliminating thrombus much faster than achievable via anticoagulation, valve integrity is maintained and PTS is prevented.
Dr. Desai reported receiving consulting fees from AngioDynamics, Boston Scientific, Cook Medical, and Spectranetics.
EXPERT ANALYSIS FROM THE NORTHWESTERN VASCULAR SYMPOSIUM
Biodegradable polymer shows no long-term benefit in heart stents
CHICAGO – The idea behind putting a biodegradable polymer on a drug-eluting coronary stent is that, once the antirestenosis drug elutes and the polymer that held it degrades, the bare-metal stent left behind would trigger fewer long-term episodes of in-stent thrombosis than would stents that retain their polymer coating. But 10-year follow-up from a large trial that matched two second-generation drug-eluting stents, one with a biodegradable polymer and the other with a durable polymer, showed no statistically significant difference between the two for any clinical outcome, including the incidence of in-stent thrombosis, Sebastian Kufner, MD, said at the American Heart Association scientific sessions.
The potential advantage of a biodegradable polymer “is expected to occur over time,” and hence following patients for 10 or more years should start to show a clear advantage, at least for the endpoint of stent thrombosis, but that didn’t happen. After a median follow-up of 10.6 years, the cumulative rate of definite or probable stent thrombosis was 1.8% among 1,299 patients who received a sirolimus-eluting stent with a biodegradable polymer (Yukon Choice) and 2.5% among 652 patients who received a second-generation everolimus-eluting stent with a durable polymer (Xience), a difference that was not statistically significant, reported Dr. Kufner, a cardiologist at the The German Heart Centre in Munich.
These two stents also produced comparable 10-year outcomes that showed no statistically significant differences for the outcomes of all-cause death, MI, need for target-lesion revascularization, or the combined incidence of all three of these outcomes. In contrast, both of these second-generation stents showed statistically significant improvements in the combined cardiac endpoint, as well as in all-cause death, and definite stent thrombosis compared with the 652 patients who received the first-generation sirolimus-eluting stent Cypher. Concurrently with Dr. Kufner’s report, the results appeared in an article online (Circulation. 2018 Nov 11. doi: 10.1161/CIRCULATIONAHA.118.038065).
Another notable finding from the 10-year follow-up was the poor prognosis these patients faced after their interventions, including the patients who received second-generation drug-eluting stents. The 10-year rate of all cause death was 30% among patients who received Xience stents, 32% among those treated with Yukon Choice stents, and 37% among patients treated with Cypher stents.
“I’m daunted by this 10-year mortality rate even with the best current drug-eluting stents,” said Roxana Mehran, MD, professor of medicine at Icahn School of Medicine at Mount Sinai in New York and a cochair of the session. “I’m depressed about this as an interventionalist. We need to do better, although it might not just be about the revascularization.” The high mortality in these patients after 10 years may also reflect a lack of optimal medical treatment in some, she suggested.
The ISAR-TEST-4 (Intracoronary Stenting and Angiographic Results: Test Efficacy of 3 Limus-Eluting Stents) trial randomized 2,603 patients during the period of September 2007–August 2008 at either of two centers in Munich. The study’s primary endpoint was the combined rate of cardiac death, MI, and target-lesion revascularization by 12 months after treatment. The 12-month results showed a similar 14% rate of this combined endpoint in the subgroup of patients treated with the biodegradable-polymer stent and in those treated with stents that used durable polymers, which proved the noninferiority of the stent with a biodegradable polymer (Eur Heart J. 2009 Oct 1;30[20]:2441-9). This initial analysis combined the patients who received Cypher and Xience stents into one comparator group: patients who received stents with durable polymers.
The new, long-term follow-up analysis included 2,153 patients (83%) followed for at least 10 years after their intervention.
ISAR-TEST-4 received no commercial funding. Dr. Kufner had no disclosures. Dr. Mehran has an ownership interest in Claret Medical and Elixir Medical, has been a consultant or adviser to Abbott Laboratories, Boston Scientific, Bristol-Myers Squibb, Janssen, Roivant Sciences, and Siemens Medical Solutions, and has received research funding from several companies.
SOURCE: Kufner S et al. AHA scientific sessions, Abstract 18630.
The absence of incremental benefit from a stent with a biodegradable polymer compared with the second generation everolimus-eluting stent with a durable polymer in this 10-year follow-up is consistent with prior reports from medium-term follow-up. At best, drug-eluting coronary stents with a biodegradable polymer are noninferior to the current generation of those with a durable polymer. Late clinical benefit from a biodegradable polymer over a second-generation drug-eluting stent with a durable polymer remains elusive. The findings begs the public health question of whether paying a higher price for a biodegradable coronary stent with a durable-polymer is a good investment.
These 10-year results also highlight that, despite using drug-eluting stent technology that remains more or less standard of care today, the treated patients showed a staggering rate of major adverse cardiac events that exceeded 3% each year. This finding suggests an urgent need to address this residual risk through further improvements in medical therapy and stent technology.
Right now, accumulated evidence supports the notion that thinner struts are less thrombogenic than thicker struts, and that not all durable polymers are equal, with some associated with less inflammation and thrombogenicity. The next frontier for stent design seems to be ultrathin struts that are less than 70 mcm in diameter. We need to now see results from a study that compares an ultrathin-strut stent with a durable polymer against one with a biodegradable polymer.
Sripal Bangalore, MD , is an interventional cardiologist and professor of medicine at New York University. He has been a consultant or adviser to Abbott Vascular, Amgen, Biotronik, and Pfizer, and he has received research funding from Abbott Vascular. He made these comments as designated discussant for ISAR-TEST-4, and in an editorial published online concurrently with his talk (Circulation. 2018 Nov 11. doi: 10.1161/CIRCULATIONAHA.118.038378 ).
The absence of incremental benefit from a stent with a biodegradable polymer compared with the second generation everolimus-eluting stent with a durable polymer in this 10-year follow-up is consistent with prior reports from medium-term follow-up. At best, drug-eluting coronary stents with a biodegradable polymer are noninferior to the current generation of those with a durable polymer. Late clinical benefit from a biodegradable polymer over a second-generation drug-eluting stent with a durable polymer remains elusive. The findings begs the public health question of whether paying a higher price for a biodegradable coronary stent with a durable-polymer is a good investment.
These 10-year results also highlight that, despite using drug-eluting stent technology that remains more or less standard of care today, the treated patients showed a staggering rate of major adverse cardiac events that exceeded 3% each year. This finding suggests an urgent need to address this residual risk through further improvements in medical therapy and stent technology.
Right now, accumulated evidence supports the notion that thinner struts are less thrombogenic than thicker struts, and that not all durable polymers are equal, with some associated with less inflammation and thrombogenicity. The next frontier for stent design seems to be ultrathin struts that are less than 70 mcm in diameter. We need to now see results from a study that compares an ultrathin-strut stent with a durable polymer against one with a biodegradable polymer.
Sripal Bangalore, MD , is an interventional cardiologist and professor of medicine at New York University. He has been a consultant or adviser to Abbott Vascular, Amgen, Biotronik, and Pfizer, and he has received research funding from Abbott Vascular. He made these comments as designated discussant for ISAR-TEST-4, and in an editorial published online concurrently with his talk (Circulation. 2018 Nov 11. doi: 10.1161/CIRCULATIONAHA.118.038378 ).
The absence of incremental benefit from a stent with a biodegradable polymer compared with the second generation everolimus-eluting stent with a durable polymer in this 10-year follow-up is consistent with prior reports from medium-term follow-up. At best, drug-eluting coronary stents with a biodegradable polymer are noninferior to the current generation of those with a durable polymer. Late clinical benefit from a biodegradable polymer over a second-generation drug-eluting stent with a durable polymer remains elusive. The findings begs the public health question of whether paying a higher price for a biodegradable coronary stent with a durable-polymer is a good investment.
These 10-year results also highlight that, despite using drug-eluting stent technology that remains more or less standard of care today, the treated patients showed a staggering rate of major adverse cardiac events that exceeded 3% each year. This finding suggests an urgent need to address this residual risk through further improvements in medical therapy and stent technology.
Right now, accumulated evidence supports the notion that thinner struts are less thrombogenic than thicker struts, and that not all durable polymers are equal, with some associated with less inflammation and thrombogenicity. The next frontier for stent design seems to be ultrathin struts that are less than 70 mcm in diameter. We need to now see results from a study that compares an ultrathin-strut stent with a durable polymer against one with a biodegradable polymer.
Sripal Bangalore, MD , is an interventional cardiologist and professor of medicine at New York University. He has been a consultant or adviser to Abbott Vascular, Amgen, Biotronik, and Pfizer, and he has received research funding from Abbott Vascular. He made these comments as designated discussant for ISAR-TEST-4, and in an editorial published online concurrently with his talk (Circulation. 2018 Nov 11. doi: 10.1161/CIRCULATIONAHA.118.038378 ).
CHICAGO – The idea behind putting a biodegradable polymer on a drug-eluting coronary stent is that, once the antirestenosis drug elutes and the polymer that held it degrades, the bare-metal stent left behind would trigger fewer long-term episodes of in-stent thrombosis than would stents that retain their polymer coating. But 10-year follow-up from a large trial that matched two second-generation drug-eluting stents, one with a biodegradable polymer and the other with a durable polymer, showed no statistically significant difference between the two for any clinical outcome, including the incidence of in-stent thrombosis, Sebastian Kufner, MD, said at the American Heart Association scientific sessions.
The potential advantage of a biodegradable polymer “is expected to occur over time,” and hence following patients for 10 or more years should start to show a clear advantage, at least for the endpoint of stent thrombosis, but that didn’t happen. After a median follow-up of 10.6 years, the cumulative rate of definite or probable stent thrombosis was 1.8% among 1,299 patients who received a sirolimus-eluting stent with a biodegradable polymer (Yukon Choice) and 2.5% among 652 patients who received a second-generation everolimus-eluting stent with a durable polymer (Xience), a difference that was not statistically significant, reported Dr. Kufner, a cardiologist at the The German Heart Centre in Munich.
These two stents also produced comparable 10-year outcomes that showed no statistically significant differences for the outcomes of all-cause death, MI, need for target-lesion revascularization, or the combined incidence of all three of these outcomes. In contrast, both of these second-generation stents showed statistically significant improvements in the combined cardiac endpoint, as well as in all-cause death, and definite stent thrombosis compared with the 652 patients who received the first-generation sirolimus-eluting stent Cypher. Concurrently with Dr. Kufner’s report, the results appeared in an article online (Circulation. 2018 Nov 11. doi: 10.1161/CIRCULATIONAHA.118.038065).
Another notable finding from the 10-year follow-up was the poor prognosis these patients faced after their interventions, including the patients who received second-generation drug-eluting stents. The 10-year rate of all cause death was 30% among patients who received Xience stents, 32% among those treated with Yukon Choice stents, and 37% among patients treated with Cypher stents.
“I’m daunted by this 10-year mortality rate even with the best current drug-eluting stents,” said Roxana Mehran, MD, professor of medicine at Icahn School of Medicine at Mount Sinai in New York and a cochair of the session. “I’m depressed about this as an interventionalist. We need to do better, although it might not just be about the revascularization.” The high mortality in these patients after 10 years may also reflect a lack of optimal medical treatment in some, she suggested.
The ISAR-TEST-4 (Intracoronary Stenting and Angiographic Results: Test Efficacy of 3 Limus-Eluting Stents) trial randomized 2,603 patients during the period of September 2007–August 2008 at either of two centers in Munich. The study’s primary endpoint was the combined rate of cardiac death, MI, and target-lesion revascularization by 12 months after treatment. The 12-month results showed a similar 14% rate of this combined endpoint in the subgroup of patients treated with the biodegradable-polymer stent and in those treated with stents that used durable polymers, which proved the noninferiority of the stent with a biodegradable polymer (Eur Heart J. 2009 Oct 1;30[20]:2441-9). This initial analysis combined the patients who received Cypher and Xience stents into one comparator group: patients who received stents with durable polymers.
The new, long-term follow-up analysis included 2,153 patients (83%) followed for at least 10 years after their intervention.
ISAR-TEST-4 received no commercial funding. Dr. Kufner had no disclosures. Dr. Mehran has an ownership interest in Claret Medical and Elixir Medical, has been a consultant or adviser to Abbott Laboratories, Boston Scientific, Bristol-Myers Squibb, Janssen, Roivant Sciences, and Siemens Medical Solutions, and has received research funding from several companies.
SOURCE: Kufner S et al. AHA scientific sessions, Abstract 18630.
CHICAGO – The idea behind putting a biodegradable polymer on a drug-eluting coronary stent is that, once the antirestenosis drug elutes and the polymer that held it degrades, the bare-metal stent left behind would trigger fewer long-term episodes of in-stent thrombosis than would stents that retain their polymer coating. But 10-year follow-up from a large trial that matched two second-generation drug-eluting stents, one with a biodegradable polymer and the other with a durable polymer, showed no statistically significant difference between the two for any clinical outcome, including the incidence of in-stent thrombosis, Sebastian Kufner, MD, said at the American Heart Association scientific sessions.
The potential advantage of a biodegradable polymer “is expected to occur over time,” and hence following patients for 10 or more years should start to show a clear advantage, at least for the endpoint of stent thrombosis, but that didn’t happen. After a median follow-up of 10.6 years, the cumulative rate of definite or probable stent thrombosis was 1.8% among 1,299 patients who received a sirolimus-eluting stent with a biodegradable polymer (Yukon Choice) and 2.5% among 652 patients who received a second-generation everolimus-eluting stent with a durable polymer (Xience), a difference that was not statistically significant, reported Dr. Kufner, a cardiologist at the The German Heart Centre in Munich.
These two stents also produced comparable 10-year outcomes that showed no statistically significant differences for the outcomes of all-cause death, MI, need for target-lesion revascularization, or the combined incidence of all three of these outcomes. In contrast, both of these second-generation stents showed statistically significant improvements in the combined cardiac endpoint, as well as in all-cause death, and definite stent thrombosis compared with the 652 patients who received the first-generation sirolimus-eluting stent Cypher. Concurrently with Dr. Kufner’s report, the results appeared in an article online (Circulation. 2018 Nov 11. doi: 10.1161/CIRCULATIONAHA.118.038065).
Another notable finding from the 10-year follow-up was the poor prognosis these patients faced after their interventions, including the patients who received second-generation drug-eluting stents. The 10-year rate of all cause death was 30% among patients who received Xience stents, 32% among those treated with Yukon Choice stents, and 37% among patients treated with Cypher stents.
“I’m daunted by this 10-year mortality rate even with the best current drug-eluting stents,” said Roxana Mehran, MD, professor of medicine at Icahn School of Medicine at Mount Sinai in New York and a cochair of the session. “I’m depressed about this as an interventionalist. We need to do better, although it might not just be about the revascularization.” The high mortality in these patients after 10 years may also reflect a lack of optimal medical treatment in some, she suggested.
The ISAR-TEST-4 (Intracoronary Stenting and Angiographic Results: Test Efficacy of 3 Limus-Eluting Stents) trial randomized 2,603 patients during the period of September 2007–August 2008 at either of two centers in Munich. The study’s primary endpoint was the combined rate of cardiac death, MI, and target-lesion revascularization by 12 months after treatment. The 12-month results showed a similar 14% rate of this combined endpoint in the subgroup of patients treated with the biodegradable-polymer stent and in those treated with stents that used durable polymers, which proved the noninferiority of the stent with a biodegradable polymer (Eur Heart J. 2009 Oct 1;30[20]:2441-9). This initial analysis combined the patients who received Cypher and Xience stents into one comparator group: patients who received stents with durable polymers.
The new, long-term follow-up analysis included 2,153 patients (83%) followed for at least 10 years after their intervention.
ISAR-TEST-4 received no commercial funding. Dr. Kufner had no disclosures. Dr. Mehran has an ownership interest in Claret Medical and Elixir Medical, has been a consultant or adviser to Abbott Laboratories, Boston Scientific, Bristol-Myers Squibb, Janssen, Roivant Sciences, and Siemens Medical Solutions, and has received research funding from several companies.
SOURCE: Kufner S et al. AHA scientific sessions, Abstract 18630.
REPORTING FROM THE AHA SCIENTIFIC SESSIONS
Key clinical point:
Major finding: The rate of adverse cardiac events was 48% with a biodegradable-polymer stent and 46% with a durable polymer.
Study details: Long-term follow-up of 2,153 patients in the ISAR-TEST-4 trial.
Disclosures: ISAR-TEST-4 received no commercial funding. Dr. Kufner had no disclosures. Dr. Mehran has an ownership interest in Claret Medical and Elixir Medical, has been a consultant or adviser to Abbott Laboratories, Boston Scientific, Bristol-Myers Squibb, Janssen, Roivant Sciences, and Siemens Medical Solutions, and has received research funding from several companies.
Source: Kufner S et al. AHA 2018, Abstract 18630.
Ticagrelor holds no edge over aspirin in CABG patients
CHICAGO – Ticagrelor performed about as well as aspirin did as monotherapy for preventing coronary bypass graft failure during the year following surgery in a randomized, multicenter trial with almost 1,900 patients.
Ticagrelor monotherapy also produced about the same number of major bleeding events as did aspirin monotherapy, Heribert Schunkert, MD, said at the American Heart Association scientific sessions. There were two limitations of the trial: The incidence of cardiovascular disease events that served as the efficacy endpoint for the study was less than what Dr. Schunkert and his associates expected, and they enrolled about half the projected number of patients because the study lost industry support and then, a couple of years later, showed a relentlessly neutral result leading to early termination of recruitment, said Dr. Schunkert, professor of cardiology and medical director of the German Heart Center in Munich.
The TiCAB (Study Comparing Ticagrelor With Aspirin for Prevention of Vascular Events in Patients Undergoing CABG) trial randomized 1,893 patients during 2013-2017 who underwent CABG at any of 26 centers in Austria, Germany, or Switzerland. Eligible patients underwent surgery for three-vessel disease, left main disease, or had two-vessel disease plus a left ventricular ejection fraction of less than 50%. About 31% of patients had unstable angina or non-ST elevation MI, with the remaining 69% having stable angina. The study included 931 patients who received 90 mg oral ticagrelor (Brilinta) b.i.d. plus aspirin placebo, and 928 who received 100 mg aspirin once daily plus ticagrelor placebo. The study medications began prior to surgery.
The study’s primary efficacy endpoint was the combined rate of cardiovascular death, MI, stroke, or need for revascularization by 1 year after surgery. This occurred in 9.7% of the ticagrelor patients and in 8.2% of those who received aspirin, a difference that was not statistically significant. Several secondary efficacy endpoints examined also showed a neutral result. The primary safety measure was the incidence of major bleeds by the Bleeding Academic Research Consortium criteria, which occurred in 3.7% of the ticagrelor patients and 3.2% of those on aspirin, not a statistically significant difference. After the year of follow-up about 85% of patients in both treatment arms remained on their assigned regimen, Dr. Schunkert said.
TiCAB received funding from AstraZeneca, which markets ticagrelor (Brilinta). Dr. Schunkert has received honoraria and research support from, and has been a speaker on behalf of, AstraZeneca. He has also received honoraria from Amgen, Bayer Vital, Boehringer Ingelheim, Daiichi Sankyo, Merck Sharp & Dohme, Novartis, Pfizer, Sanofi, and Servier.
SOURCE: Schunkert H et al. AHA 2018, Abstract 19561.
Because the TiCAB study was about half the size of the planned study, its power was low and yielded a result with wide confidence intervals. Despite that, I do not believe that a further, larger study is warranted. The TiCAB results are sufficient to show that monotherapy with ticagrelor is not superior to monotherapy with aspirin in patients undergoing coronary artery bypass grafting and during the year following surgery. The TiCAB results add to a larger body of evidence indicating ticagrelor’s noninferiority to and lack of superiority to aspirin as monotherapy for patients with coronary artery disease or a history of ischemic stroke or transient ischemic attack.
How can these two drugs produce similar efficacy outcomes? Aspirin is an effective antiplatelet drug, and evidence also suggests that treatment with opiates such as morphine (Circ Cardiovasc Interv. 2016 Sept;9[9]:e004229) and fentanyl (Circulation. 2018 Jan 16;137[3]:307-9) during and after surgery can interfere with the intestinal absorption of ticagrelor and other oral P2Y12 receptor antagonists, such as clopidogrel and prasugrel.
Another interesting finding in TiCAB was that aspirin and ticagrelor monotherapy produced similar rates of major bleeds. Results from prior studies had raised concerns about ticagrelor’s safety in patients undergoing coronary artery bypass surgery, but the new results show that this may be a problem when patients receive dual antiplatelet therapy but not when they receive ticagrelor monotherapy. Current evidence favors dual antiplatelet therapy to achieve a greater decrease in cardiovascular disease events, but this occurs at the expense of increased bleeding. Larger trials of dual therapy after coronary artery bypass grafting are warranted; further study of monotherapy is not.
Robert F. Storey, MD , is a professor of cardiology at the University of Sheffield (England). He has been a consultant to, and received honoraria and research support from, AstraZeneca, and he has been a consultant to Actelion, Avacta, Bayer, Bristol-Myers Squibb/Pfizer, Haemonetics, Novartis, PlaqueTec, and Thromboserin. He made these comments as designated discussant for the TiCAB report.
Because the TiCAB study was about half the size of the planned study, its power was low and yielded a result with wide confidence intervals. Despite that, I do not believe that a further, larger study is warranted. The TiCAB results are sufficient to show that monotherapy with ticagrelor is not superior to monotherapy with aspirin in patients undergoing coronary artery bypass grafting and during the year following surgery. The TiCAB results add to a larger body of evidence indicating ticagrelor’s noninferiority to and lack of superiority to aspirin as monotherapy for patients with coronary artery disease or a history of ischemic stroke or transient ischemic attack.
How can these two drugs produce similar efficacy outcomes? Aspirin is an effective antiplatelet drug, and evidence also suggests that treatment with opiates such as morphine (Circ Cardiovasc Interv. 2016 Sept;9[9]:e004229) and fentanyl (Circulation. 2018 Jan 16;137[3]:307-9) during and after surgery can interfere with the intestinal absorption of ticagrelor and other oral P2Y12 receptor antagonists, such as clopidogrel and prasugrel.
Another interesting finding in TiCAB was that aspirin and ticagrelor monotherapy produced similar rates of major bleeds. Results from prior studies had raised concerns about ticagrelor’s safety in patients undergoing coronary artery bypass surgery, but the new results show that this may be a problem when patients receive dual antiplatelet therapy but not when they receive ticagrelor monotherapy. Current evidence favors dual antiplatelet therapy to achieve a greater decrease in cardiovascular disease events, but this occurs at the expense of increased bleeding. Larger trials of dual therapy after coronary artery bypass grafting are warranted; further study of monotherapy is not.
Robert F. Storey, MD , is a professor of cardiology at the University of Sheffield (England). He has been a consultant to, and received honoraria and research support from, AstraZeneca, and he has been a consultant to Actelion, Avacta, Bayer, Bristol-Myers Squibb/Pfizer, Haemonetics, Novartis, PlaqueTec, and Thromboserin. He made these comments as designated discussant for the TiCAB report.
Because the TiCAB study was about half the size of the planned study, its power was low and yielded a result with wide confidence intervals. Despite that, I do not believe that a further, larger study is warranted. The TiCAB results are sufficient to show that monotherapy with ticagrelor is not superior to monotherapy with aspirin in patients undergoing coronary artery bypass grafting and during the year following surgery. The TiCAB results add to a larger body of evidence indicating ticagrelor’s noninferiority to and lack of superiority to aspirin as monotherapy for patients with coronary artery disease or a history of ischemic stroke or transient ischemic attack.
How can these two drugs produce similar efficacy outcomes? Aspirin is an effective antiplatelet drug, and evidence also suggests that treatment with opiates such as morphine (Circ Cardiovasc Interv. 2016 Sept;9[9]:e004229) and fentanyl (Circulation. 2018 Jan 16;137[3]:307-9) during and after surgery can interfere with the intestinal absorption of ticagrelor and other oral P2Y12 receptor antagonists, such as clopidogrel and prasugrel.
Another interesting finding in TiCAB was that aspirin and ticagrelor monotherapy produced similar rates of major bleeds. Results from prior studies had raised concerns about ticagrelor’s safety in patients undergoing coronary artery bypass surgery, but the new results show that this may be a problem when patients receive dual antiplatelet therapy but not when they receive ticagrelor monotherapy. Current evidence favors dual antiplatelet therapy to achieve a greater decrease in cardiovascular disease events, but this occurs at the expense of increased bleeding. Larger trials of dual therapy after coronary artery bypass grafting are warranted; further study of monotherapy is not.
Robert F. Storey, MD , is a professor of cardiology at the University of Sheffield (England). He has been a consultant to, and received honoraria and research support from, AstraZeneca, and he has been a consultant to Actelion, Avacta, Bayer, Bristol-Myers Squibb/Pfizer, Haemonetics, Novartis, PlaqueTec, and Thromboserin. He made these comments as designated discussant for the TiCAB report.
CHICAGO – Ticagrelor performed about as well as aspirin did as monotherapy for preventing coronary bypass graft failure during the year following surgery in a randomized, multicenter trial with almost 1,900 patients.
Ticagrelor monotherapy also produced about the same number of major bleeding events as did aspirin monotherapy, Heribert Schunkert, MD, said at the American Heart Association scientific sessions. There were two limitations of the trial: The incidence of cardiovascular disease events that served as the efficacy endpoint for the study was less than what Dr. Schunkert and his associates expected, and they enrolled about half the projected number of patients because the study lost industry support and then, a couple of years later, showed a relentlessly neutral result leading to early termination of recruitment, said Dr. Schunkert, professor of cardiology and medical director of the German Heart Center in Munich.
The TiCAB (Study Comparing Ticagrelor With Aspirin for Prevention of Vascular Events in Patients Undergoing CABG) trial randomized 1,893 patients during 2013-2017 who underwent CABG at any of 26 centers in Austria, Germany, or Switzerland. Eligible patients underwent surgery for three-vessel disease, left main disease, or had two-vessel disease plus a left ventricular ejection fraction of less than 50%. About 31% of patients had unstable angina or non-ST elevation MI, with the remaining 69% having stable angina. The study included 931 patients who received 90 mg oral ticagrelor (Brilinta) b.i.d. plus aspirin placebo, and 928 who received 100 mg aspirin once daily plus ticagrelor placebo. The study medications began prior to surgery.
The study’s primary efficacy endpoint was the combined rate of cardiovascular death, MI, stroke, or need for revascularization by 1 year after surgery. This occurred in 9.7% of the ticagrelor patients and in 8.2% of those who received aspirin, a difference that was not statistically significant. Several secondary efficacy endpoints examined also showed a neutral result. The primary safety measure was the incidence of major bleeds by the Bleeding Academic Research Consortium criteria, which occurred in 3.7% of the ticagrelor patients and 3.2% of those on aspirin, not a statistically significant difference. After the year of follow-up about 85% of patients in both treatment arms remained on their assigned regimen, Dr. Schunkert said.
TiCAB received funding from AstraZeneca, which markets ticagrelor (Brilinta). Dr. Schunkert has received honoraria and research support from, and has been a speaker on behalf of, AstraZeneca. He has also received honoraria from Amgen, Bayer Vital, Boehringer Ingelheim, Daiichi Sankyo, Merck Sharp & Dohme, Novartis, Pfizer, Sanofi, and Servier.
SOURCE: Schunkert H et al. AHA 2018, Abstract 19561.
CHICAGO – Ticagrelor performed about as well as aspirin did as monotherapy for preventing coronary bypass graft failure during the year following surgery in a randomized, multicenter trial with almost 1,900 patients.
Ticagrelor monotherapy also produced about the same number of major bleeding events as did aspirin monotherapy, Heribert Schunkert, MD, said at the American Heart Association scientific sessions. There were two limitations of the trial: The incidence of cardiovascular disease events that served as the efficacy endpoint for the study was less than what Dr. Schunkert and his associates expected, and they enrolled about half the projected number of patients because the study lost industry support and then, a couple of years later, showed a relentlessly neutral result leading to early termination of recruitment, said Dr. Schunkert, professor of cardiology and medical director of the German Heart Center in Munich.
The TiCAB (Study Comparing Ticagrelor With Aspirin for Prevention of Vascular Events in Patients Undergoing CABG) trial randomized 1,893 patients during 2013-2017 who underwent CABG at any of 26 centers in Austria, Germany, or Switzerland. Eligible patients underwent surgery for three-vessel disease, left main disease, or had two-vessel disease plus a left ventricular ejection fraction of less than 50%. About 31% of patients had unstable angina or non-ST elevation MI, with the remaining 69% having stable angina. The study included 931 patients who received 90 mg oral ticagrelor (Brilinta) b.i.d. plus aspirin placebo, and 928 who received 100 mg aspirin once daily plus ticagrelor placebo. The study medications began prior to surgery.
The study’s primary efficacy endpoint was the combined rate of cardiovascular death, MI, stroke, or need for revascularization by 1 year after surgery. This occurred in 9.7% of the ticagrelor patients and in 8.2% of those who received aspirin, a difference that was not statistically significant. Several secondary efficacy endpoints examined also showed a neutral result. The primary safety measure was the incidence of major bleeds by the Bleeding Academic Research Consortium criteria, which occurred in 3.7% of the ticagrelor patients and 3.2% of those on aspirin, not a statistically significant difference. After the year of follow-up about 85% of patients in both treatment arms remained on their assigned regimen, Dr. Schunkert said.
TiCAB received funding from AstraZeneca, which markets ticagrelor (Brilinta). Dr. Schunkert has received honoraria and research support from, and has been a speaker on behalf of, AstraZeneca. He has also received honoraria from Amgen, Bayer Vital, Boehringer Ingelheim, Daiichi Sankyo, Merck Sharp & Dohme, Novartis, Pfizer, Sanofi, and Servier.
SOURCE: Schunkert H et al. AHA 2018, Abstract 19561.
REPORTING FROM THE AHA SCIENTIFIC SESSIONS
Key clinical point: Ticagrelor was similar to aspirin for preventing graft failure in CABG patients.
Major finding: After 1 year, the combined cardiovascular disease endpoint occurred in 9.7% of ticagrelor patients and in 8.2% on aspirin.
Study details: TiCAB, a multicenter, randomized trial with 1,893 patients.
Disclosures: TiCAB received funding from AstraZeneca, which markets ticagrelor (Brilinta). Dr. Schunkert has received honoraria and research support from, and has been a speaker on behalf of, AstraZeneca. He has received honoraria from Amgen, Bayer Vital, Boehringer Ingelheim, Daiichi Sankyo, Merck Sharp & Dohme, Novartis, Pfizer, Sanofi, and Servier.
Source: Schunkert H et al. AHA 2018, Abstract 19561.
Reducing heart failure readmissions raises mortality
This week from MDedge Cardiology, the Hospital Readmissions Reduction Program may be doing more harm than good, ticagrelor holds no edge over aspirin in CABG patients, weight-loss apps lack evidence, and the Surgeon General sends out an alarm.
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This week from MDedge Cardiology, the Hospital Readmissions Reduction Program may be doing more harm than good, ticagrelor holds no edge over aspirin in CABG patients, weight-loss apps lack evidence, and the Surgeon General sends out an alarm.
Subscribe to Cardiocast wherever you get your podcasts.
Amazon Alexa
Apple Podcasts
This week from MDedge Cardiology, the Hospital Readmissions Reduction Program may be doing more harm than good, ticagrelor holds no edge over aspirin in CABG patients, weight-loss apps lack evidence, and the Surgeon General sends out an alarm.
Subscribe to Cardiocast wherever you get your podcasts.
Amazon Alexa
Apple Podcasts
Joint guidelines offer recommendations for treating peripheral artery disease
The report, published in the Journal of the American College of Cardiology, drew on the expertise of a broad panel of experts, including representatives from the American Heart Association, Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology, and Society for Vascular Medicine.
“Improvements in the diagnosis of peripheral artery disease (PAD) have led to an increasing number of treatment and revascularization methods, especially endovascular interventions,” wrote Steven R. Bailey, MD, who headed the multidisciplinary writing committee. “As new and increasingly sophisticated devices are developed, the medical community needs to understand how best to incorporate these technologies into daily clinical decision making and care, and how to choose between new and more established methods. This project was initiated to respond to this need and to ensure the effective use of peripheral artery revascularization.”
The document is not intended to cover every possible clinical scenario that could employ these interventions, wrote Dr. Bailey, who is the Janey Briscoe Distinguished Chair in Cardiology at the University of Texas, San Antonio, and his coauthors. “Rather, the goal is to provide generalized guidance into the use of these devices and techniques, while understanding that each clinical situation is unique, with physicians using their best judgment and the available evidence base to craft the most beneficial approach for the patient. In all cases, it is assumed that guideline-directed medical therapy should be applied first.”
The panel identified 45 scenarios in key clinical areas in which PAD interventions – either surgical or endovascular procedures – might be employed as first-line therapy. These included renal artery stenosis, lower extremity disease, critical limb ischemia, and asymptomatic artery disease. The report also discussed options for endovascular interventions, and secondary treatment options for lower extremity disease. The panel graded the value of interventions as appropriate, may be appropriate, or rarely appropriate.
“The scenarios in this document are arranged according to the clinical decision points confronting vascular practitioners in everyday clinical practice,” the panel wrote. “These include the presence or absence of symptoms, presence or absence of limb-threatening disease, severity and anatomical location of the culprit lesion, recurrent or de novo disease, the advantage of endovascular or surgical revascularization, and the expected durability of clinical benefit after an intervention.”
Renal artery stenting
Recommendations in this category were largely based on the CORAL (Cardiovascular Outcomes in Renal Atherosclerotic Lesions) study, which recommends best medical therapy as the initial treatment for a newly diagnosed patient. (N Engl J Med 2014;370:13-22).
The optimal medical approach is generally thought to be three antihypertensive medications, one of which should be a diuretic. Primary stenting can be considered for patients with an accelerating decline in renal function and bilateral or solitary significant renal artery stenosis, or moderate stenosis with translesional gradients that exceed threshold measurements. In patients with stable renal function and unilateral significant stenosis, intensifying medical therapy is appropriate. Stenting is rarely appropriate in patients with small, nonviable kidneys.
Lower extremity disease
Recommendations for lower extremity revascularization in patients with claudication are based largely on the 2016 AHA/ACC Guideline on the Management of Patients with Lower Extremity Peripheral Artery Disease.
For patients with PAD and intermittent claudication, medical therapy and exercise are the first-line treatments. Revascularization should be considered only when this option fails. The appropriateness of intervention depends on the location and length of the lesion.
Intensification of medical therapy or endovascular treatment are appropriate for patients with aortoiliac, superficial femoral artery, and popliteal artery lesions; surgery also may be appropriate here. Medical therapy is appropriate for lesions located below the knee, as well; endovascular approaches also may be appropriate. Surgery for these lesions is rarely appropriate.
Critical limb ischemia
Medical therapy is generally not considered for these patients. But regardless of the lesion location, the panel found either endovascular or surgical treatment appropriate. Indeed, revascularization is the only viable treatment for these patients.
“Revascularization, whether endovascular or surgical, is critical for the reduction of high morbidity and mortality rates associated with limb loss. Mortality rates have been reported to be as high as 20% within 6 months of diagnosis and exceeding 50% after 5 years in patients left untreated. Furthermore, this degree of PAD is commonly associated with excessive cardiovascular events, often surpassing mortality rates associated with even symptomatic coronary artery disease.”
Asymptomatic artery disease
The recommendations in this category address the need to gain arterial access for potentially life-saving cardiovascular procedures. There are no published data in this area, so the recommendations are all based on expert opinion.
To gain access for coronary interventions, endovascular treatment and surgery are both appropriate. For hemodynamic support and large vascular or valvular interventions, endovascular approaches are appropriate, and surgical approaches may be appropriate.
Options for endovascular treatment when deemed appropriate or may be appropriate
Since there is no standardized treatment when an intervention is deemed appropriate, the potential procedures are organized by general lesion location (above or below the inguinal ligament and below the knee), and by lesion length. The recommendations cover the most commonly used endovascular treatment modalities.
“Of note, the use of atherectomy in the iliac artery has been rated Rarely Appropriate in all clinical scenarios,” the team noted. “This rating derives from an absence of data supporting the use of this technology, compared with balloon angioplasty and stenting. Similarly, the use of atherectomy in the superficial femoral and popliteal arteries and below-the-knee vessels also received a lower score, again because of the lack of comparative data relative to technologies with prospectively collected data. The evidence base to judge intervention below the knees is not as developed as other lower-extremity locations, which results in more frequent use of the May Be Appropriate category. The rating panel felt that below-the-knee atherectomy once again lacked comparative evidence to support general use.”
There are some exceptions, “favoring atherectomy include severe calcification and undilatable lesions; however, other technologies had a better evidence base for routine revascularization in most settings.”
Secondary treatment options for lower-extremity disease
This section addresses options for very specific situations, including in-stent restenosis, venous bypass graft failure, and prosthetic bypass graft failure.
“It is recognized that the need for revascularization of a failing conduit, graft, or stent is a marker of adverse outcomes for all of the reparative modalities employed,” the panel wrote. “Literature comparing treatment modalities for in-stent stenosis, venous graft failures, and arterial graft failures is very limited. Therefore, the recommendations primarily reflect consensus based upon current clinical practice.”
The modality choice should probably depend more upon surgeon preference and clinical experience, rather than a blanket recommendation. In general, the panel felt that surgical revascularizations are rarely appropriate for in-stent stenosis, especially if the patient is asymptomatic.
The panel felt that endovascular approaches are generally appropriate for focal stenoses in patients with prior surgical grafts and bioprosthetic material, but in patients with diffused stenosis or thrombosed grafts, both endovascular and surgical approaches were graded as may be appropriate.
“The specific type of therapy [device or surgical procedure] is at the discretion of the clinician, dictated by the clinical scenario plus physician and facility experience.”
Dr. Bailey had no financial disclosures; however, some members of the panel did disclose relationships with device manufacturers and pharmaceutical companies.
SOURCE: Bailey SR et al. J Am Coll Cardiol. 2018 Dec 17.
The report, published in the Journal of the American College of Cardiology, drew on the expertise of a broad panel of experts, including representatives from the American Heart Association, Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology, and Society for Vascular Medicine.
“Improvements in the diagnosis of peripheral artery disease (PAD) have led to an increasing number of treatment and revascularization methods, especially endovascular interventions,” wrote Steven R. Bailey, MD, who headed the multidisciplinary writing committee. “As new and increasingly sophisticated devices are developed, the medical community needs to understand how best to incorporate these technologies into daily clinical decision making and care, and how to choose between new and more established methods. This project was initiated to respond to this need and to ensure the effective use of peripheral artery revascularization.”
The document is not intended to cover every possible clinical scenario that could employ these interventions, wrote Dr. Bailey, who is the Janey Briscoe Distinguished Chair in Cardiology at the University of Texas, San Antonio, and his coauthors. “Rather, the goal is to provide generalized guidance into the use of these devices and techniques, while understanding that each clinical situation is unique, with physicians using their best judgment and the available evidence base to craft the most beneficial approach for the patient. In all cases, it is assumed that guideline-directed medical therapy should be applied first.”
The panel identified 45 scenarios in key clinical areas in which PAD interventions – either surgical or endovascular procedures – might be employed as first-line therapy. These included renal artery stenosis, lower extremity disease, critical limb ischemia, and asymptomatic artery disease. The report also discussed options for endovascular interventions, and secondary treatment options for lower extremity disease. The panel graded the value of interventions as appropriate, may be appropriate, or rarely appropriate.
“The scenarios in this document are arranged according to the clinical decision points confronting vascular practitioners in everyday clinical practice,” the panel wrote. “These include the presence or absence of symptoms, presence or absence of limb-threatening disease, severity and anatomical location of the culprit lesion, recurrent or de novo disease, the advantage of endovascular or surgical revascularization, and the expected durability of clinical benefit after an intervention.”
Renal artery stenting
Recommendations in this category were largely based on the CORAL (Cardiovascular Outcomes in Renal Atherosclerotic Lesions) study, which recommends best medical therapy as the initial treatment for a newly diagnosed patient. (N Engl J Med 2014;370:13-22).
The optimal medical approach is generally thought to be three antihypertensive medications, one of which should be a diuretic. Primary stenting can be considered for patients with an accelerating decline in renal function and bilateral or solitary significant renal artery stenosis, or moderate stenosis with translesional gradients that exceed threshold measurements. In patients with stable renal function and unilateral significant stenosis, intensifying medical therapy is appropriate. Stenting is rarely appropriate in patients with small, nonviable kidneys.
Lower extremity disease
Recommendations for lower extremity revascularization in patients with claudication are based largely on the 2016 AHA/ACC Guideline on the Management of Patients with Lower Extremity Peripheral Artery Disease.
For patients with PAD and intermittent claudication, medical therapy and exercise are the first-line treatments. Revascularization should be considered only when this option fails. The appropriateness of intervention depends on the location and length of the lesion.
Intensification of medical therapy or endovascular treatment are appropriate for patients with aortoiliac, superficial femoral artery, and popliteal artery lesions; surgery also may be appropriate here. Medical therapy is appropriate for lesions located below the knee, as well; endovascular approaches also may be appropriate. Surgery for these lesions is rarely appropriate.
Critical limb ischemia
Medical therapy is generally not considered for these patients. But regardless of the lesion location, the panel found either endovascular or surgical treatment appropriate. Indeed, revascularization is the only viable treatment for these patients.
“Revascularization, whether endovascular or surgical, is critical for the reduction of high morbidity and mortality rates associated with limb loss. Mortality rates have been reported to be as high as 20% within 6 months of diagnosis and exceeding 50% after 5 years in patients left untreated. Furthermore, this degree of PAD is commonly associated with excessive cardiovascular events, often surpassing mortality rates associated with even symptomatic coronary artery disease.”
Asymptomatic artery disease
The recommendations in this category address the need to gain arterial access for potentially life-saving cardiovascular procedures. There are no published data in this area, so the recommendations are all based on expert opinion.
To gain access for coronary interventions, endovascular treatment and surgery are both appropriate. For hemodynamic support and large vascular or valvular interventions, endovascular approaches are appropriate, and surgical approaches may be appropriate.
Options for endovascular treatment when deemed appropriate or may be appropriate
Since there is no standardized treatment when an intervention is deemed appropriate, the potential procedures are organized by general lesion location (above or below the inguinal ligament and below the knee), and by lesion length. The recommendations cover the most commonly used endovascular treatment modalities.
“Of note, the use of atherectomy in the iliac artery has been rated Rarely Appropriate in all clinical scenarios,” the team noted. “This rating derives from an absence of data supporting the use of this technology, compared with balloon angioplasty and stenting. Similarly, the use of atherectomy in the superficial femoral and popliteal arteries and below-the-knee vessels also received a lower score, again because of the lack of comparative data relative to technologies with prospectively collected data. The evidence base to judge intervention below the knees is not as developed as other lower-extremity locations, which results in more frequent use of the May Be Appropriate category. The rating panel felt that below-the-knee atherectomy once again lacked comparative evidence to support general use.”
There are some exceptions, “favoring atherectomy include severe calcification and undilatable lesions; however, other technologies had a better evidence base for routine revascularization in most settings.”
Secondary treatment options for lower-extremity disease
This section addresses options for very specific situations, including in-stent restenosis, venous bypass graft failure, and prosthetic bypass graft failure.
“It is recognized that the need for revascularization of a failing conduit, graft, or stent is a marker of adverse outcomes for all of the reparative modalities employed,” the panel wrote. “Literature comparing treatment modalities for in-stent stenosis, venous graft failures, and arterial graft failures is very limited. Therefore, the recommendations primarily reflect consensus based upon current clinical practice.”
The modality choice should probably depend more upon surgeon preference and clinical experience, rather than a blanket recommendation. In general, the panel felt that surgical revascularizations are rarely appropriate for in-stent stenosis, especially if the patient is asymptomatic.
The panel felt that endovascular approaches are generally appropriate for focal stenoses in patients with prior surgical grafts and bioprosthetic material, but in patients with diffused stenosis or thrombosed grafts, both endovascular and surgical approaches were graded as may be appropriate.
“The specific type of therapy [device or surgical procedure] is at the discretion of the clinician, dictated by the clinical scenario plus physician and facility experience.”
Dr. Bailey had no financial disclosures; however, some members of the panel did disclose relationships with device manufacturers and pharmaceutical companies.
SOURCE: Bailey SR et al. J Am Coll Cardiol. 2018 Dec 17.
The report, published in the Journal of the American College of Cardiology, drew on the expertise of a broad panel of experts, including representatives from the American Heart Association, Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology, and Society for Vascular Medicine.
“Improvements in the diagnosis of peripheral artery disease (PAD) have led to an increasing number of treatment and revascularization methods, especially endovascular interventions,” wrote Steven R. Bailey, MD, who headed the multidisciplinary writing committee. “As new and increasingly sophisticated devices are developed, the medical community needs to understand how best to incorporate these technologies into daily clinical decision making and care, and how to choose between new and more established methods. This project was initiated to respond to this need and to ensure the effective use of peripheral artery revascularization.”
The document is not intended to cover every possible clinical scenario that could employ these interventions, wrote Dr. Bailey, who is the Janey Briscoe Distinguished Chair in Cardiology at the University of Texas, San Antonio, and his coauthors. “Rather, the goal is to provide generalized guidance into the use of these devices and techniques, while understanding that each clinical situation is unique, with physicians using their best judgment and the available evidence base to craft the most beneficial approach for the patient. In all cases, it is assumed that guideline-directed medical therapy should be applied first.”
The panel identified 45 scenarios in key clinical areas in which PAD interventions – either surgical or endovascular procedures – might be employed as first-line therapy. These included renal artery stenosis, lower extremity disease, critical limb ischemia, and asymptomatic artery disease. The report also discussed options for endovascular interventions, and secondary treatment options for lower extremity disease. The panel graded the value of interventions as appropriate, may be appropriate, or rarely appropriate.
“The scenarios in this document are arranged according to the clinical decision points confronting vascular practitioners in everyday clinical practice,” the panel wrote. “These include the presence or absence of symptoms, presence or absence of limb-threatening disease, severity and anatomical location of the culprit lesion, recurrent or de novo disease, the advantage of endovascular or surgical revascularization, and the expected durability of clinical benefit after an intervention.”
Renal artery stenting
Recommendations in this category were largely based on the CORAL (Cardiovascular Outcomes in Renal Atherosclerotic Lesions) study, which recommends best medical therapy as the initial treatment for a newly diagnosed patient. (N Engl J Med 2014;370:13-22).
The optimal medical approach is generally thought to be three antihypertensive medications, one of which should be a diuretic. Primary stenting can be considered for patients with an accelerating decline in renal function and bilateral or solitary significant renal artery stenosis, or moderate stenosis with translesional gradients that exceed threshold measurements. In patients with stable renal function and unilateral significant stenosis, intensifying medical therapy is appropriate. Stenting is rarely appropriate in patients with small, nonviable kidneys.
Lower extremity disease
Recommendations for lower extremity revascularization in patients with claudication are based largely on the 2016 AHA/ACC Guideline on the Management of Patients with Lower Extremity Peripheral Artery Disease.
For patients with PAD and intermittent claudication, medical therapy and exercise are the first-line treatments. Revascularization should be considered only when this option fails. The appropriateness of intervention depends on the location and length of the lesion.
Intensification of medical therapy or endovascular treatment are appropriate for patients with aortoiliac, superficial femoral artery, and popliteal artery lesions; surgery also may be appropriate here. Medical therapy is appropriate for lesions located below the knee, as well; endovascular approaches also may be appropriate. Surgery for these lesions is rarely appropriate.
Critical limb ischemia
Medical therapy is generally not considered for these patients. But regardless of the lesion location, the panel found either endovascular or surgical treatment appropriate. Indeed, revascularization is the only viable treatment for these patients.
“Revascularization, whether endovascular or surgical, is critical for the reduction of high morbidity and mortality rates associated with limb loss. Mortality rates have been reported to be as high as 20% within 6 months of diagnosis and exceeding 50% after 5 years in patients left untreated. Furthermore, this degree of PAD is commonly associated with excessive cardiovascular events, often surpassing mortality rates associated with even symptomatic coronary artery disease.”
Asymptomatic artery disease
The recommendations in this category address the need to gain arterial access for potentially life-saving cardiovascular procedures. There are no published data in this area, so the recommendations are all based on expert opinion.
To gain access for coronary interventions, endovascular treatment and surgery are both appropriate. For hemodynamic support and large vascular or valvular interventions, endovascular approaches are appropriate, and surgical approaches may be appropriate.
Options for endovascular treatment when deemed appropriate or may be appropriate
Since there is no standardized treatment when an intervention is deemed appropriate, the potential procedures are organized by general lesion location (above or below the inguinal ligament and below the knee), and by lesion length. The recommendations cover the most commonly used endovascular treatment modalities.
“Of note, the use of atherectomy in the iliac artery has been rated Rarely Appropriate in all clinical scenarios,” the team noted. “This rating derives from an absence of data supporting the use of this technology, compared with balloon angioplasty and stenting. Similarly, the use of atherectomy in the superficial femoral and popliteal arteries and below-the-knee vessels also received a lower score, again because of the lack of comparative data relative to technologies with prospectively collected data. The evidence base to judge intervention below the knees is not as developed as other lower-extremity locations, which results in more frequent use of the May Be Appropriate category. The rating panel felt that below-the-knee atherectomy once again lacked comparative evidence to support general use.”
There are some exceptions, “favoring atherectomy include severe calcification and undilatable lesions; however, other technologies had a better evidence base for routine revascularization in most settings.”
Secondary treatment options for lower-extremity disease
This section addresses options for very specific situations, including in-stent restenosis, venous bypass graft failure, and prosthetic bypass graft failure.
“It is recognized that the need for revascularization of a failing conduit, graft, or stent is a marker of adverse outcomes for all of the reparative modalities employed,” the panel wrote. “Literature comparing treatment modalities for in-stent stenosis, venous graft failures, and arterial graft failures is very limited. Therefore, the recommendations primarily reflect consensus based upon current clinical practice.”
The modality choice should probably depend more upon surgeon preference and clinical experience, rather than a blanket recommendation. In general, the panel felt that surgical revascularizations are rarely appropriate for in-stent stenosis, especially if the patient is asymptomatic.
The panel felt that endovascular approaches are generally appropriate for focal stenoses in patients with prior surgical grafts and bioprosthetic material, but in patients with diffused stenosis or thrombosed grafts, both endovascular and surgical approaches were graded as may be appropriate.
“The specific type of therapy [device or surgical procedure] is at the discretion of the clinician, dictated by the clinical scenario plus physician and facility experience.”
Dr. Bailey had no financial disclosures; however, some members of the panel did disclose relationships with device manufacturers and pharmaceutical companies.
SOURCE: Bailey SR et al. J Am Coll Cardiol. 2018 Dec 17.
FROM THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
CABG surpasses PCI for diabetics out to 7.5 years
CHICAGO – Patients with diabetes who underwent coronary artery bypass grafting had significantly better survival than patients with diabetes who underwent percutaneous coronary intervention after a median 7.5 years of follow-up.
Those patients comprised about half the patients enrolled in the FREEDOM randomized trial.
Long-term follow-up was only possible for just under half the 1,900 patients with diabetes and multivessel coronary disease originally enrolled in FREEDOM, but when researchers combined the long-term results with the data collected in the original study that had a median 3.8-year follow-up, they found all-cause mortality occurred in 18.3% of the patients who underwent coronary artery bypass grafting (CABG) and in 24.3% of patients treated with percutaneous coronary intervention (PCI), a 6% absolute between-group difference that was statistically significant, Valentin Fuster, MD, said at the American Heart Association scientific sessions. This fully jibed with the primary FREEDOM results, which found after 5 years a statistically significant reduction in all-cause death with CABG, compared with PCI, and also a significant reduction in the study’s primary endpoint (a combination of all-cause death, MI, and stroke), which occurred in 18.7% of patients randomized to CABG and in 26.6% of those randomized to PCI (N Engl J Med. 2012 Dec 20;367[25]:2375-84).
The extended follow-up finding lent additional support to existing society recommendations that CABG is the preferred revascularization strategy for patients with diabetes and multivessel coronary disease, most recently from the European Society of Cardiology (Eur Heart J. 2018 Aug 25. doi: 10.1093/eurheartj/ehy394), said Dr. Fuster, professor of medicine at the Icahn School of Medicine at Mount Sinai and director of Mount Sinai Heart in New York. A subgroup analysis of the extended follow-up also suggested that the survival benefit from CABG, compared with PCI, was especially strong among patients at or below the study’s median age of 63 years. In the younger subgroup survival among patients treated with CABG was twice as good as it was among patients treated with PCI.
Dr. Fuster noted that few data have been previously reported for survival rates beyond 5 years after revascularization. “This was a difficult study. Following patients for more than 5 years is hard,” he said. Concurrently with his report at the meeting the results also appeared online (J Am Coll Cardiol. 2018 Nov 11. doi: 10.1016/j.jacc.2018.11.001).
The FREEDOM (Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel Disease) trial enrolled patients at 140 participating centers during 2005-2010. A total of 25 sites agreed to participate in the extended follow-up and could track 943 patients, 50% of the starting cohort of 1,900 and 89% of the patients originally enrolled at these 25 centers. Dr. Fuster stressed that the 957 patients not included in the follow-up had not been lost, but rather had been managed at sites that declined to participate in this additional study.
Dr. Fuster acknowledged that methods and hardware for PCI have changed since the study ran a decade ago, as have options for medical management. He also highlighted that the long-term follow-up results had no data on rates of MIs and strokes.
FREEDOM had no commercial funding. Dr. Fuster reported no relevant disclosures.
SOURCE: Fuster V et al. AHA 2018, Abstract 18609.
These extended results from the FREEDOM trial that followed many patients for 10 years or longer add to the consistent evidence base that supports coronary artery bypass grafting (CABG) as the preferred revascularization strategy for patients with diabetes and multivessel coronary disease. The new findings support existing society guidelines that recommend CABG over percutaneous coronary intervention in these patients, most recently in the revascularization guidelines from the European Society of Cardiology (Eur Heart J. 2018 Aug 25. doi: 10.1093/eurheartj/ehy394). An update to the U.S. guidelines should appear in 2019.
Continued improvement of revascularization techniques, hardware, and medical management of patients with diabetes and multivessel coronary artery disease makes it challenging to apply the results of studies run in earlier eras to today’s practice. It is possible that continued evolution of coronary stent technology may reduce the differences in outcomes between bypass surgery and percutaneous coronary interventions, although this is less likely if much of CABG’s success relates to the protection it gives against new disease. Future comparisons of different approaches with revascularization will need to take into account the potential contribution of other procedures, other adverse outcomes aside from mortality during long-term follow-up, the consequences of incomplete revascularization, and the impact of new medications for treating diabetes that have been recently shown to also have cardiovascular disease effects. All these factors in concert will define the optimal approach to managing these patients.
Alice K. Jacobs, MD , is director of the cardiac catheterization laboratory at Boston Medical Center and a professor of medicine at Boston University. She has received research support from Abbott Vascular. She made these comments as designated discussant for the study.
These extended results from the FREEDOM trial that followed many patients for 10 years or longer add to the consistent evidence base that supports coronary artery bypass grafting (CABG) as the preferred revascularization strategy for patients with diabetes and multivessel coronary disease. The new findings support existing society guidelines that recommend CABG over percutaneous coronary intervention in these patients, most recently in the revascularization guidelines from the European Society of Cardiology (Eur Heart J. 2018 Aug 25. doi: 10.1093/eurheartj/ehy394). An update to the U.S. guidelines should appear in 2019.
Continued improvement of revascularization techniques, hardware, and medical management of patients with diabetes and multivessel coronary artery disease makes it challenging to apply the results of studies run in earlier eras to today’s practice. It is possible that continued evolution of coronary stent technology may reduce the differences in outcomes between bypass surgery and percutaneous coronary interventions, although this is less likely if much of CABG’s success relates to the protection it gives against new disease. Future comparisons of different approaches with revascularization will need to take into account the potential contribution of other procedures, other adverse outcomes aside from mortality during long-term follow-up, the consequences of incomplete revascularization, and the impact of new medications for treating diabetes that have been recently shown to also have cardiovascular disease effects. All these factors in concert will define the optimal approach to managing these patients.
Alice K. Jacobs, MD , is director of the cardiac catheterization laboratory at Boston Medical Center and a professor of medicine at Boston University. She has received research support from Abbott Vascular. She made these comments as designated discussant for the study.
These extended results from the FREEDOM trial that followed many patients for 10 years or longer add to the consistent evidence base that supports coronary artery bypass grafting (CABG) as the preferred revascularization strategy for patients with diabetes and multivessel coronary disease. The new findings support existing society guidelines that recommend CABG over percutaneous coronary intervention in these patients, most recently in the revascularization guidelines from the European Society of Cardiology (Eur Heart J. 2018 Aug 25. doi: 10.1093/eurheartj/ehy394). An update to the U.S. guidelines should appear in 2019.
Continued improvement of revascularization techniques, hardware, and medical management of patients with diabetes and multivessel coronary artery disease makes it challenging to apply the results of studies run in earlier eras to today’s practice. It is possible that continued evolution of coronary stent technology may reduce the differences in outcomes between bypass surgery and percutaneous coronary interventions, although this is less likely if much of CABG’s success relates to the protection it gives against new disease. Future comparisons of different approaches with revascularization will need to take into account the potential contribution of other procedures, other adverse outcomes aside from mortality during long-term follow-up, the consequences of incomplete revascularization, and the impact of new medications for treating diabetes that have been recently shown to also have cardiovascular disease effects. All these factors in concert will define the optimal approach to managing these patients.
Alice K. Jacobs, MD , is director of the cardiac catheterization laboratory at Boston Medical Center and a professor of medicine at Boston University. She has received research support from Abbott Vascular. She made these comments as designated discussant for the study.
CHICAGO – Patients with diabetes who underwent coronary artery bypass grafting had significantly better survival than patients with diabetes who underwent percutaneous coronary intervention after a median 7.5 years of follow-up.
Those patients comprised about half the patients enrolled in the FREEDOM randomized trial.
Long-term follow-up was only possible for just under half the 1,900 patients with diabetes and multivessel coronary disease originally enrolled in FREEDOM, but when researchers combined the long-term results with the data collected in the original study that had a median 3.8-year follow-up, they found all-cause mortality occurred in 18.3% of the patients who underwent coronary artery bypass grafting (CABG) and in 24.3% of patients treated with percutaneous coronary intervention (PCI), a 6% absolute between-group difference that was statistically significant, Valentin Fuster, MD, said at the American Heart Association scientific sessions. This fully jibed with the primary FREEDOM results, which found after 5 years a statistically significant reduction in all-cause death with CABG, compared with PCI, and also a significant reduction in the study’s primary endpoint (a combination of all-cause death, MI, and stroke), which occurred in 18.7% of patients randomized to CABG and in 26.6% of those randomized to PCI (N Engl J Med. 2012 Dec 20;367[25]:2375-84).
The extended follow-up finding lent additional support to existing society recommendations that CABG is the preferred revascularization strategy for patients with diabetes and multivessel coronary disease, most recently from the European Society of Cardiology (Eur Heart J. 2018 Aug 25. doi: 10.1093/eurheartj/ehy394), said Dr. Fuster, professor of medicine at the Icahn School of Medicine at Mount Sinai and director of Mount Sinai Heart in New York. A subgroup analysis of the extended follow-up also suggested that the survival benefit from CABG, compared with PCI, was especially strong among patients at or below the study’s median age of 63 years. In the younger subgroup survival among patients treated with CABG was twice as good as it was among patients treated with PCI.
Dr. Fuster noted that few data have been previously reported for survival rates beyond 5 years after revascularization. “This was a difficult study. Following patients for more than 5 years is hard,” he said. Concurrently with his report at the meeting the results also appeared online (J Am Coll Cardiol. 2018 Nov 11. doi: 10.1016/j.jacc.2018.11.001).
The FREEDOM (Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel Disease) trial enrolled patients at 140 participating centers during 2005-2010. A total of 25 sites agreed to participate in the extended follow-up and could track 943 patients, 50% of the starting cohort of 1,900 and 89% of the patients originally enrolled at these 25 centers. Dr. Fuster stressed that the 957 patients not included in the follow-up had not been lost, but rather had been managed at sites that declined to participate in this additional study.
Dr. Fuster acknowledged that methods and hardware for PCI have changed since the study ran a decade ago, as have options for medical management. He also highlighted that the long-term follow-up results had no data on rates of MIs and strokes.
FREEDOM had no commercial funding. Dr. Fuster reported no relevant disclosures.
SOURCE: Fuster V et al. AHA 2018, Abstract 18609.
CHICAGO – Patients with diabetes who underwent coronary artery bypass grafting had significantly better survival than patients with diabetes who underwent percutaneous coronary intervention after a median 7.5 years of follow-up.
Those patients comprised about half the patients enrolled in the FREEDOM randomized trial.
Long-term follow-up was only possible for just under half the 1,900 patients with diabetes and multivessel coronary disease originally enrolled in FREEDOM, but when researchers combined the long-term results with the data collected in the original study that had a median 3.8-year follow-up, they found all-cause mortality occurred in 18.3% of the patients who underwent coronary artery bypass grafting (CABG) and in 24.3% of patients treated with percutaneous coronary intervention (PCI), a 6% absolute between-group difference that was statistically significant, Valentin Fuster, MD, said at the American Heart Association scientific sessions. This fully jibed with the primary FREEDOM results, which found after 5 years a statistically significant reduction in all-cause death with CABG, compared with PCI, and also a significant reduction in the study’s primary endpoint (a combination of all-cause death, MI, and stroke), which occurred in 18.7% of patients randomized to CABG and in 26.6% of those randomized to PCI (N Engl J Med. 2012 Dec 20;367[25]:2375-84).
The extended follow-up finding lent additional support to existing society recommendations that CABG is the preferred revascularization strategy for patients with diabetes and multivessel coronary disease, most recently from the European Society of Cardiology (Eur Heart J. 2018 Aug 25. doi: 10.1093/eurheartj/ehy394), said Dr. Fuster, professor of medicine at the Icahn School of Medicine at Mount Sinai and director of Mount Sinai Heart in New York. A subgroup analysis of the extended follow-up also suggested that the survival benefit from CABG, compared with PCI, was especially strong among patients at or below the study’s median age of 63 years. In the younger subgroup survival among patients treated with CABG was twice as good as it was among patients treated with PCI.
Dr. Fuster noted that few data have been previously reported for survival rates beyond 5 years after revascularization. “This was a difficult study. Following patients for more than 5 years is hard,” he said. Concurrently with his report at the meeting the results also appeared online (J Am Coll Cardiol. 2018 Nov 11. doi: 10.1016/j.jacc.2018.11.001).
The FREEDOM (Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel Disease) trial enrolled patients at 140 participating centers during 2005-2010. A total of 25 sites agreed to participate in the extended follow-up and could track 943 patients, 50% of the starting cohort of 1,900 and 89% of the patients originally enrolled at these 25 centers. Dr. Fuster stressed that the 957 patients not included in the follow-up had not been lost, but rather had been managed at sites that declined to participate in this additional study.
Dr. Fuster acknowledged that methods and hardware for PCI have changed since the study ran a decade ago, as have options for medical management. He also highlighted that the long-term follow-up results had no data on rates of MIs and strokes.
FREEDOM had no commercial funding. Dr. Fuster reported no relevant disclosures.
SOURCE: Fuster V et al. AHA 2018, Abstract 18609.
REPORTING FROM THE AHA SCIENTIFIC SESSIONS
Key clinical point:
Major finding: After 7.5 years, mortality in the full FREEDOM cohort was 18% after coronary artery bypass grafting and 24% after percutaneous coronary intervention.
Study details: An extended follow-up of 943 of patients enrolled in FREEDOM, a randomized, multicenter trial.
Disclosures: FREEDOM had no commercial funding. Dr. Fuster reported no relevant disclosures.
Source: Fuster V et al. AHA 2018, Abstract 18609.