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FDA approves device for coronary artery perforations
according to an announcement from the agency.
These small tears in the arterial wall are rare but life-threatening complications of certain procedures, such as percutaneous coronary interventions. The device uses a balloon catheter like that used with PCI and, when successful, it can spare patients more invasive procedures, such as open heart surgery.
The approval is based on survey data from 80 patients treated with this device. In 76 of the patients (95%), the device was successfully delivered to the site of the acute coronary arterial perforation, and it successfully healed the tear in 73 patients (91%). Two patients died during the procedure, and five whose perforations were sealed successfully died in the hospital after the procedure, as did one whose perforation was not sealed.
The agency noted that this is the first device approved for the indication in 17 years. More information can be found in the full FDA announcement.
according to an announcement from the agency.
These small tears in the arterial wall are rare but life-threatening complications of certain procedures, such as percutaneous coronary interventions. The device uses a balloon catheter like that used with PCI and, when successful, it can spare patients more invasive procedures, such as open heart surgery.
The approval is based on survey data from 80 patients treated with this device. In 76 of the patients (95%), the device was successfully delivered to the site of the acute coronary arterial perforation, and it successfully healed the tear in 73 patients (91%). Two patients died during the procedure, and five whose perforations were sealed successfully died in the hospital after the procedure, as did one whose perforation was not sealed.
The agency noted that this is the first device approved for the indication in 17 years. More information can be found in the full FDA announcement.
according to an announcement from the agency.
These small tears in the arterial wall are rare but life-threatening complications of certain procedures, such as percutaneous coronary interventions. The device uses a balloon catheter like that used with PCI and, when successful, it can spare patients more invasive procedures, such as open heart surgery.
The approval is based on survey data from 80 patients treated with this device. In 76 of the patients (95%), the device was successfully delivered to the site of the acute coronary arterial perforation, and it successfully healed the tear in 73 patients (91%). Two patients died during the procedure, and five whose perforations were sealed successfully died in the hospital after the procedure, as did one whose perforation was not sealed.
The agency noted that this is the first device approved for the indication in 17 years. More information can be found in the full FDA announcement.
Risk factors for postop cardiac events differ between vascular and general surgery
Predictive risk factors for cardiac events (CEs) after general and vascular surgery differed significantly, according to a large retrospective study. However, there was no significant difference seen in the overall incidence of CEs between the two types of surgery, reported Derrick Acheampong, MD, and his colleagues at the Icahn School of Medicine at Mount Sinai, New York.
They performed a retrospective data analysis of 8,441 adult patients at their large urban teaching hospital; these patients had undergone general or vascular surgery during 2013-2016 and, in the analysis, were grouped by whether they experienced postoperative CEs.
Univariate and multivariate analyses identified predictors of postoperative CE and the association of CEs with adverse postoperative outcomes. CEs were defined as myocardial infarction or cardiac arrest within the 30-day postoperative period.
A total of 157 patients (1.9%) experienced CEs after major general and vascular surgery, with no significant difference in incidence between the two types of surgery (P = .44), according to their report, published online in the Annals of Medicine and Surgery. CE-associated mortality among this group was high, at 55.4%.
The occurrence of a CE following surgery in both groups was significantly associated with increased mortality, as well as pulmonary, renal, and neurological complications, in addition to systemic sepsis, postoperative red blood cell transfusion, unplanned return to the operating room, and prolonged hospitalization, according to the researchers.
However, predictors of CEs risk between vascular and general surgery were significantly different.
For general surgery, American Society of Anesthesiologists (ASA) status greater than 3, dependent functional status, acute renal failure or dialysis, weight loss, creatinine greater than 1.2 mg/dL, international normalized ratio (INR) greater than 1.5, and partial thromboplastin time (PTT) less than 35 seconds were all unique independent predictors of postoperative CEs.
For vascular surgery, the unique significant predictors of postoperative CEs were age greater than 65 years, emergency surgery, diabetes, congestive heart failure, systemic sepsis, and operative time greater than 240 minutes.
The only common predictive risk factors for postoperative CEs for the two forms of surgery were hematocrit less than 34% and ventilator dependence.
“The present study corroborates reported studies that recommend separate predictive CE risk indices and risk stratification among different surgical specialties. Predictors for CE greatly differed between general and vascular surgery patients in our patient population,” the authors stated.
They concluded with the hope that their study “provides useful information to surgeons and allows for the necessary resources to be focused on identified at-risk patients to improve surgical outcomes.”
Dr. Acheampong and his colleagues reported having no disclosures.
SOURCE: Acheampong D et al. Ann Med Surg. 2018. doi: 10.1016/j.amsu.2018.08.001.
Predictive risk factors for cardiac events (CEs) after general and vascular surgery differed significantly, according to a large retrospective study. However, there was no significant difference seen in the overall incidence of CEs between the two types of surgery, reported Derrick Acheampong, MD, and his colleagues at the Icahn School of Medicine at Mount Sinai, New York.
They performed a retrospective data analysis of 8,441 adult patients at their large urban teaching hospital; these patients had undergone general or vascular surgery during 2013-2016 and, in the analysis, were grouped by whether they experienced postoperative CEs.
Univariate and multivariate analyses identified predictors of postoperative CE and the association of CEs with adverse postoperative outcomes. CEs were defined as myocardial infarction or cardiac arrest within the 30-day postoperative period.
A total of 157 patients (1.9%) experienced CEs after major general and vascular surgery, with no significant difference in incidence between the two types of surgery (P = .44), according to their report, published online in the Annals of Medicine and Surgery. CE-associated mortality among this group was high, at 55.4%.
The occurrence of a CE following surgery in both groups was significantly associated with increased mortality, as well as pulmonary, renal, and neurological complications, in addition to systemic sepsis, postoperative red blood cell transfusion, unplanned return to the operating room, and prolonged hospitalization, according to the researchers.
However, predictors of CEs risk between vascular and general surgery were significantly different.
For general surgery, American Society of Anesthesiologists (ASA) status greater than 3, dependent functional status, acute renal failure or dialysis, weight loss, creatinine greater than 1.2 mg/dL, international normalized ratio (INR) greater than 1.5, and partial thromboplastin time (PTT) less than 35 seconds were all unique independent predictors of postoperative CEs.
For vascular surgery, the unique significant predictors of postoperative CEs were age greater than 65 years, emergency surgery, diabetes, congestive heart failure, systemic sepsis, and operative time greater than 240 minutes.
The only common predictive risk factors for postoperative CEs for the two forms of surgery were hematocrit less than 34% and ventilator dependence.
“The present study corroborates reported studies that recommend separate predictive CE risk indices and risk stratification among different surgical specialties. Predictors for CE greatly differed between general and vascular surgery patients in our patient population,” the authors stated.
They concluded with the hope that their study “provides useful information to surgeons and allows for the necessary resources to be focused on identified at-risk patients to improve surgical outcomes.”
Dr. Acheampong and his colleagues reported having no disclosures.
SOURCE: Acheampong D et al. Ann Med Surg. 2018. doi: 10.1016/j.amsu.2018.08.001.
Predictive risk factors for cardiac events (CEs) after general and vascular surgery differed significantly, according to a large retrospective study. However, there was no significant difference seen in the overall incidence of CEs between the two types of surgery, reported Derrick Acheampong, MD, and his colleagues at the Icahn School of Medicine at Mount Sinai, New York.
They performed a retrospective data analysis of 8,441 adult patients at their large urban teaching hospital; these patients had undergone general or vascular surgery during 2013-2016 and, in the analysis, were grouped by whether they experienced postoperative CEs.
Univariate and multivariate analyses identified predictors of postoperative CE and the association of CEs with adverse postoperative outcomes. CEs were defined as myocardial infarction or cardiac arrest within the 30-day postoperative period.
A total of 157 patients (1.9%) experienced CEs after major general and vascular surgery, with no significant difference in incidence between the two types of surgery (P = .44), according to their report, published online in the Annals of Medicine and Surgery. CE-associated mortality among this group was high, at 55.4%.
The occurrence of a CE following surgery in both groups was significantly associated with increased mortality, as well as pulmonary, renal, and neurological complications, in addition to systemic sepsis, postoperative red blood cell transfusion, unplanned return to the operating room, and prolonged hospitalization, according to the researchers.
However, predictors of CEs risk between vascular and general surgery were significantly different.
For general surgery, American Society of Anesthesiologists (ASA) status greater than 3, dependent functional status, acute renal failure or dialysis, weight loss, creatinine greater than 1.2 mg/dL, international normalized ratio (INR) greater than 1.5, and partial thromboplastin time (PTT) less than 35 seconds were all unique independent predictors of postoperative CEs.
For vascular surgery, the unique significant predictors of postoperative CEs were age greater than 65 years, emergency surgery, diabetes, congestive heart failure, systemic sepsis, and operative time greater than 240 minutes.
The only common predictive risk factors for postoperative CEs for the two forms of surgery were hematocrit less than 34% and ventilator dependence.
“The present study corroborates reported studies that recommend separate predictive CE risk indices and risk stratification among different surgical specialties. Predictors for CE greatly differed between general and vascular surgery patients in our patient population,” the authors stated.
They concluded with the hope that their study “provides useful information to surgeons and allows for the necessary resources to be focused on identified at-risk patients to improve surgical outcomes.”
Dr. Acheampong and his colleagues reported having no disclosures.
SOURCE: Acheampong D et al. Ann Med Surg. 2018. doi: 10.1016/j.amsu.2018.08.001.
FROM ANNALS OF MEDICINE AND SURGERY
Key clinical point: There was a significant difference in predictive risk factors for postoperative cardiac events between vascular and general surgery.
Major finding: The 1.9% incidence of cardiac events following general or vascular surgery was associated with a mortality rate of 55%.
Study details: Retrospective study of 8,441 patients who underwent vascular or general surgery during 2013-2015.
Disclosures: The authors reported having no disclosures.
Source: Acheampong D et al. Ann Med Surg. 2018. doi: 10.1016/j.amsu.2018.08.001.
Think DEB, not BMS, with high bleeding risk
PARIS – Treatment with a drug-eluting balloon rather than bare-metal stent provided superior outcomes in patients at high bleeding risk with large-vessel coronary lesions, according to the results of the randomized DEBUT study.
“PCI with a drug-eluting balloon, with the possibility of bailout stenting if needed, is a safe and efficient novel option in patients with high bleeding risk,” Tuomas T. Rissanen, MD, PhD, said in presenting the results of the trial at the annual meeting of the European Association of Percutaneous Cardiovascular Interventions.
“The major advantage of the drug-eluting balloon–only strategy is that DAPT [dual-antiplatelet therapy] duration is short – usually 1 month – and positive remodeling of the treated vessel may occur because there is no metallic material present,” added Dr. Rissanen, head of the Heart Center at the University of Eastern Finland in Joensuu.
DEBUT (Drug-Eluting Balloon in Stable and Unstable Angina in a Randomized Controlled Noninferiority Trial) was a five-center, single-blind Finnish study in which patients at elevated bleeding risk – most often because they required oral anticoagulation and were over age 80 – were randomized to a paclitaxel-coated drug-eluting balloon (DEB) applied for a minimum of 30 seconds or a bare-metal stent (BMS). They were placed on DAPT for 1 month if they had stable coronary artery disease and 6 months after an acute coronary syndrome.
Participants had to have a target vessel diameter amenable for PCI with a DEB: that is, 2.5-4.0 mm. Patients with in-stent restenosis, an unprotected left main lesion, ST-elevation MI, chronic total occlusion, a dissection sufficient to reduce flow, greater than 30% recoil after predilation, or a bifurcation lesion requiring side branch stenting were excluded.
The impetus for the DEBUT trial was a recognition that, while the use of DEBs is recommended for treatment of in-stent restenosis by European Society of Cardiology guidelines, until DEBUT there were no high-quality randomized trial data regarding the use of such devices in de novo coronary lesions, the cardiologist noted.
The study results were unequivocal. Indeed, DEBUT, planned for 530 patients, was halted after enrollment of only 208 because an interim analysis showed clear superiority for the DEB strategy.
To wit, the primary endpoint – a composite of cardiovascular death, nonfatal MI, or target lesion revascularization at 9 months post PCI – occurred in 1.9% of the DEB group, compared with 12.4% of BMS recipients. This absolute 10.5% difference in risk translated to an 85% relative risk reduction.
Target lesion revascularization, a major secondary outcome, occurred in none of the DEB group and 4.8% of the BMS group. Bleeding Academic Research Consortium (BARC) type 2 bleeding rates were similar at 11%-12% in the two groups.
Four percent of the DEB group required bailout stenting.
“Importantly, at 9 months, there were two definite stent thrombosis cases in the BMS group and no vessel closures in the DEB group,” Dr. Rissanen observed.
Discussant Antonio Colombo, MD, said, “I think a strategy with a drug-eluting balloon makes sense.”
Even though the 2-year results of the LEADERS FREE trial have shown that the BioFreedom polymer-free drug-coated stent proved safer and more effective than a BMS in high–bleeding risk patients with 1 month of DAPT (J Am Coll Cardiol. 2017 Jan 17;69[2]:162-71), not all PCI centers have access to the BioFreedom stent.
“Why do you need to place a stent in everyone? If you have a good result with the DEB, there is no reason to. Maybe you should use fractional flow reserve [FFR] to give reassurance that the result is really good, but I am in favor of this strategy. I think if you find a small dissection, and the residual lumen is large, it’s okay. It will usually heal. I think a dissection is problematic when the residual lumen is not large,” said Dr. Colombo, chief of invasive cardiology at San Raffaele Hospital in Milan.
There is a practical problem with the DEB-only strategy, however: “Many operators are uncomfortable in not using a stent in a large vessel, even when they have a good result,” he noted.
His fellow discussant Marc Bosiers, MD, said interventional cardiologists need to get over that hangup, which isn’t evidence based.
“We have the same experience in the periphery: We leave arteries as is after DEB therapy with only small Type A, B, and even C dissections, and we have fantastic results. We have total vessel remodeling. In many cases we see the patients back after 6 months or a year and do follow-up angiography, and you’ll be surprised at what you see with DEB alone,” according to Dr. Bosiers, head of the department of vascular surgery at St. Blasius Hospital in Dendermonde, Belgium.
Dr. Rissanen said that, for their next research project, he and his coinvestigators plan to mount a multicenter randomized trial of DEB versus a drug-eluting stent rather than a BMS in high–bleeding risk patients with de novo coronary lesions. And they’re considering ditching the 1 month of DAPT in the DEB patients.
“What is this 1-month DAPT for DEB based on, anyway? I don’t think we need it at all. We could use single-antiplatelet therapy or only the loading dose of the second agent,” he asserted.
But, as one of the discussants responded, that may well be true, and perhaps in the future a course of post-DEB therapy with a single antiplatelet agent or a direct-acting oral anticoagulant will be the routine strategy, but before clinical practice is revised such novel proposals will need to be well-grounded in proof of safety and efficacy. Dr. Rissanen reported having no financial conflicts regarding the DEBUT study, conducted free of commercial support.
PARIS – Treatment with a drug-eluting balloon rather than bare-metal stent provided superior outcomes in patients at high bleeding risk with large-vessel coronary lesions, according to the results of the randomized DEBUT study.
“PCI with a drug-eluting balloon, with the possibility of bailout stenting if needed, is a safe and efficient novel option in patients with high bleeding risk,” Tuomas T. Rissanen, MD, PhD, said in presenting the results of the trial at the annual meeting of the European Association of Percutaneous Cardiovascular Interventions.
“The major advantage of the drug-eluting balloon–only strategy is that DAPT [dual-antiplatelet therapy] duration is short – usually 1 month – and positive remodeling of the treated vessel may occur because there is no metallic material present,” added Dr. Rissanen, head of the Heart Center at the University of Eastern Finland in Joensuu.
DEBUT (Drug-Eluting Balloon in Stable and Unstable Angina in a Randomized Controlled Noninferiority Trial) was a five-center, single-blind Finnish study in which patients at elevated bleeding risk – most often because they required oral anticoagulation and were over age 80 – were randomized to a paclitaxel-coated drug-eluting balloon (DEB) applied for a minimum of 30 seconds or a bare-metal stent (BMS). They were placed on DAPT for 1 month if they had stable coronary artery disease and 6 months after an acute coronary syndrome.
Participants had to have a target vessel diameter amenable for PCI with a DEB: that is, 2.5-4.0 mm. Patients with in-stent restenosis, an unprotected left main lesion, ST-elevation MI, chronic total occlusion, a dissection sufficient to reduce flow, greater than 30% recoil after predilation, or a bifurcation lesion requiring side branch stenting were excluded.
The impetus for the DEBUT trial was a recognition that, while the use of DEBs is recommended for treatment of in-stent restenosis by European Society of Cardiology guidelines, until DEBUT there were no high-quality randomized trial data regarding the use of such devices in de novo coronary lesions, the cardiologist noted.
The study results were unequivocal. Indeed, DEBUT, planned for 530 patients, was halted after enrollment of only 208 because an interim analysis showed clear superiority for the DEB strategy.
To wit, the primary endpoint – a composite of cardiovascular death, nonfatal MI, or target lesion revascularization at 9 months post PCI – occurred in 1.9% of the DEB group, compared with 12.4% of BMS recipients. This absolute 10.5% difference in risk translated to an 85% relative risk reduction.
Target lesion revascularization, a major secondary outcome, occurred in none of the DEB group and 4.8% of the BMS group. Bleeding Academic Research Consortium (BARC) type 2 bleeding rates were similar at 11%-12% in the two groups.
Four percent of the DEB group required bailout stenting.
“Importantly, at 9 months, there were two definite stent thrombosis cases in the BMS group and no vessel closures in the DEB group,” Dr. Rissanen observed.
Discussant Antonio Colombo, MD, said, “I think a strategy with a drug-eluting balloon makes sense.”
Even though the 2-year results of the LEADERS FREE trial have shown that the BioFreedom polymer-free drug-coated stent proved safer and more effective than a BMS in high–bleeding risk patients with 1 month of DAPT (J Am Coll Cardiol. 2017 Jan 17;69[2]:162-71), not all PCI centers have access to the BioFreedom stent.
“Why do you need to place a stent in everyone? If you have a good result with the DEB, there is no reason to. Maybe you should use fractional flow reserve [FFR] to give reassurance that the result is really good, but I am in favor of this strategy. I think if you find a small dissection, and the residual lumen is large, it’s okay. It will usually heal. I think a dissection is problematic when the residual lumen is not large,” said Dr. Colombo, chief of invasive cardiology at San Raffaele Hospital in Milan.
There is a practical problem with the DEB-only strategy, however: “Many operators are uncomfortable in not using a stent in a large vessel, even when they have a good result,” he noted.
His fellow discussant Marc Bosiers, MD, said interventional cardiologists need to get over that hangup, which isn’t evidence based.
“We have the same experience in the periphery: We leave arteries as is after DEB therapy with only small Type A, B, and even C dissections, and we have fantastic results. We have total vessel remodeling. In many cases we see the patients back after 6 months or a year and do follow-up angiography, and you’ll be surprised at what you see with DEB alone,” according to Dr. Bosiers, head of the department of vascular surgery at St. Blasius Hospital in Dendermonde, Belgium.
Dr. Rissanen said that, for their next research project, he and his coinvestigators plan to mount a multicenter randomized trial of DEB versus a drug-eluting stent rather than a BMS in high–bleeding risk patients with de novo coronary lesions. And they’re considering ditching the 1 month of DAPT in the DEB patients.
“What is this 1-month DAPT for DEB based on, anyway? I don’t think we need it at all. We could use single-antiplatelet therapy or only the loading dose of the second agent,” he asserted.
But, as one of the discussants responded, that may well be true, and perhaps in the future a course of post-DEB therapy with a single antiplatelet agent or a direct-acting oral anticoagulant will be the routine strategy, but before clinical practice is revised such novel proposals will need to be well-grounded in proof of safety and efficacy. Dr. Rissanen reported having no financial conflicts regarding the DEBUT study, conducted free of commercial support.
PARIS – Treatment with a drug-eluting balloon rather than bare-metal stent provided superior outcomes in patients at high bleeding risk with large-vessel coronary lesions, according to the results of the randomized DEBUT study.
“PCI with a drug-eluting balloon, with the possibility of bailout stenting if needed, is a safe and efficient novel option in patients with high bleeding risk,” Tuomas T. Rissanen, MD, PhD, said in presenting the results of the trial at the annual meeting of the European Association of Percutaneous Cardiovascular Interventions.
“The major advantage of the drug-eluting balloon–only strategy is that DAPT [dual-antiplatelet therapy] duration is short – usually 1 month – and positive remodeling of the treated vessel may occur because there is no metallic material present,” added Dr. Rissanen, head of the Heart Center at the University of Eastern Finland in Joensuu.
DEBUT (Drug-Eluting Balloon in Stable and Unstable Angina in a Randomized Controlled Noninferiority Trial) was a five-center, single-blind Finnish study in which patients at elevated bleeding risk – most often because they required oral anticoagulation and were over age 80 – were randomized to a paclitaxel-coated drug-eluting balloon (DEB) applied for a minimum of 30 seconds or a bare-metal stent (BMS). They were placed on DAPT for 1 month if they had stable coronary artery disease and 6 months after an acute coronary syndrome.
Participants had to have a target vessel diameter amenable for PCI with a DEB: that is, 2.5-4.0 mm. Patients with in-stent restenosis, an unprotected left main lesion, ST-elevation MI, chronic total occlusion, a dissection sufficient to reduce flow, greater than 30% recoil after predilation, or a bifurcation lesion requiring side branch stenting were excluded.
The impetus for the DEBUT trial was a recognition that, while the use of DEBs is recommended for treatment of in-stent restenosis by European Society of Cardiology guidelines, until DEBUT there were no high-quality randomized trial data regarding the use of such devices in de novo coronary lesions, the cardiologist noted.
The study results were unequivocal. Indeed, DEBUT, planned for 530 patients, was halted after enrollment of only 208 because an interim analysis showed clear superiority for the DEB strategy.
To wit, the primary endpoint – a composite of cardiovascular death, nonfatal MI, or target lesion revascularization at 9 months post PCI – occurred in 1.9% of the DEB group, compared with 12.4% of BMS recipients. This absolute 10.5% difference in risk translated to an 85% relative risk reduction.
Target lesion revascularization, a major secondary outcome, occurred in none of the DEB group and 4.8% of the BMS group. Bleeding Academic Research Consortium (BARC) type 2 bleeding rates were similar at 11%-12% in the two groups.
Four percent of the DEB group required bailout stenting.
“Importantly, at 9 months, there were two definite stent thrombosis cases in the BMS group and no vessel closures in the DEB group,” Dr. Rissanen observed.
Discussant Antonio Colombo, MD, said, “I think a strategy with a drug-eluting balloon makes sense.”
Even though the 2-year results of the LEADERS FREE trial have shown that the BioFreedom polymer-free drug-coated stent proved safer and more effective than a BMS in high–bleeding risk patients with 1 month of DAPT (J Am Coll Cardiol. 2017 Jan 17;69[2]:162-71), not all PCI centers have access to the BioFreedom stent.
“Why do you need to place a stent in everyone? If you have a good result with the DEB, there is no reason to. Maybe you should use fractional flow reserve [FFR] to give reassurance that the result is really good, but I am in favor of this strategy. I think if you find a small dissection, and the residual lumen is large, it’s okay. It will usually heal. I think a dissection is problematic when the residual lumen is not large,” said Dr. Colombo, chief of invasive cardiology at San Raffaele Hospital in Milan.
There is a practical problem with the DEB-only strategy, however: “Many operators are uncomfortable in not using a stent in a large vessel, even when they have a good result,” he noted.
His fellow discussant Marc Bosiers, MD, said interventional cardiologists need to get over that hangup, which isn’t evidence based.
“We have the same experience in the periphery: We leave arteries as is after DEB therapy with only small Type A, B, and even C dissections, and we have fantastic results. We have total vessel remodeling. In many cases we see the patients back after 6 months or a year and do follow-up angiography, and you’ll be surprised at what you see with DEB alone,” according to Dr. Bosiers, head of the department of vascular surgery at St. Blasius Hospital in Dendermonde, Belgium.
Dr. Rissanen said that, for their next research project, he and his coinvestigators plan to mount a multicenter randomized trial of DEB versus a drug-eluting stent rather than a BMS in high–bleeding risk patients with de novo coronary lesions. And they’re considering ditching the 1 month of DAPT in the DEB patients.
“What is this 1-month DAPT for DEB based on, anyway? I don’t think we need it at all. We could use single-antiplatelet therapy or only the loading dose of the second agent,” he asserted.
But, as one of the discussants responded, that may well be true, and perhaps in the future a course of post-DEB therapy with a single antiplatelet agent or a direct-acting oral anticoagulant will be the routine strategy, but before clinical practice is revised such novel proposals will need to be well-grounded in proof of safety and efficacy. Dr. Rissanen reported having no financial conflicts regarding the DEBUT study, conducted free of commercial support.
REPORTING FROM EUROPCR 2018
Key clinical point:
Major finding: The 9-month MACE rate was 1.9% in the drug-eluting balloon group versus 12.4% with a bare-metal stent.
Study details: This prospective, multicenter, single-blind trial randomized 208 high–bleeding risk patients with de novo lesions in large coronary vessels to PCI with a drug-eluting balloon-only or a bare-metal stent.
Disclosures: The presenter reported having no financial conflicts regarding the DEBUT study, conducted free of commercial support.
New stroke intervention guidelines stress volume
A consensus working group from numerous international societies has published new guidelines for standards of practice in the treatment of acute ischemic stroke (AIS). The new guidelines differ somewhat from the Joint Commission guideline, released in 2015, primarily by raising the bar for the number of mechanical thrombectomy (MT) procedures that level 1 and level 2 stroke centers should perform annually in order to maintain a minimum safety threshold.
Previous studies have shown lower mortality in high-volume centers, but setting minimum standards can be a challenge, especially in under-served countries and localities. The authors, led by first author Laurent Pierot, MD, PhD, of University Hospital Reims (France), acknowledge that newly established level 2 centers may struggle to meet the minimum requirement for MT procedures, but that this is acceptable as long as the volume is expected to meet the minimum within 12-24 months.
The guidelines were created by a working group of delegates from 13 international societies, including the American Society of Neuroradiology, European Stroke Organization, World Stroke Organization, and the Society of NeuroInterventional Surgery.
The publication in 2015 of studies showing the efficacy of MT in anterior circulation emergent large-vessel occlusion (ELVO) stroke patients reverberated through the stroke care community, but posed a challenge in delivering this therapy to populations in diverse localities that have no access to level 1 stroke centers.
The guidelines, published online in the Journal of NeuroInterventional Surgery, aim to ensure that facilities can handle not only the MT procedure, but also the medical management before, during, and after the procedure.
According to the new guidelines, level 2 centers should handle cases when a level 1 center cannot be reached within 2 hours. Level 2 centers should care for at least 100 AIS patients per year and should also have a relationship with a level 1 center to maintain staff training, teleconsultations, referrals, and other collaborations.
Previous studies have identified 35 or 36 MT procedures annually as a threshold to be considered “high volume,” a category that led to lower mortality. The new recommendations fall below that threshold because they are intended to apply broadly, to regions that may be under-served. In highly developed countries, stroke centers should follow regional or national guidelines that have higher limits.
Level 2 centers should perform at least 50 intracranial thrombectomy procedures for ELVO, and a total of 120 diagnostic or interventional neuroendovascular procedures per year. Individual interventionists should conduct at least 15 intracranial thrombectomy and 50 interventional neuroendovascular procedures per year.
Other recommendations cover additional details about personnel, as well as community and emergency medical services outreach.
In many ways, the recommendations are in line with the Joint Commission (TJC), according to David Tirschwell, MD, who is the medical director for the UW Medicine* Comprehensive Stroke Center at Harborview Medical Center, Seattle. He was not involved in the development of the new guidelines.
Dr. Tirschwell noted one key difference with respect to the number of MT procedures required to qualify. TJC offered no minimum annual procedures for Comprehensive Stroke Centers (equivalent to level 1), and only 15 for Thrombectomy Capable Stroke Centers (level 2), versus 50 in the new guidelines. The minimum procedure numbers are also higher for individual clinicians.
The guidelines also recommend that level 2 centers have at least three interventionalists on staff available at all times, while TJC does not address this element of staffing.
“The higher minimum number of procedures in the new international recommendations is a substantial difference and would make it harder for many hospitals to qualify, compared to the TJC requirements. As such, a lower number of hospitals may qualify, and such a barrier could prevent access to mechanical thrombectomy for many patients. On the other hand, the higher minimum number may ensure a higher quality of care, which can be seen as a strong positive feature,” Dr. Tirschwell said.
A spokesman for the Joint Commission and the American Heart Association indicated that they will review the new guidelines and consider whether to make changes to their 2015 guidelines.
SOURCE: Pierot Laurent et al. J Neurointervent Surg. 2018 Aug 28. doi: 10.1136/neurintsurg-2018-014287.
*Updated Sept. 14, 2018.
A consensus working group from numerous international societies has published new guidelines for standards of practice in the treatment of acute ischemic stroke (AIS). The new guidelines differ somewhat from the Joint Commission guideline, released in 2015, primarily by raising the bar for the number of mechanical thrombectomy (MT) procedures that level 1 and level 2 stroke centers should perform annually in order to maintain a minimum safety threshold.
Previous studies have shown lower mortality in high-volume centers, but setting minimum standards can be a challenge, especially in under-served countries and localities. The authors, led by first author Laurent Pierot, MD, PhD, of University Hospital Reims (France), acknowledge that newly established level 2 centers may struggle to meet the minimum requirement for MT procedures, but that this is acceptable as long as the volume is expected to meet the minimum within 12-24 months.
The guidelines were created by a working group of delegates from 13 international societies, including the American Society of Neuroradiology, European Stroke Organization, World Stroke Organization, and the Society of NeuroInterventional Surgery.
The publication in 2015 of studies showing the efficacy of MT in anterior circulation emergent large-vessel occlusion (ELVO) stroke patients reverberated through the stroke care community, but posed a challenge in delivering this therapy to populations in diverse localities that have no access to level 1 stroke centers.
The guidelines, published online in the Journal of NeuroInterventional Surgery, aim to ensure that facilities can handle not only the MT procedure, but also the medical management before, during, and after the procedure.
According to the new guidelines, level 2 centers should handle cases when a level 1 center cannot be reached within 2 hours. Level 2 centers should care for at least 100 AIS patients per year and should also have a relationship with a level 1 center to maintain staff training, teleconsultations, referrals, and other collaborations.
Previous studies have identified 35 or 36 MT procedures annually as a threshold to be considered “high volume,” a category that led to lower mortality. The new recommendations fall below that threshold because they are intended to apply broadly, to regions that may be under-served. In highly developed countries, stroke centers should follow regional or national guidelines that have higher limits.
Level 2 centers should perform at least 50 intracranial thrombectomy procedures for ELVO, and a total of 120 diagnostic or interventional neuroendovascular procedures per year. Individual interventionists should conduct at least 15 intracranial thrombectomy and 50 interventional neuroendovascular procedures per year.
Other recommendations cover additional details about personnel, as well as community and emergency medical services outreach.
In many ways, the recommendations are in line with the Joint Commission (TJC), according to David Tirschwell, MD, who is the medical director for the UW Medicine* Comprehensive Stroke Center at Harborview Medical Center, Seattle. He was not involved in the development of the new guidelines.
Dr. Tirschwell noted one key difference with respect to the number of MT procedures required to qualify. TJC offered no minimum annual procedures for Comprehensive Stroke Centers (equivalent to level 1), and only 15 for Thrombectomy Capable Stroke Centers (level 2), versus 50 in the new guidelines. The minimum procedure numbers are also higher for individual clinicians.
The guidelines also recommend that level 2 centers have at least three interventionalists on staff available at all times, while TJC does not address this element of staffing.
“The higher minimum number of procedures in the new international recommendations is a substantial difference and would make it harder for many hospitals to qualify, compared to the TJC requirements. As such, a lower number of hospitals may qualify, and such a barrier could prevent access to mechanical thrombectomy for many patients. On the other hand, the higher minimum number may ensure a higher quality of care, which can be seen as a strong positive feature,” Dr. Tirschwell said.
A spokesman for the Joint Commission and the American Heart Association indicated that they will review the new guidelines and consider whether to make changes to their 2015 guidelines.
SOURCE: Pierot Laurent et al. J Neurointervent Surg. 2018 Aug 28. doi: 10.1136/neurintsurg-2018-014287.
*Updated Sept. 14, 2018.
A consensus working group from numerous international societies has published new guidelines for standards of practice in the treatment of acute ischemic stroke (AIS). The new guidelines differ somewhat from the Joint Commission guideline, released in 2015, primarily by raising the bar for the number of mechanical thrombectomy (MT) procedures that level 1 and level 2 stroke centers should perform annually in order to maintain a minimum safety threshold.
Previous studies have shown lower mortality in high-volume centers, but setting minimum standards can be a challenge, especially in under-served countries and localities. The authors, led by first author Laurent Pierot, MD, PhD, of University Hospital Reims (France), acknowledge that newly established level 2 centers may struggle to meet the minimum requirement for MT procedures, but that this is acceptable as long as the volume is expected to meet the minimum within 12-24 months.
The guidelines were created by a working group of delegates from 13 international societies, including the American Society of Neuroradiology, European Stroke Organization, World Stroke Organization, and the Society of NeuroInterventional Surgery.
The publication in 2015 of studies showing the efficacy of MT in anterior circulation emergent large-vessel occlusion (ELVO) stroke patients reverberated through the stroke care community, but posed a challenge in delivering this therapy to populations in diverse localities that have no access to level 1 stroke centers.
The guidelines, published online in the Journal of NeuroInterventional Surgery, aim to ensure that facilities can handle not only the MT procedure, but also the medical management before, during, and after the procedure.
According to the new guidelines, level 2 centers should handle cases when a level 1 center cannot be reached within 2 hours. Level 2 centers should care for at least 100 AIS patients per year and should also have a relationship with a level 1 center to maintain staff training, teleconsultations, referrals, and other collaborations.
Previous studies have identified 35 or 36 MT procedures annually as a threshold to be considered “high volume,” a category that led to lower mortality. The new recommendations fall below that threshold because they are intended to apply broadly, to regions that may be under-served. In highly developed countries, stroke centers should follow regional or national guidelines that have higher limits.
Level 2 centers should perform at least 50 intracranial thrombectomy procedures for ELVO, and a total of 120 diagnostic or interventional neuroendovascular procedures per year. Individual interventionists should conduct at least 15 intracranial thrombectomy and 50 interventional neuroendovascular procedures per year.
Other recommendations cover additional details about personnel, as well as community and emergency medical services outreach.
In many ways, the recommendations are in line with the Joint Commission (TJC), according to David Tirschwell, MD, who is the medical director for the UW Medicine* Comprehensive Stroke Center at Harborview Medical Center, Seattle. He was not involved in the development of the new guidelines.
Dr. Tirschwell noted one key difference with respect to the number of MT procedures required to qualify. TJC offered no minimum annual procedures for Comprehensive Stroke Centers (equivalent to level 1), and only 15 for Thrombectomy Capable Stroke Centers (level 2), versus 50 in the new guidelines. The minimum procedure numbers are also higher for individual clinicians.
The guidelines also recommend that level 2 centers have at least three interventionalists on staff available at all times, while TJC does not address this element of staffing.
“The higher minimum number of procedures in the new international recommendations is a substantial difference and would make it harder for many hospitals to qualify, compared to the TJC requirements. As such, a lower number of hospitals may qualify, and such a barrier could prevent access to mechanical thrombectomy for many patients. On the other hand, the higher minimum number may ensure a higher quality of care, which can be seen as a strong positive feature,” Dr. Tirschwell said.
A spokesman for the Joint Commission and the American Heart Association indicated that they will review the new guidelines and consider whether to make changes to their 2015 guidelines.
SOURCE: Pierot Laurent et al. J Neurointervent Surg. 2018 Aug 28. doi: 10.1136/neurintsurg-2018-014287.
*Updated Sept. 14, 2018.
FROM THE JOURNAL OF NEUROINTERVENTIONAL SURGERY
Coronary CT angiography radiation dose fell 78% from 2007-2017
MUNICH – The median radiation dosage received by patients worldwide undergoing coronary CT angiography fell by 78% from 2007 to 2017, according to a prospective study with more than 4,500 patients.
This substantial drop in radiation occurred with a steady rate of nondiagnostic CT scans, less than 2% in both 2007 and 2017.
“Given the high diagnostic accuracy and the low radiation dose, coronary CT angiography should be considered as a first-line diagnostic test,” Jörg Hausleiter, MD, said at the annual congress of the European Society of Cardiology.
The results also showed a huge disparity in the range of radiation doses used worldwide, with a 37-fold intersite variability in the median dose. This finding “underlines the need for further site-specific training and adaptation of contemporary cardiac scan protocols,” said Dr. Hausleiter, professor of medicine at the University of Munich Clinic. He suggested updated imaging guidelines on radiation levels, more educational sessions on how to perform coronary CT angiography, and actions by vendors to adjust their standard imaging protocols.
The Prospective Multicenter Registry on Radiation Dose Estimates of Cardiac CT Angiography in Daily Practice in 2017 (PROTECTION-VI) study included 4,502 patients from a total of 61 sites in 32 countries. At each participating site, investigators enrolled consecutive adults during a randomly selected month in 2017, with a median of 51 patients enrolled at each site undergoing diagnostic coronary CT angiography. Comparison data for 2007 came from a similar study run by Dr. Hausleiter and his associates at that time, with 1,965 patients undergoing coronary CT angiography (JAMA. 2009 Feb 4;301[5]:500-7). In 2007, the median dose-length product of radiation for each scan was 885 mGy x cm, which corresponds to a radiation dose of about 12.4 mSv. In 2017, the median dose-length product was 195 mGy x cm, corresponding to a dose of about 2.7 mSv. By both measures the median dose dropped by roughly 78%.
A multivariate analysis identified three changes in the way clinicians obtained most of the CT scans during the two studied time periods that seemed to explain the drop in radiation dose. First, more scan protocols in 2017 used low tube potential; second, more protocols in 2017 used prospectively ECG-triggered axial high-pitch scans; and third, 2017 had increased use of iterative image reconstruction, Dr. Hausleiter said. Patient variables that had modest but significant links with increased radiation doses were higher body weight, higher heart rate, and no sinus rhythm.
Concurrently with Dr. Hausleiter’s talk at the congress, the results appeared in an article online (Euro Heart J. 2018 Aug 25. doi: 10.1093/eurheartj/ehy546).
The results from the PROTECTION VI study show that the radiation doses used today for coronary CT angiography are very low. But the study is limited by looking only at the median doses used at 61 sites worldwide. I hope that the dose level seen in the study is what is now used at community hospitals across the United States, but for the time being we can’t be sure.
With today’s CT technology, as long as the dose-length product a patient receives is less than 200 mGy x cm, the facility is doing a good job of minimizing radiation exposure. As CT technology continues to improve, we can expect the median dose to fall even more in the future.
Todd C. Villines, MD , a cardiologist at Georgetown University in Washington and immediate past president of the Society of Cardiovascular CT, made these comments in an interview. He had no relevant disclosures.
The results from the PROTECTION VI study show that the radiation doses used today for coronary CT angiography are very low. But the study is limited by looking only at the median doses used at 61 sites worldwide. I hope that the dose level seen in the study is what is now used at community hospitals across the United States, but for the time being we can’t be sure.
With today’s CT technology, as long as the dose-length product a patient receives is less than 200 mGy x cm, the facility is doing a good job of minimizing radiation exposure. As CT technology continues to improve, we can expect the median dose to fall even more in the future.
Todd C. Villines, MD , a cardiologist at Georgetown University in Washington and immediate past president of the Society of Cardiovascular CT, made these comments in an interview. He had no relevant disclosures.
The results from the PROTECTION VI study show that the radiation doses used today for coronary CT angiography are very low. But the study is limited by looking only at the median doses used at 61 sites worldwide. I hope that the dose level seen in the study is what is now used at community hospitals across the United States, but for the time being we can’t be sure.
With today’s CT technology, as long as the dose-length product a patient receives is less than 200 mGy x cm, the facility is doing a good job of minimizing radiation exposure. As CT technology continues to improve, we can expect the median dose to fall even more in the future.
Todd C. Villines, MD , a cardiologist at Georgetown University in Washington and immediate past president of the Society of Cardiovascular CT, made these comments in an interview. He had no relevant disclosures.
MUNICH – The median radiation dosage received by patients worldwide undergoing coronary CT angiography fell by 78% from 2007 to 2017, according to a prospective study with more than 4,500 patients.
This substantial drop in radiation occurred with a steady rate of nondiagnostic CT scans, less than 2% in both 2007 and 2017.
“Given the high diagnostic accuracy and the low radiation dose, coronary CT angiography should be considered as a first-line diagnostic test,” Jörg Hausleiter, MD, said at the annual congress of the European Society of Cardiology.
The results also showed a huge disparity in the range of radiation doses used worldwide, with a 37-fold intersite variability in the median dose. This finding “underlines the need for further site-specific training and adaptation of contemporary cardiac scan protocols,” said Dr. Hausleiter, professor of medicine at the University of Munich Clinic. He suggested updated imaging guidelines on radiation levels, more educational sessions on how to perform coronary CT angiography, and actions by vendors to adjust their standard imaging protocols.
The Prospective Multicenter Registry on Radiation Dose Estimates of Cardiac CT Angiography in Daily Practice in 2017 (PROTECTION-VI) study included 4,502 patients from a total of 61 sites in 32 countries. At each participating site, investigators enrolled consecutive adults during a randomly selected month in 2017, with a median of 51 patients enrolled at each site undergoing diagnostic coronary CT angiography. Comparison data for 2007 came from a similar study run by Dr. Hausleiter and his associates at that time, with 1,965 patients undergoing coronary CT angiography (JAMA. 2009 Feb 4;301[5]:500-7). In 2007, the median dose-length product of radiation for each scan was 885 mGy x cm, which corresponds to a radiation dose of about 12.4 mSv. In 2017, the median dose-length product was 195 mGy x cm, corresponding to a dose of about 2.7 mSv. By both measures the median dose dropped by roughly 78%.
A multivariate analysis identified three changes in the way clinicians obtained most of the CT scans during the two studied time periods that seemed to explain the drop in radiation dose. First, more scan protocols in 2017 used low tube potential; second, more protocols in 2017 used prospectively ECG-triggered axial high-pitch scans; and third, 2017 had increased use of iterative image reconstruction, Dr. Hausleiter said. Patient variables that had modest but significant links with increased radiation doses were higher body weight, higher heart rate, and no sinus rhythm.
Concurrently with Dr. Hausleiter’s talk at the congress, the results appeared in an article online (Euro Heart J. 2018 Aug 25. doi: 10.1093/eurheartj/ehy546).
MUNICH – The median radiation dosage received by patients worldwide undergoing coronary CT angiography fell by 78% from 2007 to 2017, according to a prospective study with more than 4,500 patients.
This substantial drop in radiation occurred with a steady rate of nondiagnostic CT scans, less than 2% in both 2007 and 2017.
“Given the high diagnostic accuracy and the low radiation dose, coronary CT angiography should be considered as a first-line diagnostic test,” Jörg Hausleiter, MD, said at the annual congress of the European Society of Cardiology.
The results also showed a huge disparity in the range of radiation doses used worldwide, with a 37-fold intersite variability in the median dose. This finding “underlines the need for further site-specific training and adaptation of contemporary cardiac scan protocols,” said Dr. Hausleiter, professor of medicine at the University of Munich Clinic. He suggested updated imaging guidelines on radiation levels, more educational sessions on how to perform coronary CT angiography, and actions by vendors to adjust their standard imaging protocols.
The Prospective Multicenter Registry on Radiation Dose Estimates of Cardiac CT Angiography in Daily Practice in 2017 (PROTECTION-VI) study included 4,502 patients from a total of 61 sites in 32 countries. At each participating site, investigators enrolled consecutive adults during a randomly selected month in 2017, with a median of 51 patients enrolled at each site undergoing diagnostic coronary CT angiography. Comparison data for 2007 came from a similar study run by Dr. Hausleiter and his associates at that time, with 1,965 patients undergoing coronary CT angiography (JAMA. 2009 Feb 4;301[5]:500-7). In 2007, the median dose-length product of radiation for each scan was 885 mGy x cm, which corresponds to a radiation dose of about 12.4 mSv. In 2017, the median dose-length product was 195 mGy x cm, corresponding to a dose of about 2.7 mSv. By both measures the median dose dropped by roughly 78%.
A multivariate analysis identified three changes in the way clinicians obtained most of the CT scans during the two studied time periods that seemed to explain the drop in radiation dose. First, more scan protocols in 2017 used low tube potential; second, more protocols in 2017 used prospectively ECG-triggered axial high-pitch scans; and third, 2017 had increased use of iterative image reconstruction, Dr. Hausleiter said. Patient variables that had modest but significant links with increased radiation doses were higher body weight, higher heart rate, and no sinus rhythm.
Concurrently with Dr. Hausleiter’s talk at the congress, the results appeared in an article online (Euro Heart J. 2018 Aug 25. doi: 10.1093/eurheartj/ehy546).
REPORTING FROM THE ESC CONGRESS 2018
Key clinical point: The median radiation dose during coronary CT angiography fell from 2007 to 2017.
Major finding: The median dose-length product was 195 mGY x cm in 2017 and 885 mGy x cm in 2007.
Study details: PROTECTION VI, a prospective study run at 61 sites in 32 countries.
Disclosures: PROTECTION VI received no commercial funding. Dr. Hausleiter has received research funding from Abbott Vascular.
Restrictive transfusions do not increase long-term CV surgery risk
MUNICH – in a large, randomized trial presented at the annual congress of the European Society of Cardiology, and published simultaneously in the New England Journal of Medicine.
The investigators previously reported that 28 day outcomes were non-inferior with the restrictive approach, but they wanted to look into 6 month results to rule out latent problems, such as sequelae from perioperative organ hypoxia.
The new outcomes from the study, dubbed the Transfusion Requirements in Cardiac Surgery (TRICS) III trial, offer some reassurance at a time when cardiac surgeons are shifting towards more restrictive transfusion policies (N Engl J Med. 2018 Aug 26.doi: 10.1056/NEJMoa1808561).
The trial randomized 2,317 patients to red cell transfusions if their hemoglobin concentrations fell below 7.5 g/dL intraoperatively or postoperatively. Another 2,347 were randomized to the liberal approach, with transfusions below 9.5 g/dL in the operating room and ICU, and below 8.5 g/dL outside of the ICU. The arms were well matched, with a mean score of 8 in both groups on the 47-point European System for Cardiac Operative Risk Evaluation I score.
At 6 months, 17.4% of patients in the restrictive arm, versus 17.1% in the liberal-threshold group, met the primary composite outcome of death from any cause, myocardial infarction, stroke, or new onset renal failure with dialysis (P = .006 for noninferiority with the restrictive threshold); 6.2% of patients in the restrictive-threshold group, versus 6.4% in the liberal-arm, had died at that point, a statistically insignificant difference.
Also at 6 months, 43.8% of patients in the restrictive-threshold group, versus 42.8% in the liberal arm, met the study’s secondary composite outcome, which included the components of the primary outcome plus hospital readmissions, ED visits, and coronary revascularization. The difference was again statistically insignificant.
The restrictive strategy saved a lot of blood. Just over half of the patients, versus almost three-quarters in the liberal arm, were transfused during their index admissions. When transfused, patients in the restrictive arm received a median of 2 units of red cells; liberal-arm patients received a median of 3 units.
Unexpectedly, patients 75 years and older had a lower risk of poor outcomes with the restrictive strategy, while the liberal strategy was associated with lower risk in younger subjects. The findings “appear to contradict” current practice, “in which a liberal transfusion strategy is used in older patients undergoing cardiac or noncardiac surgery,” said investigators led by C. David Mazer, MD, a professor in the department of anesthesia at the University of Toronto.
“One could hypothesize that older patients may have unacceptable adverse effects related to transfusion (e.g., volume overload and inflammatory and infectious complications) or that there may be age-related differences in the adverse-effect profile of transfusion or anemia. ... Whether transfusion thresholds should differ according to age” needs to be determined, they said.
The participants were a mean of 72 years old, and 35% were women. The majority in both arms underwent coronary artery bypass surgery, valve surgery, or both. Heart transplants were excluded. The trial was conducted in 19 countries, including China and India; results were consistent across study sites.
The work was funded by the Canadian Institutes of Health Research, among others. Dr. Mazer had no relevant disclosures.
SOURCE: Mazer CD et al. N Engl J Med. 2018 Aug 26. doi:10.1056/NEJMoa1808561
MUNICH – in a large, randomized trial presented at the annual congress of the European Society of Cardiology, and published simultaneously in the New England Journal of Medicine.
The investigators previously reported that 28 day outcomes were non-inferior with the restrictive approach, but they wanted to look into 6 month results to rule out latent problems, such as sequelae from perioperative organ hypoxia.
The new outcomes from the study, dubbed the Transfusion Requirements in Cardiac Surgery (TRICS) III trial, offer some reassurance at a time when cardiac surgeons are shifting towards more restrictive transfusion policies (N Engl J Med. 2018 Aug 26.doi: 10.1056/NEJMoa1808561).
The trial randomized 2,317 patients to red cell transfusions if their hemoglobin concentrations fell below 7.5 g/dL intraoperatively or postoperatively. Another 2,347 were randomized to the liberal approach, with transfusions below 9.5 g/dL in the operating room and ICU, and below 8.5 g/dL outside of the ICU. The arms were well matched, with a mean score of 8 in both groups on the 47-point European System for Cardiac Operative Risk Evaluation I score.
At 6 months, 17.4% of patients in the restrictive arm, versus 17.1% in the liberal-threshold group, met the primary composite outcome of death from any cause, myocardial infarction, stroke, or new onset renal failure with dialysis (P = .006 for noninferiority with the restrictive threshold); 6.2% of patients in the restrictive-threshold group, versus 6.4% in the liberal-arm, had died at that point, a statistically insignificant difference.
Also at 6 months, 43.8% of patients in the restrictive-threshold group, versus 42.8% in the liberal arm, met the study’s secondary composite outcome, which included the components of the primary outcome plus hospital readmissions, ED visits, and coronary revascularization. The difference was again statistically insignificant.
The restrictive strategy saved a lot of blood. Just over half of the patients, versus almost three-quarters in the liberal arm, were transfused during their index admissions. When transfused, patients in the restrictive arm received a median of 2 units of red cells; liberal-arm patients received a median of 3 units.
Unexpectedly, patients 75 years and older had a lower risk of poor outcomes with the restrictive strategy, while the liberal strategy was associated with lower risk in younger subjects. The findings “appear to contradict” current practice, “in which a liberal transfusion strategy is used in older patients undergoing cardiac or noncardiac surgery,” said investigators led by C. David Mazer, MD, a professor in the department of anesthesia at the University of Toronto.
“One could hypothesize that older patients may have unacceptable adverse effects related to transfusion (e.g., volume overload and inflammatory and infectious complications) or that there may be age-related differences in the adverse-effect profile of transfusion or anemia. ... Whether transfusion thresholds should differ according to age” needs to be determined, they said.
The participants were a mean of 72 years old, and 35% were women. The majority in both arms underwent coronary artery bypass surgery, valve surgery, or both. Heart transplants were excluded. The trial was conducted in 19 countries, including China and India; results were consistent across study sites.
The work was funded by the Canadian Institutes of Health Research, among others. Dr. Mazer had no relevant disclosures.
SOURCE: Mazer CD et al. N Engl J Med. 2018 Aug 26. doi:10.1056/NEJMoa1808561
MUNICH – in a large, randomized trial presented at the annual congress of the European Society of Cardiology, and published simultaneously in the New England Journal of Medicine.
The investigators previously reported that 28 day outcomes were non-inferior with the restrictive approach, but they wanted to look into 6 month results to rule out latent problems, such as sequelae from perioperative organ hypoxia.
The new outcomes from the study, dubbed the Transfusion Requirements in Cardiac Surgery (TRICS) III trial, offer some reassurance at a time when cardiac surgeons are shifting towards more restrictive transfusion policies (N Engl J Med. 2018 Aug 26.doi: 10.1056/NEJMoa1808561).
The trial randomized 2,317 patients to red cell transfusions if their hemoglobin concentrations fell below 7.5 g/dL intraoperatively or postoperatively. Another 2,347 were randomized to the liberal approach, with transfusions below 9.5 g/dL in the operating room and ICU, and below 8.5 g/dL outside of the ICU. The arms were well matched, with a mean score of 8 in both groups on the 47-point European System for Cardiac Operative Risk Evaluation I score.
At 6 months, 17.4% of patients in the restrictive arm, versus 17.1% in the liberal-threshold group, met the primary composite outcome of death from any cause, myocardial infarction, stroke, or new onset renal failure with dialysis (P = .006 for noninferiority with the restrictive threshold); 6.2% of patients in the restrictive-threshold group, versus 6.4% in the liberal-arm, had died at that point, a statistically insignificant difference.
Also at 6 months, 43.8% of patients in the restrictive-threshold group, versus 42.8% in the liberal arm, met the study’s secondary composite outcome, which included the components of the primary outcome plus hospital readmissions, ED visits, and coronary revascularization. The difference was again statistically insignificant.
The restrictive strategy saved a lot of blood. Just over half of the patients, versus almost three-quarters in the liberal arm, were transfused during their index admissions. When transfused, patients in the restrictive arm received a median of 2 units of red cells; liberal-arm patients received a median of 3 units.
Unexpectedly, patients 75 years and older had a lower risk of poor outcomes with the restrictive strategy, while the liberal strategy was associated with lower risk in younger subjects. The findings “appear to contradict” current practice, “in which a liberal transfusion strategy is used in older patients undergoing cardiac or noncardiac surgery,” said investigators led by C. David Mazer, MD, a professor in the department of anesthesia at the University of Toronto.
“One could hypothesize that older patients may have unacceptable adverse effects related to transfusion (e.g., volume overload and inflammatory and infectious complications) or that there may be age-related differences in the adverse-effect profile of transfusion or anemia. ... Whether transfusion thresholds should differ according to age” needs to be determined, they said.
The participants were a mean of 72 years old, and 35% were women. The majority in both arms underwent coronary artery bypass surgery, valve surgery, or both. Heart transplants were excluded. The trial was conducted in 19 countries, including China and India; results were consistent across study sites.
The work was funded by the Canadian Institutes of Health Research, among others. Dr. Mazer had no relevant disclosures.
SOURCE: Mazer CD et al. N Engl J Med. 2018 Aug 26. doi:10.1056/NEJMoa1808561
REPORTING FROM THE ESC CONGRESS 2018
Key clinical point: A restrictive transfusion strategy during cardiovascular surgery, versus a more traditional liberal approach, did not increase the risk of poor outcomes at 6 months.
Major finding: At 6 months, 17.4% of patients in the restrictive arm, versus 17.1% in the liberal-threshold group, met the primary composite outcome of death from any cause, myocardial infarction, stroke, or new onset renal failure with dialysis (P = .006 for noninferiority with the restrictive approach).
Study details: Randomized, multicenter trial with over 5,000 surgery patients
Disclosures: The work was funded by the Canadian Institutes of Health Research, among others. The lead investigator had no relevant disclosures.
Source: Mazer CD et al. N Engl J Med. 2018 Aug 26. doi:10.1056/NEJMoa1808561
Culprit-vessel PCI may be safer long term in cardiogenic shock
At 30 days, culprit lesion–only PCI was associated with fewer cases of death or renal replacement therapy than immediate multivessel PCI.
However, not all the news was good for culprit lesion–only PCI: At 1 year, it was associated with a higher frequency of rehospitalization for heart failure and of repeat vascularization, according to Holger Thiele, MD, of the Heart Center Leipzig at the University of Leipzig (Germany) and his colleagues.
These results from the Culprit Only Lesion PCI versus Multivessel PCI in Cardiogenic Shock (CULPRIT-SHOCK) study were presented at the annual congress of the European Society of Cardiology and published simultaneously in the New England Journal of Medicine.
The 30-day results from the study, published in the journal last year, were enough to convince the creators of the European revascularization guidelines to downgrade immediate multivessel PCI in cardiogenic shock to a class III B recommendation, which indicates that it is not effective and may cause harm.
However, the results also caused controversy because complete revascularization via immediate multivessel PCI in cardiogenic shock patients might lead to long-term benefits. In fact, evidence from nonrandomized trials and a registry study had suggested that immediate multivessel PCI may reduce mortality at 1 year.
But the new 1-year data don’t support that hypothesis of long-term benefit, Dr. Thiele and his colleagues found.
The CULPRIT-SHOCK trial randomized 684 patients at 83 centers to culprit lesion–only PCI or multivessel PCI. At 30 days, death or renal replacement therapy occurred at a lower frequency in the culprit lesion–only group (45.9% vs. 55.4%; relative risk, 0.83; P = .01).
At 1 year, all-cause mortality was 50.0% in the group that underwent culprit lesion–only PCI, compared with 56.9% in the group that underwent multivessel PCI, a result that was not statistically significant (RR, 0.88; 95% CI, 0.76-1.01). There was also no significant difference in death from cardiovascular causes, 46.2% in culprit lesion–only patients, compared with 52.8% in multivessel patients (RR, 0.88; 95% CI, 0.75-1.02).
Mortality rates between baseline and 1 year were similar in the intention-to-treat, per-protocol, and as-treated populations.
The researchers conducted a post hoc analysis of the original primary endpoint – death or renal replacement therapy – at 1 year, and they found results similar to those seen at 30 days: 52.0% in the culprit lesion–only group and 59.5% in the multivessel group (RR, 0.87; 95% CI, 0.76-0.99).
Some results favored multivessel PCI: 32.3% of the culprit lesion–only group underwent repeat revascularization, compared with 9.4% of multivessel PCI (RR, 3.44; 95% CI, 2.39-4.95). Rehospitalizations for congestive heart failure were rare, but occurred in 5.2% of the culprit lesion–only group, compared with 1.2% of the multivessel group (RR, 4.46; 95% CI, 1.53-13.04).
The study was funded by the European Union Seventh Framework Programme, the German Heart Research Foundation, and the German Centre for Cardiovascular Research. Dr. Thiele had no relevant conflicts of interest.
SOURCE: Thiele H et al. N Engl J Med. 2018 Aug 2
At 30 days, culprit lesion–only PCI was associated with fewer cases of death or renal replacement therapy than immediate multivessel PCI.
However, not all the news was good for culprit lesion–only PCI: At 1 year, it was associated with a higher frequency of rehospitalization for heart failure and of repeat vascularization, according to Holger Thiele, MD, of the Heart Center Leipzig at the University of Leipzig (Germany) and his colleagues.
These results from the Culprit Only Lesion PCI versus Multivessel PCI in Cardiogenic Shock (CULPRIT-SHOCK) study were presented at the annual congress of the European Society of Cardiology and published simultaneously in the New England Journal of Medicine.
The 30-day results from the study, published in the journal last year, were enough to convince the creators of the European revascularization guidelines to downgrade immediate multivessel PCI in cardiogenic shock to a class III B recommendation, which indicates that it is not effective and may cause harm.
However, the results also caused controversy because complete revascularization via immediate multivessel PCI in cardiogenic shock patients might lead to long-term benefits. In fact, evidence from nonrandomized trials and a registry study had suggested that immediate multivessel PCI may reduce mortality at 1 year.
But the new 1-year data don’t support that hypothesis of long-term benefit, Dr. Thiele and his colleagues found.
The CULPRIT-SHOCK trial randomized 684 patients at 83 centers to culprit lesion–only PCI or multivessel PCI. At 30 days, death or renal replacement therapy occurred at a lower frequency in the culprit lesion–only group (45.9% vs. 55.4%; relative risk, 0.83; P = .01).
At 1 year, all-cause mortality was 50.0% in the group that underwent culprit lesion–only PCI, compared with 56.9% in the group that underwent multivessel PCI, a result that was not statistically significant (RR, 0.88; 95% CI, 0.76-1.01). There was also no significant difference in death from cardiovascular causes, 46.2% in culprit lesion–only patients, compared with 52.8% in multivessel patients (RR, 0.88; 95% CI, 0.75-1.02).
Mortality rates between baseline and 1 year were similar in the intention-to-treat, per-protocol, and as-treated populations.
The researchers conducted a post hoc analysis of the original primary endpoint – death or renal replacement therapy – at 1 year, and they found results similar to those seen at 30 days: 52.0% in the culprit lesion–only group and 59.5% in the multivessel group (RR, 0.87; 95% CI, 0.76-0.99).
Some results favored multivessel PCI: 32.3% of the culprit lesion–only group underwent repeat revascularization, compared with 9.4% of multivessel PCI (RR, 3.44; 95% CI, 2.39-4.95). Rehospitalizations for congestive heart failure were rare, but occurred in 5.2% of the culprit lesion–only group, compared with 1.2% of the multivessel group (RR, 4.46; 95% CI, 1.53-13.04).
The study was funded by the European Union Seventh Framework Programme, the German Heart Research Foundation, and the German Centre for Cardiovascular Research. Dr. Thiele had no relevant conflicts of interest.
SOURCE: Thiele H et al. N Engl J Med. 2018 Aug 2
At 30 days, culprit lesion–only PCI was associated with fewer cases of death or renal replacement therapy than immediate multivessel PCI.
However, not all the news was good for culprit lesion–only PCI: At 1 year, it was associated with a higher frequency of rehospitalization for heart failure and of repeat vascularization, according to Holger Thiele, MD, of the Heart Center Leipzig at the University of Leipzig (Germany) and his colleagues.
These results from the Culprit Only Lesion PCI versus Multivessel PCI in Cardiogenic Shock (CULPRIT-SHOCK) study were presented at the annual congress of the European Society of Cardiology and published simultaneously in the New England Journal of Medicine.
The 30-day results from the study, published in the journal last year, were enough to convince the creators of the European revascularization guidelines to downgrade immediate multivessel PCI in cardiogenic shock to a class III B recommendation, which indicates that it is not effective and may cause harm.
However, the results also caused controversy because complete revascularization via immediate multivessel PCI in cardiogenic shock patients might lead to long-term benefits. In fact, evidence from nonrandomized trials and a registry study had suggested that immediate multivessel PCI may reduce mortality at 1 year.
But the new 1-year data don’t support that hypothesis of long-term benefit, Dr. Thiele and his colleagues found.
The CULPRIT-SHOCK trial randomized 684 patients at 83 centers to culprit lesion–only PCI or multivessel PCI. At 30 days, death or renal replacement therapy occurred at a lower frequency in the culprit lesion–only group (45.9% vs. 55.4%; relative risk, 0.83; P = .01).
At 1 year, all-cause mortality was 50.0% in the group that underwent culprit lesion–only PCI, compared with 56.9% in the group that underwent multivessel PCI, a result that was not statistically significant (RR, 0.88; 95% CI, 0.76-1.01). There was also no significant difference in death from cardiovascular causes, 46.2% in culprit lesion–only patients, compared with 52.8% in multivessel patients (RR, 0.88; 95% CI, 0.75-1.02).
Mortality rates between baseline and 1 year were similar in the intention-to-treat, per-protocol, and as-treated populations.
The researchers conducted a post hoc analysis of the original primary endpoint – death or renal replacement therapy – at 1 year, and they found results similar to those seen at 30 days: 52.0% in the culprit lesion–only group and 59.5% in the multivessel group (RR, 0.87; 95% CI, 0.76-0.99).
Some results favored multivessel PCI: 32.3% of the culprit lesion–only group underwent repeat revascularization, compared with 9.4% of multivessel PCI (RR, 3.44; 95% CI, 2.39-4.95). Rehospitalizations for congestive heart failure were rare, but occurred in 5.2% of the culprit lesion–only group, compared with 1.2% of the multivessel group (RR, 4.46; 95% CI, 1.53-13.04).
The study was funded by the European Union Seventh Framework Programme, the German Heart Research Foundation, and the German Centre for Cardiovascular Research. Dr. Thiele had no relevant conflicts of interest.
SOURCE: Thiele H et al. N Engl J Med. 2018 Aug 2
REPORTING FROM THE ESC CONGRESS 2018
Key clinical point: Culprit-vessel PCI may be safer than multivessel PCI.
Major finding: At 1 year, treating patients with acute MI, cardiogenic shock, and multivessel coronary artery disease with either culprit-vessel PCI or multivessel PCI had similar mortality rates.
Study details: A randomized, controlled trial of 684 patients.
Disclosures: The study was funded by the European Union Seventh Framework Programme, the German Heart Research Foundation, and the German Centre for Cardiovascular Research. Dr. Thiele had no relevant conflicts of interest.
Source: Thiele H et al. N Engl J Med. 2018 Aug 25. doi: 10.1056/NEJMoa1808788.
BIO-RESORT trial: Synergy, Orsiro, Resolution stents go head to head to head
PARIS – Three contemporary yet very different drug-eluting stents – two very-thin-strut biodegradable devices and one that leaves behind a durable polymer – achieved similarly low target vessel failure rates through 2 years of prospective follow-up in the large, all-comers, randomized BIO-RESORT trial, Marlies M. Kok, MD, reported at the annual meeting of the European Association of Percutaneous Cardiovascular Interventions.
That being said, the study provided an intriguing signal that the Orsiro sirolimus-eluting stent might reduce the risk of revascularization after the first year of follow-up, compared with the Synergy everolimus-eluting stent and Resolute Integrity zotarolimus-eluting stent.
“This is a signal of great interest,” noted Dr. Kok, a cardiologist at Thoraxcentrum Twente in Enschede, the Netherlands.
The BIO-RESORT trial was a multicenter, three-arm, patient- and assessor-blinded Dutch study in which 3,514 patients undergoing percutaneous coronary intervention (PCI) were randomized to the Resolute Integrity, Synergy, or Orsiro stent. This was an all-comers trial in which everyone who needed PCI with a drug-eluting stent was included. Most (70%) patients had an acute coronary syndrome; 31% presented with ST-segment elevation MI. At 1 year of follow-up, 86% of patients were on dual-antiplatelet therapy. The 1-year safety and efficacy outcomes, previously reported, were reassuringly similar in the three groups (Lancet. 2016 Nov 26;388[10060]:2607-17).
This was the first randomized trial to examine the safety and efficacy of the Synergy stent in all comers. Dr. Kok presented the new 2-year results, featuring 99% patient follow-up. It’s important to look at outcomes well beyond 1 year, she said, because the three stents are so different.
The Synergy and Orsiro stents feature very-thin, flexible struts with an uncoated thickness of 74 mm and 60 mm, respectively, compared with 91 mm for the Resolute Integrity stent. While the Synergy and Orsiro stents both utilize biodegradable polymer frames, the two devices utilize different drugs with different drug-eluting and polymer-resorption times. The polymer coating of the Synergy stent is resorbed within 4 months, while the Orsiro stent’s polymer degrades after 12 months and is resorbed by 24 months. Everolimus is distributed abluminally in the Synergy stent, while the other two stents feature circumferential drug placement. The Synergy frame is platinum and chromium, while other two utilize cobalt-chromium frames.
The thinking has been that treatment of coronary artery disease with drug-eluting stents, such as the Resolute Integrity, might delay arterial healing as a consequence of the life-long presence of the polymer in the vessel. Very-thin-strut biodegradable polymer stents were developed as a means of getting around this problem. But, at 1 year, the primary endpoint of target vessel failure – a safety and efficacy composite comprising cardiac death, target vessel-related MI, or clinically driven target vessel revascularization – was 5% in all three groups.
Dr. Kok reported that, at 2 years, the target vessel failure rate remained nonsignificantly different between the three study arms: 8.3% with the zotarolimus-eluting Resolute Integrity stent, 6.8% with the everolimus-eluting Synergy stent, and 6.6% with the sirolimus-eluting Orsiro stent. Nor were there any significant differences in the individual components of the primary endpoint. However, the secondary endpoint of target lesion failure – comprising cardiac death, any MI, or clinically driven target lesion revascularization – was a different story. At 1 year, there were no significant between-group differences in this composite outcome. But, a landmark analysis showed that between years 1 and 2, the incidence was 2.4% in the Resolute Integrity group, 1.6% with the Synergy group, and 1.1% in patients randomized to the Orsiro stent. The difference in target lesion failure between the Resolute Integrity and Orsiro groups was statistically significant. This difference was driven in part by the rates of target lesion revascularization: 1.5% with the Resolute Integrity, 0.9% with the Synergy, and 0.6% with the Orsiro stent.
The 2-year rates of definite or probable stent thrombosis were low and similar in the three groups: 1.0% with the Synergy stent, 0.8% with the Resolute Integrity, and 0.6% with the Orsiro, she continued.
Longer-term follow-up is planned.
The latest BIO-RESORT results received a skeptical reception from the session’s discussion panel. Nick E. J. West, MD, of Royal Papworth Hospital in Cambridge, England, praised the study as large and well run, yet, “notwithstanding some post hoc statistical nitty-gritty, there are essentially no differences. Have we come as far as we’re going to go with metallic stents in terms of the devices, and is it now a bit more about implantation, about accuracy, about dual-antiplatelet therapy?” he asked.
Mirvat Al Alasnag, MD, an interventional cardiologist at King Fahd Armed Forces Hospital in Jeddah, Saudi Arabia, said, “An all-comers trial design does not necessarily tell you that something is good for everyone. We try and make everything simple, and it is not that simple. I do believe that stent choice decisions should be individualized.”
The BIO-RESORT trial was funded by institutional research grants from Biotronik, Boston Scientific, and Medtronic.
PARIS – Three contemporary yet very different drug-eluting stents – two very-thin-strut biodegradable devices and one that leaves behind a durable polymer – achieved similarly low target vessel failure rates through 2 years of prospective follow-up in the large, all-comers, randomized BIO-RESORT trial, Marlies M. Kok, MD, reported at the annual meeting of the European Association of Percutaneous Cardiovascular Interventions.
That being said, the study provided an intriguing signal that the Orsiro sirolimus-eluting stent might reduce the risk of revascularization after the first year of follow-up, compared with the Synergy everolimus-eluting stent and Resolute Integrity zotarolimus-eluting stent.
“This is a signal of great interest,” noted Dr. Kok, a cardiologist at Thoraxcentrum Twente in Enschede, the Netherlands.
The BIO-RESORT trial was a multicenter, three-arm, patient- and assessor-blinded Dutch study in which 3,514 patients undergoing percutaneous coronary intervention (PCI) were randomized to the Resolute Integrity, Synergy, or Orsiro stent. This was an all-comers trial in which everyone who needed PCI with a drug-eluting stent was included. Most (70%) patients had an acute coronary syndrome; 31% presented with ST-segment elevation MI. At 1 year of follow-up, 86% of patients were on dual-antiplatelet therapy. The 1-year safety and efficacy outcomes, previously reported, were reassuringly similar in the three groups (Lancet. 2016 Nov 26;388[10060]:2607-17).
This was the first randomized trial to examine the safety and efficacy of the Synergy stent in all comers. Dr. Kok presented the new 2-year results, featuring 99% patient follow-up. It’s important to look at outcomes well beyond 1 year, she said, because the three stents are so different.
The Synergy and Orsiro stents feature very-thin, flexible struts with an uncoated thickness of 74 mm and 60 mm, respectively, compared with 91 mm for the Resolute Integrity stent. While the Synergy and Orsiro stents both utilize biodegradable polymer frames, the two devices utilize different drugs with different drug-eluting and polymer-resorption times. The polymer coating of the Synergy stent is resorbed within 4 months, while the Orsiro stent’s polymer degrades after 12 months and is resorbed by 24 months. Everolimus is distributed abluminally in the Synergy stent, while the other two stents feature circumferential drug placement. The Synergy frame is platinum and chromium, while other two utilize cobalt-chromium frames.
The thinking has been that treatment of coronary artery disease with drug-eluting stents, such as the Resolute Integrity, might delay arterial healing as a consequence of the life-long presence of the polymer in the vessel. Very-thin-strut biodegradable polymer stents were developed as a means of getting around this problem. But, at 1 year, the primary endpoint of target vessel failure – a safety and efficacy composite comprising cardiac death, target vessel-related MI, or clinically driven target vessel revascularization – was 5% in all three groups.
Dr. Kok reported that, at 2 years, the target vessel failure rate remained nonsignificantly different between the three study arms: 8.3% with the zotarolimus-eluting Resolute Integrity stent, 6.8% with the everolimus-eluting Synergy stent, and 6.6% with the sirolimus-eluting Orsiro stent. Nor were there any significant differences in the individual components of the primary endpoint. However, the secondary endpoint of target lesion failure – comprising cardiac death, any MI, or clinically driven target lesion revascularization – was a different story. At 1 year, there were no significant between-group differences in this composite outcome. But, a landmark analysis showed that between years 1 and 2, the incidence was 2.4% in the Resolute Integrity group, 1.6% with the Synergy group, and 1.1% in patients randomized to the Orsiro stent. The difference in target lesion failure between the Resolute Integrity and Orsiro groups was statistically significant. This difference was driven in part by the rates of target lesion revascularization: 1.5% with the Resolute Integrity, 0.9% with the Synergy, and 0.6% with the Orsiro stent.
The 2-year rates of definite or probable stent thrombosis were low and similar in the three groups: 1.0% with the Synergy stent, 0.8% with the Resolute Integrity, and 0.6% with the Orsiro, she continued.
Longer-term follow-up is planned.
The latest BIO-RESORT results received a skeptical reception from the session’s discussion panel. Nick E. J. West, MD, of Royal Papworth Hospital in Cambridge, England, praised the study as large and well run, yet, “notwithstanding some post hoc statistical nitty-gritty, there are essentially no differences. Have we come as far as we’re going to go with metallic stents in terms of the devices, and is it now a bit more about implantation, about accuracy, about dual-antiplatelet therapy?” he asked.
Mirvat Al Alasnag, MD, an interventional cardiologist at King Fahd Armed Forces Hospital in Jeddah, Saudi Arabia, said, “An all-comers trial design does not necessarily tell you that something is good for everyone. We try and make everything simple, and it is not that simple. I do believe that stent choice decisions should be individualized.”
The BIO-RESORT trial was funded by institutional research grants from Biotronik, Boston Scientific, and Medtronic.
PARIS – Three contemporary yet very different drug-eluting stents – two very-thin-strut biodegradable devices and one that leaves behind a durable polymer – achieved similarly low target vessel failure rates through 2 years of prospective follow-up in the large, all-comers, randomized BIO-RESORT trial, Marlies M. Kok, MD, reported at the annual meeting of the European Association of Percutaneous Cardiovascular Interventions.
That being said, the study provided an intriguing signal that the Orsiro sirolimus-eluting stent might reduce the risk of revascularization after the first year of follow-up, compared with the Synergy everolimus-eluting stent and Resolute Integrity zotarolimus-eluting stent.
“This is a signal of great interest,” noted Dr. Kok, a cardiologist at Thoraxcentrum Twente in Enschede, the Netherlands.
The BIO-RESORT trial was a multicenter, three-arm, patient- and assessor-blinded Dutch study in which 3,514 patients undergoing percutaneous coronary intervention (PCI) were randomized to the Resolute Integrity, Synergy, or Orsiro stent. This was an all-comers trial in which everyone who needed PCI with a drug-eluting stent was included. Most (70%) patients had an acute coronary syndrome; 31% presented with ST-segment elevation MI. At 1 year of follow-up, 86% of patients were on dual-antiplatelet therapy. The 1-year safety and efficacy outcomes, previously reported, were reassuringly similar in the three groups (Lancet. 2016 Nov 26;388[10060]:2607-17).
This was the first randomized trial to examine the safety and efficacy of the Synergy stent in all comers. Dr. Kok presented the new 2-year results, featuring 99% patient follow-up. It’s important to look at outcomes well beyond 1 year, she said, because the three stents are so different.
The Synergy and Orsiro stents feature very-thin, flexible struts with an uncoated thickness of 74 mm and 60 mm, respectively, compared with 91 mm for the Resolute Integrity stent. While the Synergy and Orsiro stents both utilize biodegradable polymer frames, the two devices utilize different drugs with different drug-eluting and polymer-resorption times. The polymer coating of the Synergy stent is resorbed within 4 months, while the Orsiro stent’s polymer degrades after 12 months and is resorbed by 24 months. Everolimus is distributed abluminally in the Synergy stent, while the other two stents feature circumferential drug placement. The Synergy frame is platinum and chromium, while other two utilize cobalt-chromium frames.
The thinking has been that treatment of coronary artery disease with drug-eluting stents, such as the Resolute Integrity, might delay arterial healing as a consequence of the life-long presence of the polymer in the vessel. Very-thin-strut biodegradable polymer stents were developed as a means of getting around this problem. But, at 1 year, the primary endpoint of target vessel failure – a safety and efficacy composite comprising cardiac death, target vessel-related MI, or clinically driven target vessel revascularization – was 5% in all three groups.
Dr. Kok reported that, at 2 years, the target vessel failure rate remained nonsignificantly different between the three study arms: 8.3% with the zotarolimus-eluting Resolute Integrity stent, 6.8% with the everolimus-eluting Synergy stent, and 6.6% with the sirolimus-eluting Orsiro stent. Nor were there any significant differences in the individual components of the primary endpoint. However, the secondary endpoint of target lesion failure – comprising cardiac death, any MI, or clinically driven target lesion revascularization – was a different story. At 1 year, there were no significant between-group differences in this composite outcome. But, a landmark analysis showed that between years 1 and 2, the incidence was 2.4% in the Resolute Integrity group, 1.6% with the Synergy group, and 1.1% in patients randomized to the Orsiro stent. The difference in target lesion failure between the Resolute Integrity and Orsiro groups was statistically significant. This difference was driven in part by the rates of target lesion revascularization: 1.5% with the Resolute Integrity, 0.9% with the Synergy, and 0.6% with the Orsiro stent.
The 2-year rates of definite or probable stent thrombosis were low and similar in the three groups: 1.0% with the Synergy stent, 0.8% with the Resolute Integrity, and 0.6% with the Orsiro, she continued.
Longer-term follow-up is planned.
The latest BIO-RESORT results received a skeptical reception from the session’s discussion panel. Nick E. J. West, MD, of Royal Papworth Hospital in Cambridge, England, praised the study as large and well run, yet, “notwithstanding some post hoc statistical nitty-gritty, there are essentially no differences. Have we come as far as we’re going to go with metallic stents in terms of the devices, and is it now a bit more about implantation, about accuracy, about dual-antiplatelet therapy?” he asked.
Mirvat Al Alasnag, MD, an interventional cardiologist at King Fahd Armed Forces Hospital in Jeddah, Saudi Arabia, said, “An all-comers trial design does not necessarily tell you that something is good for everyone. We try and make everything simple, and it is not that simple. I do believe that stent choice decisions should be individualized.”
The BIO-RESORT trial was funded by institutional research grants from Biotronik, Boston Scientific, and Medtronic.
REPORTING FROM EUROPCR 2018
Key clinical point: Three contemporary, very dissimilar drug-eluting stents show impressively low 2-year target vessel failure rates.
Major finding:
Study details: This was a multicenter, randomized trial with 99% 2-year follow-up of 3,514 patients, deemed to need PCI, who were randomized to one of three contemporary drug-eluting stents.
Disclosures: The study was funded by institutional research grants from Biotronik, Boston Scientific, and Medtronic.
Open AAA and peripheral bypass surgery patients among the highest users of post-acute care
in Medicare spending, according to the findings of a study that used data from the National Inpatient Sample (NIS) and the Veterans Affairs health system (VA) regarding surgical patients.
PAC, including skilled nursing facilities and inpatient rehabilitation, accounts for 73% of regional variation in Medicare spending, and studies on hospital variation in this area have typically focused on nonsurgical patients or been limited to Medicare data. However, a high degree of variation also appears to hold for surgical patients, according to the authors of this large database study of more than 4 million patients who had aortic aneurysm repair, peripheral vascular bypass, colorectal surgery, hepatectomy, pancreatectomy, or coronary bypass.
“We found that there is significant variation in use of PAC and rates of home discharge following complex cardiac, abdominal, and vascular surgery,” Courtney J. Balentine, MD, of the University of Alabama at Birmingham and his colleagues wrote in their report in the Journal of Surgical Research.
To explore hospital variation in post-surgery PAC, they evaluated 3,487,365 patients from the NIS (39% were aged 70 years or older, and 60% were men) and 60,666 from the VA (32% were aged 70 years or older, and 98% were men) who had surgery during 2008-2011.
Within the NIS, 631,199 patients (18%) were discharged to PAC facilities, and among the 60,666 veterans, 4744 (7.8%) were discharged to PAC facilities. In addition, hospital rates of discharge to PAC facilities varied from 1% to 36% for VA hospitals and from 1% to 59% for non-VA hospitals, according to the researchers. They found that some VA hospitals were four times more likely to discharge patients to PAC facilities than would be expected from their patients’ characteristics, while others were 90% more likely to send patients home than would be expected, according to Dr. Balentine and his colleagues.
Procedure-specific rates of discharge to PAC facilities from VA hospitals ranged from 2% following endovascular aneurysm repair to 10% after pancreatectomy and peripheral vascular bypass. Among the NIS hospitals, in contrast, rates of discharge to PAC facilities ranged from 6% following hepatectomy to as high as 44% following open aneurysm repair.
“These data could be used to characterize practices that promote more effective recovery from surgery and minimize the need for PAC,” the authors wrote. “Given that skilled nursing facilities and inpatient rehabilitation cost [$5,000]-$24,000 more than treatment at home, even minor reductions in the need for PAC facilities could result in substantial cost savings,” they stated.
“Our findings suggest that there is considerable room for improvement in the use of PAC after surgery and that we still have a long way to go in terms of using PAC to help patients recover and regain their independence,” the researchers concluded.
The authors reported that they had no conflicts of interest.
SOURCE: Balentine CJ et al. J Surg Res. 2018 Oct;230:61-70.
in Medicare spending, according to the findings of a study that used data from the National Inpatient Sample (NIS) and the Veterans Affairs health system (VA) regarding surgical patients.
PAC, including skilled nursing facilities and inpatient rehabilitation, accounts for 73% of regional variation in Medicare spending, and studies on hospital variation in this area have typically focused on nonsurgical patients or been limited to Medicare data. However, a high degree of variation also appears to hold for surgical patients, according to the authors of this large database study of more than 4 million patients who had aortic aneurysm repair, peripheral vascular bypass, colorectal surgery, hepatectomy, pancreatectomy, or coronary bypass.
“We found that there is significant variation in use of PAC and rates of home discharge following complex cardiac, abdominal, and vascular surgery,” Courtney J. Balentine, MD, of the University of Alabama at Birmingham and his colleagues wrote in their report in the Journal of Surgical Research.
To explore hospital variation in post-surgery PAC, they evaluated 3,487,365 patients from the NIS (39% were aged 70 years or older, and 60% were men) and 60,666 from the VA (32% were aged 70 years or older, and 98% were men) who had surgery during 2008-2011.
Within the NIS, 631,199 patients (18%) were discharged to PAC facilities, and among the 60,666 veterans, 4744 (7.8%) were discharged to PAC facilities. In addition, hospital rates of discharge to PAC facilities varied from 1% to 36% for VA hospitals and from 1% to 59% for non-VA hospitals, according to the researchers. They found that some VA hospitals were four times more likely to discharge patients to PAC facilities than would be expected from their patients’ characteristics, while others were 90% more likely to send patients home than would be expected, according to Dr. Balentine and his colleagues.
Procedure-specific rates of discharge to PAC facilities from VA hospitals ranged from 2% following endovascular aneurysm repair to 10% after pancreatectomy and peripheral vascular bypass. Among the NIS hospitals, in contrast, rates of discharge to PAC facilities ranged from 6% following hepatectomy to as high as 44% following open aneurysm repair.
“These data could be used to characterize practices that promote more effective recovery from surgery and minimize the need for PAC,” the authors wrote. “Given that skilled nursing facilities and inpatient rehabilitation cost [$5,000]-$24,000 more than treatment at home, even minor reductions in the need for PAC facilities could result in substantial cost savings,” they stated.
“Our findings suggest that there is considerable room for improvement in the use of PAC after surgery and that we still have a long way to go in terms of using PAC to help patients recover and regain their independence,” the researchers concluded.
The authors reported that they had no conflicts of interest.
SOURCE: Balentine CJ et al. J Surg Res. 2018 Oct;230:61-70.
in Medicare spending, according to the findings of a study that used data from the National Inpatient Sample (NIS) and the Veterans Affairs health system (VA) regarding surgical patients.
PAC, including skilled nursing facilities and inpatient rehabilitation, accounts for 73% of regional variation in Medicare spending, and studies on hospital variation in this area have typically focused on nonsurgical patients or been limited to Medicare data. However, a high degree of variation also appears to hold for surgical patients, according to the authors of this large database study of more than 4 million patients who had aortic aneurysm repair, peripheral vascular bypass, colorectal surgery, hepatectomy, pancreatectomy, or coronary bypass.
“We found that there is significant variation in use of PAC and rates of home discharge following complex cardiac, abdominal, and vascular surgery,” Courtney J. Balentine, MD, of the University of Alabama at Birmingham and his colleagues wrote in their report in the Journal of Surgical Research.
To explore hospital variation in post-surgery PAC, they evaluated 3,487,365 patients from the NIS (39% were aged 70 years or older, and 60% were men) and 60,666 from the VA (32% were aged 70 years or older, and 98% were men) who had surgery during 2008-2011.
Within the NIS, 631,199 patients (18%) were discharged to PAC facilities, and among the 60,666 veterans, 4744 (7.8%) were discharged to PAC facilities. In addition, hospital rates of discharge to PAC facilities varied from 1% to 36% for VA hospitals and from 1% to 59% for non-VA hospitals, according to the researchers. They found that some VA hospitals were four times more likely to discharge patients to PAC facilities than would be expected from their patients’ characteristics, while others were 90% more likely to send patients home than would be expected, according to Dr. Balentine and his colleagues.
Procedure-specific rates of discharge to PAC facilities from VA hospitals ranged from 2% following endovascular aneurysm repair to 10% after pancreatectomy and peripheral vascular bypass. Among the NIS hospitals, in contrast, rates of discharge to PAC facilities ranged from 6% following hepatectomy to as high as 44% following open aneurysm repair.
“These data could be used to characterize practices that promote more effective recovery from surgery and minimize the need for PAC,” the authors wrote. “Given that skilled nursing facilities and inpatient rehabilitation cost [$5,000]-$24,000 more than treatment at home, even minor reductions in the need for PAC facilities could result in substantial cost savings,” they stated.
“Our findings suggest that there is considerable room for improvement in the use of PAC after surgery and that we still have a long way to go in terms of using PAC to help patients recover and regain their independence,” the researchers concluded.
The authors reported that they had no conflicts of interest.
SOURCE: Balentine CJ et al. J Surg Res. 2018 Oct;230:61-70.
FROM THE JOURNAL OF SURGICAL RESEARCH
Key clinical point: The wide disparity among hospitals in their rates of postsurgery discharge to post-acute care (PAC) could be an area of focus for cost containment in Medicare spending.
Major finding: Rates of discharge to PAC facilities varied from 1% to 36% for VA hospitals and from 1% to 59% for non-VA hospitals.
Study details: A database analysis of 3,487,365 National Inpatient Sample patients and 60,666 VA patients who had surgery during 2008-2011.
Disclosures: The authors reported that they had no conflicts of interest.
Source: Balentine CJ et al. J Surg Res. 2018 Oct;230:61-70.
Hybrid PCI strategy rules for complex CTO
PARIS – The so-called hybrid strategy is now the preferred approach to percutaneous coronary intervention (PCI) for chronic total occlusions (CTO), 12-month outcomes of the multicenter observational CONSISTENT CTO trial suggest, according to Simon J. Walsh, MD, an interventional cardiologist at Belfast Health and Social Care Trust.
With use of the hybrid strategy, a CTO’s anatomic complexity is no longer a barrier to performing PCI with a success rate that by former standards would be considered astronomical, he said in presenting the CONSISTENT CTO results at the annual meeting of the European Association of Percutaneous Cardiovascular Interventions.
Indeed, the key take-home messages from CONSISTENT CTO were that technical success rates were dramatic at 98.6%, the target vessel failure rate at 12 months was impressively low at 5.24%, and quality of life scores showed clinically meaningful gains maintained through 1 year.
“Opening a CTO makes people better, reduces their symptom burden, and is something worth doing,” Dr. Walsh concluded.
That hasn’t always been the prevailing view. Historically, most interventional cardiologists had a pessimistic attitude regarding PCI for CTOs. The procedures had a low technical success rate, frequent complications, and lousy durability. Moreover, these subpar results came at a considerable price in terms of extensive radiation exposure and catheterization laboratory time. These various shortcomings became particularly prominent when traditional wire-based PCI strategies were applied to long, complex occlusions.
All that has changed as a result of improved stent technologies and procedural techniques, along with the development of the hybrid PCI algorithm by U.S. cardiologists. Using these tools, an interventionalist skilled in the hybrid strategy now selects cases on the basis of clinical indications, such as disabling angina, rather than on anatomic considerations. This point was emphatically brought home in CONSISTENT CTO (Conventional antegrade vs. sub-intimal synergy stenting in chronic total occlusions).
“This is the most complex set of treated CTO lesions ever investigated in this rigorous way,” according to Dr. Walsh.
This assertion was bolstered by the fact that the average Japan CTO (JCTO) score in the 210 study participants was 2.4, climbing to 2.9 in the 101 patients with dissection present. Further adding to the lesion complexity was the fact that roughly one in five subjects had a degenerated coronary artery graft in their target vessel. The average lesion length as measured at the study core lab was 29.1 mm. The impetus for the CONSISTENT CTO Study was a recognition that, even though a growing number of skilled operators are embracing the hybrid PCI strategy with heretofore unprecedented favorable results, there remains an evidence gap, with little in the way of long-term studies featuring rigorous follow-up. Participants in CONSISTENT CTO therefore underwent baseline formal quality of life assessment, repeated at 12 months of follow-up together with angiography and/or optical coherence tomography. Further follow-up is planned at 2, 3, and 5 years.
Of the 231 patients who consented to participate in the study, 210, or 90%, were able to have their CTO opened with a Synergy everolimus-eluting stent. Those 210 constituted the study population.
The hybrid algorithm-based PCI strategy utilizes an individual’s CTO anatomy to dictate the initial choice of approach. The goal is to pick the strategy that is most likely to achieve successful outcome efficiently, with minimal contrast and radiation doses for that particular type of CTO. The hybrid algorithm begins with dual-catheter injection and intravascular ultrasound aimed at determining whether four key anatomic features are present: an ambiguous proximal cap, a poor distal target, good interventional collaterals, and a major side branch at the distal cap.
If those four features are absent and the CTO lesion is less than 20-mm long, the algorithm dictates that the initial approach is antegrade wire escalation; if the lesion is 20 mm or more, the first approach is antegrade dissection reentry. However, if those anatomic features are present, the initial strategy is retrograde wire escalation if the lesion is less than 20 mm, and retrograde dissection reentry for longer lesions. When the initial approach fails, structured protocols dictate the selection of second and third approaches (JACC Cardiovasc Interv. 2012 Apr;5[4]:367-79).
The right coronary artery was the site of the CTO in 70% of study participants. Dual-catheter access was utilized in 79% of patients; only 10% had exclusively radial access. An average of 2.8 Synergy stents were deployed, with a whopping mean total stent length of 96.6 mm in the 48% of patients with dissection and 75.4 mm in those without. Mean procedure time was 122 minutes, with a fluoroscopy time of 44.6 minutes.
The primary efficacy endpoint was the rate of target vessel failure (TVF) at 12 months, defined as cardiac death, MI related to the target vessel, or any ischemia-driven revascularization of the target vessel. The rate was 5.24%.
“We were pleasantly surprised by that,” Dr. Walsh admitted.
Indeed, based upon studies of PCI for CTO published by other investigators, he and his colleagues had initially projected a 13% TVF rate, then bumped it up to 15% because of the high degree of lesion complexity.
Diabetes was the main predictor of target vessel revascularization.
At the time of the index PCI, 19% of patients were scheduled to return for an early optimization procedure within 3 months. This was arranged when operators anticipated significant positive remodeling would occur as the target vessel readjusted to blood flow or distal disease of borderline severity was noted beyond the CTO segment. These were not counted as adverse events. Half of the returnees underwent angiography and no further action was undertaken. The others underwent postdilation of their Synergy stents or new stenting of distal disease.
Complete revascularization of the target territory was achieved in 98.6% of patients. Key complications consisted of 5 perforations, 10 hematomas at vascular access sites, 2 cases of pericardiocentesis, and 4 instances of bleeding requiring transfusion.
The final successful CTO revascularization strategy was antegrade dissection reentry in 18% of patients, retrograde dissection reentry in 30%, antegrade wire escalation in 34%, and retrograde wire escalation in 18%. A switch from the initial algorithm-based strategy to a second strategy occurred in 41% of patients, and a third strategy was employed in 9%.
“I think the key message is you need to have more than one option to treat complicated disease. Half of patients had a switch in strategy,” Dr. Walsh observed.
Intravascular ultrasound (IVUS) adjudication in the central core lab showed a humbling rate of discordance between the operators’ impression of how their procedures were proceeding and what was really going on.
“There’s a bit of a mantra [that says] if you’re wiring stuff you’re always in the lumen, and if you’re using dissection techniques you’re always not in the lumen. In fact, that’s nonsense. You get it wrong one in six times. When you use IVUS adjudication to see if you’re outside the lumen or not, with wire-based retrograde escalation you’re out of the lumen and in the subintimal space 27% of the time. And with dissection strategies you’re wrong in about 15%,” according to the cardiologist.
He described the study participants as “extremely limited” at baseline as evidenced by their scores on the Seattle Angina Questionnaire Physical Limitation, Angina Stability, and Angina Frequency domains. At 12 months of follow-up, patients averaged 20- to 40-point improvements across all three domains.
One member of the discussion panel expressed a wish that the study had included a sham PCI arm. He raised the possibility that PCI had exerted an enormous placebo effect that could conceivably account for the substantial quality of life benefits documented in the study. But another panelist scoffed at this notion. This wasn’t a modest improvement in quality of life, nor was it measured after a mere 6 weeks, as was the case in the sham-controlled ORBITA trial.
“It’s really difficult to imagine a sham effect that persists out to a year,” he argued.
Dr. Walsh reported receiving research grants from and serving as a consultant to Boston Scientific, which funded the CONSISTENT CTO Study.
PARIS – The so-called hybrid strategy is now the preferred approach to percutaneous coronary intervention (PCI) for chronic total occlusions (CTO), 12-month outcomes of the multicenter observational CONSISTENT CTO trial suggest, according to Simon J. Walsh, MD, an interventional cardiologist at Belfast Health and Social Care Trust.
With use of the hybrid strategy, a CTO’s anatomic complexity is no longer a barrier to performing PCI with a success rate that by former standards would be considered astronomical, he said in presenting the CONSISTENT CTO results at the annual meeting of the European Association of Percutaneous Cardiovascular Interventions.
Indeed, the key take-home messages from CONSISTENT CTO were that technical success rates were dramatic at 98.6%, the target vessel failure rate at 12 months was impressively low at 5.24%, and quality of life scores showed clinically meaningful gains maintained through 1 year.
“Opening a CTO makes people better, reduces their symptom burden, and is something worth doing,” Dr. Walsh concluded.
That hasn’t always been the prevailing view. Historically, most interventional cardiologists had a pessimistic attitude regarding PCI for CTOs. The procedures had a low technical success rate, frequent complications, and lousy durability. Moreover, these subpar results came at a considerable price in terms of extensive radiation exposure and catheterization laboratory time. These various shortcomings became particularly prominent when traditional wire-based PCI strategies were applied to long, complex occlusions.
All that has changed as a result of improved stent technologies and procedural techniques, along with the development of the hybrid PCI algorithm by U.S. cardiologists. Using these tools, an interventionalist skilled in the hybrid strategy now selects cases on the basis of clinical indications, such as disabling angina, rather than on anatomic considerations. This point was emphatically brought home in CONSISTENT CTO (Conventional antegrade vs. sub-intimal synergy stenting in chronic total occlusions).
“This is the most complex set of treated CTO lesions ever investigated in this rigorous way,” according to Dr. Walsh.
This assertion was bolstered by the fact that the average Japan CTO (JCTO) score in the 210 study participants was 2.4, climbing to 2.9 in the 101 patients with dissection present. Further adding to the lesion complexity was the fact that roughly one in five subjects had a degenerated coronary artery graft in their target vessel. The average lesion length as measured at the study core lab was 29.1 mm. The impetus for the CONSISTENT CTO Study was a recognition that, even though a growing number of skilled operators are embracing the hybrid PCI strategy with heretofore unprecedented favorable results, there remains an evidence gap, with little in the way of long-term studies featuring rigorous follow-up. Participants in CONSISTENT CTO therefore underwent baseline formal quality of life assessment, repeated at 12 months of follow-up together with angiography and/or optical coherence tomography. Further follow-up is planned at 2, 3, and 5 years.
Of the 231 patients who consented to participate in the study, 210, or 90%, were able to have their CTO opened with a Synergy everolimus-eluting stent. Those 210 constituted the study population.
The hybrid algorithm-based PCI strategy utilizes an individual’s CTO anatomy to dictate the initial choice of approach. The goal is to pick the strategy that is most likely to achieve successful outcome efficiently, with minimal contrast and radiation doses for that particular type of CTO. The hybrid algorithm begins with dual-catheter injection and intravascular ultrasound aimed at determining whether four key anatomic features are present: an ambiguous proximal cap, a poor distal target, good interventional collaterals, and a major side branch at the distal cap.
If those four features are absent and the CTO lesion is less than 20-mm long, the algorithm dictates that the initial approach is antegrade wire escalation; if the lesion is 20 mm or more, the first approach is antegrade dissection reentry. However, if those anatomic features are present, the initial strategy is retrograde wire escalation if the lesion is less than 20 mm, and retrograde dissection reentry for longer lesions. When the initial approach fails, structured protocols dictate the selection of second and third approaches (JACC Cardiovasc Interv. 2012 Apr;5[4]:367-79).
The right coronary artery was the site of the CTO in 70% of study participants. Dual-catheter access was utilized in 79% of patients; only 10% had exclusively radial access. An average of 2.8 Synergy stents were deployed, with a whopping mean total stent length of 96.6 mm in the 48% of patients with dissection and 75.4 mm in those without. Mean procedure time was 122 minutes, with a fluoroscopy time of 44.6 minutes.
The primary efficacy endpoint was the rate of target vessel failure (TVF) at 12 months, defined as cardiac death, MI related to the target vessel, or any ischemia-driven revascularization of the target vessel. The rate was 5.24%.
“We were pleasantly surprised by that,” Dr. Walsh admitted.
Indeed, based upon studies of PCI for CTO published by other investigators, he and his colleagues had initially projected a 13% TVF rate, then bumped it up to 15% because of the high degree of lesion complexity.
Diabetes was the main predictor of target vessel revascularization.
At the time of the index PCI, 19% of patients were scheduled to return for an early optimization procedure within 3 months. This was arranged when operators anticipated significant positive remodeling would occur as the target vessel readjusted to blood flow or distal disease of borderline severity was noted beyond the CTO segment. These were not counted as adverse events. Half of the returnees underwent angiography and no further action was undertaken. The others underwent postdilation of their Synergy stents or new stenting of distal disease.
Complete revascularization of the target territory was achieved in 98.6% of patients. Key complications consisted of 5 perforations, 10 hematomas at vascular access sites, 2 cases of pericardiocentesis, and 4 instances of bleeding requiring transfusion.
The final successful CTO revascularization strategy was antegrade dissection reentry in 18% of patients, retrograde dissection reentry in 30%, antegrade wire escalation in 34%, and retrograde wire escalation in 18%. A switch from the initial algorithm-based strategy to a second strategy occurred in 41% of patients, and a third strategy was employed in 9%.
“I think the key message is you need to have more than one option to treat complicated disease. Half of patients had a switch in strategy,” Dr. Walsh observed.
Intravascular ultrasound (IVUS) adjudication in the central core lab showed a humbling rate of discordance between the operators’ impression of how their procedures were proceeding and what was really going on.
“There’s a bit of a mantra [that says] if you’re wiring stuff you’re always in the lumen, and if you’re using dissection techniques you’re always not in the lumen. In fact, that’s nonsense. You get it wrong one in six times. When you use IVUS adjudication to see if you’re outside the lumen or not, with wire-based retrograde escalation you’re out of the lumen and in the subintimal space 27% of the time. And with dissection strategies you’re wrong in about 15%,” according to the cardiologist.
He described the study participants as “extremely limited” at baseline as evidenced by their scores on the Seattle Angina Questionnaire Physical Limitation, Angina Stability, and Angina Frequency domains. At 12 months of follow-up, patients averaged 20- to 40-point improvements across all three domains.
One member of the discussion panel expressed a wish that the study had included a sham PCI arm. He raised the possibility that PCI had exerted an enormous placebo effect that could conceivably account for the substantial quality of life benefits documented in the study. But another panelist scoffed at this notion. This wasn’t a modest improvement in quality of life, nor was it measured after a mere 6 weeks, as was the case in the sham-controlled ORBITA trial.
“It’s really difficult to imagine a sham effect that persists out to a year,” he argued.
Dr. Walsh reported receiving research grants from and serving as a consultant to Boston Scientific, which funded the CONSISTENT CTO Study.
PARIS – The so-called hybrid strategy is now the preferred approach to percutaneous coronary intervention (PCI) for chronic total occlusions (CTO), 12-month outcomes of the multicenter observational CONSISTENT CTO trial suggest, according to Simon J. Walsh, MD, an interventional cardiologist at Belfast Health and Social Care Trust.
With use of the hybrid strategy, a CTO’s anatomic complexity is no longer a barrier to performing PCI with a success rate that by former standards would be considered astronomical, he said in presenting the CONSISTENT CTO results at the annual meeting of the European Association of Percutaneous Cardiovascular Interventions.
Indeed, the key take-home messages from CONSISTENT CTO were that technical success rates were dramatic at 98.6%, the target vessel failure rate at 12 months was impressively low at 5.24%, and quality of life scores showed clinically meaningful gains maintained through 1 year.
“Opening a CTO makes people better, reduces their symptom burden, and is something worth doing,” Dr. Walsh concluded.
That hasn’t always been the prevailing view. Historically, most interventional cardiologists had a pessimistic attitude regarding PCI for CTOs. The procedures had a low technical success rate, frequent complications, and lousy durability. Moreover, these subpar results came at a considerable price in terms of extensive radiation exposure and catheterization laboratory time. These various shortcomings became particularly prominent when traditional wire-based PCI strategies were applied to long, complex occlusions.
All that has changed as a result of improved stent technologies and procedural techniques, along with the development of the hybrid PCI algorithm by U.S. cardiologists. Using these tools, an interventionalist skilled in the hybrid strategy now selects cases on the basis of clinical indications, such as disabling angina, rather than on anatomic considerations. This point was emphatically brought home in CONSISTENT CTO (Conventional antegrade vs. sub-intimal synergy stenting in chronic total occlusions).
“This is the most complex set of treated CTO lesions ever investigated in this rigorous way,” according to Dr. Walsh.
This assertion was bolstered by the fact that the average Japan CTO (JCTO) score in the 210 study participants was 2.4, climbing to 2.9 in the 101 patients with dissection present. Further adding to the lesion complexity was the fact that roughly one in five subjects had a degenerated coronary artery graft in their target vessel. The average lesion length as measured at the study core lab was 29.1 mm. The impetus for the CONSISTENT CTO Study was a recognition that, even though a growing number of skilled operators are embracing the hybrid PCI strategy with heretofore unprecedented favorable results, there remains an evidence gap, with little in the way of long-term studies featuring rigorous follow-up. Participants in CONSISTENT CTO therefore underwent baseline formal quality of life assessment, repeated at 12 months of follow-up together with angiography and/or optical coherence tomography. Further follow-up is planned at 2, 3, and 5 years.
Of the 231 patients who consented to participate in the study, 210, or 90%, were able to have their CTO opened with a Synergy everolimus-eluting stent. Those 210 constituted the study population.
The hybrid algorithm-based PCI strategy utilizes an individual’s CTO anatomy to dictate the initial choice of approach. The goal is to pick the strategy that is most likely to achieve successful outcome efficiently, with minimal contrast and radiation doses for that particular type of CTO. The hybrid algorithm begins with dual-catheter injection and intravascular ultrasound aimed at determining whether four key anatomic features are present: an ambiguous proximal cap, a poor distal target, good interventional collaterals, and a major side branch at the distal cap.
If those four features are absent and the CTO lesion is less than 20-mm long, the algorithm dictates that the initial approach is antegrade wire escalation; if the lesion is 20 mm or more, the first approach is antegrade dissection reentry. However, if those anatomic features are present, the initial strategy is retrograde wire escalation if the lesion is less than 20 mm, and retrograde dissection reentry for longer lesions. When the initial approach fails, structured protocols dictate the selection of second and third approaches (JACC Cardiovasc Interv. 2012 Apr;5[4]:367-79).
The right coronary artery was the site of the CTO in 70% of study participants. Dual-catheter access was utilized in 79% of patients; only 10% had exclusively radial access. An average of 2.8 Synergy stents were deployed, with a whopping mean total stent length of 96.6 mm in the 48% of patients with dissection and 75.4 mm in those without. Mean procedure time was 122 minutes, with a fluoroscopy time of 44.6 minutes.
The primary efficacy endpoint was the rate of target vessel failure (TVF) at 12 months, defined as cardiac death, MI related to the target vessel, or any ischemia-driven revascularization of the target vessel. The rate was 5.24%.
“We were pleasantly surprised by that,” Dr. Walsh admitted.
Indeed, based upon studies of PCI for CTO published by other investigators, he and his colleagues had initially projected a 13% TVF rate, then bumped it up to 15% because of the high degree of lesion complexity.
Diabetes was the main predictor of target vessel revascularization.
At the time of the index PCI, 19% of patients were scheduled to return for an early optimization procedure within 3 months. This was arranged when operators anticipated significant positive remodeling would occur as the target vessel readjusted to blood flow or distal disease of borderline severity was noted beyond the CTO segment. These were not counted as adverse events. Half of the returnees underwent angiography and no further action was undertaken. The others underwent postdilation of their Synergy stents or new stenting of distal disease.
Complete revascularization of the target territory was achieved in 98.6% of patients. Key complications consisted of 5 perforations, 10 hematomas at vascular access sites, 2 cases of pericardiocentesis, and 4 instances of bleeding requiring transfusion.
The final successful CTO revascularization strategy was antegrade dissection reentry in 18% of patients, retrograde dissection reentry in 30%, antegrade wire escalation in 34%, and retrograde wire escalation in 18%. A switch from the initial algorithm-based strategy to a second strategy occurred in 41% of patients, and a third strategy was employed in 9%.
“I think the key message is you need to have more than one option to treat complicated disease. Half of patients had a switch in strategy,” Dr. Walsh observed.
Intravascular ultrasound (IVUS) adjudication in the central core lab showed a humbling rate of discordance between the operators’ impression of how their procedures were proceeding and what was really going on.
“There’s a bit of a mantra [that says] if you’re wiring stuff you’re always in the lumen, and if you’re using dissection techniques you’re always not in the lumen. In fact, that’s nonsense. You get it wrong one in six times. When you use IVUS adjudication to see if you’re outside the lumen or not, with wire-based retrograde escalation you’re out of the lumen and in the subintimal space 27% of the time. And with dissection strategies you’re wrong in about 15%,” according to the cardiologist.
He described the study participants as “extremely limited” at baseline as evidenced by their scores on the Seattle Angina Questionnaire Physical Limitation, Angina Stability, and Angina Frequency domains. At 12 months of follow-up, patients averaged 20- to 40-point improvements across all three domains.
One member of the discussion panel expressed a wish that the study had included a sham PCI arm. He raised the possibility that PCI had exerted an enormous placebo effect that could conceivably account for the substantial quality of life benefits documented in the study. But another panelist scoffed at this notion. This wasn’t a modest improvement in quality of life, nor was it measured after a mere 6 weeks, as was the case in the sham-controlled ORBITA trial.
“It’s really difficult to imagine a sham effect that persists out to a year,” he argued.
Dr. Walsh reported receiving research grants from and serving as a consultant to Boston Scientific, which funded the CONSISTENT CTO Study.
REPORTING FROM EUROPCR 2018
Key clinical point: The hybrid PCI strategy is now the preferred approach to treatment of CTOs.
Major finding: The 1-year target vessel failure rate following PCI for complex CTOs was 5.24%, with durable major quality of life improvements.
Study details: This prospective multicenter study included 210 patients with highly complex CTOs treated using Synergy stents according to the hybrid algorithm.
Disclosures: The presenter reported receiving research grants from and serving as a consultant to Boston Scientific, which sponsored the CONSISTENT CTO Study.