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CHICAGO – Two women in their 30s resumed menstruation about 7 months after one of their ovaries was injected with human mesenchymal stem cells obtained from their hips.

Neither of the women had menstruated for about 5 years; both were in premature menopause and wanted desperately to start a family. Estrogen levels began increasing soon after treatment, and night sweats and other symptoms of menopause almost disappeared. After a year, the treated ovary was almost the size of a normal premenopausal ovary. There weren’t any complications or side effects, and both women are now pursuing pregnancy.

The results are “very exciting, very encouraging,” said senior investigator Ayman Al-Hendy, MD, PhD, a gynecology professor at the University of Illinois at Chicago.

Robert Lodge/MDEdge News

aotto@mdedge.com

SOURCE: Al-Hendy A et al. ENDO 2018, Abstract OR33-6.

CHICAGO – Two women in their 30s resumed menstruation about 7 months after one of their ovaries was injected with human mesenchymal stem cells obtained from their hips.

Neither of the women had menstruated for about 5 years; both were in premature menopause and wanted desperately to start a family. Estrogen levels began increasing soon after treatment, and night sweats and other symptoms of menopause almost disappeared. After a year, the treated ovary was almost the size of a normal premenopausal ovary. There weren’t any complications or side effects, and both women are now pursuing pregnancy.

The results are “very exciting, very encouraging,” said senior investigator Ayman Al-Hendy, MD, PhD, a gynecology professor at the University of Illinois at Chicago.

Robert Lodge/MDEdge News

aotto@mdedge.com

SOURCE: Al-Hendy A et al. ENDO 2018, Abstract OR33-6.

CHICAGO – Two women in their 30s resumed menstruation about 7 months after one of their ovaries was injected with human mesenchymal stem cells obtained from their hips.

Neither of the women had menstruated for about 5 years; both were in premature menopause and wanted desperately to start a family. Estrogen levels began increasing soon after treatment, and night sweats and other symptoms of menopause almost disappeared. After a year, the treated ovary was almost the size of a normal premenopausal ovary. There weren’t any complications or side effects, and both women are now pursuing pregnancy.

The results are “very exciting, very encouraging,” said senior investigator Ayman Al-Hendy, MD, PhD, a gynecology professor at the University of Illinois at Chicago.

Robert Lodge/MDEdge News

aotto@mdedge.com

SOURCE: Al-Hendy A et al. ENDO 2018, Abstract OR33-6.

CHICAGO – Testosterone levels dropped by one third for women with polycystic ovary syndrome (PCOS) and hyperandrogenemia when they received a centrally acting medication currently in development. The proof-of-concept phase 2 trial, which saw no concerning safety signals for the medication, fezolinetant, sets the stage for a larger, and perhaps longer, study to learn more about the neurokinin 3 receptor antagonist’s efficacy against PCOS.

“The primary outcome for this phase 2 trial was to see if we could lower testosterone levels in these PCOS patients,” said Graeme Fraser, PhD, chief scientific officer for Ogeda, discussing the poster he and his colleagues presented at the annual meeting of the Endocrine Society.

“Testosterone levels decreased: Measured at about 3 hours postdose, which is the approximate pharmacokinetic Cmax [maximum serum concentration], there was … a more than 30% decrease in testosterone levels,” said Dr. Fraser. By week 12, he said, “there was a very consistent decrease of 30% of testosterone levels. So that was quite good; we successfully hit the primary outcome.”

At 12 weeks, the higher dose of fezolinetant decreased testosterone by 0.64 nmol/L, compared with the 0.04 nmol/L seen with placebo (P less than .01).

koakes@frontlinemedcom.com

SOURCE: Fraser G et al. ENDO 2018, Abstract SAT-305-LB.

CHICAGO – Testosterone levels dropped by one third for women with polycystic ovary syndrome (PCOS) and hyperandrogenemia when they received a centrally acting medication currently in development. The proof-of-concept phase 2 trial, which saw no concerning safety signals for the medication, fezolinetant, sets the stage for a larger, and perhaps longer, study to learn more about the neurokinin 3 receptor antagonist’s efficacy against PCOS.

“The primary outcome for this phase 2 trial was to see if we could lower testosterone levels in these PCOS patients,” said Graeme Fraser, PhD, chief scientific officer for Ogeda, discussing the poster he and his colleagues presented at the annual meeting of the Endocrine Society.

“Testosterone levels decreased: Measured at about 3 hours postdose, which is the approximate pharmacokinetic Cmax [maximum serum concentration], there was … a more than 30% decrease in testosterone levels,” said Dr. Fraser. By week 12, he said, “there was a very consistent decrease of 30% of testosterone levels. So that was quite good; we successfully hit the primary outcome.”

At 12 weeks, the higher dose of fezolinetant decreased testosterone by 0.64 nmol/L, compared with the 0.04 nmol/L seen with placebo (P less than .01).

koakes@frontlinemedcom.com

SOURCE: Fraser G et al. ENDO 2018, Abstract SAT-305-LB.

CHICAGO – Testosterone levels dropped by one third for women with polycystic ovary syndrome (PCOS) and hyperandrogenemia when they received a centrally acting medication currently in development. The proof-of-concept phase 2 trial, which saw no concerning safety signals for the medication, fezolinetant, sets the stage for a larger, and perhaps longer, study to learn more about the neurokinin 3 receptor antagonist’s efficacy against PCOS.

“The primary outcome for this phase 2 trial was to see if we could lower testosterone levels in these PCOS patients,” said Graeme Fraser, PhD, chief scientific officer for Ogeda, discussing the poster he and his colleagues presented at the annual meeting of the Endocrine Society.

“Testosterone levels decreased: Measured at about 3 hours postdose, which is the approximate pharmacokinetic Cmax [maximum serum concentration], there was … a more than 30% decrease in testosterone levels,” said Dr. Fraser. By week 12, he said, “there was a very consistent decrease of 30% of testosterone levels. So that was quite good; we successfully hit the primary outcome.”

At 12 weeks, the higher dose of fezolinetant decreased testosterone by 0.64 nmol/L, compared with the 0.04 nmol/L seen with placebo (P less than .01).

koakes@frontlinemedcom.com

SOURCE: Fraser G et al. ENDO 2018, Abstract SAT-305-LB.

CHICAGO – There is no “safe” lower glycemic threshold for pregnant women with diabetes below which adverse maternal and fetal/neonatal outcomes aren’t seen. In particular, “several retrospective studies have shown that the risk for congenital malformations is increased with higher hemoglobin A_1c levels,” said Susan Kirk, MD, speaking at a “Meet the Professor” session at the annual meeting of the Endocrine Society.

However, pointed out Dr. Kirk, fact-based counseling about pregnancy risks for women with type 1 or type 2 diabetes can – and should – occur within the framework of a strong and accepting physician-patient relationship.

Most women with diabetes have received pre-conception counseling about the risks of pregnancy with diabetes and the importance of glycemic control. “Despite that, I think many of us are often surprised by the percentage of unplanned pregnancies,” said Dr. Kirk, of the University of Virginia, Charlottesville, in an interview.

“What I have learned is that the desire to become pregnant is so strong, and the contemplation of all the adverse events that can happen … is really scary, not only to the woman but to her partner as well.”

Dr. Kirk continued, “The more compassion you can show, and the more emphasis that you can place on the fact that she’s most likely to have a healthy baby, the chances are she’ll work with you from the beginning to get her control where she needs to be.”

Target numbers for hemoglobin A_1c have become lower over the past several years, with the American Diabetes Association now recommending pre-conception levels below 6.5%. “There’s no randomized controlled trial that defines what that ideal number should be, but with the passage of time and some larger studies, we now know that ‘as close to normal as possible’ should be the goal,” Dr. Kirk said. This means that if women can tolerate the lower blood glucose levels without serious symptoms of hypoglycemia, a level of less than 6% is more preferable still, she said.

In terms of medication management for women with diabetes who become pregnant, physicians need to think about angiotensin converting enzyme inhibitors and statins, both of which are contraindicated for use during pregnancy. If a patient is pregnant or trying for a pregnancy, “I will stop those, and either leave them off all medicine entirely, or transition them to something that’s safe for use during pregnancy,” said Dr. Kirk.

koakes@frontlinemedcom.com

SOURCE: Kirk S. ENDO 2018, Session M-02-3.

CHICAGO – There is no “safe” lower glycemic threshold for pregnant women with diabetes below which adverse maternal and fetal/neonatal outcomes aren’t seen. In particular, “several retrospective studies have shown that the risk for congenital malformations is increased with higher hemoglobin A_1c levels,” said Susan Kirk, MD, speaking at a “Meet the Professor” session at the annual meeting of the Endocrine Society.

However, pointed out Dr. Kirk, fact-based counseling about pregnancy risks for women with type 1 or type 2 diabetes can – and should – occur within the framework of a strong and accepting physician-patient relationship.

Most women with diabetes have received pre-conception counseling about the risks of pregnancy with diabetes and the importance of glycemic control. “Despite that, I think many of us are often surprised by the percentage of unplanned pregnancies,” said Dr. Kirk, of the University of Virginia, Charlottesville, in an interview.

“What I have learned is that the desire to become pregnant is so strong, and the contemplation of all the adverse events that can happen … is really scary, not only to the woman but to her partner as well.”

Dr. Kirk continued, “The more compassion you can show, and the more emphasis that you can place on the fact that she’s most likely to have a healthy baby, the chances are she’ll work with you from the beginning to get her control where she needs to be.”

Target numbers for hemoglobin A_1c have become lower over the past several years, with the American Diabetes Association now recommending pre-conception levels below 6.5%. “There’s no randomized controlled trial that defines what that ideal number should be, but with the passage of time and some larger studies, we now know that ‘as close to normal as possible’ should be the goal,” Dr. Kirk said. This means that if women can tolerate the lower blood glucose levels without serious symptoms of hypoglycemia, a level of less than 6% is more preferable still, she said.

In terms of medication management for women with diabetes who become pregnant, physicians need to think about angiotensin converting enzyme inhibitors and statins, both of which are contraindicated for use during pregnancy. If a patient is pregnant or trying for a pregnancy, “I will stop those, and either leave them off all medicine entirely, or transition them to something that’s safe for use during pregnancy,” said Dr. Kirk.

koakes@frontlinemedcom.com

SOURCE: Kirk S. ENDO 2018, Session M-02-3.

CHICAGO – There is no “safe” lower glycemic threshold for pregnant women with diabetes below which adverse maternal and fetal/neonatal outcomes aren’t seen. In particular, “several retrospective studies have shown that the risk for congenital malformations is increased with higher hemoglobin A_1c levels,” said Susan Kirk, MD, speaking at a “Meet the Professor” session at the annual meeting of the Endocrine Society.

However, pointed out Dr. Kirk, fact-based counseling about pregnancy risks for women with type 1 or type 2 diabetes can – and should – occur within the framework of a strong and accepting physician-patient relationship.

Most women with diabetes have received pre-conception counseling about the risks of pregnancy with diabetes and the importance of glycemic control. “Despite that, I think many of us are often surprised by the percentage of unplanned pregnancies,” said Dr. Kirk, of the University of Virginia, Charlottesville, in an interview.

“What I have learned is that the desire to become pregnant is so strong, and the contemplation of all the adverse events that can happen … is really scary, not only to the woman but to her partner as well.”

Dr. Kirk continued, “The more compassion you can show, and the more emphasis that you can place on the fact that she’s most likely to have a healthy baby, the chances are she’ll work with you from the beginning to get her control where she needs to be.”

Target numbers for hemoglobin A_1c have become lower over the past several years, with the American Diabetes Association now recommending pre-conception levels below 6.5%. “There’s no randomized controlled trial that defines what that ideal number should be, but with the passage of time and some larger studies, we now know that ‘as close to normal as possible’ should be the goal,” Dr. Kirk said. This means that if women can tolerate the lower blood glucose levels without serious symptoms of hypoglycemia, a level of less than 6% is more preferable still, she said.

In terms of medication management for women with diabetes who become pregnant, physicians need to think about angiotensin converting enzyme inhibitors and statins, both of which are contraindicated for use during pregnancy. If a patient is pregnant or trying for a pregnancy, “I will stop those, and either leave them off all medicine entirely, or transition them to something that’s safe for use during pregnancy,” said Dr. Kirk.

koakes@frontlinemedcom.com

SOURCE: Kirk S. ENDO 2018, Session M-02-3.

ORLANDO – Patients who received vouchers to cover copayments were more likely to receive prescriptions for more effective antiplatelet medication, according to data from a multicenter, randomized trial.

“We know that guidelines are very clear; we need to treat patients with antiplatelet therapy for 12 months,” and that the most potent drug, ticagrelor, should be used, Tracy Wang, MD, of Duke University, Durham, N.C., said in a video interview at the annual meeting of the American College of Cardiology. However, in the United States, clopidogrel, though less effective, is prescribed much more often, and many patients discontinue their P2Y₁₂ inhibitor therapy within the first year because of cost, she added.

“We hypothesized that, by reducing the out of pocket costs, treatment would be more evidence driven, rather than driven by what patients could afford,” she said.

The Affordability and Real-World Antiplatelet Treatment Effectiveness After Myocardial Infarction Study (ARTEMIS) included 11,001 MI patients at 301 hospitals across the United States. Patients in the treatment hospital group received a voucher to use at a pharmacy or through a mail-order pharmacy to reduce out of pocket costs. Randomization occurred at the hospital level, and hospital characteristics were similar between the groups.

Overall, patients in the treatment group were significantly more likely to receive a prescription for ticagrelor than clopidogrel (60% vs. 36%); 55% and 32% of patients in the usual care group were prescribed ticagrelor and clopidogrel, respectively. Nonpersistence, defined as a gap in P2Y₁₂-inhibitor use of at least 30 days within 1 year, was significantly lower in the treatment group than it was in the usual care group based on patient reported analysis (13% vs. 16%).

However, the incidence of major adverse cardiac events was roughly 10% in both groups. The similar outcomes may stem from the fact that 28% of patients with vouchers did not fill their prescriptions for reasons that the study did not explore, said Dr. Wang.

All patients had health insurance: 64% private, 42% Medicare, 9% Medicaid. The average age of the patients was 62 years, and 31% were women. Patient demographics and clinical characteristics were similar between the groups.

The vouchers affected choice of treatment but didn’t help clinical outcomes, which suggests that copayment reduction should be part of a broader strategy to help patients with adherence over time, said Dr. Wang.

Next steps for research include taking a subset of patients who are more likely to be nonadherent and at high risk for adverse events and targeting them for additional intervention, she noted.

Discussant Craig J. Beavers, PharmD, of the University of Kentucky College of Pharmacy, Lexington, agreed that a multipronged approach is needed to get patients to take their medicines. “We have to figure out what other barriers there are,” he said. “The real trick is, even if you lead a horse to water, how to get them to drink it,” he said.

The study was funded by AstraZeneca. Dr. Wang disclosed relationships with companies including Gilead Sciences, Merck, and Sanofi Pasteur. Dr. Beavers had no financial conflicts to disclose.

SOURCE: Wang T. ACC 18.

ORLANDO – Patients who received vouchers to cover copayments were more likely to receive prescriptions for more effective antiplatelet medication, according to data from a multicenter, randomized trial.

“We know that guidelines are very clear; we need to treat patients with antiplatelet therapy for 12 months,” and that the most potent drug, ticagrelor, should be used, Tracy Wang, MD, of Duke University, Durham, N.C., said in a video interview at the annual meeting of the American College of Cardiology. However, in the United States, clopidogrel, though less effective, is prescribed much more often, and many patients discontinue their P2Y₁₂ inhibitor therapy within the first year because of cost, she added.

“We hypothesized that, by reducing the out of pocket costs, treatment would be more evidence driven, rather than driven by what patients could afford,” she said.

The Affordability and Real-World Antiplatelet Treatment Effectiveness After Myocardial Infarction Study (ARTEMIS) included 11,001 MI patients at 301 hospitals across the United States. Patients in the treatment hospital group received a voucher to use at a pharmacy or through a mail-order pharmacy to reduce out of pocket costs. Randomization occurred at the hospital level, and hospital characteristics were similar between the groups.

Overall, patients in the treatment group were significantly more likely to receive a prescription for ticagrelor than clopidogrel (60% vs. 36%); 55% and 32% of patients in the usual care group were prescribed ticagrelor and clopidogrel, respectively. Nonpersistence, defined as a gap in P2Y₁₂-inhibitor use of at least 30 days within 1 year, was significantly lower in the treatment group than it was in the usual care group based on patient reported analysis (13% vs. 16%).

However, the incidence of major adverse cardiac events was roughly 10% in both groups. The similar outcomes may stem from the fact that 28% of patients with vouchers did not fill their prescriptions for reasons that the study did not explore, said Dr. Wang.

All patients had health insurance: 64% private, 42% Medicare, 9% Medicaid. The average age of the patients was 62 years, and 31% were women. Patient demographics and clinical characteristics were similar between the groups.

The vouchers affected choice of treatment but didn’t help clinical outcomes, which suggests that copayment reduction should be part of a broader strategy to help patients with adherence over time, said Dr. Wang.

Next steps for research include taking a subset of patients who are more likely to be nonadherent and at high risk for adverse events and targeting them for additional intervention, she noted.

Discussant Craig J. Beavers, PharmD, of the University of Kentucky College of Pharmacy, Lexington, agreed that a multipronged approach is needed to get patients to take their medicines. “We have to figure out what other barriers there are,” he said. “The real trick is, even if you lead a horse to water, how to get them to drink it,” he said.

The study was funded by AstraZeneca. Dr. Wang disclosed relationships with companies including Gilead Sciences, Merck, and Sanofi Pasteur. Dr. Beavers had no financial conflicts to disclose.

SOURCE: Wang T. ACC 18.

ORLANDO – Patients who received vouchers to cover copayments were more likely to receive prescriptions for more effective antiplatelet medication, according to data from a multicenter, randomized trial.

“We know that guidelines are very clear; we need to treat patients with antiplatelet therapy for 12 months,” and that the most potent drug, ticagrelor, should be used, Tracy Wang, MD, of Duke University, Durham, N.C., said in a video interview at the annual meeting of the American College of Cardiology. However, in the United States, clopidogrel, though less effective, is prescribed much more often, and many patients discontinue their P2Y₁₂ inhibitor therapy within the first year because of cost, she added.

“We hypothesized that, by reducing the out of pocket costs, treatment would be more evidence driven, rather than driven by what patients could afford,” she said.

The Affordability and Real-World Antiplatelet Treatment Effectiveness After Myocardial Infarction Study (ARTEMIS) included 11,001 MI patients at 301 hospitals across the United States. Patients in the treatment hospital group received a voucher to use at a pharmacy or through a mail-order pharmacy to reduce out of pocket costs. Randomization occurred at the hospital level, and hospital characteristics were similar between the groups.

Overall, patients in the treatment group were significantly more likely to receive a prescription for ticagrelor than clopidogrel (60% vs. 36%); 55% and 32% of patients in the usual care group were prescribed ticagrelor and clopidogrel, respectively. Nonpersistence, defined as a gap in P2Y₁₂-inhibitor use of at least 30 days within 1 year, was significantly lower in the treatment group than it was in the usual care group based on patient reported analysis (13% vs. 16%).

However, the incidence of major adverse cardiac events was roughly 10% in both groups. The similar outcomes may stem from the fact that 28% of patients with vouchers did not fill their prescriptions for reasons that the study did not explore, said Dr. Wang.

All patients had health insurance: 64% private, 42% Medicare, 9% Medicaid. The average age of the patients was 62 years, and 31% were women. Patient demographics and clinical characteristics were similar between the groups.

The vouchers affected choice of treatment but didn’t help clinical outcomes, which suggests that copayment reduction should be part of a broader strategy to help patients with adherence over time, said Dr. Wang.

Next steps for research include taking a subset of patients who are more likely to be nonadherent and at high risk for adverse events and targeting them for additional intervention, she noted.

Discussant Craig J. Beavers, PharmD, of the University of Kentucky College of Pharmacy, Lexington, agreed that a multipronged approach is needed to get patients to take their medicines. “We have to figure out what other barriers there are,” he said. “The real trick is, even if you lead a horse to water, how to get them to drink it,” he said.

The study was funded by AstraZeneca. Dr. Wang disclosed relationships with companies including Gilead Sciences, Merck, and Sanofi Pasteur. Dr. Beavers had no financial conflicts to disclose.

SOURCE: Wang T. ACC 18.

ORLANDO – Treating patients who developed myocardial injury after noncardiac surgery with the anticoagulant dabigatran significantly cut the rate of subsequent major vascular complications in a randomized, multicenter trial with 1,754 patients, a result that gives surgeons and physicians the first evidence-based intervention for treating a common postsurgical condition.

“Because we have not systematically followed noncardiac surgery patients, it’s easy to presume that everyone is okay, but all the epidemiology data show that these patients [who develop myocardial injury after noncardiac surgery] don’t do okay. We need to be aggressive with secondary prophylaxis,” P.J. Devereaux, MD, said at the annual meeting of the American College of Cardiology. “The unfortunate thing is that right now, we don’t do much for these patients,” said Dr. Devereaux, professor of medicine and director of cardiology at McMaster University in Hamilton, Ont.

Results from prior epidemiology studies have shown that, among the roughly 200 million patients who undergo noncardiac surgery worldwide each year, 8% will develop MINS (myocardial injury after noncardiac surgery) (Anesthesiology. 2014 March;120[3]:564-78). The myocardial injury that defines MINS is identified by either an overt MI that meets the universal definition, or an otherwise unexplained rise in serum troponin levels from baseline in the first couple of days after surgery. In the new study, Dr. Devereaux and his associates identified 80% of MINS by a troponin rise and 20% by a diagnosed MI.

The challenge in diagnosing MINS and then administering dabigatran will be implementation of this strategy into routine practice, commented Erin A. Bohula May, MD, a cardiologist at Brigham and Women’s Hospital in Boston. “The problem is, troponin is not routinely measured in postoperative patients. It will be hard to change practice,” she noted.

Dr. Devereaux agreed that a significant barrier is convincing clinicians, especially surgeons, to routinely measure a patient’s troponin levels just before and immediately after surgery. “People are lulled into a false sense of security because patients [who develop MINS] usually don’t have chest pain,” he said in a video interview. “When we first showed that patients with MINS have bad outcomes, that convinced some [surgeons] to measure troponin after surgery. “Showing we can do something about it” is another important step toward fostering more awareness of and interest in diagnosing and treating MINS.

The Management of Myocardial Injury After Noncardiac Surgery Trial (MANAGE) enrolled 1,754 patients at 82 centers in 19 countries. Researchers randomized patients to treatment with either 110 mg dabigatran b.i.d. or placebo. A majority of patients in both arms also received aspirin and a statin, treatments that Dr. Devereaux should be used along with dabigatran in routine practice, based on observational findings, although the efficacy of these drugs for MINS patients has not been tested in randomized studies. The study’s primary endpoint was the incidence of major vascular complications, a composite that included vascular mortality, nonfatal MI, nonfatal and nonhemorrhagic stroke, peripheral arterial thrombosis, amputation, or symptomatic venous thromboembolism.

After an average follow-up of 16 months, the primary endpoint occurred in 11% of the dabigatran-treated patients and in 15% of controls, which represented a 28% risk reduction that was statistically significant. The study’s primary safety endpoint was a composite of life-threatening, major, and critical organ bleeds, which occurred in 3% of the dabigatran-treated patients and in 4% of controls, a nonsignificant difference. The dabigatran-treated patients showed a significant excess of both minor bleeds – 15% compared with 10% in controls – and “nonsignificant” lower gastrointestinal bleeds, 4% with dabigatran and 1% in the controls. The dabigatran-treated patients also had a significantly higher incidence of dyspepsia.

MANAGE was funded by the Population Health Research Institute and had no commercial funding. Dr. Devereaux has received research support from Abbott Diagnostics, Boehringer Ingelheim, Philips Healthcare, and Roche Diagnostics. Dr. May has been a consultant to Daiichi Sankyo, Merck, and Servier and has received research funding from Eisai.

mzoler@frontlinemedcom.com

SOURCE: Devereaux P et al. ACC 18.

ORLANDO – Treating patients who developed myocardial injury after noncardiac surgery with the anticoagulant dabigatran significantly cut the rate of subsequent major vascular complications in a randomized, multicenter trial with 1,754 patients, a result that gives surgeons and physicians the first evidence-based intervention for treating a common postsurgical condition.

“Because we have not systematically followed noncardiac surgery patients, it’s easy to presume that everyone is okay, but all the epidemiology data show that these patients [who develop myocardial injury after noncardiac surgery] don’t do okay. We need to be aggressive with secondary prophylaxis,” P.J. Devereaux, MD, said at the annual meeting of the American College of Cardiology. “The unfortunate thing is that right now, we don’t do much for these patients,” said Dr. Devereaux, professor of medicine and director of cardiology at McMaster University in Hamilton, Ont.

Results from prior epidemiology studies have shown that, among the roughly 200 million patients who undergo noncardiac surgery worldwide each year, 8% will develop MINS (myocardial injury after noncardiac surgery) (Anesthesiology. 2014 March;120[3]:564-78). The myocardial injury that defines MINS is identified by either an overt MI that meets the universal definition, or an otherwise unexplained rise in serum troponin levels from baseline in the first couple of days after surgery. In the new study, Dr. Devereaux and his associates identified 80% of MINS by a troponin rise and 20% by a diagnosed MI.

The challenge in diagnosing MINS and then administering dabigatran will be implementation of this strategy into routine practice, commented Erin A. Bohula May, MD, a cardiologist at Brigham and Women’s Hospital in Boston. “The problem is, troponin is not routinely measured in postoperative patients. It will be hard to change practice,” she noted.

Dr. Devereaux agreed that a significant barrier is convincing clinicians, especially surgeons, to routinely measure a patient’s troponin levels just before and immediately after surgery. “People are lulled into a false sense of security because patients [who develop MINS] usually don’t have chest pain,” he said in a video interview. “When we first showed that patients with MINS have bad outcomes, that convinced some [surgeons] to measure troponin after surgery. “Showing we can do something about it” is another important step toward fostering more awareness of and interest in diagnosing and treating MINS.

The Management of Myocardial Injury After Noncardiac Surgery Trial (MANAGE) enrolled 1,754 patients at 82 centers in 19 countries. Researchers randomized patients to treatment with either 110 mg dabigatran b.i.d. or placebo. A majority of patients in both arms also received aspirin and a statin, treatments that Dr. Devereaux should be used along with dabigatran in routine practice, based on observational findings, although the efficacy of these drugs for MINS patients has not been tested in randomized studies. The study’s primary endpoint was the incidence of major vascular complications, a composite that included vascular mortality, nonfatal MI, nonfatal and nonhemorrhagic stroke, peripheral arterial thrombosis, amputation, or symptomatic venous thromboembolism.

After an average follow-up of 16 months, the primary endpoint occurred in 11% of the dabigatran-treated patients and in 15% of controls, which represented a 28% risk reduction that was statistically significant. The study’s primary safety endpoint was a composite of life-threatening, major, and critical organ bleeds, which occurred in 3% of the dabigatran-treated patients and in 4% of controls, a nonsignificant difference. The dabigatran-treated patients showed a significant excess of both minor bleeds – 15% compared with 10% in controls – and “nonsignificant” lower gastrointestinal bleeds, 4% with dabigatran and 1% in the controls. The dabigatran-treated patients also had a significantly higher incidence of dyspepsia.

MANAGE was funded by the Population Health Research Institute and had no commercial funding. Dr. Devereaux has received research support from Abbott Diagnostics, Boehringer Ingelheim, Philips Healthcare, and Roche Diagnostics. Dr. May has been a consultant to Daiichi Sankyo, Merck, and Servier and has received research funding from Eisai.

mzoler@frontlinemedcom.com

SOURCE: Devereaux P et al. ACC 18.

ORLANDO – Treating patients who developed myocardial injury after noncardiac surgery with the anticoagulant dabigatran significantly cut the rate of subsequent major vascular complications in a randomized, multicenter trial with 1,754 patients, a result that gives surgeons and physicians the first evidence-based intervention for treating a common postsurgical condition.

“Because we have not systematically followed noncardiac surgery patients, it’s easy to presume that everyone is okay, but all the epidemiology data show that these patients [who develop myocardial injury after noncardiac surgery] don’t do okay. We need to be aggressive with secondary prophylaxis,” P.J. Devereaux, MD, said at the annual meeting of the American College of Cardiology. “The unfortunate thing is that right now, we don’t do much for these patients,” said Dr. Devereaux, professor of medicine and director of cardiology at McMaster University in Hamilton, Ont.

Results from prior epidemiology studies have shown that, among the roughly 200 million patients who undergo noncardiac surgery worldwide each year, 8% will develop MINS (myocardial injury after noncardiac surgery) (Anesthesiology. 2014 March;120[3]:564-78). The myocardial injury that defines MINS is identified by either an overt MI that meets the universal definition, or an otherwise unexplained rise in serum troponin levels from baseline in the first couple of days after surgery. In the new study, Dr. Devereaux and his associates identified 80% of MINS by a troponin rise and 20% by a diagnosed MI.

The challenge in diagnosing MINS and then administering dabigatran will be implementation of this strategy into routine practice, commented Erin A. Bohula May, MD, a cardiologist at Brigham and Women’s Hospital in Boston. “The problem is, troponin is not routinely measured in postoperative patients. It will be hard to change practice,” she noted.

Dr. Devereaux agreed that a significant barrier is convincing clinicians, especially surgeons, to routinely measure a patient’s troponin levels just before and immediately after surgery. “People are lulled into a false sense of security because patients [who develop MINS] usually don’t have chest pain,” he said in a video interview. “When we first showed that patients with MINS have bad outcomes, that convinced some [surgeons] to measure troponin after surgery. “Showing we can do something about it” is another important step toward fostering more awareness of and interest in diagnosing and treating MINS.

The Management of Myocardial Injury After Noncardiac Surgery Trial (MANAGE) enrolled 1,754 patients at 82 centers in 19 countries. Researchers randomized patients to treatment with either 110 mg dabigatran b.i.d. or placebo. A majority of patients in both arms also received aspirin and a statin, treatments that Dr. Devereaux should be used along with dabigatran in routine practice, based on observational findings, although the efficacy of these drugs for MINS patients has not been tested in randomized studies. The study’s primary endpoint was the incidence of major vascular complications, a composite that included vascular mortality, nonfatal MI, nonfatal and nonhemorrhagic stroke, peripheral arterial thrombosis, amputation, or symptomatic venous thromboembolism.

After an average follow-up of 16 months, the primary endpoint occurred in 11% of the dabigatran-treated patients and in 15% of controls, which represented a 28% risk reduction that was statistically significant. The study’s primary safety endpoint was a composite of life-threatening, major, and critical organ bleeds, which occurred in 3% of the dabigatran-treated patients and in 4% of controls, a nonsignificant difference. The dabigatran-treated patients showed a significant excess of both minor bleeds – 15% compared with 10% in controls – and “nonsignificant” lower gastrointestinal bleeds, 4% with dabigatran and 1% in the controls. The dabigatran-treated patients also had a significantly higher incidence of dyspepsia.

MANAGE was funded by the Population Health Research Institute and had no commercial funding. Dr. Devereaux has received research support from Abbott Diagnostics, Boehringer Ingelheim, Philips Healthcare, and Roche Diagnostics. Dr. May has been a consultant to Daiichi Sankyo, Merck, and Servier and has received research funding from Eisai.

mzoler@frontlinemedcom.com

SOURCE: Devereaux P et al. ACC 18.

ORLANDO – The HeartMate 3 magnetically levitated left ventricular assist (LVAD) device provided far superior outcomes, compared with the widely used HeartMate II axial-flow pump at 2 years of follow-up in patients with advanced heart failure in the large multicenter MOMENTUM 3 trial, Mandeep R. Mehra, MD, reported at the annual meeting of the American College of Cardiology.

Bruce Jancin/Frontline Medical News

HeartMate 3 recipients had a 90% lower risk of undergoing reoperation to replace or remove their device because of malfunction, and a stroke rate half that in the HeartMate II group.

“This was the lowest rate of stroke ever seen in any LVAD trial,” according to Dr. Mehra, medical director of the Brigham and Women’s Hospital Heart and Vascular Center, Boston, and professor of medicine at Harvard Medical School.

“We believe this is a practice-changing result in the field, and that the real implication of our findings is to reassure those who refer or treat patients with advanced heart failure that it is perhaps going to be ignorant not to refer patients for consideration for destination therapy,” he said at a press conference highlighting the MOMENTUM 3 results, also presented in a late-breaking clinical trials session.

The HeartMate 3 is a miniaturized centrifugal-flow device that fits entirely within the chest, whereas the HeartMate II requires creation of a pocket in the abdomen. The HeartMate 3 was designed to prevent pump thrombosis – a common limiting problem with the HeartMate II and other LVADs – by employing three innovations: use of wide blood-flow passages to reduce shear stress and minimize disruption of red blood cells as they pass through the pump; reliance on magnetic levitation technology to create a frictionless pump with no mechanical bearings, which are subject to wear and tear; and incorporation of an artificial fixed pulse that speeds up and slows every 2 seconds in order to minimize blood stasis, which promotes thrombosis, the cardiologist explained in a video interview.

Bruce Jancin/Frontline Medical News

Discussant James L. Janzuzzi Jr., called the MOMENTUM 3 results “a very-much-needed step forward.”

bjancin@frontlinemedcom.com

SOURCE: Mehra M et al. ACC 18.

ORLANDO – The HeartMate 3 magnetically levitated left ventricular assist (LVAD) device provided far superior outcomes, compared with the widely used HeartMate II axial-flow pump at 2 years of follow-up in patients with advanced heart failure in the large multicenter MOMENTUM 3 trial, Mandeep R. Mehra, MD, reported at the annual meeting of the American College of Cardiology.

Bruce Jancin/Frontline Medical News

HeartMate 3 recipients had a 90% lower risk of undergoing reoperation to replace or remove their device because of malfunction, and a stroke rate half that in the HeartMate II group.

“This was the lowest rate of stroke ever seen in any LVAD trial,” according to Dr. Mehra, medical director of the Brigham and Women’s Hospital Heart and Vascular Center, Boston, and professor of medicine at Harvard Medical School.

“We believe this is a practice-changing result in the field, and that the real implication of our findings is to reassure those who refer or treat patients with advanced heart failure that it is perhaps going to be ignorant not to refer patients for consideration for destination therapy,” he said at a press conference highlighting the MOMENTUM 3 results, also presented in a late-breaking clinical trials session.

The HeartMate 3 is a miniaturized centrifugal-flow device that fits entirely within the chest, whereas the HeartMate II requires creation of a pocket in the abdomen. The HeartMate 3 was designed to prevent pump thrombosis – a common limiting problem with the HeartMate II and other LVADs – by employing three innovations: use of wide blood-flow passages to reduce shear stress and minimize disruption of red blood cells as they pass through the pump; reliance on magnetic levitation technology to create a frictionless pump with no mechanical bearings, which are subject to wear and tear; and incorporation of an artificial fixed pulse that speeds up and slows every 2 seconds in order to minimize blood stasis, which promotes thrombosis, the cardiologist explained in a video interview.

Bruce Jancin/Frontline Medical News

Discussant James L. Janzuzzi Jr., called the MOMENTUM 3 results “a very-much-needed step forward.”

bjancin@frontlinemedcom.com

SOURCE: Mehra M et al. ACC 18.

ORLANDO – The HeartMate 3 magnetically levitated left ventricular assist (LVAD) device provided far superior outcomes, compared with the widely used HeartMate II axial-flow pump at 2 years of follow-up in patients with advanced heart failure in the large multicenter MOMENTUM 3 trial, Mandeep R. Mehra, MD, reported at the annual meeting of the American College of Cardiology.

Bruce Jancin/Frontline Medical News

HeartMate 3 recipients had a 90% lower risk of undergoing reoperation to replace or remove their device because of malfunction, and a stroke rate half that in the HeartMate II group.

“This was the lowest rate of stroke ever seen in any LVAD trial,” according to Dr. Mehra, medical director of the Brigham and Women’s Hospital Heart and Vascular Center, Boston, and professor of medicine at Harvard Medical School.

“We believe this is a practice-changing result in the field, and that the real implication of our findings is to reassure those who refer or treat patients with advanced heart failure that it is perhaps going to be ignorant not to refer patients for consideration for destination therapy,” he said at a press conference highlighting the MOMENTUM 3 results, also presented in a late-breaking clinical trials session.

The HeartMate 3 is a miniaturized centrifugal-flow device that fits entirely within the chest, whereas the HeartMate II requires creation of a pocket in the abdomen. The HeartMate 3 was designed to prevent pump thrombosis – a common limiting problem with the HeartMate II and other LVADs – by employing three innovations: use of wide blood-flow passages to reduce shear stress and minimize disruption of red blood cells as they pass through the pump; reliance on magnetic levitation technology to create a frictionless pump with no mechanical bearings, which are subject to wear and tear; and incorporation of an artificial fixed pulse that speeds up and slows every 2 seconds in order to minimize blood stasis, which promotes thrombosis, the cardiologist explained in a video interview.

Bruce Jancin/Frontline Medical News

Discussant James L. Janzuzzi Jr., called the MOMENTUM 3 results “a very-much-needed step forward.”

bjancin@frontlinemedcom.com

SOURCE: Mehra M et al. ACC 18.

Click here to view the articles published in March 2018.

Click here to view the articles published in March 2018.

Click here to view the articles published in March 2018.

This video was filmed at Metabolic & Endocrine Disease Summit (MEDS). Click here to learn more.

This video was filmed at Metabolic & Endocrine Disease Summit (MEDS). Click here to learn more.

This video was filmed at Metabolic & Endocrine Disease Summit (MEDS). Click here to learn more.