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VIDEO: Dabigatran effective for myocardial injury after noncardiac surgery

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Treatment now possible for a new clinical entity

Dr. Devereaux and his associates are to be congratulated on identifying a new disease entity, MINS (myocardial injury after noncardiac surgery), and now giving us a way to treat it. MINS is extremely common and quite morbid, and there had never before been a trial that studied its treatment. Identifying patients with MINS is extremely important. These are very-high-risk patients, and they are very hard to find. The results from MANAGE give us a way to do something about MINS and an opportunity to improve patient outcomes.

Dr. Pamela S. Douglas is a cardiologist and professor of medicine at Duke University in Durham, N.C. Mitchel L. Zoler/Frontline Medical News

Dr. Pamela S. Douglas

The etiology of MINS puts the responsibility primarily on surgeons to diagnose and treat MINS. I hope the message will reach surgeons about MINS and how it can be treated. It does not seem practical for cardiologists to play a role in most of these cases. I also have some concern that, while surgeons are the logical clinicians to diagnose and treat MINS, they also might feel some disincentive to identify patients who develop an initially asymptomatic complication because of the surgery they have undergone.

Pamela S. Douglas, MD , is a cardiologist and professor of medicine at Duke University in Durham, N.C. She had no disclosures. She made these comments as a discussant for MANAGE and in an interview.



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.

SOURCE: Devereaux P et al. ACC 18.


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