ORLANDO — Dabigatran (Pradaxa) reduces risk of major vascular events for patients who have a heart attack or troponin elevation after noncardiac surgery, the MANAGE trial showed.
The composite primary endpoint of major vascular outcomes — vascular mortality and nonfatal MI, non-hemorrhagic stroke, peripheral arterial thrombosis, amputation, and symptomatic venous thromboembolism — came out 11% versus 15% with placebo (HR 0.72, P=0.012), reported PJ Devereaux, MD, PhD, of Population Health Research Institute in Hamilton, Ontario, at the American College of Cardiology (ACC) annual meeting.
The number of myocardial injury after noncardiac surgery (MINS) patients needed to treat was 24 to prevent a major vascular complication. Safety in terms of life-threatening, major, and critical organ bleeding was similar between groups.
“The problem is, because we’ve not been systematically following patients, it’s easy to think they’re doing okay… but many don’t do okay,” Devereaux said. “Hopefully this will change minds,” he added, emphasizing that these are not trivial events, as vascular death was the most common endpoint component.
ACC press conference discussant Erin Bohula, MD, DPhil, of Brigham and Women’s Hospital in Boston, noted that about 80% of the patients had no ischemic symptoms but were found by elevated troponin level an average 1 day after the surgery. Fully 91% did not have symptoms with the troponin elevation.
“That’s most important part of trial, not the particular drug,” agreed Pamela Douglas, MD, of Duke University in Durham, North Carolina, ACC discussant at the late-breaking clinical trial session. “This entity has never had a trial,” she noted.
However, “the challenge is implementation,” Bohula noted, pointing out that troponin is not routinely measured after noncardiac surgery. She predicted MANAGE may change practice in that way.
Devereaux noted that it may be attractive to screen people with prior vascular disease and those age >65.