Patients with myocardial injury after noncardiac surgery (MINS) treated with dabigatran (Pradaxa; Boehringer Ingelheim) were found to be at reduced risk for major vascular complications, according to data presented at the ACC.18 Scientific Sessions & Expo.
The MANAGE (Management of myocardial injury After NoncArdiac surGEry) Trial enrolled 1,754 patients who experienced MINS and randomized them to dabigatran 110mg twice daily vs matching placebo. In addition, patients not taking a proton pump inhibitor (PPI) were randomized to omeprazole 20mg daily vs a matching placebo. Physicians were able to prescribe aspirin and a statin to all study participants.
The primary efficacy outcome was major vascular complication, defined as a composite of vascular mortality and the following nonfatal events: myocardial infarction, non-hemorrhagic stroke, peripheral arterial thrombosis, amputation, and symptomatic venous thromboembolism. The primary safety outcome was a composite of life-threatening bleeding, major bleeding, and critical organ bleeding.
Findings from the trial showed treatment with dabigatran reduced the risk of 1 or more of the primary efficacy outcome events by 28% vs placebo. This benefit was observed for each component of the primary outcome: 20% reduced risk of CV death, 20% reduced risk of myocardial infarction, 30% reduced risk of having an amputation, and 53% reduced risk of developing a venous blood clot, all compared to placebo.
Study authors also found a statistically significant 80% risk reduction for non-hemorrhagic stroke when compared with patients who received placebo.
No statistically significant differences were seen between the treatment arms with regard to life-threatening, major or critical organ bleeding. Nearly half of the patients taking dabigatran (45.3%), however, discontinued the study drug after the follow-up period; while most were due to patient requests, 14% of them were due to major complications.
“We have shown for the first time that dabigatran reduces the risk of major cardiovascular complications and offers an option for improving outcomes in a large at-risk population who have MINS,” said lead author, P.J. Devereaux, MD, PhD, director of cardiology at McMaster University in Hamilton, Canada.
Deveraux PJ, Duceppe E, Tandon V, et al. The Effect of Dabigatran in Patients Suffering Myocardial Injury After Noncardiac Surgery. Presented at: ACC.18 Scientific Sessions & Expo. March 10–12, 2018; Orlando, FL. Abstract #404-14.