ORLANDO, Fla. – Treatment with Pradaxa (dabigatran, Boehringer Ingelheim) reduced the risk for death, MI and stroke in patients with elevated risk for these events as a result of myocardial injury after noncardiac surgery, according to Steven Cohn, MD, who presented data from an American College of Cardiology late-breaking trial here at Hospital Medicine 2018.
Each year, myocardial injury after noncardiac surgery (MINS) occurs in more than 8 million adults. MINS is associated with increased risk of major cardiovascular complications and death in the first 2 years after noncardiac surgery.
The idea behind the MANAGE study was that “if you get these components and they are elevated, what do you do?” Cohn said.
Patients (n = 1,754) age 45 years and older were randomly assigned to receive twice-daily dabigatran 110 mg or placebo 35 days after MINS.
“What [researchers] showed was that dabigatran was affective in reducing the incidence of the composite of vascular death, nonfatal MI, nonhemorrhagic stroke, peripheral arterial thrombosis, amputation and symptomatic venous thromboembolism. So, you have a whole collection of things in there that may or may not related, but it was significantly significant (HR = 0.72; 95% CI, 0.55-0.93),” he said
“As far as safety was concerned, it had an HR of 0.92, which was not statistically significant,” he said. “So, [there was] no increase in bleeding in patients who received dabigatran.”
Cohn’s caveat is “look at relevant cardiac outcomes, bleeding definitions, and which patients showed a benefit (for example, MI vs. MINS) before jumping on the bandwagon.”
Please read Healio’s full report of the study here. – by Joan-Marie Stiglich, ELS, and Dave Quaile
Cohn S. “A whole new world” of perioperative medicine: The 2018 update. Presented at: Hospital Medicine 2018. April 9-11, 2018; Orlando.
Disclosure: Cohn reports no relevant financial disclosures. The study was funded by grants by Boehringer Ingelheim and the Canadian Institutes of Health Research.