MANAGE: Reduced Mortality and Cardiovascular Events in MINS Patients Receiving Dabigatran
Dabigatran significantly reduced the risk of death, myocardial infarction (MI), stroke and other vascular complications among patients with myocardial injury after noncardiac surgery (MINS), according to results of the MANAGE trial presented by P.J. Devereaux, MD, PhD, on Sunday, March 11 in a Late-Breaking Clinical Trial session at ACC.18 in Orlando, FL.
MANAGE was a large international, double-blind study, in which 1,754 patients with MINS were randomized to receive dabigatran 110 mg twice daily or matching placebo. The patients received dabigatran for a maximum of two years and a minimum of four months. The primary efficacy endpoint was a major vascular complication – a composite of vascular mortality and MI, nonhemorrhagic stroke, peripheral arterial thrombosis, amputation and symptomatic venous thromboembolism. The primary safety endpoint was a composite of life-threatening bleeding, major bleeding and critical organ bleeding.
After an average follow-up of 16 months, 11.1 percent of patients receiving dabigatran experienced one or more primary efficacy endpoint events compared with 15.2 percent of patients on placebo, for a 28 percent reduction in risk for patients on dabigatran. Analysis of the individual efficacy endpoints showed that patients on dabigatran had a statistically significant 80 percent reduced risk of nonhemorrhagic stroke than those receiving placebo although the absolute event rates were low (2 vs. 10 strokes). Patients receiving dabigatran were 20 percent less likely to die from a cardiovascular cause, 20 percent less likely to have an MI, 30 percent less likely to have an amputation and 53 percent less likely to have a venous thromboembolism. However, none of these individual differences were statistically significant.
There were no statistically significant differences between the two groups in the primary safety endpoint. More patients receiving dabigatran experienced lower gastrointestinal tract bleeding and minor bleeding compared with patients receiving placebo. Most patients (98.9 percent) completed follow-up but 45.3 percent of those on dabigatran discontinued the drug (14 percent because of a major complication).
“It is encouraging that we did not see an increase in major or life-threatening bleeding in patients on dabigatran,” Devereaux said, adding that further research is needed to evaluate other treatment options for these high-risk patients.
Keywords: ACC18, ACC Annual Scientific Session, Angina, Stable, Antithrombins, Aspirin, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Venous Thromboembolism, Proton Pump Inhibitors, Omeprazole, Odds Ratio, Stroke, Myocardial Infarction, Myocardial Infarction, Intracranial Hemorrhages, Venous Thrombosis, Thrombosis, Amputation, Health Personnel
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