Devereaux PJ, Duceppe E, Tandon V, et al. Lancet. 2018; 391: 2325-2334.
Study Question: Can dabigatran administration following myocardial injury after non-cardiac surgery prevent major vascular complications?
Study Description: This is an international, randomized, placebo-controlled trial that recruited patients from 84 hospitals in 19 different countries. Patients were included if they were at least 45 years of age, underwent a non-cardiac surgery, and were within 35 days of myocardial injury post non-cardiac surgery. Included patients were randomized to receive either dabigatran 110 mg orally twice daily or placebo for a maximum of 2 years or until termination of the study. The primary efficacy outcome was the occurrence of a major vascular complication (composite of vascular mortality and non-fatal myocardial infarction, non-hemorrhagic stroke, peripheral arterial thrombosis, amputation, and symptomatic venous thromboembolism). The primary safety outcome was a composite of life threatening, major, and critical organ bleed.
Results: A total of 877 patients were enrolled in the dabigatran group and 877 patients in the placebo group. The study drug was discontinued in 46% of patients in the dabigatran group and 43% in the placebo group. The composite primary efficacy outcome occurred in 11% of the patients treated with dabigatran versus 15% of the patients treated with placebo [HR 0.72 (95% CI 0.55-0.93), p = 0.0115]. The primary safety composite outcome occurred in 3% of patients receiving dabigatran and 4% of patients in the placebo group [HR 0.92 (95% CI 0.55-1.53), p = 0.76].
Conclusion(s): Dabigatran 110 mg twice daily reduced the incidence of major vascular complications following myocardial injury after non-cardiac surgery as compared to placebo with no additional major bleeding concerns.
Perspective: This is one of the first studies to date examining the efficacy of dabigatran following myocardial injury after non-cardiac surgery. Roughly 90% of patients in this study would not have been otherwise identified if it weren’t for the troponin screening, highlighting the benefit of routine troponin monitoring in at-risk patients undergoing non-cardiac surgery. In those patients with myocardial injury present, anti-coagulation with dabigatran may be an acceptable therapeutic option.