6/28/23, 11:16 PM MANAGE Pathway Feedback Search Clinical Topics Home Studies MANAGE MANAGE Disease Disease Non-ST-elevation myocardial inf ST-elevation myocardial infarction Trial question What is role of dabigatran in patients with myocardial injury after noncardiac surgery? Study design Multi-center Double blinded RCT Population Characteristics of study participants 49.0% female N = 1754 51.0% male 1754 patients (858 female, 896 male) Inclusion criteria: patients who had undergone noncardiac surgery and were within 35 days of myocardial injury after noncardiac surgery Key exclusion criteria: hypersensitivity or known allergy to dabigatran, history of intracranial, intraocular or spinal bleeding, hemorrhagic disorder or bleeding diathesis, pregnant or breastfeeding women, or conditions necessitating therapeutic dose anticoagulation Interventions N=877 dabigatran (110 mg PO BID for a maximum of 2 years or until termination of the trial) N=877 placebo (matched for a maximum of 2 years) Primary outcome https://web.pathway.md/studies/reckvSbNfmLJlNj0r 1/2 6/28/23, 11:16 PM MANAGE Pathway Major vascular complications 15.0 % 15 11.3 % 11 7.5 % Significant decrease 3.8 % NNT = 25 0.0 % Dabigatran Placebo Significant decrease in major vascular complications (11% vs. 15%; HR 0.72, 95% CI 0.55 to 0.93) Secondary outcomes No significant difference in vascular death (6% vs. 7%; HR 0.8, 95% CI 0.56 to 1.16) Safety outcomes No significant differences in life-threatening, critical, or major organ bleeding. Significant differences in 3% vs. 4%, p = 0.76; HR 0.92, 95% CI 0.55-1.53. Conclusion In patients who had undergone noncardiac surgery and were within 35 days of myocardial injury after noncardiac surgery, dabigatran was superior to placebo with respect to major vascular complications. Reference Devereaux PJ, Duceppe E, Guyatt G et al. Dabigatran in patients with myocardial injury after non- cardiac surgery (MANAGE): an international, randomised, placebo-controlled trial. Lancet. 2018 Jun 9;391(10137):2325-2334. Open reference URL https://web.pathway.md/studies/reckvSbNfmLJlNj0r 2/2