MANAGE
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
51.0% male
N = 1754
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; pregnancy or lactation; 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
Major vascular complications
11%
15%
15.0 %
11.3 %
7.5 %
3.8 %
0.0 %
Dabigatran
Placebo
Significant
decrease ▼
NNT = 25
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.
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