John Cairns, MD
Does dabigatran increase risk for myocardial infarction (MI) or an acute coronary syndrome (ACS)?
Included studies compared dabigatran with any control group and reported MI or ACS as secondary outcomes. Primary outcomes for the review were MI or ACS (confirmed unstable angina, MI, or cardiac death). Secondary outcome was mortality.
PubMed, Scopus, and Web of Science were searched to May 2011 for randomized controlled trials (RCTs). 7 RCTs (n = 30 514) met inclusion criteria. Comparators were adjusted-dose warfarin (2 RCTs of stroke prophylaxis in atrial fibrillation, n = 18 628, and 1 in acute venous thromboembolism, n = 2539); placebo (1 RCT in ACS, n = 1861); and enoxaparin (3 RCTs of short-term deep venous thrombosis prophylaxis in joint replacement, n = 7552). All trials evaluated the noninferiority of dabigatran for bleeding events and were sponsored by the manufacturer. 6 trials were judged to have high quality (Jadad scale scores ≥ 3 out of 5).
Meta-analyses showed that dabigatran increased risk for MI or ACS and reduced risk for mortality compared with warfarin, enoxaparin, or placebo (Table).
Dabigatran increases risk for myocardial infarction compared with warfarin, enoxaparin, or placebo in various clinical settings, but decreases mortality.
Dabigatran vs control (warfarin, enoxaparin, or placebo) for several clinical indications*
*ACS = acute coronary syndrome (confirmed unstable angina, MI, or cardiac death); MI = myocardial infarction; other abbreviations defined in Glossary. RRI, RRR, NNH, NNT, and CI calculated from relative risks and risk differences in article (Mantel–Haenszel fixed effect). Calculations based on original RE-LY results.
Cairns J. Review: Dabigatran increases MI and reduces mortality compared with warfarin, enoxaparin, or placebo. Ann Intern Med. ;156:JC6–11. doi: 10.7326/0003-4819-156-12-201206190-02011
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Published: Ann Intern Med. 2012;156(12):JC6-11.
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