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Dabigatran Associated with Increased Risk for Heart Attack

The anticoagulant dabigatran has been linked to an increased risk of heart attack or acute coronary syndrome in patients when tested against other medications, a new study shows.

"Clinicians should consider the potential of these serious harmful cardiovascular effects with use of dabigatran," the study concludes.

Dabigatran etexilate was first approved in 2008 by the European Medicines Agency for prevention of venous thromboembolism (VTE) in adults who have undergone total hip or knee replacement and in 2010 by the U.S. Food and Drug Administration for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (AF).

An original trial suggested a slight increased risk of heart attack with the use of dabigatran compared to warfarin in patients with atrial fibrillation.

Dr. Ken Uchino and Dr. Adrian V. Hernandez of the Cleveland Clinic in Ohio, searched the medical literature for randomized controlled trials of dabigatran that reported on myocardial infarction - or heart attack - or acute coronary syndrome (ACS) as secondary outcomes. Seven trials were selected for their meta-analysis that involved 30,514 participants.

The trials they analyzed included: two studies of stroke prophylaxis in atrial fibrillation, one in acute venous thromboembolism and one in ACS, along with three trials or short-term prophylaxis of deep venous thrombosis in joint replacement. The control groups included administration of enoxaparin, warfarin or placebo.

Dabigatran was significantly associated with a higher risk of heart attack or ACS than that seen with agents used in the control group, according to researchers. They note the risk of MI or ACS was similar when using revised results of a previous trial and after the exclusion of short-term trials.

"Although the relative risk increase was 33 percent, the absolute risk increase was very small, at 0.27 percent," the authors write.

Researchers suggest that while dabigatran might not directly increase the risk of heart attack, it may lack the beneficial effects that warfarin and aspirin have in heart attack prevention.

"The overall benefit and risk balance of dabigatran use appears to be favorable in patients with AF because of reduction in ischemic stroke. However, the cardiac risk of dabigatran should be investigated further, especially if it is used in populations at high risk of MI or ACS," the authors conclude.






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