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Promising stroke, bleeding rates after cardioversion reported with dabigatran use
Nagarakanti R. Circulation. 2011;123:131-136.
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Stroke and major bleeding rates after cardioversion among patients from the RE-LY trial who were taking two doses of dabigatran were low and comparable with those who were treated with warfarin.
In the sub-analysis, investigators analyzed 1,983 cardioversions that were performed on 1,270 patients with nonvalvular atrial fibrillation from the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) trial. Overall, 647 procedures were performed on patients assigned 110 mg dabigatran (Pradaxa, Boehringer Ingelheim) twice-daily, 672 procedures on those assigned 150 mg dabigatran twice-daily and 664 procedures in patients assigned warfarin (Coumadin, Bristol-Myers Squibb).
At 30 days, stroke and systemic embolism rates were 0.8% in the 110-mg dabigatran arm, 0.3% in 150-mg dabigatran arm and 0.6% in the warfarin group, with differences between both doses of dabigatran not reaching statistical significance when compared with warfarin. Similarly, major bleeding rates between 110 mg dabigatran (1.7%) and 150 mg dabigatran (0.6%) were comparable with warfarin (0.6%).
“The RE-LY trial confirmed the efficacy and safety of warfarin in cardioversion in a large cohort of warfarin-treated patients. It also allowed comparison with the new oral anticoagulant dabigatran. The results show that the two drugs are comparable in this setting,” the researchers concluded.
The study was funded by a grant provided by Boehringer Ingelheim.
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