New Sub-Analysis of RE-LY Trial Examines Pradaxa in Patients with Atrial Fibrillation Undergoing Cardioversion

Wed, 01/05/2011 - 3:33am

RIDGEFIELD, Conn., Jan. 5, 2011 /PRNewswire/ -- Results of a post-hoc analysis of the RE-LY® trial among patients with non-valvular atrial fibrillation (NVAF) undergoing cardioversion, a treatment to convert an abnormal heartbeat back to normal sinus rhythm, were published online on Jan. 3 in Circulation.(1)  Stroke and systemic embolism and major bleeding episodes within 30 days of the cardioversion were the major outcome measures.  The analysis reported that rates of stroke and systemic embolism and major bleeding were low and comparable to warfarin in cardioverted patients receiving Pradaxa® (dabigatran etexilate mesylate) 150mg capsules,(1) an oral anticoagulant recently approved by the U.S. Food and Drug Administration (FDA) to reduce the risk of stroke and systemic embolism in patients with NVAF.(2)

In RE-LY, a total of 1,983 cardioversions were performed in 1,270 patients, with similar numbers in each treatment group (647 in the dabigatran 110mg* group, 672 in the PRADAXA 150mg group and 664 in the warfarin group).(1)  Rates of stroke and systemic embolism within 30 days of cardioversion were low and did not differ significantly between treatment arms (0.77%, 0.3% and 0.6%, respectively; dabigatran 110mg vs. warfarin, p=0.71; PRADAXA 150mg vs. warfarin, p=0.45),(1) though the RE-LY trial and this subgroup analysis were not powered to demonstrate statistical significance.  Similarly, major bleeding within 30 days of cardioversion was infrequent and comparable between treatment groups (1.7%, 0.6% and 0.6%, respectively).(1)

"Cardioversion is one treatment option for patients with atrial fibrillation and requires anticoagulation both prior to and following treatment in order to reduce the risk of stroke," said Rangadham Nagarakanti, MD, Louisiana State University School of Medicine.  "It's helpful to know that patients on PRADAXA who underwent cardioversion had low rates of stroke and systemic embolism




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