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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