August 29th, 2010

Superiority of Dabigatran More Evident in Places Where INR Is Not Well Controlled

At last year’s ESC meeting, the RE-LY trial heightened interest in the prospect of dabigatran as a potential replacement for warfarin. Now the RE-LY investigators have analyzed the trial data in an attempt to see whether the local standard of care has an impact on the beneficial effects of switching to dabigatran. In a presentation at the ESC in Stockholm and a simultaneous publication in the Lancet, Lars Wallentin and the RE-LY investigators estimated the time in the therapeutic range at each trial center (cTTR). They found that — irrespective of cTTR — when compared with warfarin,  high-dose dabigatran was effective at reducing stroke, low-dose dabigatran was effective at reducing bleeding, and both doses reduced intracranial bleeding. The investigators write that the “advantages of dabigatran were greater at sites with poor INR control than at those with good INR control,” and concluded that “overall, these results show that local standards of care affect the benefits of use of new treatment alternatives.”

In an accompanying comment, Deirdre Lane and Gregory YH Lip write that “when oral anticoagulants are clearly appropriate (ie, CHA2DS2-VASc score ≥1), dabigatran should be considered as an alternative to adjusted dose warfarin therapy.” High-dose dabigatran might be appropriate in patients at low risk for bleeding while low-dose dabigatran could be considered in patients with a higher bleeding risk, they write.

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