Abstract 10684: RE-LY and RELY-ABLE: Long-term Follow-up of Patients With Non-valvular Atrial Fibrillation Receiving Dabigatran Etexilate for Up to 6.7 Years
Background: Dabigatran was shown effective for stroke prevention in atrial fibrillation (AF) in RE-LY; and RELY-ABLE provided additional follow-up of dabigatran. Combining these two studies enabled a comprehensive long-term analysis of double-blind dabigatran.
Methods: There were 12,091 patients randomized to dabigatran 110 mg BID or 150 mg BID in RE-LY, and 5,851 continued the same blinded dose of dabigatran in RELY-ABLE. The present analysis includes all dabigatran patients; with censoring for study discontinuation either at the end of participation in RE-LY or RELY-ABLE.
Results: Median follow up was 4.6 years (maximum 6.7 years). Stroke or systemic embolization rates were 1.25% and 1.54% per year on dabigatran 150 mg BID (D150) or 110 mg BID (D110), respectively; hazard ratio (HR) 0.81 (95% CI: 0.68-0.96). Rate of ischemic stroke was 1.03%/yr or 1.29%/yr on D150 or D110, respectively; HR 0.79 (95% CI: 0.66-0.95). Rate of major hemorrhage was 3.34%/yr or 2.76%/yr on D150 or D110, respectively; HR 1.22 (95% CI: 1.08-1.37). Rates of hemorrhagic stroke were very low over the whole follow-up; at just over one case per thousand per year on each dose of dabigatran. Rates of mortality were very similar on the two dabigatran doses; 3.43%/yr and 3.55%/yr for D150 and D110 respectively; HR 0.97 (95% CI: 0.87-1.08).
Conclusions: This follow-up provides additional evidence of the long-term efficacy and safety of dabigatran. During median follow up of > 4 years with some patients followed over 6 years, rates of stroke and major bleeding on dabigatran are consistent with those seen during RE-LY. The very low rates of hemorrhagic stroke seen during RE-LY on both doses of dabigatran are also observed over the whole duration of follow-up. Rates of stroke or systemic embolism were lower on D150, but rates of major hemorrhage were lower on D110. Mortality rates are similar for the two dabigatran doses.
- © 2013 by American Heart Association, Inc.