Pradaxa Efficacy Comparable to Warfarin for Treating Patients with AF

For patients with atrial fibrillation (AF), with or without the presence of valvular heart disease (VHD), treatment with Pradaxa (dabigatran; Boehringer Ingelheim) demonstrated comparable benefits and risks to warfarin, according to a post-hoc analysis of from the RE-LY (Randomized Evaluation of Long-term Anticoagulant Therapy) clinical trial.

The researchers compared use of dabigatran150 mg (D150) and dabigatran110 mg (D110) BID with use of warfarin in 18,113 atrial fibrillation patients. Patients with prosthetic heart valves, significant mitral stenosis and VHD requiring intervention were excluded, however, some patients with less severe VHD included. The RE-LY study population consisted of 3950 patients with any VHD, 3101 mitral regurgitation patients, 1179 tricuspid regurgitation patients, 817 aortic regurgitations patients, 471 aortic stenosis patients, and 193 mild mitral stenosis patients.

Patients with VHD experienced more heart failure, coronary disease, renal impairment and persistent atrial fibrillation at baseline. Furthermore, patients with any VHD had higher rates of major bleeds (HR = 1.32; 95% CI, 1.16-1.5) but had similar stroke or systemic embolism rates (HR = 1.09; 95% CI, 0.88-1.33).

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Study results showed that major bleed rates were lower than warfarin patients, among D110 patients with VHD (HR = 0.73; 95% CI, 0.56-0.95), and without VHD (HR = 0.84; 95% CI, 0.71-0.99). For patients in the D150 patient group, bleed rates were similar to warfarin patients with or without VHD.

Stroke or systemic embolism rates were lower among D150 patients when compared with warfarin patients with and without VHD and similar to warfarin for D110 irrespective of presence of VHD. Furthermore, intracranial bleeding and death rates for both the D110 and D150 groups were lower versus warfarin, independent of VHD presence.

The post-hoc analysis was sponsored by a research grant from Boehringer-Ingelheim Pharmaceuticals. --Julie Gould

Reference:

Ezekowitz MD, Nagarakanti R, Noack H, et al. Comparison of Dabigatran versus Warfarin in Patients with Atrial Fibrillation and Valvular Heart Disease: The RE-LY Trial [published online ahead of print August 5, 2016]. Circulation. 2016;134(7). Doi:  https://dx.doi.org/10.1161/CIRCULATIONAHA.115.020950