Comparison of Dabigatran versus Warfarin in Patients with Atrial Fibrillation and Valvular Heart Disease: The RE-LY Trial
Background—The Randomized Evaluation of Long-term Anticoagulant Therapy (RE-LY) trial compared dabigatran150 mg (D150) and dabigatran110 mg (D110) BID with warfarin in 18113 atrial fibrillation patients. Those with prosthetic heart valves, significant mitral stenosis and valvular heart disease (VHD) requiring intervention were excluded. Others with VHD were included.
Methods—This is a post-hoc analysis of RE-LY trial.
Results—There were 3950 patients with any VHD: 3101 had mitral regurgitation, 1179 tricuspid regurgitation, 817 aortic regurgitations, 471 aortic stenosis and 193 mild mitral stenosis. At baseline patients with any VHD had more heart failure, coronary disease, renal impairment and persistent atrial fibrillation. Patients with any VHD had higher rates of major bleeds (HR 1.32; 95% CI 1.16-1.5) but similar stroke or systemic embolism (SEE) rates (HR 1.09; 95% CI 0.88-1.33). For D110 patients, major bleed rates were lower than warfarin (HR 0.73; 95% CI 0.56-0.95 with and HR 0.84; 95% CI 0.71-0.99 without VHD) and for D150 similar to warfarin in patients with (HR 0.82; 95% CI 0.64-1.06) or without VHD (HR 0.98; 95% CI 0.83-1.15). For D150 patients stroke/SEE rates were lower versus warfarin with (HR 0.59; 95% CI 0.37-0.93) and without VHD (HR 0.67; 95% CI 0.52-0.86) and similar to warfarin for D110 irrespective of presence of VHD (HR 0.97 CI 0.65-1.45 and 0.85 CI 0.70-1.10). For intracranial bleeds and death rates for D150 and D110 were lower vs warfarin independent of presence of VHD.
Conclusions—The presence of any VHD did not influence the comparison of dabigatran with warfarin.
Clinical Trial Registration—URL: http://clinicaltrials.gov. Unique Identifier: NCT00262600.
- Received December 16, 2015.
- Revision received May 16, 2016.
- Accepted June 22, 2016.