Direct Oral Anticoagulants in Patients With Atrial Fibrillation and Valvular Heart Disease Other Than Significant Mitral Stenosis and Mechanical Valves

Abstract

The introduction of direct oral anticoagulants (DOACs) transformed the approach to thromboembolic prophylaxis in atrial fibrillation (AF), but uncertainty remains about the use of these medications in patients with valvular heart disease (VHD). The randomized controlled trials (RCTs) that established the favorable clinical profile of DOACs excluded patients with valvular AF, referring to hemodynamically significant mitral stenosis and mechanical valves. However, the definition of this term is inconsistent in the literature. Although other forms of VHD were included in the trials, many clinicians are hesitant to prescribe DOACs in patients with some degree of VHD. Limited data pertain specifically to this population, mostly from post hoc analyses of RCTs. Therefore, we sought to address the effectiveness and safety of DOACs in patients with VHD by synthesizing all available RCT data. We searched the Medline, Cochrane Central Register of Controlled Trials, and Embase databases (accessed November 9, 2016) and presentations in major cardiology meetings within the last year (American Heart Assocation, American College of Cardiology, European Society of Cardiology, Heart Rhythm Society) for RCTs (or secondary analyses thereof) comparing the currently approved DOACs to warfarin and reporting outcomes for patients with AF and VHD other than hemodynamically significant mitral stenosis and mechanical valves. We documented hazard ratios and 95% confidence intervals for stroke/systemic embolism and major bleeding, adhering to the VHD and outcome definitions of each individual study. Meta-analysis estimates were calculated with random-effects DerSimonian-Laird model for …