RIvaroxaban in mitral stenosis (RISE MS): A pilot randomized clinical trial.

ABSTRACT

BACKGROUND: Patients with moderate-to-severe mitral stenosis (MS) have bee excluded from all major randomized controlled trials (RCTs) comparing non-vitamin K antagonist oral anticoagulants (NOACs) with warfarin in patients with atrial fibrillation (AF). METHODS AND RESULTS: In this pilot RCT, 40 patients were randomized to rivaroxaban 20 mg daily or warfarin. No patients experienced symptomatic ischemic strokes and systemic embolic events (the primary composite study outcome) during a 12-month follow-up. No major bleeding was reported. During the follow-up, 18.2% of patients in both groups showed echocardiographic signs of increased thrombogenicity in the left atrial appendage. The rate of silent cerebral ischemia was 13.3% in the rivaroxaban group and 17.6% in the warfarin group at brain magnetic resonance imaging. CONCLUSION: Our results suggest acceptable efficacy and safety for rivaroxaban in patients with AF and moderate-to-severe MS and are encouraging for larger RCTs in this so far neglected setting (NCT03926156).