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

• DOI: 10.1016/j.ijcard.2022.03.037
• Publication Date: 2022-03-16T16:26:24Z
• Authors: Parham Sadeghipour; Hamidreza Pourali...; Mozhgan Parsaee; Maryam Shojaeifard; Melody Farrashi; Sepehr JamalKhani; Ahmad Tashakori B...; Saman Rostambeigi; Saeed Ebrahimi Me...; Ata Firouzi; Mohammad Mehdi Pe...; Mohammad Javad Al...; Majid Haghjoo; Feridoun Noohi; Majid Maleki; Raffaele De Caterina
• Keywords: Administration, Oral; Anticoagulants; Atrial fibrillation; Direct oral anticoagulants; Mitral stenosis; Non-vitamin K antagonist oral anticoagulants; Pilot Projects; Stroke; 03 medical and health sciences; Treatment Outcome; 0302 clinical medicine; Rivaroxaban; Atrial Fibrillation; Animals; Humans; Mitral Valve Stenosis; Warfarin

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).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.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).