利伐沙班治疗二尖瓣狭窄（RISE-MS）：一项先导随机临床试验。
RIvaroxaban in mitral stenosis (RISE MS): A pilot randomized clinical trial.
机构信息
Cardiovascular Intervention Research Center, Rajaie Cardiovascular Medical and Research Center, Iran University of Medical Sciences, Tehran, Iran; Clinical Trial Center, Rajaie Cardiovascular Medical and Research Center, Iran University of Medical Sciences, Tehran, Iran.
Rajaie Cardiovascular Medical and Research Center, Iran University of Medical Sciences, Tehran, Iran.
出版信息
Int J Cardiol. 2022 Jun 1;356:83-86. doi: 10.1016/j.ijcard.2022.03.037. Epub 2022 Mar 16.
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).
背景
所有比较非维生素 K 拮抗剂口服抗凝剂（NOACs）与华法林在房颤（AF）患者中的疗效的主要随机对照试验（RCT）均排除了中重度二尖瓣狭窄（MS）患者。
方法和结果
在这项先导性 RCT 中，40 名患者被随机分配至每日服用利伐沙班 20mg 或华法林。在 12 个月的随访期间，没有患者发生有症状的缺血性卒中和全身性栓塞事件（主要复合研究结局）。没有报告大出血。在随访期间，两组各有 18.2%的患者出现左心耳血栓形成增加的超声心动图征象。利伐沙班组的无症状性脑缺血发生率为 13.3%，华法林组为 17.6%，在脑磁共振成像上发现。
结论
我们的结果表明，利伐沙班在中重度 MS 合并 AF 患者中的疗效和安全性可接受，并为这一迄今为止被忽视的领域的更大 RCT 提供了令人鼓舞的结果（NCT03926156）。
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