International journal of cardiology · 2022
RIvaroxaban in mitral stenosis (RISE MS): A pilot randomized clinical trial.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Sadeghipour Parham, Pouraliakbar Hamidreza, Parsaee Mozhgan, Shojaeifard Maryam, Farrashi Melody, JamalKhani Sepehr, Tashakori Beheshti Ahmad, Rostambeigi Saman, Ebrahimi Meimand Saeed, Firouzi Ata, Peighambari Mohammad Mehdi, Alemzadeh-Ansari Mohammad Javad, Haghjoo Majid, Noohi Feridoun, Maleki Majid, De Caterina Raffaele
Аннотация
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).
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).