Department of Pulmonary Vessel and Thrombotic Disease, Sixth Medical Center, Chinese PLA General Hospital, Beijing, People's Republic of China.
Liverpool Centre for Cardiovascular Sciences, University of Liverpool, Liverpool John Moores University and Liverpool Heart and Chest Hospital, William Henry Duncan Building, 6 West Derby St, Liverpool, L7 8TX, UK.
Intern Emerg Med. 2023 Jun;18(4):1041-1048. doi: 10.1007/s11739-023-03249-0. Epub 2023 Mar 16.
AF patients with history of thromboembolic events are at higher risk of thromboembolic recurrences, despite appropriate antithrombotic treatment. We aimed to evaluate the effect of mobile health (mHealth) technology-implemented 'Atrial fibrillation Better Care' (ABC) pathway approach (mAFA intervention) in secondary prevention AF patients. The Mobile Health Technology for Improved Screening and Optimized Integrated Care in AF (mAFA-II) cluster randomized trial enrolled adult AF patients across 40 centers in China. The main outcome was the composite outcome of stroke or thromboembolism, all-cause death, and rehospitalization. Using Inverse Probability of Treatment Weighting (IPTW), we evaluated the effect of the mAFA intervention in patients with and without prior history of thromboembolic events (i.e., ischemic stroke or thromboembolism). Among the 3324 patients enrolled in the trial, 496 (14.9%, mean age: 75.1 ± 11.4 years, 35.9% females) had a previous episode of thromboembolic event. No significant interaction was observed for the effect of mAFA intervention in patients with vs. without history of thromboembolic events [Hazard ratio, (HR): 0.38, 95% confidence interval (CI):0.18-0.80 vs. HR 0.55, 95% CI 0.17-1.76, p for interaction = 0.587); however, a trend towards lower efficacy of mAFA intervention among AF patients in secondary prevention was observed for secondary outcomes, with significant interaction for bleeding events (p = 0.034) and the composite of cardiovascular events (p = 0.015). A mHealth-technology-implemented ABC pathway provided generally consistent reduction of the risk of primary outcome in both primary and secondary prevention AF patients. Secondary prevention patients may require further specific approaches to improve clinical outcomes such as bleeding and cardiovascular events.Trial registration: WHO International Clinical Trials Registry Platform (ICTRP) Registration number ChiCTR-OOC-17014138.
尽管进行了适当的抗血栓治疗，有血栓栓塞事件史的房颤患者仍有更高的血栓栓塞复发风险。我们旨在评估移动医疗（mHealth）技术实施的“房颤更好护理”（ABC）途径方法（mAFA 干预）在二级预防房颤患者中的效果。移动医疗技术改善筛查和优化房颤综合护理（mAFA-II）的多中心随机试验纳入了中国 40 个中心的成年房颤患者。主要结局是中风或血栓栓塞、全因死亡和再住院的复合结局。通过逆概率处理权重（Inverse Probability of Treatment Weighting，IPTW），我们评估了 mAFA 干预对有和无血栓栓塞史（即缺血性中风或血栓栓塞）的患者的效果。在试验中纳入的 3324 例患者中，有 496 例（14.9%，平均年龄：75.1±11.4 岁，35.9%为女性）有血栓栓塞史。在有和无血栓栓塞史的患者中，mAFA 干预的效果没有观察到显著的交互作用[风险比（Hazard ratio，HR）：0.38，95%置信区间（CI）：0.18-0.80 与 HR 0.55，95% CI 0.17-1.76，p 交互 = 0.587]；然而，在二级预防房颤患者的次要结局中，mAFA 干预的效果呈下降趋势，且出血事件（p=0.034）和心血管事件复合结局（p=0.015）存在显著交互作用。移动医疗技术实施的 ABC 途径为一级和二级预防房颤患者的主要结局风险提供了一致的降低效果。二级预防患者可能需要进一步的特定方法来改善出血和心血管事件等临床结局。
世界卫生组织国际临床试验注册平台（ICTRP）注册编号 ChiCTR-OOC-17014138。
