Department of Cardiology, Xinhua Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.
Department of Cardiology, Xinhua Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China
BMJ Open. 2021 Mar 15;11(3):e044695. doi: 10.1136/bmjopen-2020-044695.
It is the common clinical practice to prescribe indefinite aspirin for patients with non-valvular atrial fibrillation (NVAF) post left atrial appendage occlusion (LAAO). However, aspirin as a primary prevention strategy for cardiovascular diseases has recently been challenged due to increased risk of bleeding. Therefore, aspirin discontinuation after LAAO in atrial fibrillation (ASPIRIN LAAO) trial is designed to assess the uncertainty about the risks and benefits of discontinuing aspirin therapy at 6 months postimplantation with a Watchman LAAO device in NVAF patients.
The ASPIRIN LAAO study is a prospective, multicentre, randomised, double-blinded, placebo-controlled non-inferiority trial. Patients implanted with a Watchman device within 6 months prior to enrollment and without pre-existing conditions requiring long-term aspirin therapy according to current guidelines are eligible for participating the trial. Subjects will be randomised in a 1:1 allocation ratio to either the Aspirin group (aspirin 100 mg/day) or the control group (placebo) at 6 months postimplantation. A total of 1120 subjects will be enrolled from 12 investigational sites in China. The primary composite endpoint is stroke, systemic embolism, cardiovascular/unexplained death, major bleeding, acute coronary syndrome and coronary or periphery artery disease requiring revascularisation at 24 months. Follow-up visits are scheduled at 6 and 12 months and then every 12 months until 24 months after the last patient recruitment.
Ethics approval was obtained from the Ethics Committee of Xinhua Hospital, Shanghai, China (reference number XHEC-C-2018-065-5). The protocol is also submitted and approved by the institutional Ethics Committee at each participating centre. Results are expected in 2024 and will be disseminated through peer-reviewed journals and presentations at national and international conferences.
NCT03821883.
在左心耳封堵（LAAO）术后，临床上常为非瓣膜性心房颤动（NVAF）患者开具阿司匹林进行无限期治疗。然而，由于出血风险增加，阿司匹林作为心血管疾病的一级预防策略最近受到了挑战。因此，这项名为“阿司匹林左心耳封堵（ASPIRIN LAAO）”的试验旨在评估在 NVAF 患者中，使用 Watchman LAAO 装置植入后 6 个月停用阿司匹林治疗的风险和获益的不确定性。
ASPIRIN LAAO 研究是一项前瞻性、多中心、随机、双盲、安慰剂对照的非劣效性试验。在入组前 6 个月内植入 Watchman 装置且根据现行指南无长期阿司匹林治疗适应证的患者有资格参加该试验。受试者将以 1:1 的比例随机分配至阿司匹林组（阿司匹林 100mg/天）或对照组（安慰剂），在植入后 6 个月时进行分组。该研究将在中国 12 个研究中心共纳入 1120 例受试者。主要复合终点为 24 个月时的卒中、全身性栓塞、心血管/不明原因死亡、大出血、急性冠脉综合征和需要血运重建的冠状动脉或外周动脉疾病。随访时间分别在 6 个月、12 个月和最后一名患者入组后 24 个月。
该研究已获得中国上海新华医院伦理委员会的批准（编号：XHEC-C-2018-065-5）。方案也已在各参与中心的机构伦理委员会提交并获得批准。预计结果将于 2024 年公布，并将通过同行评议的期刊和国内外会议上的演讲进行传播。
NCT03821883。
