Department of Cardiac Surgery, Capital Medical University, Beijing, China.
Department of Cardiac Surgery, Beijing Tiantan Hospital, Beijing, China.
BMJ Open. 2022 Oct 28;12(10):e063931. doi: 10.1136/bmjopen-2022-063931.
Non-valvular atrial fibrillation (NVAF) is a high-risk factor for ischaemic stroke. The 2016 European Society of Cardiology Atrial Fibrillation Management guidelines recommend oral anticoagulants (OACs) to prevent stroke in men with CHADS-VASc scores ≥2 and women ≥3. However, in patients with a high risk of stroke and a high risk of bleeding (HAS-BLED (Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile international normalized ratio, Elderly (> 65 years), Drugs/alcohol concomitantly) score≥3), OAC had a higher risk of bleeding. Left atrial appendage closure (LAAC) is non-inferior to OAC as a means of preventing stroke in several studies. As a minimally invasive intervention to prevent stroke, transthoracic LAAC (TS-LAAC) has a high successful closure rate, but there is a lack of literature reports directly comparing it with OAC. Our research compares TS-LAAC with novel oral anticoagulants (NOACs) and provides an appropriate programme for stroke prevention in a specific population.
This is a non-randomised controlled trial study protocol, and we will conduct this study from April 2022 to April 2025. The study included 186 patients with confirmed NVAF, 93 of whom completed thoracoscopic LAAC, and the control group treated with NOACs. The primary outcome was the incidence of stroke and systemic embolism, as well as the composite endpoint events (stroke, systemic embolism, myocardial infarction, bleeding, cardiovascular death, etc). Secondary outcomes were ischaemic stroke, haemorrhagic stroke, any bleeding events, death from cardiovascular causes, death from all causes, residual root rate in the surgery group, device-related thrombosis in the surgery group, changes in blood pressure, cardiac chamber size changes, etc. Each subject completed at least 1 year of follow-up.
The study has been approved by the Medical Ethics Committee of Beijing Tiantan Hospital, Capital Medical University, China (approval number: KY2022-013-02). The results from this study will be disseminated through manuscript publications and national/international conferences.
ChiCTR2200058109.
非瓣膜性心房颤动（NVAF）是缺血性中风的高危因素。2016 年欧洲心脏病学会心房颤动管理指南建议口服抗凝剂（OACs）预防 CHADS-VASc 评分≥2 的男性和 CHADS-VASc 评分≥3 的女性中风。然而，在具有高中风风险和高出血风险（HAS-BLED（高血压、肾功能/肝功能异常、中风、出血史或倾向、不稳定的国际标准化比值、年龄>65 岁、同时使用药物/酒精）评分≥3）的患者中，OAC 出血风险更高。几项研究表明，左心耳封堵（LAAC）作为预防中风的手段不劣于 OAC。作为一种预防中风的微创介入治疗，经胸 LAAC（TS-LAAC）具有较高的成功率，但缺乏直接与 OAC 进行比较的文献报道。我们的研究将 TS-LAAC 与新型口服抗凝剂（NOACs）进行比较，为特定人群的中风预防提供了一个合适的方案。
这是一项非随机对照试验研究方案，我们将从 2022 年 4 月至 2025 年 4 月进行这项研究。该研究纳入了 186 例确诊的 NVAF 患者，其中 93 例完成了胸腔镜 LAAC，对照组接受了 NOAC 治疗。主要结局是中风和全身性栓塞的发生率，以及复合终点事件（中风、全身性栓塞、心肌梗死、出血、心血管死亡等）。次要结局是缺血性中风、出血性中风、任何出血事件、心血管原因死亡、全因死亡、手术组残余根部率、手术组器械相关血栓形成、血压变化、心腔大小变化等。每位患者完成至少 1 年的随访。
该研究已获得中国首都医科大学附属北京天坛医院医学伦理委员会的批准（批准号：KY2022-013-02）。本研究结果将通过论文发表和全国/国际会议传播。
ChiCTR2200058109。
