Wang Yubin, Wu Dewei, Ma Juan, Liu Xiangping, Zhang Haitong, So Chak-Yu, Lam Yin-Yat, Wang Bincheng, Wang Jiande, Zhang Hongliang, Wang Moyang, Song Guangyuan, Wu Yongjian
Department of Cardiology, Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Science and Peking Union Medical College Beijing, China.
Department of Cardiology, Xuanwu Hospital, Capital Medical University Beijing 100053, China.
Am J Cardiovasc Dis. 2021 Oct 25;11(5):679-687. eCollection 2021.
The anti-thrombotic strategy for patients with atrial fibrillation (AF) who have undergone percutaneous coronary intervention (PCI) for coronary artery disease (CAD) is a common and difficult challenge. This pilot study aimed to assess the feasibility and safety of "one-stop" left atrial appendage closure (LAAC) combined with PCI as an alternative stroke prophylaxis strategy.
From March 2017 to October 2019, AF patients with elevated bleeding risk and significant stable CAD requiring PCI were recruited to undergo LAAC as alternative stroke prophylaxis in Fuwai Hospital, Beijing, China. LAAC was performed either in the same setting with PCI (i.e. "one-stop" LAAC/PCI), or as staged procedure after PCI. Dual antiplatelet therapy was given for all patients after LAAC. Peri-procedural and intermediate-term clinical outcomes were assessed through hospital clinical records review and standardized telephone interviews.
A total of 24 patients were recruited including 13 (54.2%) underwent stage procedure and 11 (45.8%) underwent "one-stop" procedure respectively. The mean CHADS-VASc and HAS-BLED scores were 4.5±1.4 and 3 (IQR 3,4) respectively. Six patients (46.1%) in the staged procedure cohort were treated with triple anti-thrombotic following PCI, with 2 developed minor bleeding before LAAC. One patient ("one-stop" cohort) had gastrointestinal bleeding 1 day after procedure. Otherwise, there was no device related complication or peri-procedural stroke/myocardial infarction. After a mean 19±5.4 months follow-up, there was no death, myocardial infarction, stroke and systemic embolization detected.
In this pilot study, "one-stop" LAAC with PCI was shown to be efficacious with no stroke, MI, VARC-2 major bleeding or CV death reported over a mean follow-up of 19 months, and safe with no major peri-procedural bleeding or device related complications.
对于因冠状动脉疾病（CAD）接受经皮冠状动脉介入治疗（PCI）的心房颤动（AF）患者，抗血栓形成策略是一个常见且棘手的挑战。这项前瞻性研究旨在评估“一站式”左心耳封堵术（LAAC）联合PCI作为一种替代性卒中预防策略的可行性和安全性。
2017年3月至2019年10月，在中国北京阜外医院，招募有出血风险升高且患有严重稳定CAD需要PCI的AF患者，接受LAAC作为替代性卒中预防措施。LAAC与PCI在同一环境下进行（即“一站式”LAAC/PCI），或在PCI后作为分期手术进行。所有患者在LAAC后均接受双联抗血小板治疗。通过医院临床记录审查和标准化电话访谈评估围手术期和中期临床结果。
共招募了24例患者，其中13例（54.2%）接受分期手术，11例（45.8%）接受“一站式”手术。平均CHADS-VASc和HAS-BLED评分分别为4.5±1.4和3（四分位间距3,4）。分期手术队列中的6例患者（46.1%）在PCI后接受三联抗血栓治疗，其中2例在LAAC前发生轻微出血。1例患者（“一站式”队列）在术后1天出现胃肠道出血。除此之外，没有与器械相关的并发症或围手术期卒中/心肌梗死。平均随访19±5.4个月后，未检测到死亡、心肌梗死、卒中和全身性栓塞。
在这项前瞻性研究中，“一站式”LAAC联合PCI在平均19个月的随访中显示有效，未报告卒中、心肌梗死、VARC-2大出血或心血管死亡，且安全，没有围手术期大出血或与器械相关的并发症。
