经 WATCHMAN 左心耳封堵术后口服抗凝与抗血小板治疗的倾向性匹配比较。
Propensity-Matched Comparison of Oral Anticoagulation Versus Antiplatelet Therapy After Left Atrial Appendage Closure With WATCHMAN.
机构信息
Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
Rigshospitalet, University of Copenhagen, Copenhagen, Denmark; Medicine and Geriatric Department, Tuen Mun Hospital, Hong Kong, China.
出版信息
JACC Cardiovasc Interv. 2019 Jun 10;12(11):1055-1063. doi: 10.1016/j.jcin.2019.04.004.
OBJECTIVES
In this propensity-matched analysis of post-left atrial appendage closure antithrombotic therapy, the safety and effectiveness of oral anticoagulation (OAC) and antiplatelet therapy (APT) were compared.
BACKGROUND
Left atrial appendage closure with the WATCHMAN device is an alternative to OAC in patients with nonvalvular atrial fibrillation, who are at high bleeding risk. Initial trials included 45 days of post-implantation OAC, but registry data suggest that APT may suffice.
METHODS
Patients from the PROTECT-AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation), PREVAIL (Watchman LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy), CAP (Continued Access to PROTECT-AF), CAP2 (Continued Access to PREVAIL), ASAP (ASA Plavix Feasibility Study With Watchman Left Atrial Appendage Closure Technology), and EWOLUTION (Registry on WATCHMAN Outcomes in Real-Life Utilization) trials receiving either OAC or APT post-implantation were matched and compared for nonprocedural bleeding and stroke or systemic thromboembolism over 6 months following implantation. Each patient on APT was matched with 2 patients on OAC, with propensity scores derived from age, sex, congestive heart failure, hypertension, diabetes, prior transient ischemic attack or stroke, peripheral vascular disease, left ventricular ejection fraction, renal impairment, and different atrial fibrillation subtypes.
RESULTS
The cohort on OAC (n = 1,018; 95% receiving warfarin and 5% receiving nonwarfarin OAC) was prescribed 45-day OAC post-implantation (92% also received single APT), followed by 6-month single or dual APT. The cohort on APT (n = 509; 91% receiving dual APT and 9% receiving single APT) received APT for variable durations. Six-month freedom from nonprocedural major bleeding was similar (OAC, 95.7%; APT, 95.5%; p = 0.775) despite more early bleeds with OAC. Freedom from thromboembolism beyond 7 days was similar between groups (OAC, 98.8%; APT, 99.4%; p = 0.089). However, device-related thrombosis was more frequent with APT (OAC, 1.4%; APT, 3.1%; p = 0.018).
CONCLUSIONS
After left atrial appendage closure with the WATCHMAN, although device-related thrombosis was more common with APT, both APT and OAC strategies resulted in similar safety and efficacy endpoints.
目的
在这项左心耳封堵术后抗栓治疗的倾向匹配分析中，比较了口服抗凝剂（OAC）和抗血小板治疗（APT）的安全性和有效性。
背景
对于非瓣膜性心房颤动且出血风险较高的患者，使用 WATCHMAN 装置进行左心耳封堵术是 OAC 的替代方法。最初的试验包括植入后 45 天的 OAC，但登记数据表明 APT 可能就足够了。
方法
来自 PROTECT-AF（Watchman 左心耳系统在心房颤动患者中的栓塞保护）、PREVAIL（心房颤动患者的 Watchman LAA 封堵装置与长期华法林治疗）、CAP（持续获得 PROTECT-AF）、CAP2（持续获得 PREVAIL）、ASAP（ASA Plavix 可行性研究与 Watchman 左心耳封堵技术）和 EWOLUTION（WATCHMAN 结果在真实世界应用中的登记）试验的患者，在植入后接受 OAC 或 APT 治疗，根据年龄、性别、充血性心力衰竭、高血压、糖尿病、既往短暂性脑缺血发作或中风、外周血管疾病、左心室射血分数、肾功能不全和不同的心房颤动类型，进行倾向性评分匹配，并比较 6 个月内的非手术出血和中风或全身性血栓栓塞事件。每个接受 APT 的患者与接受 OAC 的 2 名患者相匹配，OAC 的患者接受 45 天的 OAC 治疗（95%的患者接受华法林治疗，5%的患者接受非华法林 OAC 治疗），随后接受 6 个月的单一或双重 APT 治疗。接受 APT 的患者（n=509；91%接受双重 APT，9%接受单一 APT）接受了不同持续时间的 APT。尽管 OAC 患者早期出血更多，但 6 个月时非手术大出血的无复发率相似（OAC：95.7%；APT：95.5%；p=0.775）。两组 7 天后的血栓栓塞事件无差异（OAC：98.8%；APT：99.4%；p=0.089）。然而，APT 时设备相关血栓形成更常见（OAC：1.4%；APT：3.1%；p=0.018）。
结论
在使用 WATCHMAN 进行左心耳封堵术后，尽管 APT 时设备相关血栓形成更常见，但 APT 和 OAC 策略均导致相似的安全性和有效性终点。
Zotero 插件