Left Atrial Appendage Closure as an Alternative to Warfarin for Stroke Prevention in Atrial Fibrillation A Patient-Level Meta-Analysis
Left Atrial Appendage Closure as an Alternative to Warfarin for Stroke Prevention in Atrial Fibrillation A Patient-Level Meta-Analysis
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DOI：
10.1016/j.jacc.2015.04.025
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发表时间：
2015-06-23
影响因子：
24
通讯作者：
Reddy, Vivek Y.
中科院分区：
文献类型：
--
作者：
Holmes, David R., Jr.;Doshi, Shephal K.;Reddy, Vivek Y.
背景左心耳封堵术（LAAC）与全身治疗的风险-受益比（华法林）用于预防非瓣膜性心房颤动（NVAF）中的中风、全身性栓塞和心血管死亡需要继续评价。结论本研究试图在2个随机试验中评估关于左心耳闭合（LAAC）与华法林相比用于预防中风、全身性栓塞、方法我们的荟萃分析包括2,406例非瓣膜性房颤患者，931患者-年（PY）的随访，来自CRT-T AF（用于房颤患者栓塞保护的Watchman左心房封堵系统）和PREVAIL（Watchman左心耳封堵器在房颤患者中与长期warfare治疗的前瞻性随机评价）试验，及其各自的登记册（继续访问CANTT AF注册中心和继续访问PREVAIL注册中心）。结果平均随访2.69年，使用Watchman器械接受LAAC的患者出血性卒中显著减少（0.15 vs. 0.96起事件/100患者-年[PY];风险比[HR]：0.22; p = 0.004），心血管/不明原因死亡（1.1 vs. 2.3起事件/100 PY; HR：0.48; p = 0.006）和非手术性出血（6.0% vs. 11.3%; HR：0.51; p = 0.006）。两种策略的全因卒中或全身性栓塞相似（1.75 vs. 1.87起事件/100 PY; HR：1.02; 95% CI：0.62 - 1.7; p = 0.94）。器械组的缺血性卒中更多（1.6 vs. 0.9和0.2 vs. 1.0起事件/100 PY; HR：分别为1.95和0.22; p = 0.05和0.004）。两项试验和登记确定了相似的事件发生率和一致的设备效果在多个subset.CONCLUSIONS在NVAF患者在中风或出血的风险增加谁是长期抗凝治疗的候选人，LAAC导致出血性中风，心血管/不明原因的死亡，和非手术性出血的发生率相比，华法林。(C)2015年美国心脏病学院基金会。
BACKGROUND The risk-benefit ratio of left atrial appendage closure (LAAC) versus systemic therapy (warfarin) for prevention of stroke, systemic embolism, and cardiovascular death in nonvalvular atrial fibrillation (NVAF) requires continued evaluation.OBJECTIVES This study sought to assess composite data regarding left atrial appendage closure (LAAC) in 2 randomized trials compared to warfarin for prevention of stroke, systemic embolism, and cardiovascular death in patients with nonvalvular AF.METHODS Our meta-analysis included 2,406 patients with 5,931 patient-years (PY) of follow-up from the PROTECT AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients with Atrial Fibrillation) and PREVAIL (Prospective Randomized Evaluation of the Watchman LAA Closure Device In Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy) trials, and their respective registries (Continued Access to PROTECT AF registry and Continued Access to PREVAIL registry).RESULTS With mean follow-up of 2.69 years, patients receiving LAAC with the Watchman device had significantly fewer hemorrhagic strokes (0.15 vs. 0.96 events/100 patient-years [PY]; hazard ratio [HR]: 0.22; p = 0.004), cardiovascular/ unexplained death (1.1 vs. 2.3 events/100 PY; HR: 0.48; p = 0.006), and nonprocedural bleeding (6.0% vs. 11.3%; HR: 0.51; p = 0.006) compared with warfarin. All-cause stroke or systemic embolism was similar between both strategies (1.75 vs. 1.87 events/100 PY; HR: 1.02; 95% CI: 0.62 to 1.7; p = 0.94). There were more ischemic strokes in the device group (1.6 vs. 0.9 and 0.2 vs. 1.0 events/100 PY; HR: 1.95 and 0.22, respectively; p = 0.05 and 0.004, respectively). Both trials and registries identified similar event rates and consistent device effect in multiple subsets.CONCLUSIONS In patients with NVAF at increased risk for stroke or bleeding who are candidates for chronic anticoagulation, LAAC resulted in improved rates of hemorrhagic stroke, cardiovascular/unexplained death, and nonprocedural bleeding compared to warfarin. (C) 2015 by the American College of Cardiology Foundation.