Prospective Randomized Evaluation of the Watchman Left Atrial Appendage Closure Device in Patients With Atrial Fibrillation Versus Long-Term Warfarin Therapy
Prospective Randomized Evaluation of the Watchman Left Atrial Appendage Closure Device in Patients With Atrial Fibrillation Versus Long-Term Warfarin Therapy
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DOI：
10.1016/j.jacc.2014.04.029
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发表时间：
2014-07-08
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.;Kar, Saibal;Reddy, Vivek Y.
背景资料（Watchman左心房封堵技术用于房颤患者的栓塞保护）试验，评价了非瓣膜性房颤（NVAF）患者，左心耳（LAA）封堵术在预防卒中方面不劣于华法林，但是发现围手术期安全性危险。结论本研究的目的是评估左心耳封堵术治疗卒中的安全性和有效性方法：本随机试验进一步评估了Watchman装置的有效性和安全性。CHADS（2）（充血性心力衰竭、高血压、年龄> 75岁、糖尿病和既往中风/短暂性脑缺血发作）评分>= 2或1且有另一个风险因素的NVAF患者有资格。患者被随机分配（以2：1的比例）接受左心耳封堵术和随后停用华法林（干预组，n = 269）或接受长期华法林治疗（对照组，n = 138）。两个疗效和1个安全性共同主要终点进行了评估。（卒中、全身性栓塞[SE]和心血管/不明原因死亡的复合终点）在器械组中为0.064，对照组为0.063（率比1.07 [95%可信区间（CrI）：0.57至1.89]），未达到预先规定的非劣效性标准（95%可信区间（CrI）的上限>= 1.75）。第二个共同主要疗效终点（随机化后卒中或SE > 7天）的发生率为0.0253 vs 0.0200（风险差异0.0053 [95% CrI：-0.0190至0.0273]），达到非劣效性。Watchman组的早期安全性事件发生率为2.2%，显著低于TVT AF，满足预先规定的安全性性能目标。使用更广泛、更包容的不良反应定义，PREVAIL（房颤患者Watchman LAA封堵器与长期华法林治疗）试验中的不良反应仍然低于PROTECT AF（4.2%与8.7%; p = 0.004）。需要手术修复的心包积液从1.6%下降到0.4%（p = 0.027），需要心包穿刺术的心包积液从2.9%下降到1.5%（p = 0.36），尽管事件数量很少。尽管总体疗效未达到非劣效性，但两组的事件发生率均较低，且在数值上相当。手术安全性显著提高。本试验提供了额外的数据，证明左心耳封堵术是华法林治疗的合理替代方案，可用于预防无短期华法林治疗绝对禁忌症的NVAF患者的卒中。(C)2014年由美国心脏病学会基金会。
BACKGROUND In the PROTECT AF (Watchman Left Atrial Appendage Closure Technology for Embolic Protection in Patients With Atrial Fibrillation) trial that evaluated patients with nonvalvular atrial fibrillation (NVAF), left atrial appendage (LAA) occlusion was noninferior to warfarin for stroke prevention, but a periprocedural safety hazard was identified.OBJECTIVES The goal of this study was to assess the safety and efficacy of LAA occlusion for stroke prevention in patients with NVAF compared with long-term warfarin therapy.METHODS This randomized trial further assessed the efficacy and safety of the Watchman device. Patients with NVAF who had a CHADS(2) (congestive heart failure, hypertension, age > 75 years, diabetes mellitus, and previous stroke/transient ischemic attack) score >= 2 or 1 and another risk factor were eligible. Patients were randomly assigned (in a 2: 1 ratio) to undergo LAA occlusion and subsequent discontinuation of warfarin (intervention group, n = 269) or receive chronic warfarin therapy (control group, n 138). Two efficacy and 1 safety coprimary endpoints were assessed.RESULTS At 18 months, the rate of the first coprimary efficacy endpoint (composite of stroke, systemic embolism [SE], and cardiovascular/unexplained death) was 0.064 in the device group versus 0.063 in the control group (rate ratio 1.07 [95% credible interval (CrI): 0.57 to 1.89]) and did not achieve the prespecified criteria noninferiority (upper boundary of 95% CrI >= 1.75). The rate for the second coprimary efficacy endpoint (stroke or SE > 7 days' postrandomization) was 0.0253 versus 0.0200 (risk difference 0.0053 [95% CrI: -0.0190 to 0.0273]), achieving noninferiority. Early safety events occurred in 2.2% of the Watchman arm, significantly lower than in PROTECT AF, satisfying the pre-specified safety performance goal. Using a broader, more inclusive definition of adverse effects, these still were lower in PREVAIL (Watchman LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy) trial than in PROTECT AF (4.2% vs. 8.7%; p = 0.004). Pericardial effusions requiring surgical repair decreased from 1.6% to 0.4% (p = 0.027), and those requiring pericardiocentesis decreased from 2.9% to 1.5% (p = 0.36), although the number of events was small.CONCLUSIONS In this trial, LAA occlusion was noninferior to warfarin for ischemic stroke prevention or SE > 7 days' post-procedure. Although noninferiority was not achieved for overall efficacy, event rates were low and numerically comparable in both arms. Procedural safety has significantly improved. This trial provides additional data that LAA occlusion is a reasonable alternative to warfarin therapy for stroke prevention in patients with NVAF who do not have an absolute contraindication to short-term warfarin therapy. (C) 2014 by the American College of Cardiology Foundation.