经皮左心耳封堵术预防房颤患者卒中：PROTECT AF 试验（Watchman 左心耳封堵系统预防房颤患者栓塞）的 2.3 年随访。
Percutaneous left atrial appendage closure for stroke prophylaxis in patients with atrial fibrillation: 2.3-Year Follow-up of the PROTECT AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients with Atrial Fibrillation) Trial.
机构信息
Helmsley Electrophysiology Center, The Cardiovascular Institute, Mount Sinai School of Medicine, One Gustave L. Levy Place, Box 1030, New York, NY 10029, USA.
出版信息
Circulation. 2013 Feb 12;127(6):720-9. doi: 10.1161/CIRCULATIONAHA.112.114389. Epub 2013 Jan 16.
BACKGROUND
The multicenter PROTECT AF study (Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation) was conducted to determine whether percutaneous left atrial appendage closure with a filter device (Watchman) was noninferior to warfarin for stroke prevention in atrial fibrillation.
METHODS AND RESULTS
Patients (n=707) with nonvalvular atrial fibrillation and at least 1 risk factor (age >75 years, hypertension, heart failure, diabetes, or prior stroke/transient ischemic attack) were randomized to either the Watchman device (n=463) or continued warfarin (n=244) in a 2:1 ratio. After device implantation, warfarin was continued for ≈45 days, followed by clopidogrel for 4.5 months and lifelong aspirin. Study discontinuation rates were 15.3% (71/463) and 22.5% (55/244) for the Watchman and warfarin groups, respectively. The time in therapeutic range for the warfarin group was 66%. The composite primary efficacy end point included stroke, systemic embolism, and cardiovascular death, and the primary analysis was by intention to treat. After 1588 patient-years of follow-up (mean 2.3±1.1 years), the primary efficacy event rates were 3.0% and 4.3% (percent per 100 patient-years) in the Watchman and warfarin groups, respectively (relative risk, 0.71; 95% confidence interval, 0.44%-1.30% per year), which met the criteria for noninferiority (probability of noninferiority >0.999). There were more primary safety events in the Watchman group (5.5% per year; 95% confidence interval, 4.2%-7.1% per year) than in the control group (3.6% per year; 95% confidence interval, 2.2%-5.3% per year; relative risk, 1.53; 95% confidence interval, 0.95-2.70).
CONCLUSIONS
The "local" strategy of left atrial appendage closure is noninferior to "systemic" anticoagulation with warfarin. PROTECT AF has, for the first time, implicated the left atrial appendage in the pathogenesis of stroke in atrial fibrillation.
CLINICAL TRIAL REGISTRATION
: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00129545.
背景
多中心 PROTECT AF 研究（Watchman 左心耳系统在房颤患者中的栓塞保护作用）旨在确定经皮左心耳封堵术（Watchman）与华法林预防房颤卒中的疗效是否非劣效。
方法和结果
纳入 707 例非瓣膜性房颤且至少存在 1 项危险因素（年龄＞75 岁、高血压、心力衰竭、糖尿病或既往卒中/短暂性脑缺血发作）的患者，按 2:1 随机分为 Watchman 组（n=463）或继续华法林治疗组（n=244）。植入装置后，华法林继续使用约 45 天，随后使用氯吡格雷 4.5 个月和阿司匹林终身治疗。Watchman 组和华法林组的停药率分别为 15.3%（71/463）和 22.5%（55/244）。华法林组的治疗范围时间为 66%。复合主要疗效终点包括卒中、全身性栓塞和心血管死亡，主要分析为意向治疗。随访 1588 患者-年（平均 2.3±1.1 年）后，Watchman 组和华法林组的主要疗效事件发生率分别为 3.0%和 4.3%（每 100 患者-年的发生率）（相对风险，0.71；95%置信区间，0.44%-1.30%/年），符合非劣效性标准（非劣效概率＞0.999）。Watchman 组主要安全性事件发生率更高（5.5%/年；95%置信区间，4.2%-7.1%/年），而对照组为 3.6%/年（95%置信区间，2.2%-5.3%/年）（相对风险，1.53；95%置信区间，0.95-2.70）。
结论
左心耳“局部”封堵策略不劣于华法林的“全身”抗凝。PROTECT AF 首次提示左心耳在房颤卒中发病机制中发挥作用。
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