Bleeding Outcomes After Left Atrial Appendage Closure Compared With Long-Term Warfarin A Pooled, Patient-Level Analysis of the WATCHMAN Randomized Trial Experience
Bleeding Outcomes After Left Atrial Appendage Closure Compared With Long-Term Warfarin A Pooled, Patient-Level Analysis of the WATCHMAN Randomized Trial Experience
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DOI：
10.1016/j.jcin.2015.08.035
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发表时间：
2015-12-28
影响因子：
11.3
通讯作者：
Holmes, David R., Jr.
中科院分区：
文献类型：
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作者：
Price, Matthew J.;Reddy, Vivek Y.;Holmes, David R., Jr.
目的 本研究的目的是比较左心耳 (LAA) 封堵术与长期华法林治疗相比发生大出血的相对风险。 背景 LAA 封堵术是慢性口服抗凝药的一种替代方法，用于预防心房颤动 (AF) 患者的血栓栓塞。 方法 我们对比较 WATCHMAN（Boston Scientific、Natick、马萨诸塞州）使用长期华法林治疗 AF 进行左心耳封堵术。 结果 总共纳入 1,114 名患者，中位随访时间为 3.1 年。治疗组之间从随机分组到随访结束的大出血总体发生率相似（每 100 名患者年 3.5 例事件与 3.6 例事件；发生率比 [RR]：0.96；95% 置信区间 [CI]：0.66 至 1.40；p = 0.84）。随机分组后 7 天以上，左心耳封堵显着减少了出血（每 100 患者年 1.8 例事件 vs 3.6 例事件；RR：0.49；95% CI：0.32 至 0.75；p - 0.001），随机分组后 6 个月出现差异（每 100 患者年 1.0 例事件 vs 3.5 例事件；RR：0.28；p - 0.001）。当分配至左心耳封堵术的患者能够停止辅助口服抗凝和抗血小板治疗时，95% CI：0.16 至 0.49；p < 0.001。左心耳封堵术的出血减少在所有患者亚组中是一致的。 结论 在 3 年的随访中，与延长华法林治疗相比，接受左心耳封堵术的患者的总体大出血率没有差异。然而，左心耳封堵术显着减少了手术期后的出血，特别是在辅助药物治疗停止后。在为非瓣膜性房颤患者选择卒中预防策略时，应考虑左心耳封堵对长期出血的有利影响。 （用于房颤患者栓塞保护的 WATCHMAN 左心耳系统；NCT00129545；以及房颤患者使用 WATCHMAN LAA 封堵器与长期华法林治疗的评估 [PREVAIL]；NCT01182441）。 (C) 2015 年，美国心脏病学会基金会。
OBJECTIVES The purpose of this study was to compare the relative risk of major bleeding with left atrial appendage (LAA) closure compared with long-term warfarin therapy.BACKGROUND LAA closure is an alternative approach to chronic oral anticoagulation for the prevention of thromboembolism in patients with atrial fibrillation (AF).METHODS We conducted a pooled, patient-level analysis of the 2 randomized clinical trials that compared WATCHMAN (Boston Scientific, Natick, Massachusetts) LAA closure with long-term warfarin therapy in AF.RESULTS A total of 1,114 patients were included, with a median follow-up of 3.1 years. The overall rate of major bleeding from randomization to the end of follow-up was similar between treatment groups (3.5 events vs. 3.6 events per 100 patient-years; rate ratio [RR]: 0.96; 95% confidence interval [CI]: 0.66 to 1.40; p = 0.84). LAA closure significantly reduced bleeding > 7 days post-randomization (1.8 events vs. 3.6 events per 100 patient-years; RR: 0.49; 95% CI: 0.32 to 0.75; p - 0.001), with the difference emerging 6 months after randomization (1.0 events vs. 3.5 events per 100 patient-years; RR: 0.28; 95% CI: 0.16 to 0.49; p < 0.001), when patients assigned to LAA closure were able to discontinue adjunctive oral anticoagulation and antiplatelet therapy. The reduction in bleeding with LAA closure was directionally consistent across all patient subgroups.CONCLUSIONS There was no difference in the overall rate of major bleeding in patients assigned to LAA closure compared with extended warfarin therapy over 3 years of follow-up. However, LAA closure significantly reduced bleeding beyond the procedural period, particularly once adjunctive pharmacotherapy was discontinued. The favorable effect of LAA closure on long-term bleeding should be considered when selecting a stroke prevention strategy for patients with nonvalvular AF. (WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation; NCT00129545; and Evaluation of the WATCHMAN LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy [PREVAIL]; NCT01182441). (C) 2015 by the American College of Cardiology Foundation.