1 Icahn School of Medicine at Mount Sinai New York NY.
2 University of Sheffield United Kingdom.
J Am Heart Assoc. 2019 Jul 2;8(13):e011577. doi: 10.1161/JAHA.118.011577. Epub 2019 Jun 22.
Background Recent publications reached conflicting conclusions about the cost-effectiveness of left atrial appendage closure (LAAC) with the Watchman device (Boston Scientific, Marlborough, MA) for stroke risk reduction in nonvalvular atrial fibrillation (AF). This analysis sought to assess the cost-effectiveness of LAAC relative to both warfarin and nonwarfarin oral anticoagulants (NOACs) using pooled, long-term data from the randomized 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) trials. Methods and Results A Markov model was constructed from a US payer perspective with a lifetime (20-year) horizon. LAAC clinical event rates and stroke outcomes were from pooled PROTECT AF and PREVAIL trial 5-year data. Warfarin and NOAC inputs were derived from published meta-analyses. The model was populated with a cohort of 10 000 patients, aged 70 years, at moderate stroke and bleeding risk. Sensitivity analyses were performed. LAAC was cost-effective relative to warfarin by year 7 ($48 674/quality-adjusted life-year) and dominant (more effective and less costly) by year 10. LAAC became cost-effective and dominant compared with NOACs by year 5. Over a lifetime, LAAC provided 0.60 more quality-adjusted life-years than warfarin and 0.29 more than NOACs. In sensitivity analyses, LAAC was cost-effective relative to warfarin and NOACs in 98% and 95% of simulations, respectively. Conclusions Using pooled, 5-year PROTECT AF and PREVAIL trial data, LAAC proved to be not only cost-effective, but cost saving relative to warfarin and NOACs. LAAC with the Watchman device is an economically viable stroke risk reduction strategy for patients with AF seeking an alternative to lifelong anticoagulation.
最近的一些出版物对于使用 Watchman 装置（波士顿科学公司，马萨诸塞州马尔伯勒）进行左心耳封堵术（LAAC）以降低非瓣膜性心房颤动（AF）患者的中风风险的成本效益得出了相互矛盾的结论。本分析旨在使用随机 PROTECT AF（Watchman 左心耳系统用于房颤患者的栓塞保护）和 PREVAIL（前瞻性随机评价 Watchman LAA 封堵装置在房颤患者与长期华法林的比较）试验的 pooled，长期数据评估 LAAC 相对于华法林和非华法林口服抗凝剂（NOAC）的成本效益。
从美国支付者的角度构建了一个具有终生（20 年）时间范围的 Markov 模型。LAAC 的临床事件发生率和中风结果来自 pooled PROTECT AF 和 PREVAIL 试验的 5 年数据。华法林和 NOAC 的输入来自已发表的荟萃分析。该模型使用 10000 名年龄为 70 岁、中度中风和出血风险的患者队列进行填充。进行了敏感性分析。在第 7 年，LAAC 相对于华法林具有成本效益（48674 美元/质量调整生命年），在第 10 年具有优势（更有效且成本更低）。在第 5 年，LAAC 相对于 NOAC 具有成本效益和优势。在一生中，LAAC 比华法林提供 0.60 更多的质量调整生命年，比 NOAC 提供 0.29 更多的质量调整生命年。在敏感性分析中，LAAC 在 98%和 95%的模拟中相对于华法林和 NOAC 均具有成本效益。
使用 pooled 的 5 年 PROTECT AF 和 PREVAIL 试验数据，LAAC 不仅具有成本效益，而且相对于华法林和 NOAC 具有成本节约。对于寻求替代终生抗凝的 AF 患者，使用 Watchman 装置的 LAAC 是一种经济可行的降低中风风险的策略。
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