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房颤卒中预防策略的时间成本效益分析:华法林、NOAC 与左心耳封堵的比较

Time to Cost-Effectiveness Following Stroke Reduction Strategies in AF: Warfarin Versus NOACs Versus LAA Closure.

机构信息

Mount Sinai Medical Center, New York, New York.

University of Sheffield, Sheffield, United Kingdom.

出版信息

J Am Coll Cardiol. 2015 Dec 22;66(24):2728-2739. doi: 10.1016/j.jacc.2015.09.084. Epub 2015 Nov 23.

Abstract

BACKGROUND

Left atrial appendage closure (LAAC) and nonwarfarin oral anticoagulants (NOACs) have emerged as safe and effective alternatives to warfarin for stroke prophylaxis in patients with nonvalvular atrial fibrillation (AF).

OBJECTIVES

This analysis assessed the cost-effectiveness of warfarin, NOACs, and LAAC with the Watchman device (Boston Scientific, Marlborough, Massachusetts) for stroke risk reduction in patients with nonvalvular AF at multiple time points over a lifetime horizon.

METHODS

A Markov model was developed to assess the cost-effectiveness of LAAC, NOACs, and warfarin from the perspective of the Centers for Medicare & Medicaid Services over a lifetime (20-year) horizon. Patients were 70 years of age and at moderate risk for stroke and bleeding. Clinical event rates, stroke outcomes, and quality of life information were drawn predominantly from PROTECT AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients with Atrial Fibrillation) 4-year data and meta-analyses of warfarin and NOACs. Costs for stroke risk reduction therapies, treatment of associated acute events, and long-term care following disabling stroke were presented in 2015 U.S. dollars.

RESULTS

Relative to warfarin, LAAC was cost-effective at 7 years ($42,994/quality-adjusted life-years [QALY]), and NOACs were cost-effective at 16 years ($48,446/QALY). LAAC was dominant over NOACs by year 5 and warfarin by year 10. At 10 years, LAAC provided more QALYs than warfarin and NOACs (5.855 vs. 5.601 vs. 5.751, respectively). In sensitivity analyses, LAAC remained cost-effective relative to warfarin ($41,470/QALY at 11 years) and NOACs ($21,964/QALY at 10 years), even if procedure costs were doubled.

CONCLUSIONS

Both NOACs and LAAC with the Watchman device were cost-effective relative to warfarin, but LAAC was also found to be cost-effective and to offer better value relative to NOACs. The results of this analysis should be considered when formulating policy and practice guidelines for stroke prevention in AF.

摘要

背景

左心耳封堵术(LAAC)和新型口服抗凝剂(NOACs)已成为非瓣膜性心房颤动(AF)患者预防卒中的安全有效替代华法林的方法。

目的

本分析评估了在多个时间点,对于非瓣膜性房颤患者,华法林、NOAC 和 Watchman 装置(波士顿科学公司,马萨诸塞州的马尔伯勒)用于卒中风险降低的成本效益。

方法

建立了一个马尔可夫模型,从医疗保险和医疗补助服务中心(CMS)的角度,在 20 年的时间范围内评估 LAAC、NOAC 和华法林的成本效益。患者年龄为 70 岁,且具有中度卒中和出血风险。临床事件发生率、卒中和生存质量信息主要来自 PROTECT AF(Watchman 左心耳封堵系统预防房颤栓塞)4 年数据和华法林及新型口服抗凝剂的荟萃分析。以 2015 年的美元表示,降低卒中风险治疗、相关急性事件治疗和致残性卒中后的长期护理费用。

结果

与华法林相比,LAAC 在 7 年时具有成本效益(42994 美元/质量调整生命年[QALY]),NOAC 在 16 年时具有成本效益(48446 美元/QALY)。LAAC 在第 5 年优于 NOAC,在第 10 年优于华法林。在 10 年时,LAAC 提供的 QALY 多于华法林和 NOAC(分别为 5.855、5.601 和 5.751)。在敏感性分析中,即使将手术费用增加一倍,LAAC 相对于华法林(11 年时为 41470 美元/QALY)和 NOAC(10 年时为 21964 美元/QALY)仍然具有成本效益。

结论

NOAC 和 Watchman 装置的 LAAC 均与华法林相比具有成本效益,但 LAAC 相对于 NOAC 也具有成本效益,并且提供了更好的价值。在制定 AF 卒中预防政策和实践指南时,应考虑本分析的结果。

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