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经导管主动脉瓣置换术与无法手术的重度主动脉瓣狭窄患者标准治疗的成本效益比较:来自放置主动脉经导管瓣膜(PARTNER)试验(队列 B)的结果。

Cost-effectiveness of transcatheter aortic valve replacement compared with standard care among inoperable patients with severe aortic stenosis: results from the placement of aortic transcatheter valves (PARTNER) trial (Cohort B).

机构信息

Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City School of Medicine, Kansas City, MO 64111, USA.

出版信息

Circulation. 2012 Mar 6;125(9):1102-9. doi: 10.1161/CIRCULATIONAHA.111.054072. Epub 2012 Feb 3.

DOI:10.1161/CIRCULATIONAHA.111.054072
PMID:22308299
Abstract

BACKGROUND

In patients with severe aortic stenosis who cannot have surgery, transcatheter aortic valve replacement (TAVR) has been shown to improve survival and quality of life compared with standard therapy, but the costs and cost-effectiveness of this strategy are not yet known.

METHODS AND RESULTS

The PARTNER trial randomized patients with symptomatic, severe aortic stenosis who were not candidates for surgery to TAVR (n=179) or standard therapy (n=179). Empirical data regarding survival, quality of life, medical resource use, and hospital costs were collected during the trial and used to project life expectancy, quality-adjusted life expectancy, and lifetime medical care costs to estimate the incremental cost-effectiveness of TAVR from a US perspective. For patients treated with TAVR, mean costs for the initial procedure and hospitalization were $42 806 and $78 542, respectively. Follow-up costs through 12 months were lower with TAVR ($29 289 versus $53 621) because of reduced hospitalization rates, but cumulative 1-year costs remained higher ($106 076 versus $53 621). We projected that over a patient's lifetime, TAVR would increase discounted life expectancy by 1.6 years (1.3 quality-adjusted life-years) at an incremental cost of $79 837. The incremental cost-effectiveness ratio for TAVR was thus estimated at $50 200 per year of life gained or $61 889 per quality-adjusted life-year gained. These results were stable across a broad range of uncertainty and sensitivity analyses.

CONCLUSIONS

For patients with severe aortic stenosis who are not candidates for surgery, TAVR increases life expectancy at an incremental cost per life-year gained well within accepted values for commonly used cardiovascular technologies.

CLINICAL TRIAL REGISTRATION

URL: http://www.clinicaltrials.gov. Unique identifier: NCT00530894.

摘要

背景

在不能进行手术的严重主动脉瓣狭窄患者中,与标准治疗相比,经导管主动脉瓣置换术(TAVR)已被证明可提高生存率和生活质量,但该策略的成本和成本效益尚不清楚。

方法和结果

PARTNER 试验将有症状的、不能进行手术的严重主动脉瓣狭窄患者随机分为 TAVR(n=179)或标准治疗组(n=179)。在试验过程中收集了有关生存、生活质量、医疗资源使用和医院费用的数据,并用于预测预期寿命、质量调整预期寿命和终生医疗保健费用,以从美国的角度估计 TAVR 的增量成本效益。接受 TAVR 治疗的患者,初始手术和住院费用分别为 42806 美元和 78542 美元。由于住院率降低,TAVR 的 12 个月随访成本较低(29289 美元对 53621 美元),但 1 年的累计成本仍较高(106076 美元对 53621 美元)。我们预计,在患者的一生中,TAVR 将增加 1.6 年(1.3 个质量调整生命年)的贴现预期寿命,增量成本为 79837 美元。因此,TAVR 的增量成本效益比估计为每年每获得 50200 美元的生命或每获得 61889 美元的质量调整生命年。这些结果在广泛的不确定性和敏感性分析中是稳定的。

结论

对于不能进行手术的严重主动脉瓣狭窄患者,TAVR 可在增加预期寿命方面增加增量成本,每获得一年的生命成本远低于常用心血管技术的可接受值。

临床试验注册

网址:http://www.clinicaltrials.gov。唯一标识符:NCT00530894。

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