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在真实临床环境中药物洗脱支架与第三代裸金属支架相比的增量成本效益:随机巴塞尔支架成本效益试验(BASKET)

Incremental cost-effectiveness of drug-eluting stents compared with a third-generation bare-metal stent in a real-world setting: randomised Basel Stent Kosten Effektivitäts Trial (BASKET).

作者信息

Kaiser Christoph, Brunner-La Rocca Hans Peter, Buser Peter T, Bonetti Piero O, Osswald Stefan, Linka André, Bernheim Alain, Zutter Andreas, Zellweger Michael, Grize Leticia, Pfisterer Matthias E

机构信息

Division of Cardiology, University of Basel, CH-4031 Basel, Switzerland.

出版信息

Lancet. 2005;366(9489):921-9. doi: 10.1016/S0140-6736(05)67221-2.

Abstract

BACKGROUND

No prospective trial-based data are available for incremental cost-effectiveness of drug-eluting stents (DES) compared with bare-metal stents (BMS) in unselected patients, as treated in everyday practice.

METHODS

The Basel stent cost-effectiveness trial (BASKET) included 826 consecutive patients treated with angioplasty and stenting for 1281 de-novo lesions, irrespective of indication for angioplasty. Patients were randomised to one of two DES (Cypher, n=264; Taxus, n=281) or to a cobalt-chromium-based BMS (Vision, n=281) and followed up for 6 months for occurrence of major adverse cardiac events and costs. Analysis was by intention-to-treat. The primary endpoint was cost-effectiveness after 6 months, with effectiveness defined as reduction of major adverse cardiac events.

FINDINGS

Cardiac death, myocardial infarction, or target vessel revascularisation occurred in 39 of 544 (7.2%) patients with DES and 34 of 280 (12.1%) with BMS (odds ratio 0.56, 95% CI 0.35-0.91; p=0.02), without significant differences between the two DES. Total costs at 6 months were higher with DES (mean 10,544, SD 6849) than with BMS (9639, 9067; p<0.0001); higher stent costs of DES were not compensated for by lower follow-up costs. Incremental cost-effectiveness ratio of DES compared with BMS to avoid one major event was 18,311, and costs per quality-adjusted life-year gained were more than 50 000. Subgroup analyses showed that DES were more cost-effective for elderly patients in specific high-risk groups.

INTERPRETATION

In a real-world setting, use of DES in all patients is less cost effective than in studies with selected patients. Use of these stents could be restricted to patients in high-risk groups.

摘要

背景

在日常临床实践中,对于未经过挑选的患者,与裸金属支架(BMS)相比,药物洗脱支架(DES)的增量成本效益尚无基于前瞻性试验的数据。

方法

巴塞尔支架成本效益试验(BASKET)纳入了826例连续接受血管成形术和支架植入治疗1281处新发病变的患者,不考虑血管成形术的适应证。患者被随机分为两种DES之一(西罗莫司洗脱支架,n = 264;紫杉醇洗脱支架,n = 281)或钴铬合金裸金属支架(Vision,n = 281),并随访6个月,观察主要不良心脏事件的发生情况和成本。分析采用意向性分析。主要终点是6个月后的成本效益,有效性定义为主要不良心脏事件的减少。

研究结果

544例接受DES治疗的患者中有39例(7.2%)发生心脏死亡、心肌梗死或靶血管血运重建,280例接受BMS治疗的患者中有34例(12.1%)发生(比值比0.56,95%可信区间0.35 - 0.91;p = 0.02),两种DES之间无显著差异。DES组6个月时的总成本(平均10544,标准差6849)高于BMS组(9639,9067;p < 0.0001);DES较高的支架成本未被较低的随访成本所抵消。DES与BMS相比,避免一次主要事件的增量成本效益比为18311,每获得一个质量调整生命年的成本超过50000。亚组分析显示,DES在特定高危组的老年患者中更具成本效益。

解读

在现实世界中,在所有患者中使用DES的成本效益低于在挑选患者的研究中。这些支架的使用可限于高危组患者。

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