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巴塞尔支架成本效益试验(BASKET)中药物洗脱支架在发生重大心脏事件高风险或低风险患者中的成本效益:一项为期18个月的分析。

Cost-effectiveness of drug-eluting stents in patients at high or low risk of major cardiac events in the Basel Stent KostenEffektivitäts Trial (BASKET): an 18-month analysis.

作者信息

Brunner-La Rocca Hans Peter, Kaiser Christoph, Bernheim Alain, Zellweger Michael J, Jeger Raban, Buser Peter T, Osswald Stefan, Pfisterer Matthias

机构信息

Department of Cardiology, University Hospital, Basel, Switzerland.

出版信息

Lancet. 2007 Nov 3;370(9598):1552-9. doi: 10.1016/S0140-6736(07)61660-2.

Abstract

BACKGROUND

Our aim was to determine whether drug-eluting stents are good value for money in long-term, everyday practice.

METHODS

We did an 18-month cost-effectiveness analysis of the Basel Stent KostenEffektivitäts Trial (BASKET), which randomised 826 patients 2:1 to drug-eluting stents (n=545) or to bare-metal stents (281). We used non-parametric bootstrap techniques to determine incremental cost-effectiveness ratios (ICERs) of drug-eluting versus bare-metal stents, to compare low-risk (> or =3.0 mm stents in native vessels; n=558, 68%) and high-risk patients (<3.0 mm stents/bypass graft stenting; n=268, 32%), and to do sensitivity analyses by altering costs and event rates in the whole study sample and in predefined subgroups. Quality-adjusted life-years (QALYs) were assessed by EQ-5D questionnaire (available in 703/826 patients).

FINDINGS

Overall costs were higher for patients with drug-eluting stents than in those with bare-metal stents (11,808 euros [SD 400] per patient with drug-eluting stents and 10,450 euros [592] per patient with bare-metal stents, mean difference 1358 euros [717], p<0.0001), due to higher stent costs. We calculated an ICER of 64,732 euros to prevent one major adverse cardiac event, and of 40,467 euros per QALY gained. Stent costs, number of events, and QALYs affected ICERs most, but unrealistic alterations would have been required to achieve acceptable cost-effectiveness. In low-risk patients, the probability of drug-eluting stents achieving an arbitrary ICER of 10,000 euros or less to prevent one major adverse cardiac event was 0.016; by contrast, it was 0.874 in high-risk patients.

INTERPRETATION

If used in all patients, drug-eluting stents are not good value for money, even if prices were substantially reduced. Drug-eluting stents are cost effective in patients needing small vessel or bypass graft stenting, but not in those who require large native vessel stenting.

摘要

背景

我们的目的是确定药物洗脱支架在长期日常临床实践中是否具有性价比优势。

方法

我们对巴塞尔支架成本效益试验(BASKET)进行了为期18个月的成本效益分析,该试验将826例患者按2:1随机分为药物洗脱支架组(n = 545)和裸金属支架组(281例)。我们使用非参数自助法技术来确定药物洗脱支架与裸金属支架的增量成本效益比(ICER),比较低风险患者(天然血管中支架直径≥3.0 mm;n = 558,68%)和高风险患者(支架直径<3.0 mm/旁路移植血管支架置入;n = 268,32%),并通过改变整个研究样本及预定义亚组中的成本和事件发生率进行敏感性分析。采用EQ - 5D问卷评估质量调整生命年(QALY)(826例患者中有703例可获得数据)。

结果

药物洗脱支架组患者的总体成本高于裸金属支架组(药物洗脱支架组每位患者11,808欧元[标准差400],裸金属支架组每位患者10,450欧元[592],平均差值1358欧元[717],p<0.0001),原因是支架成本较高。我们计算出预防1例主要不良心脏事件的ICER为64,732欧元,每获得1个QALY的ICER为40,467欧元。支架成本、事件数量和QALY对ICER影响最大,但要实现可接受的成本效益,需要进行不切实际的改变。在低风险患者中,药物洗脱支架预防1例主要不良心脏事件达到任意ICER为10,000欧元或更低的概率为0.016;相比之下,在高风险患者中为0.874。

解读

如果在所有患者中使用,即使大幅降价,药物洗脱支架也不具有性价比优势。药物洗脱支架在需要小血管或旁路移植血管支架置入的患者中具有成本效益,但在需要大天然血管支架置入的患者中并非如此。

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