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
Division of Cardiology, University of Basel, CH-4031 Basel, Switzerland.
Lancet. 2005;366(9489):921-9. doi: 10.1016/S0140-6736(05)67221-2.
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.
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.
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.
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.
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。
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。
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。
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。
