Bakhai Ameet, Stone Gregg W, Mahoney Elizabeth, Lavelle Tara A, Shi Chunxue, Berezin Ronna H, Lahue Betsy J, Clark Mary Ann, Lacey Michael J, Russell Mary E, Ellis Stephen G, Hermiller James B, Cox David A, Cohen David J
Harvard Clinical Research Institute, Boston, Massachusetts, USA.
J Am Coll Cardiol. 2006 Jul 18;48(2):253-61. doi: 10.1016/j.jacc.2006.02.063. Epub 2006 Jun 22.
This study sought to compare aggregate medical care costs for patients undergoing percutaneous coronary intervention with paclitaxel-eluting stents (PES) and bare-metal stents (BMS) and to formally evaluate the incremental cost effectiveness of PES for patients undergoing single-vessel percutaneous coronary intervention.
Although the cost effectiveness of SES has been studied in both clinical trials and decision-analytic models, few data exist on the cost effectiveness of alternative drug-eluting stent (DES) designs. In addition, no clinical trials have specifically examined the cost effectiveness of DES among patients managed without mandatory angiographic follow-up.
We performed a prospective economic evaluation among 1,314 patients undergoing percutaneous coronary revascularization randomized to either PES (N = 662) or BMS (N = 652) in the TAXUS-IV trial. Clinical outcomes, resource use, and costs (from a societal perspective) were assessed prospectively for all patients over a 1-year follow-up period. Cost effectiveness was defined as the incremental cost per target vessel revascularization (TVR) event avoided and was analyzed separately among cohorts assigned to mandatory angiographic follow-up (n = 732) or clinical follow-up alone (n = 582).
The PES reduced TVR by 12.2 events per 100 patients treated, resulting in a 1-year cost difference of 572 dollars per patient with incremental cost-effectiveness ratios of 4,678 dollars per TVR avoided and 47,798 dollars/quality-adjusted life year (QALY) gained. Among patients assigned to clinical follow-up alone, the net 1-year cost difference was 97 dollars per patient with cost-effectiveness ratios of 760 dollars per TVR event avoided and $5,105/QALY gained.
In the TAXUS-IV trial, treatment with PES led to substantial reductions in the need for repeat revascularization while increasing 1-year costs only modestly. The cost-effectiveness ratio for PES in the study population compares reasonably with that for other treatments that reduce coronary restenosis, including alternative drug-eluting stent platforms.
本研究旨在比较接受紫杉醇洗脱支架(PES)和裸金属支架(BMS)的经皮冠状动脉介入治疗患者的总体医疗费用,并正式评估PES对接受单支血管经皮冠状动脉介入治疗患者的增量成本效益。
尽管在临床试验和决策分析模型中都对药物洗脱支架(SES)的成本效益进行了研究,但关于其他药物洗脱支架(DES)设计的成本效益数据很少。此外,没有临床试验专门研究在没有强制血管造影随访的患者中DES的成本效益。
我们在TAXUS-IV试验中对1314例接受经皮冠状动脉血运重建的患者进行了前瞻性经济评估,这些患者被随机分为PES组(N = 662)或BMS组(N = 652)。在1年的随访期内对所有患者的临床结局、资源使用和成本(从社会角度)进行前瞻性评估。成本效益定义为避免每例靶血管血运重建(TVR)事件的增量成本,并在分配接受强制血管造影随访的队列(n = 732)或仅接受临床随访的队列(n = 582)中分别进行分析。
每100例接受治疗的患者中,PES使TVR减少了12.2例,导致每位患者1年的成本差异为572美元,避免每例TVR的增量成本效益比为4678美元,每获得1个质量调整生命年(QALY)的成本效益比为47798美元。在仅接受临床随访的患者中,每位患者1年的净成本差异为97美元,避免每例TVR事件的成本效益比为760美元,每获得1个QALY的成本效益比为5105美元。
在TAXUS-IV试验中,使用PES治疗可大幅减少重复血运重建的需求,同时仅适度增加1年成本。研究人群中PES的成本效益比与其他减少冠状动脉再狭窄的治疗方法(包括其他药物洗脱支架平台)的成本效益比相比合理。