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药物涂层球囊治疗冠状动脉小血管疾病的成本效益:来自BASKET-SMALL 2随机对照试验的报告。

Cost-Effectiveness of Drug-Coated Balloons in the Treatment of Coronary Small Vessel Disease: A Report From the BASKET-SMALL 2 Randomized Controlled Trial.

作者信息

Cattaneo Marco E G V, Coslovsky Michael, Malkin Samuel J P, Fahrni Gregor, Kaiser Christoph, Gilgen Nicole, Scheller Bruno, Jeger Raban V

机构信息

University Hospital Basel, Department of Clinical Research University of Basel Basel Switzerland.

Ossian Health Economics and Communications GmbH Basel Switzerland.

出版信息

J Am Heart Assoc. 2025 Aug 5;14(15):e037214. doi: 10.1161/JAHA.124.037214. Epub 2025 Jul 17.

DOI:10.1161/JAHA.124.037214
PMID:40673517
Abstract

BACKGROUND

Drug-coated balloons (DCB) are noninferior to second-generation drug-eluting stents (DES) in the treatment of small vessel coronary artery disease regarding major adverse cardiac events (MACE). However, the economic implication of this finding is unclear.

METHODS

In the BASKET-SMALL 2 study (Basel Stent Kosten-Effektivitäts Trial: Drug-Coated Balloons Versus Drug-Eluting Stents in Small Vessel Interventions 2), 738 patients were treated with either DCB or DES and followed up regarding MACE, that is, target vessel revascularization, myocardial infarction, or cardiac death, over 3 years. A cost-effectiveness analysis was performed using German diagnosis-related group data to evaluate total expected costs and quality-adjusted life expectancy, expressed in quality-adjusted life-years, for the entire cohort and each treatment option.

RESULTS

DCB led to fewer MACE than DES (14.5% versus 15.3%) but also reduced quality-adjusted life expectancy during the 3-year follow-up (2.35 versus 2.36 quality-adjusted life-years). Regarding direct costs, DCB was less expensive than DES: 5243 versus 5341 EUR during the first 3 years. The incremental cost-effectiveness ratio for DES versus DCB was 6863 EUR per quality-adjusted life-year gained, whereas DCB was more effective and less costly than DES in terms of MACE avoided. Sensitivity analyses emphasized the uncertainty in the results.

CONCLUSIONS

Despite reducing the probability of MACE, in terms of quality-adjusted life expectancy DCB was less cost effective than DES at 3 years in the treatment of small vessel coronary artery disease, although results varied substantially when accounting for uncertainty in model parameters.

摘要

背景

在治疗小血管冠状动脉疾病时,就主要不良心脏事件(MACE)而言,药物涂层球囊(DCB)不劣于第二代药物洗脱支架(DES)。然而,这一发现的经济意义尚不清楚。

方法

在BASKET-SMALL 2研究(巴塞尔支架成本效益试验:小血管介入中药物涂层球囊与药物洗脱支架对比2)中,738例患者接受了DCB或DES治疗,并在3年期间对MACE进行随访,即靶血管血运重建、心肌梗死或心源性死亡。使用德国诊断相关组数据进行成本效益分析,以评估整个队列以及每种治疗方案的总预期成本和质量调整生命预期(以质量调整生命年表示)。

结果

DCB导致的MACE少于DES(14.5%对15.3%),但在3年随访期间也降低了质量调整生命预期(2.35对2.36质量调整生命年)。在直接成本方面,DCB比DES便宜:前3年分别为5243欧元和5341欧元。DES与DCB相比的增量成本效益比为每获得一个质量调整生命年6863欧元,而就避免的MACE而言,DCB更有效且成本更低。敏感性分析强调了结果的不确定性。

结论

尽管降低了MACE的发生率,但就质量调整生命预期而言,在治疗小血管冠状动脉疾病时,DCB在3年时的成本效益低于DES,不过在考虑模型参数的不确定性时结果差异很大。

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