Health Economics and Health Technology Assessment, Institute of Health and Wellbeing, University of Glasgow, 1 Lilybank Gardens, Glasgow, G12 8RZ, UK.
London School of Hygiene & Tropical Medicine, London, UK.
Eur J Health Econ. 2020 Nov;21(8):1197-1209. doi: 10.1007/s10198-020-01235-3. Epub 2020 Oct 7.
The CULPRIT-SHOCK trial compared two treatment strategies for patients with acute myocardial infarction and multivessel coronary artery disease complicated by cardiogenic shock: (a) culprit vessel only percutaneous coronary intervention (CO-PCI), with additional staged revascularisation if indicated, and (b) immediate multivessel PCI (MV-PCI).
A German societal and national health service perspective was considered for three different analyses. The cost utility analysis (CUA) estimated costs and quality adjusted life years (QALYs) based on a pre-trial decision analytic model taking a lifelong time horizon. In addition, a within trial CUA estimated QALYs and costs for 1 year. Finally, the cost effectiveness analysis (CEA) used the composite primary outcome, mortality and renal failure at 30-day follow-up, and the within trial costs. Econometric and survival analysis on the trial data was used for the estimation of the model parameters. Subgroup analysis was performed following an economic protocol.
The lifelong CUA showed an incremental cost effectiveness ratio (ICER), CO-PCI vs. MV-PCI, of €7010 per QALY and a probability of CO-PCI being the most cost-effective strategy > 64% at a €30,000 threshold. The ICER for the within trial CUA was €14,600 and the incremental cost per case of death/renal failure avoided at 30-day follow-up was €9010. Cost-effectiveness improved with patient age and for those without diabetes.
The estimates of cost-effectiveness for CO-PCI vs. MV-PCI have been shown to change depending on the time horizon and type of economic evaluation performed. The results favoured a long-term horizon analysis for avoiding underestimation of QALY gains from the CO-PCI arm.
CULPRIT-SHOCK 试验比较了急性心肌梗死和多支冠状动脉疾病合并心源性休克患者的两种治疗策略：（a）罪犯血管仅经皮冠状动脉介入治疗（CO-PCI），如有必要则进行分期血运重建，以及（b）即刻多支血管 PCI（MV-PCI）。
从德国社会和国家卫生服务的角度考虑了三种不同的分析。成本效用分析（CUA）基于术前决策分析模型估算成本和质量调整生命年（QALYs），该模型采用终生时间范围。此外，还进行了一项试验内 CUA 来估算 1 年的 QALYs 和成本。最后，成本效益分析（CEA）使用复合主要结局、30 天随访时的死亡率和肾衰竭，以及试验内成本。对试验数据进行了计量经济学和生存分析，以估算模型参数。按照经济方案进行了亚组分析。
终生 CUA 显示 CO-PCI 与 MV-PCI 的增量成本效果比（ICER）为每 QALY 7010 欧元，在 30000 欧元阈值下 CO-PCI 成为最具成本效益策略的概率>64%。试验内 CUA 的 ICER 为 14600 欧元，每避免一例 30 天随访时死亡/肾衰竭的增量成本为 9010 欧元。成本效益随着患者年龄的增长和无糖尿病患者的增加而提高。
CO-PCI 与 MV-PCI 的成本效益估计值已被证明会根据所进行的时间范围和经济评估类型而变化。结果表明，为避免低估 CO-PCI 组的 QALY 获益，长期时间范围分析更为有利。
