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经皮冠状动脉介入治疗与旁路手术治疗左主干病变患者的成本效益:EXCEL 试验结果。

Cost-Effectiveness of Percutaneous Coronary Intervention Versus Bypass Surgery for Patients With Left Main Disease: Results From the EXCEL Trial.

机构信息

Saint Luke's Mid America Heart Institute, Kansas City, MO (E.A.M., K.C., K.V.).

University of Missouri-Kansas City (E.A.M.).

出版信息

Circ Cardiovasc Interv. 2022 Jul;15(7):e011981. doi: 10.1161/CIRCINTERVENTIONS.122.011981. Epub 2022 Jul 19.

DOI:10.1161/CIRCINTERVENTIONS.122.011981
PMID:35861797
Abstract

BACKGROUND

The EXCEL trial (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) demonstrated in patients with left main coronary artery disease, no significant difference between coronary artery bypass graft surgery (CABG) and percutaneous coronary intervention (PCI) with everolimus-eluting stents for the composite end point of death, stroke, or myocardial infarction at 5 years. However, all-cause mortality at 5 years was higher with PCI. Long-term cost-effectiveness of these 2 strategies has heretofore not been evaluated.

METHODS

From 2010 to 2014, 1905 patients with left main coronary artery disease were randomized to CABG (n=957) or PCI (n=948). Costs ($2019) were assessed over 5 years using resource-based costing and Medicare reimbursement rates. Health utilities were assessed using the EuroQOL 5-dimension questionnaire. Five-year EXCEL data in combination with US lifetables were used to develop a Markov model to evaluate lifetime cost-effectiveness. An incremental cost-effectiveness ratio <$50 000 per quality-adjusted life year (QALY) gained was considered highly cost-effective.

RESULTS

Index revascularization procedure costs were $4,850/patient higher with CABG, and total costs for the index hospitalization were $17 610/patient higher with CABG ($32 297 versus $19 687, <0.001). Cumulative 5-year costs were $20 449/patient higher with CABG. CABG was projected to increase lifetime costs by $21 551 while increasing quality-adjusted life expectancy by 0.49 QALYs, yielding an incremental cost-effectiveness ratio of $44 235/QALY. In a post hoc sensitivity analysis using mortality hazard ratios from a meta-analysis of all randomized CABG versus PCI in left main disease trials, the gain associated with CABG was 0.08 to 0.14 QALYs, resulting in an incremental cost-effectiveness ratio of $139 775 to $232 710/QALY gained.

CONCLUSIONS

Based on data from the EXCEL trial, CABG is an economically attractive revascularization strategy compared with PCI over a lifetime horizon for patients with significant left main coronary artery disease. However, this conclusion is sensitive to the long-term mortality rates with the 2 strategies, and CABG is no longer highly cost-effective when substituting the pooled treatment effect from the 4 major PCI versus CABG trials for left main disease.

REGISTRATION

URL: https://www.

CLINICALTRIALS

gov; Unique identifier: NCT01205776.

摘要

背景

EXCEL 试验(评价依维莫司洗脱支架经皮冠状动脉介入治疗与冠状动脉旁路移植术治疗左主干病变的有效性)显示,在左主干冠状动脉疾病患者中,冠状动脉旁路移植术(CABG)和经皮冠状动脉介入治疗(PCI)与依维莫司洗脱支架治疗 5 年的复合终点(死亡、卒中和心肌梗死)无显著差异。然而,PCI 后 5 年全因死亡率更高。这两种策略的长期成本效益尚未得到评估。

方法

2010 年至 2014 年,1905 例左主干冠状动脉疾病患者被随机分为 CABG 组(n=957)或 PCI 组(n=948)。使用基于资源的成本核算和医疗保险报销率评估 5 年的成本($2019)。使用 EuroQOL 5 维度问卷评估健康效用。结合美国生命表,使用 5 年的 EXCEL 数据开发马尔可夫模型,以评估终生成本效益。增量成本效益比(ICER)<$50000/质量调整生命年(QALY)增加被认为是高度成本效益的。

结果

CABG 的索引血运重建手术费用每例患者增加$4850,CABG 的索引住院总费用每例患者增加$17610($32297 比$19687,<0.001)。5 年累计成本每例患者增加$20449。CABG 预计将增加终生成本$21551,同时增加 0.49 QALY 的质量调整生命预期,ICER 为$44235/QALY。在一项使用左主干疾病随机 CABG 与 PCI 试验荟萃分析的死亡率风险比的事后敏感性分析中,CABG 相关的获益在 0.08 到 0.14 QALY 之间,ICER 为$139775 到$232710/QALY。

结论

基于 EXCEL 试验的数据,对于有明显左主干冠状动脉疾病的患者,与 PCI 相比,CABG 是一种具有吸引力的血管重建策略,从终生角度来看具有成本效益。然而,这一结论对两种策略的长期死亡率敏感,当用 4 项主要的 PCI 与 CABG 试验的左主干疾病汇总治疗效果替代时,CABG 不再具有高度成本效益。

注册

网址:https://www.clinicaltrials.gov;唯一标识符:NCT01205776。

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