BACKGROUND: Percutaneous coronary intervention (PCI) is frequently undertaken in patients with ischemic left ventricular systolic dysfunction. The REVIVED (Revascularization for Ischemic Ventricular Dysfunction)-BCIS2 (British Cardiovascular Society-2) trial concluded that PCI did not reduce the incidence of all-cause death or heart failure hospitalization; however, patients assigned to PCI reported better initial health-related quality of life than those assigned to optimal medical therapy (OMT) alone. The aim of this study was to assess the cost-effectiveness of PCI+OMT compared with OMT alone. METHODS: REVIVED-BCIS2 was a prospective, multicenter UK trial, which randomized patients with severe ischemic left ventricular systolic dysfunction to either PCI+OMT or OMT alone. Health care resource use (including planned and unplanned revascularizations, medication, device implantation, and heart failure hospitalizations) and health outcomes data (EuroQol 5-dimension 5-level questionnaire) on each patient were collected at baseline and up to 8 years post-randomization. Resource use was costed using publicly available national unit costs. Within the trial, mean total costs and quality-adjusted life-years (QALYs) were estimated from the perspective of the UK health system. Cost-effectiveness was evaluated using estimated mean costs and QALYs in both groups. Regression analysis was used to adjust for clinically relevant predictors. RESULTS: Between 2013 and 2020, 700 patients were recruited (mean age: PCI+OMT=70 years, OMT=68 years; male (%): PCI+OMT=87, OMT=88); median follow-up was 3.4 years. Over all follow-ups, patients undergoing PCI yielded similar health benefits at higher costs compared with OMT alone (PCI+OMT: 4.14 QALYs, £22 352; OMT alone: 4.16 QALYs, £15 569; difference: −0.015, £6782). For both groups, most health resource consumption occurred in the first 2 years post-randomization. Probabilistic results showed that the probability of PCI being cost-effective was 0. CONCLUSIONS: A minimal difference in total QALYs was identified between arms, and PCI+OMT was not cost-effective compared with OMT, given its additional cost. A strategy of routine PCI to treat ischemic left ventricular systolic dysfunction does not seem to be a justifiable use of health care resources in the United Kingdom. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01920048.

中文翻译：

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经皮血运重建术治疗缺血性左心功能不全：REVIVED-BCIS2 试验的成本效益分析

背景：经皮冠状动脉介入治疗（PCI）常用于缺血性左心室收缩功能障碍的患者。REVIVED（缺血性心室功能障碍血运重建）-BCIS2（英国心血管学会-2）试验得出结论，PCI 并未降低全因死亡或心力衰竭住院的发生率；然而，分配到 PCI 的患者报告的初始健康相关生活质量比分配到仅接受最佳药物治疗 (OMT) 的患者要好。本研究的目的是评估 PCI+OMT 与单独 OMT 相比的成本效益。 方法：REVIVED-BCIS2 是一项前瞻性、多中心英国试验，将严重缺血性左心室收缩功能障碍患者随机分为 PCI+OMT 或单独 OMT。在基线和随机化后 8 年之内收集每位患者的医疗保健资源使用情况（包括计划内和计划外的血运重建、药物治疗、装置植入和心力衰竭住院治疗）和健康结果数据（EuroQol 5 维 5 级问卷） 。资源使用成本是使用公开的国家单位成本计算的。在试验中，从英国卫生系统的角度估计了平均总成本和质量调整生命年（QALY）。使用两组的估计平均成本和 QALY 来评估成本效益。使用回归分析来调整临床相关的预测因子。 结果：2013年至2020年间，招募了700名患者（平均年龄：PCI+OMT=70岁，OMT=68岁；男性（%）：PCI+OMT=87，OMT=88）；中位随访时间为 3.4 年。在所有随访中，与单独使用 OMT 相比，接受 PCI 的患者以更高的成本获得了相似的健康益处（PCI+OMT：4.14 QALY，22 352 英镑；单独 OMT：4.16 QALY，15 569 英镑；差异：-0.015，6782 英镑） 。对于两组来说，大部分卫生资源消耗发生在随机分组后的头两年。概率结果显示 PCI 具有成本效益的概率为 0。 结论：各组之间的总 QALY 差异很小，考虑到 PCI+OMT 的额外成本，与 OMT 相比，其成本效益不高。在英国，常规 PCI 治疗缺血性左心室收缩功能障碍的策略似乎并不是医疗保健资源的合理使用。 登记：网址：https://www.clinicaltrials.gov; 唯一标识符：NCT01920048。