BACKGROUND:Although clinical benefits of intravascular imaging-guided percutaneous coronary intervention (PCI) in patients with complex coronary artery lesions have been observed in previous trials, the cost-effectiveness of this strategy is uncertain.METHODS:RENOVATE-COMPLEX-PCI (Randomized Controlled Trial of Intravascular Imaging Guidance vs Angiography-Guidance on Clinical Outcomes After Complex Percutaneous Coronary Intervention) was conducted in Korea between May 2018 and May 2021. This prespecified cost-effectiveness substudy was conducted using Markov model that simulated 3 states: (1) post-PCI, (2) spontaneous myocardial infarction, and (3) death. A simulated cohort was derived from the intention-to-treat population, and input parameters were extracted from either the trial data or previous publications. Cost-effectiveness was evaluated using time horizon of 3 years (within trial) and lifetime. The primary outcome was incremental cost-effectiveness ratio (ICER), an indicator of incremental cost on additional quality-adjusted life years (QALYs) gained, in intravascular imaging-guided PCI compared with angiography-guided PCI. The current analysis was performed using the Korean health care sector perspective with reporting the results in US dollar (1200 Korean Won, ₩=1 dollar, $). Willingness to pay threshold was $35 000 per QALY gained.RESULTS:A total of 1639 patients were included in the trial. During 3-year follow-up, medical costs ($8661 versus $7236; incremental cost, $1426) and QALY (2.34 versus 2.31; incremental QALY, 0.025) were both higher in intravascular imaging-guided PCI than angiography-guided PCI, resulting incremental cost-effectiveness ratio of $57 040 per QALY gained within trial data. Conversely, lifetime simulation showed total cumulative medical cost was reversed between the 2 groups ($40 455 versus $49 519; incremental cost, −$9063) with consistently higher QALY (8.24 versus 7.89; incremental QALY, 0.910) in intravascular imaging-guided PCI than angiography-guided PCI, resulting in a dominant incremental cost-effectiveness ratio. Consistently, 70% of probabilistic iterations showed cost-effectiveness of intravascular imaging-guided PCI in probabilistic sensitivity analysis.CONCLUSIONS:The current cost-effectiveness analysis suggests that imaging-guided PCI is more cost-effective than angiography-guided PCI by reducing medical cost and increasing quality-of-life in complex coronary artery lesions in long-term follow-up.REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifier: NCT03381872.

中文翻译：

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血管内成像引导的复杂 PCI 的成本效益：RENOVATE-COMPLEX-PCI 试验的预设分析

背景：尽管在之前的试验中已经观察到血管内成像引导下的经皮冠状动脉介入治疗（PCI）对复杂冠状动脉病变患者的临床益处，但该策略的成本效益尚不确定。 方法：RENOVATE-COMPLEX-PCI（随机对照） 2018 年 5 月至 2021 年 5 月在韩国进行了血管内成像指导与血管造影的试验（复杂经皮冠状动脉介入治疗后临床结果的指导）。这项预先指定的成本效益子研究是使用模拟 3 种状态的马尔可夫模型进行的：（1）术后PCI，(2) 自发性心肌梗塞，以及 (3) 死亡。模拟队列来自意向治疗人群，输入参数是从试验数据或之前的出版物中提取的。使用 3 年时间范围（试验内）和生命周期来评估成本效益。主要结果是增量成本效益比 (ICER)，这是血管内成像引导 PCI 与血管造影引导 PCI 相比获得的额外质量调整生命年 (QALY) 的增量成本指标。当前的分析是从韩国医疗保健部门的角度进行的，并以美元（1200 韩元，₩=1 美元，$）报告结果。每获得 QALY，支付意愿门槛为 35 000 美元。 结果：试验共纳入 1639 名患者。在 3 年随访期间，血管内成像引导 PCI 的医疗成本（8661 美元对比 7236 美元；增量成本 1426 美元）和 QALY（2.34 对比 2.31；增量 QALY，0.025）均高于血管造影引导 PCI，导致成本增量-试验数据中获得的每个 QALY 的有效性比率为 57 040 美元。相反，终生模拟显示，两组之间的总累计医疗成本是相反的（40 455 美元对比 49 519 美元；增量成本 - 9063 美元），血管内成像引导 PCI 的 QALY 始终高于血管造影（8.24 对比 7.89；增量 QALY，0.910） -引导PCI，导致增量成本效益比占主导地位。一致地，在概率敏感性分析中，70% 的概率迭代显示了血管内成像引导 PCI 的成本效益。 结论：当前的成本效益分析表明，通过降低医疗成本，影像引导 PCI 比血管造影引导 PCI 更具成本效益并在长期随访中提高复杂冠状动脉病变的生活质量。注册：URL：https://www.clinicaltrials.gov；唯一标识符：NCT03381872。