血管内成像指导下复杂 PCI 的成本效益：RENOVATE-COMPLEX-PCI 试验的预设分析。
Cost-Effectiveness of Intravascular Imaging-Guided Complex PCI: Prespecified Analysis of RENOVATE-COMPLEX-PCI Trial.
机构信息
Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea (D.H., K.H.C., T.K.P., J.H.Y., S.-H.C., H.-C.G., Y.B.S., J.-Y.H., J.M.L.).
Center for Clinical Epidemiology, Samsung Medical Center, Sungkyunkwan University, Seoul, South Korea (J.L., J.C., D.K.).
出版信息
Circ Cardiovasc Qual Outcomes. 2024 Mar;17(3):e010230. doi: 10.1161/CIRCOUTCOMES.123.010230. Epub 2024 Mar 13.
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, -$9063) with consistently higher QALY (8.24 versus 7.89; incremental QALY, 0.910) in intravascular imaging-guided PCI than angiography-guided PCI, resulting in a dominant incremental cost-effectiveness ratio. Consistently, 70% of probabilistic iterations showed cost-effectiveness of intravascular imaging-guided PCI in probabilistic sensitivity analysis.
CONCLUSIONS
The current cost-effectiveness analysis suggests that imaging-guided PCI is more cost-effective than angiography-guided PCI by reducing medical cost and increasing quality-of-life in complex coronary artery lesions in long-term follow-up.
REGISTRATION
URL: https://www.clinicaltrials.gov; Unique identifier: NCT03381872.
背景
虽然先前的试验已经观察到血管内影像学指导的经皮冠状动脉介入治疗（PCI）在复杂冠状动脉病变患者中的临床获益，但这种策略的成本效益尚不确定。
方法
RENOVATE-COMPLEX-PCI（复杂经皮冠状动脉介入治疗中血管内影像学指导与血管造影指导的临床结局的随机对照试验）于 2018 年 5 月至 2021 年 5 月在韩国进行。本预先设定的成本效益子研究使用 Markov 模型进行，该模型模拟了 3 种状态：（1）PCI 后，（2）自发性心肌梗死，（3）死亡。从意向治疗人群中得出模拟队列，输入参数从试验数据或先前的出版物中提取。使用 3 年（试验内）和终生时间范围评估成本效益。主要结果是血管内影像学指导 PCI 与血管造影指导 PCI 相比的增量成本效益比（ICER），这是额外质量调整生命年（QALY）获益的增量成本的指标。本分析使用韩国医疗保健部门的视角进行，以美元报告结果（1200 韩元，₩=1 美元，$）。愿意支付的阈值为每获得 1 个 QALY 支付 35000 美元。
结果
共有 1639 名患者参与了试验。在 3 年随访期间，血管内影像学指导 PCI 的医疗费用（$8661 比 $7236；增量成本，$1426）和 QALY（2.34 比 2.31；增量 QALY，0.025）均高于血管造影指导 PCI，导致试验内数据每获得 1 个 QALY 的增量成本效益比为$57040。相反，终身模拟显示，两组之间的总累计医疗费用发生逆转（$40455 比 $49519；增量成本，-$9063），血管内影像学指导 PCI 的 QALY 始终更高（8.24 比 7.89；增量 QALY，0.910），导致血管内影像学指导 PCI 的增量成本效益比占主导地位。同样，在概率敏感性分析中，70%的概率迭代表明血管内影像学指导 PCI 的成本效益。
结论
本成本效益分析表明，在长期随访中，通过降低医疗成本和提高生活质量，血管内影像学指导 PCI 在复杂冠状动脉病变中的成本效益优于血管造影指导 PCI。
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