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.
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.
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.
URL: https://www.clinicaltrials.gov; Unique identifier: NCT03381872.
■RENOVATE-COMPLEX-PCI(血管内成像指南与血管造影指南的随机对照试验-复杂经皮冠状动脉介入治疗后的临床结果指南)于2018年5月至2021年5月在韩国进行。这项预设的成本-效果子研究使用马尔可夫模型进行,该模型模拟了3种状态:(1)PCI后,(2)自发性心肌梗死,(3)死亡。一个模拟队列来自意向治疗人群,和输入参数从试验数据或以前的出版物中提取.使用3年(试验内)和终身的时间范围评估成本效益。主要结果是增量成本效益比(ICER),获得的额外质量调整寿命年(QALYs)的增量成本指标,在血管内成像引导的PCI与血管造影引导的PCI相比。当前的分析是使用韩国医疗保健行业的观点进行的,并以美元(1200韩元,
■共有1639名患者被纳入试验。在3年的随访中,医疗费用(8661美元对7236美元;增量成本,1426美元)和QALY(2.34对2.31;增量QALY,0.025)在血管内成像引导的PCI中均高于血管造影引导的PCI,因此在试验数据中获得的每QALY增量成本效益比为57040美元。相反,终生模拟显示,两组之间的累计医疗费用总额是相反的(40455美元对49519美元;增量成本,-9063美元),QALY持续较高(8.24对7.89;增量QALY,0.910)在血管内成像引导的PCI比血管造影引导的PCI,导致成本效益比占主导地位。始终如一,70%的概率迭代显示了在概率敏感性分析中血管内成像引导的PCI的成本效益。
■当前的成本效益分析表明,在长期随访中,影像学引导的PCI比血管造影引导的PCI更具成本效益,可以降低复杂冠状动脉病变的医疗成本并提高生活质量。
■URL:https://www。clinicaltrials.gov;唯一标识符:NCT03381872。