Abstract：
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.
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 (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, -$9063) with consistently higher QALY (8.24 versus 7.89; incremental QALY, 0.910) in intravascular imaging-guided PCI than angiography-guided PCI, resulting in a dominant incremental cost-effectiveness ratio. Consistently, 70% of probabilistic iterations showed cost-effectiveness of intravascular imaging-guided PCI in probabilistic sensitivity analysis.
The current cost-effectiveness analysis suggests that imaging-guided PCI is more cost-effective than angiography-guided PCI by reducing medical cost and increasing quality-of-life in complex coronary artery lesions in long-term follow-up.
URL: https://www.clinicaltrials.gov; Unique identifier: NCT03381872.
摘要：
尽管在先前的试验中已经观察到血管内成像引导经皮冠状动脉介入治疗（PCI）对复杂冠状动脉病变患者的临床益处，这一战略的成本效益是不确定的。
■RENOVATE-COMPLEX-PCI（血管内成像指南与血管造影指南的随机对照试验-复杂经皮冠状动脉介入治疗后的临床结果指南）于2018年5月至2021年5月在韩国进行。这项预设的成本-效果子研究使用马尔可夫模型进行，该模型模拟了3种状态：（1）PCI后，（2）自发性心肌梗死，（3）死亡。一个模拟队列来自意向治疗人群，和输入参数从试验数据或以前的出版物中提取.使用3年（试验内）和终身的时间范围评估成本效益。主要结果是增量成本效益比(ICER)，获得的额外质量调整寿命年(QALYs)的增量成本指标，在血管内成像引导的PCI与血管造影引导的PCI相比。当前的分析是使用韩国医疗保健行业的观点进行的，并以美元(1200韩元，=1美元，$).支付意愿门槛为每QALY获得35000美元。
■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。
■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。
