血管造影定量血流比率引导冠状动脉介入治疗的成本效益:一项多中心、随机、假对照试验。

IF 7.5 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL
Chinese Medical Journal Pub Date : 2025-05-20 Epub Date: 2025-03-03 DOI:10.1097/CM9.0000000000003484
Yanyan Zhao, Changdong Guan, Yang Wang, Zening Jin, Bo Yu, Guosheng Fu, Yundai Chen, Lijun Guo, Xinkai Qu, Yaojun Zhang, Kefei Dou, Yongjian Wu, Weixian Yang, Shengxian Tu, Javier Escaned, William F Fearon, Shubin Qiao, David J Cohen, Harlan M Krumholz, Bo Xu, Lei Song
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引用次数: 0

摘要

背景:FAVOR(冠状动脉疾病患者在定量血流比引导下经皮介入治疗与血管造影引导下经皮介入治疗的比较)III中国试验表明,与标准血管造影引导相比,使用定量血流比(QFR)测量(一种基于血管造影估计分数血流储备的新型方法)选择经皮冠状动脉介入治疗(PCI)病变可改善两年的临床疗效。本研究旨在从目前中国医疗体系的角度评估QFR指导下PCI的成本效益:本研究是对 FAVOR III 中国试验的预指定分析,该试验纳入了 2018 年 12 月 25 日至 2020 年 1 月 19 日期间在中国 26 个中心随机接受治疗的 3825 名患者。稳定型或不稳定型心绞痛患者或心肌梗死后≥72小时的患者,且至少有一个病变的冠状动脉直径狭窄在50%至90%之间,目测参考血管直径≥2.5毫米,按1:1的比例随机接受QFR引导策略或血管造影引导策略。在为期两年的随访期间,收集了临床结果、质量调整生命年(QALYs)、指数手术住院估计费用、心血管门诊用药以及重大不良心脑血管事件(MACCE)导致的再住院等数据。主要分析计算的增量成本效益比(ICER)为每避免一次 MACCE 的成本。在中国,ICER 为 10,000 日元/避免的 MACCE 事件被认为具有经济吸引力:结果:两年后,QFR引导组的MACCE发生率比血管造影引导组低(10.8%对14.7%,P 结论:QFR引导组的MACCE发生率比血管造影引导组低(10.8%对14.7%,P 结论:QFR引导组的MACCE发生率比血管造影引导组低):从中国医疗系统的角度来看,在接受 PCI 治疗的患者中,QFR 引导策略比血管造影引导策略更具经济吸引力:试验注册:ClinicalTrials.gov,NCT03656848。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Cost-effectiveness of angiographic quantitative flow ratio-guided coronary intervention: A multicenter, randomized, sham-controlled trial.

Background: The FAVOR (Comparison of Quantitative Flow Ratio Guided and Angiography Guided Percutaneous Intervention in Patients with Coronary Artery Disease) III China trial demonstrated that percutaneous coronary intervention (PCI) lesion selection using quantitative flow ratio (QFR) measurement, a novel angiography-based approach for estimating fractional flow reserve, improved two-year clinical outcomes compared with standard angiography guidance. This study aimed to assess the cost-effectiveness of QFR-guided PCI from the perspective of the current Chinese healthcare system.

Methods: This study is a pre-specified analysis of the FAVOR III China trial, which included 3825 patients randomized between December 25, 2018, and January 19, 2020, from 26 centers in China. Patients with stable or unstable angina pectoris or those ≥72 hours post-myocardial infarction who had at least one lesion with a diameter stenosis between 50% and 90% in a coronary artery with a ≥2.5 mm reference vessel diameter by visual assessment were randomized to a QFR-guided strategy or an angiography-guided strategy with 1:1 ratio. During the two-year follow-up, data were collected on clinical outcomes, quality-adjusted life-years (QALYs), estimated costs of index procedure hospitalization, outpatient cardiovascular medication use, and rehospitalization due to major adverse cardiac and cerebrovascular events (MACCE). The primary analysis calculated the incremental cost-effectiveness ratio (ICER) as the cost per MACCE avoided. An ICER of ¥10,000/MACCE event avoided was considered economically attractive in China.

Results: At two years, the QFR-guided group demonstrated a reduced rate of MACCE compared to the angiography-guided group (10.8% vs . 14.7%, P <0.01). Total two-year costs were similar between the groups (¥50,803 ± 21,121 vs . ¥50,685 ± 23,495, P = 0.87). The ICER for the QFR-guided strategy was ¥3055 per MACCE avoided, and the probability of QFR being economically attractive was 64% at a willingness-to-pay threshold of ¥10,000/MACCE avoided. Sensitivity analysis showed that QFR-guided PCI would become cost-saving if the cost of QFR were below ¥3682 (current cost: ¥3800). Cost-utility analysis yielded an ICER of ¥56,163 per QALY gained, with a 53% probability of being cost-effective at a willingness-to-pay threshold of ¥85,000 per QALY gained.

Conclusion: In patients undergoing PCI, a QFR-guided strategy appears economically attractive compared to angiographic guidance from the perspective of the Chinese healthcare system.

Trial registration: ClinicalTrials.gov , NCT03656848.

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来源期刊
Chinese Medical Journal
Chinese Medical Journal 医学-医学:内科
CiteScore
9.80
自引率
4.90%
发文量
19245
审稿时长
6 months
期刊介绍: The Chinese Medical Journal (CMJ) is published semimonthly in English by the Chinese Medical Association, and is a peer reviewed general medical journal for all doctors, researchers, and health workers regardless of their medical specialty or type of employment. Established in 1887, it is the oldest medical periodical in China and is distributed worldwide. The journal functions as a window into China’s medical sciences and reflects the advances and progress in China’s medical sciences and technology. It serves the objective of international academic exchange. The journal includes Original Articles, Editorial, Review Articles, Medical Progress, Brief Reports, Case Reports, Viewpoint, Clinical Exchange, Letter,and News,etc. CMJ is abstracted or indexed in many databases including Biological Abstracts, Chemical Abstracts, Index Medicus/Medline, Science Citation Index (SCI), Current Contents, Cancerlit, Health Plan & Administration, Embase, Social Scisearch, Aidsline, Toxline, Biocommercial Abstracts, Arts and Humanities Search, Nuclear Science Abstracts, Water Resources Abstracts, Cab Abstracts, Occupation Safety & Health, etc. In 2007, the impact factor of the journal by SCI is 0.636, and the total citation is 2315.
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