中国医学科学院北京协和医学院徐波教授团队研究了血管造影定量血流分数指导冠状动脉介入治疗对患者临床预后的影响。该研究于2021年11月4日发表在《柳叶刀》杂志上。

与视觉血管造影评估相比，基于压力线的生理测量可更准确地识别冠状动脉疾病患者的血流限制性病变。尽管如此，血管造影仍是引导经皮冠状动脉介入治疗（PCI）最广泛使用的方法。通过使用定量血流分数（QFR）的PCI病变选择可改善临床结局，QFR是一种基于血管造影的新方法，用于估计血流分数储备。

研究组在中国26家医院进行了一项多中心、双盲、随机、假对照试验，招募年龄在18岁及以上，患有稳定型或不稳定型心绞痛，或在筛查前至少72小时患有心肌梗死的患者，至少有一处病变的冠状动脉直径狭窄程度为50–90%，参考血管直径至少为2.5 mm（通过目测评估）。

将患者随机分配，分别接受QFR指导策略（仅在QFR≤0.80时进行PCI））或血管造影指导策略（基于标准视觉血管造影评估的PCI）。参与者和临床评估员双盲。主要终点是重大心脏不良事件的1年发生率，包括全因死亡、心肌梗死或缺血驱动的血运重建。初步分析是在意向治疗人群中进行的。

2018年12月25日至2020年1月19日，研究组共登记了3847名患者。排除22名选择不接受PCI或由医生撤回的患者后，3825名参与者被纳入意向治疗人群（QFR指导组1913名，血管造影指导组1912名）。平均年龄为62.7岁，男性2699例（70.6%），女性1126例（29.4%），糖尿病1295例（33.9%），急性冠脉综合征2428例（63.5%）。QFR指导组中有110名（Kaplan-Meier估计率5.8%）参与者发生1年主要终点，显著低于血管造影指导组中的167名（8.8%）。QFR指导组的心肌梗死和缺血驱动的血运重建发生率显著少于血管造影指导组。

研究结果表明，中国接受PCI的患者中，与标准血管造影指导相比，QFR指导的病变选择策略显著改善了1年后的临床预后。

附：英文原文

Title: Angiographic quantitative flow ratio-guided coronary intervention (FAVOR III China): a multicentre, randomised, sham-controlled trial

Author: Bo Xu, Shengxian Tu, Lei Song, Zening Jin, Bo Yu, Guosheng Fu, Yujie Zhou, Jian’an Wang, Yundai Chen, Jun Pu, Lianglong Chen, Xinkai Qu, Junqing Yang, Xuebo Liu, Lijun Guo, Chengxing Shen, Yaojun Zhang, Qi Zhang, Hongwei Pan, Xiaogang Fu, Jian Liu, Yanyan Zhao, Javier Escaned, Yang Wang, William F Fearon, Kefei Dou, Ajay J Kirtane, Yongjian Wu, Patrick W Serruys, Weixian Yang, William Wijns, Changdong Guan, Martin B Leon, Shubin Qiao, Gregg W Stone

Issue&Volume: 2021-11-04

Abstract:

Background

Compared with visual angiographic assessment, pressure wire-based physiological measurement more accurately identifies flow-limiting lesions in patients with coronary artery disease. Nonetheless, angiography remains the most widely used method to guide percutaneous coronary intervention (PCI). In FAVOR III China, we aimed to establish whether clinical outcomes might be improved by lesion selection for PCI using the quantitative flow ratio (QFR), a novel angiography-based approach to estimate the fractional flow reserve.

Methods

FAVOR III China is a multicentre, blinded, randomised, sham-controlled trial done at 26 hospitals in China. Patients aged 18 years or older, with stable or unstable angina pectoris or patients who had a myocardial infarction at least 72 h before screening, who had at least one lesion with a diameter stenosis of 50–90% in a coronary artery with a reference vessel of at least 2·5 mm diameter by visual assessment were eligible. Patients were randomly assigned to a QFR-guided strategy (PCI performed only if QFR ≤0·80) or an angiography-guided strategy (PCI based on standard visual angiographic assessment). Participants and clinical assessors were masked to treatment allocation. The primary endpoint was the 1-year rate of major adverse cardiac events, a composite of death from any cause, myocardial infarction, or ischaemia-driven revascularisation. The primary analysis was done in the intention-to-treat population. The trial was registered with ClinicalTrials.gov (NCT03656848).

Findings

Between Dec 25, 2018, and Jan 19, 2020, 3847 patients were enrolled. After exclusion of 22 patients who elected not to undergo PCI or who were withdrawn by their physicians, 3825 participants were included in the intention-to-treat population (1913 in the QFR-guided group and 1912 in the angiography-guided group). The mean age was 62·7 years (SD 10·1), 2699 (70·6%) were men and 1126 (29·4%) were women, 1295 (33·9%) had diabetes, and 2428 (63·5%) presented with an acute coronary syndrome. The 1-year primary endpoint occurred in 110 (Kaplan-Meier estimated rate 5·8%) participants in the QFR-guided group and in 167 (8·8%) participants in the angiography-guided group (difference, –3·0% [95% CI –4·7 to –1·4]; hazard ratio 0·65 [95% CI 0·51 to 0·83]; p=0·0004), driven by fewer myocardial infarctions and ischaemia-driven revascularisations in the QFR-guided group than in the angiography-guided group.

Interpretation

In FAVOR III China, among patients undergoing PCI, a QFR-guided strategy of lesion selection improved 1-year clinical outcomes compared with standard angiography guidance.

DOI: 10.1016/S0140-6736(21)02248-0

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)02248-0/fulltext