Angiography-derived fractional flow reserve versus coronary angiography to guide coronary artery bypass grafting in patients undergoing surgical valve procedures with concomitant coronary artery disease in China (FAVOR IV-QVAS): a multicentre, triple-blind, randomised trial.

We aimed to test whether a physiologically guided strategy using angiography-derived fractional flow reserve (FFR) could improve clinical outcomes in this population.

我们旨在测试一种基于生理学指导的策略，使用冠状动脉造影衍生的分数流量储备(FFR)，是否能改善这一人群的临床结果。

Methods

FAVOR IV-QVAS is an investigator-initiated, multicentre, randomised, triple-blind trial done at 12 tertiary hospitals in China.

FAVOR IV-QVAS 是一项由研究者发起的、在中国12家三级医院进行的多中心、随机、三盲试验。

Eligible patients were aged 18 years or older and were scheduled for valve surgery, with at least one clinically significant stenosis in a major coronary artery.

符合条件的患者年龄在18岁或以上，并且计划进行瓣膜手术，至少有一处主要冠状动脉存在临床显著的狭窄。

Patients were randomly assigned (1:1) to undergo physiologically guided CABG (for lesions with an angiography-derived FFR value ≤0·80) or anatomically guided CABG (for lesions with a stenosis diameter ≥50% on coronary angiography).

患者被随机分配（1:1），接受基于生理学指导的冠状动脉旁路移植术（对于血管造影导出的FFR值≤0.80的病变）或基于解剖学指导的冠状动脉旁路移植术（对于冠状动脉造影上狭窄直径≥50%的病变）。

Randomisation was done using a web-based program and stratified by site with fixed blocks of four.

随机分组使用基于网络的程序进行，并按地点分层，使用固定大小为四的块。

Patients, surgeons, follow-up physicians, and outcome assessors were masked to treatment allocation.

患者、外科医生、随访医生和结果评估者对治疗分配情况不知情。

The primary outcome was a composite of death, myocardial infarction, stroke, unplanned coronary revascularisation, and new renal failure requiring dialysis within 30 days after surgery.

主要结果是术后30天内死亡、心肌梗死、中风、计划外冠状动脉血运重建和需要透析的新发肾衰竭的复合指标。

The key secondary outcome was a composite of death, myocardial infarction, stroke, unplanned coronary revascularisation, and hospitalisation for unstable angina or heart failure at a minimum follow-up of 1 year.

主要次要结果是死亡、心肌梗死、中风、计划外冠状动脉血运重建以及不稳定型心绞痛或心力衰竭住院的复合终点，随访时间至少为1年。

The primary analysis of the primary and key secondary outcomes was done in a modified intention-to-treatpopulation that included all randomly assigned patients who underwent surgery and had available data for the primary outcome.

主要和关键次要结果的初步分析是在修改后的意向治疗人群中进行的，该人群包括所有接受手术并有主要结果数据的随机分配患者。

Missing data for the primary outcome were planned to be analysed using complete-case analysis or multiple imputation, with a proportion of missing data of 2% as the threshold.

计划使用完整案例分析或多重插补来分析主要结果的缺失数据，以2%的缺失数据比例作为阈值。

This trial is registered at ClinicalTrials.gov (NCT03977129); extended follow-up is ongoing.

该试验已在ClinicalTrials.gov注册（NCT03977129）；延长随访正在进行中。

Results

Between Aug 4, 2019, and Aug 13, 2024, 793 patients were enrolled. 396 were randomly assigned to the angiography-derived FFR group and 397 to the coronary angiography group; one patient in the coronary angiography group declined surgery and was excluded from the modified intention-to-treatpopulation.

2019年8月4日至2024年8月13日期间，共有793名患者被纳入研究。其中396名被随机分配到基于血管造影的FFR（血流储备分数）组，另外397名被分配到冠状动脉造影组；冠状动脉造影组中有一名患者拒绝手术，因此从修正意向治疗人群中排除。

The median age was 65 years (IQR 59-70), 221 (28%) patients were female, and 571 (72%) were male.

中位年龄为65岁（四分位数间距59-70岁），221名（28%）患者为女性，571名（72%）为男性。

Concomitant CABG was done in 223 (56%) patients in the angiography-derived FFR group and in 388 (98%) patients in the coronary angiography group.

在基于血管造影的FFR组中有223名（56%）患者接受了联合CABG手术，而在冠状动脉造影组中有388名（98%）患者接受了联合CABG手术。

The primary outcome occurred in 31 (7·8%) patients in the angiography-derived FFR group and 53 (13·4%) in the coronary angiography group (absolute difference -5·6 percentage points [95% CI -9·9 to -1·3]; risk ratio 0·58 [95% CI 0·38 to 0·89]; p=0·011).

主要结局事件在基于血管造影的FFR组的31名（7.8%）患者和冠状动脉造影组的53名（13.4%）患者中发生（绝对差异为-5.6个百分点[95%置信区间-9.9至-1.3]；风险比为0.58[95%置信区间0.38至0.89]；p=0.011）。

Death within 30 days occurred in 11 (2·8%) patients in the angiography-derived FFR group and 17 (4·3%) patients in the coronary angiography group.

在30天内死亡的患者中，有11名（2.8%）患者来自基于血管造影的FFR组，17名（4.3%）患者来自冠状动脉造影组。

At a median follow-up of 27 months (28 months [IQR 18-44] in the angiography-derived FFR group and 27 months [18-42] in the coronary angiography group), the key secondary outcome occurred in 82 (20·7%) patients in the angiography-derived FFR group and in 106 (26·8%) patients in the coronary angiography group (hazard ratio0·74 [95% CI 0·55-0·98]; p=0·036).

在中位随访27个月时（基于血管造影的FFR组为28个月[四分位数间距18-44]，冠状动脉造影组为27个月[18-42]），主要次要结果发生在基于血管造影的FFR组的82名（20.7%）患者和冠状动脉造影组的106名（26.8%）患者中（风险比0.74[95%置信区间0.55-0.98]；p=0.036）。

interpretation

Among patients undergoing valve surgery with concomitant coronary artery disease, physiologically guided CABG using angiography-derived FFR reduced the incidenceof the composite perioperative outcome compared with anatomically guided CABG.

在同时患有瓣膜疾病和冠状动脉疾病的瓣膜手术患者中，使用基于血管造影的血流储备分数（FFR）指导的冠状动脉旁路移植术（CABG）降低了与基于解剖学指导的CABG相比，围手术期复合结果的发生率。

These findings support a selective approach to surgical coronary revascularisation guided by physiological assessment in patients undergoing valve procedures.

这些发现支持在瓣膜手术患者中，采用基于生理评估的冠状动脉血运重建手术的选择性方法。

funding

Shanghai Hospital Development Center, Shanghai Municipal Science and Technology Commission, and Ministry of Science and Technology of the People's Republic of China.

上海市医院发展中心、上海市科学技术委员会以及中华人民共和国科学技术部。