Coronary Revascularization Guided With Fractional Flow Reserve or Instantaneous Wave-Free Ratio: A 5-Year Follow-Up of the DEFINE FLAIR Randomized Clinical Trial.

Background

To compare long-term outcomes of iFR- and FFR-based strategies to guide revascularization.

比较基于iFR和FFR策略指导血运重建的长期结果。

DESIGN, SETTING, AND PARTICIPANTS: The DEFINE-FLAIR multicenter study randomized patients with coronary artery disease to use either iFR or FFR as a pressure index to guide revascularization.

设计、环境和参与者：DEFINE-FLAIR多中心研究随机将冠状动脉疾病患者分配到使用iFR或FFR作为压力指数以指导血运重建。

Patients from 5 continents with coronary artery disease and angiographically intermediate severity stenoses who underwent hemodynamic interrogation with pressure wires were included.

来自五大洲的冠状动脉疾病患者，他们有血管造影中度严重狭窄，并使用压力导丝进行了血流动力学检测，被纳入研究。

These data were analyzed from March, 13, 2014, through April, 27, 2021.

这些数据的分析时间范围从2014年3月13日至2021年4月27日。

Methods

Five-year major adverse cardiac events (MACE) (a composite of all-cause death, nonfatal myocardial infarction, and unplanned revascularization), as well as the individual components of the combined end point.

五年主要不良心脏事件（MACE）（包括全因死亡、非致命性心肌梗死和计划外血管重建的复合终点），以及组合终点的各个组成部分。

Results

At 5 years of follow-up, no significant differences were found between the iFR (mean age [SD], 65.5 [10.8] years; 962 male [77.5%]) and FFR (mean age [SD], 65.2 [10.6] years; 929 male [74.3%]) groups in terms of MACE (21.1% vs 18.4%, respectively; hazard ratio[HR], 1.18; 95% CI, 0.99-1.42; P = .06).

在5年的随访期间，iFR组（平均年龄[标准差]，65.5[10.8]岁；962名男性[77.5%]）和FFR组（平均年龄[标准差]，65.2[10.6]岁；929名男性[74.3%]）在主要不良心血管事件（MACE）方面没有显著差异（分别为21.1%和18.4%；风险比[HR]，1.18；95%置信区间，0.99-1.42；P = .06）。

While all-cause death was higher among patients randomized to iFR, it was not driven by myocardial infarction (6.3% vs 6.2% in the FFR study arm; HR, 1.01; 95% CI, 0.74-1.38; P = .94) or unplanned revascularization (11.9% vs 12.2% in the FFR group; HR, 0.98; 95% CI, 0.78-1.23; P = .87).

尽管随机分配到iFR的患者的全因死亡率较高，但这并非由心肌梗死（iFR组为6.3%，FFR研究组为6.2%；HR，1.01；95% CI，0.74-1.38；P = .94）或计划外的血运重建（iFR组为11.9%，FFR组为12.2%；HR，0.98；95% CI，0.78-1.23；P = .87）所驱动。

Furthermore, patients in whom revascularization was deferred on the basis of iFR or FFR had similar MACE in both study arms (17.9% in the iFR group vs 17.5% in the FFR group; HR, 1.03; 95% CI, 0.79-1.35; P = .80) with similar rates of the components of MACE, including all-cause death.

此外，在基于瞬时无波比率（iFR）或血流储备分数（FFR）延迟血运重建的患者中，两组的主要不良心血管事件（MACE）发生率相似（iFR组为17.9%，FFR组为17.5%；风险比，1.03；95%置信区间，0.79-1.35；P = .80），MACE的组成部分，包括全因死亡的发生率也相似。

On the contrary, in patients who underwent revascularization after physiologic interrogation, the incidenceof MACE was higher in the iFR group (24.6%) compared with the FFR group (19.2%) (HR, 1.36; 95% CI, 1.07-1.72; P = .01).

相反，在接受生理检测后进行血运重建的患者中，iFR组的主要不良心血管事件（MACE）发生率（24.6%）高于FFR组（19.2%）（风险比，1.36；95%置信区间，1.07-1.72；P = .01）。

conclusions_and_relevance

At 5-year follow up, an iFR based-strategy was not statistically different than an FFR strategy to guide revascularization in terms of MACE, nonfatal myocardial infarction, and unplanned revascularization.

在5年的随访中，基于瞬时无波形比（iFR）的策略与基于血流储备分数（FFR）的策略在指导血运重建方面，在主要不良心血管事件（MACE）、非致命性心肌梗死和计划外血运重建方面没有统计学差异。

trial_registration

ClinicalTrials.gov Identifier: NCT02053038.

ClinicalTrials.gov 注册号：NCT02053038。