Importance The differences between the use of fractional flow reserve (FFR) or instantaneous wave-free ratio (iFR) in the long term are unknown. Objective To compare long-term outcomes of iFR- and FFR-based strategies to guide revascularization. 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. Patients from 5 continents with coronary artery disease and angiographically intermediate severity stenoses who underwent hemodynamic interrogation with pressure wires were included. These data were analyzed from March, 13, 2014, through April, 27, 2021. MAIN OUTCOME MEASURES 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. 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). 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). 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. On the contrary, in patients who underwent revascularization after physiologic interrogation, the incidence of 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). 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. Trial Registration ClinicalTrials.gov Identifier: NCT02053038.

中文翻译：

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以分数血流储备或瞬时无波比值引导冠状动脉血运重建：DEFINE FLAIR 随机临床试验的 5 年随访。


重要性 从长期来看，分数流储备 （FFR） 或瞬时无波比 （iFR） 的差异尚不清楚。目的 比较基于 iFR 和 FFR 的策略指导血运重建的长期结果。设计、设置和参与者 DEFINE-FLAIR 多中心研究将冠状动脉疾病患者随机分配，使用 iFR 或 FFR 作为压力指数来指导血运重建。包括来自 5 大洲的冠状动脉疾病和血管造影中度严重狭窄患者，他们接受了压力丝血流动力学询问。这些数据是在 2014 年 3 月 13 日至 2021 年 4 月 27 日期间进行的分析的。主要结局指标 五年主要不良心脏事件 （MACE） （全因死亡、非致命性心肌梗死和计划外血运重建的复合），以及联合终点的各个组成部分。结果 在 5 年的随访中，iFR （平均年龄 [SD]，65.5 [10.8] 岁;962 名男性 [77.5%]）和 FFR （平均年龄 [SD]，65.2 [10.6] 岁;929 名男性 [74.3%]）组之间在 MACE 方面没有显着差异（分别为 21.1% 和 18.4%;风险比 [HR]，1.18;95% CI，0.99-1.42;P = .06）。虽然随机分配至 iFR 的患者全因死亡率较高，但并非由心肌梗死驱动（6.3% vs FFR 研究组为 6.2%;心率，1.01;95% CI，0.74-1.38;P = .94）或计划外血运重建 （11.9% vs FFR 组 12.2%;心率，0.98;95% CI，0.78-1.23;P = .87）。此外，根据 iFR 或 FFR 推迟血运重建的患者在两个研究组中具有相似的 MACE （iFR 组为 17.9%，FFR 组为 17.5%;心率，1.03;95% CI，0.79-1.35;P = .80） MACE 成分的发生率相似，包括全因死亡率。相反，在生理询问后接受血运重建的患者中，iFR 组 （24.6%） 的 MACE 发生率高于 FFR 组 （19.2%） （HR，1.36;95% CI，1.07-1.72;P = .01）。结论和相关性在 5 年随访中，基于 iFR 的策略与 FFR 策略在 MACE、非致死性心肌梗死和计划外血运重建方面指导血运重建没有统计学差异。试验注册 ClinicalTrials.gov 标识符： NCT02053038.