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

IF 14.8 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS JAMA cardiology Pub Date : 2024-10-16 DOI:10.1001/jamacardio.2024.3314
Javier Escaned,Alejandro Travieso,Hakim-Moulay Dehbi,Sukhjinder S Nijjer,Sayan Sen,Ricardo Petraco,Manesh Patel,Patrick W Serruys,Justin Davies,
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These data were analyzed from March, 13, 2014, through April, 27, 2021.\r\n\r\nMAIN OUTCOME MEASURES\r\nFive-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.\r\n\r\nResults\r\nAt 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. 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引用次数: 0

摘要

重要性长期使用分数血流储备(FFR)或瞬时无波比(iFR)之间的差异尚不清楚。目的比较基于 iFR 和 FFR 指导血管再通策略的长期疗效。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为使用 iFR 或 FFR 作为压力指数来指导血管再通的患者。研究纳入了来自五大洲的冠状动脉疾病和血管造影中度狭窄患者,他们都接受了压力导线的血液动力学检查。主要结局指标5年主要心脏不良事件(MACE)(全因死亡、非致命性心肌梗死和意外血管再通的复合指标)以及综合终点的各个组成部分。结果随访5年后,iFR组(平均年龄[标码]65.5[10.8]岁;962名男性[77.5%])和FFR组(平均年龄[标码]65.2[10.6]岁;929名男性[74.3%])的MACE(分别为21.1% vs 18.4%;危险比[HR],1.18;95% CI,0.99-1.42;P = .06)无明显差异。虽然随机接受 iFR 治疗的患者全因死亡的比例较高,但心肌梗死(6.3% 对 FFR 研究组的 6.2%;HR,1.01;95% CI,0.74-1.38;P = .94)或意外血运重建(11.9% 对 FFR 组的 12.2%;HR,0.98;95% CI,0.78-1.23;P = .87)并不导致全因死亡。此外,根据 iFR 或 FFR 而推迟血管重建的患者在两个研究臂中的 MACE 相似(iFR 组为 17.9% vs FFR 组为 17.5%;HR,1.03;95% CI,0.79-1.35;P = .80),包括全因死亡在内的 MACE 成分发生率相似。相反,在生理检查后接受血管再通的患者中,iFR 组的 MACE 发生率(24.6%)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,在MACE、非致命性心肌梗死和非计划性血管再通方面,基于iFR的策略与FFR策略在指导血管再通方面没有统计学差异:NCT02053038。
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Coronary Revascularization Guided With Fractional Flow Reserve or Instantaneous Wave-Free Ratio: A 5-Year Follow-Up of the DEFINE FLAIR Randomized Clinical Trial.
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.
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来源期刊
JAMA cardiology
JAMA cardiology Medicine-Cardiology and Cardiovascular Medicine
CiteScore
45.80
自引率
1.70%
发文量
264
期刊介绍: JAMA Cardiology, an international peer-reviewed journal, serves as the premier publication for clinical investigators, clinicians, and trainees in cardiovascular medicine worldwide. As a member of the JAMA Network, it aligns with a consortium of peer-reviewed general medical and specialty publications. Published online weekly, every Wednesday, and in 12 print/online issues annually, JAMA Cardiology attracts over 4.3 million annual article views and downloads. Research articles become freely accessible online 12 months post-publication without any author fees. Moreover, the online version is readily accessible to institutions in developing countries through the World Health Organization's HINARI program. Positioned at the intersection of clinical investigation, actionable clinical science, and clinical practice, JAMA Cardiology prioritizes traditional and evolving cardiovascular medicine, alongside evidence-based health policy. It places particular emphasis on health equity, especially when grounded in original science, as a top editorial priority.
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