FFR-Guided Percutaneous Coronary Intervention vs Coronary Artery Bypass Grafting in Patients With Diabetes.

IF 14.8 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

JAMA cardiology Pub Date : 2025-03-12 DOI:10.1001/jamacardio.2025.0095

Kuniaki Takahashi, Hisao Otsuki, Frederik M Zimmermann, Victoria Y Ding, Thomas Engstrøm, Hans Gustav Hørsted Thyregod, Branko Beleslin, Svetozar Putnik, Luke Tapp, Thomas Barker, Simon Redwood, Christopher Young, G Jan-Willem Bech, Gerard J F Hoohenkerk, Bernard De Bruyne, Nico H J Pijls, William F Fearon

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引用次数: 0

Abstract

Importance: Outcomes in patients with diabetes after fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) using current-generation drug-eluting stents (DES) compared with coronary artery bypass grafting (CABG) are unknown.

Objectives: To investigate the relative treatment effect of PCI vs CABG according to diabetes status with respect to major adverse cardiac and cerebrovascular events (MACCE) at 3 years and to evaluate the impact of the SYNTAX score.

Design, setting, and participants: This is a prespecified subgroup analysis of the FAME (Fractional Flow Reserve vs Angiography for Multivessel Evaluation) 3 trial, an investigator-initiated, randomized clinical trial conducted at 48 centers worldwide. The FAME 3 trial enrolled patients with 3-vessel coronary artery disease not involving the left main undergoing coronary revascularization between August 2014 and December 2019. Data analysis was conducted in August 2023. Clinical follow-up was performed at hospital discharge and at 1 month, 6 months, 1 year, 2 years, and 3 years after randomization.

Intervention: Either FFR-guided PCI with current-generation DES or CABG.

Main outcomes and measures: The primary end point was MACCE, defined as the composite of all-cause death, myocardial infarction, stroke, or repeat revascularization at 3 years.

Results: Of 1500 total patients enrolled, mean (SD) patient age was 65.1 (8.4) years, and 265 patients (17.7%) were female. The FAME 3 trial included 428 patients with diabetes (28.5%). Patients with diabetes, especially those receiving insulin, had a higher risk of MACCE at 3 years compared with those without diabetes. Regarding relative treatment effect, the risk of MACCE was higher after FFR-guided PCI compared with CABG in both patients with diabetes (hazard ratio [HR], 1.44; 95% CI, 0.91-2.28; P = .12) and those without diabetes (HR, 1.50; 95% CI, 1.08-2.07; P = .02), with no significant interaction (P for interaction = .94). In patients with a low SYNTAX score (<23), there was no significant difference in MACCE between PCI and CABG, while in patients with an intermediate to high SYNTAX score (≥23), PCI had a higher risk of MACCE than CABG, regardless of diabetes status.

Conclusions and relevance: In this subgroup analysis of the FAME 3 randomized clinical trial, the relative benefit of CABG compared with FFR-guided PCI was similar among patients with and without diabetes.

Trial registration: ClinicalTrials.gov Identifier: NCT02100722.

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来源期刊

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.