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Randomized Controlled Trial
. 2025 Jun 1;10(6):603-608.
doi: 10.1001/jamacardio.2025.0095.

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

Kuniaki Takahashi  1   2 , Hisao Otsuki  1   2 , Frederik M Zimmermann  3   4 , Victoria Y Ding  1   2 , Thomas Engstrøm  5 , Hans Gustav Hørsted Thyregod  5 , Branko Beleslin  6 , Svetozar Putnik  6 , Luke Tapp  7 , Thomas Barker  7 , Simon Redwood  8 , Christopher Young  8 , G Jan-Willem Bech  9 , Gerard J F Hoohenkerk  9 , Bernard De Bruyne  10 , Nico H J Pijls  4 , William F Fearon  1   2   11 ; FAME 3 Trial Investigators
Affiliations
Randomized Controlled Trial

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

Kuniaki Takahashi et al. JAMA Cardiol. .

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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Conflict of interest statement

Conflict of Interest Disclosures: Dr Otsuki reported grants from Abbott, Boston Scientific, Terumo, and the Uehara Memorial Foundation outside the submitted work. Dr Engstrøm reported advisory board and speaker fees from Abbott and Novo Nordisk outside the submitted work. Dr Hørsted Thyregod reported grants from Stanford University during the conduct of the study. Dr De Bruyne reported institutional consulting relationships with Abbott Vascular, Boston Scientific, CathWorks, Coroventis Research, GE Healthcare, Hexacath, and Siemens; receiving institutional research grants from Abbott Vascular, Boston Scientific, CathWorks, and Coroventis Research; and holding minor equity in Bayer, CathWorks, Celiad, Edwards Life Sciences, GE Healthcare, HeartFlow, Medyria, Philips, Sanofi, Siemens, and Xenter outside the submitted work. Dr Pijls reported serving as a board member for and holding equity in HeartFlow during the conduct of the study and grants from Abbott outside the submitted work. Dr Fearon reported institutional research support from Abbott Vascular, Boston Scientific, CathWorks, and Medtronic; consulting work for CathWorks; and holding stock options in HeartFlow outside the submitted work. No other disclosures were reported.

References

    1. Wang R, Serruys PW, Gao C, et al. Ten-year all-cause death after percutaneous or surgical revascularization in diabetic patients with complex coronary artery disease. Eur Heart J. 2021;43(1):56-67. doi: 10.1093/eurheartj/ehab441 - DOI - PMC - PubMed
    1. Chichareon P, Modolo R, Kogame N, et al. Association of diabetes with outcomes in patients undergoing contemporary percutaneous coronary intervention: pre-specified subgroup analysis from the randomized GLOBAL LEADERS study. Atherosclerosis. 2020;295:45-53. doi: 10.1016/j.atherosclerosis.2020.01.002 - DOI - PubMed
    1. Takahashi K, Serruys PW, Fuster V, et al. ; SYNTAXES, FREEDOM, BEST, and PRECOMBAT trial investigators . Redevelopment and validation of the SYNTAX score II to individualise decision making between percutaneous and surgical revascularisation in patients with complex coronary artery disease: secondary analysis of the multicentre randomised controlled SYNTAXES trial with external cohort validation. Lancet. 2020;396(10260):1399-1412. doi: 10.1016/S0140-6736(20)32114-0 - DOI - PubMed
    1. Takahashi K, van Klaveren D, Steyerberg EW, Onuma Y, Serruys PW. Concerns with the new SYNTAX score - authors’ reply. Lancet. 2021;397(10276):795-796. doi: 10.1016/S0140-6736(21)00195-1 - DOI - PubMed
    1. Takahashi K, Serruys PW, Fuster V, et al. ; SYNTAX, BEST, and FREEDOM Trial investigators . External validation of the FREEDOM score for individualized decision making between CABG and PCI. J Am Coll Cardiol. 2022;79(15):1458-1473. doi: 10.1016/j.jacc.2022.01.049 - DOI - PubMed

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