TY - JOUR
T1 - FFR-guided percutaneous coronary intervention vs coronary artery bypass grafting in patients with diabetes
AU - Takahashi, Kuniaki
AU - Otsuki, Hisao
AU - Zimmermann, Frederik M.
AU - Ding, Victoria Y.
AU - Engstrøm, Thomas
AU - Hørsted Thyregod, Hans Gustav
AU - Beleslin, Branko
AU - Putnik, Svetozar
AU - Tapp, Luke
AU - Barker, Thomas
AU - Redwood, Simon
AU - Young, Christopher
AU - Bech, G. Jan Willem
AU - Hoohenkerk, Gerard J. F.
AU - De Bruyne, Bernard
AU - Pijls, Nico H. J.
AU - Fearon, William F.
AU - the FAME 3 Trial Investigators
AU - Bhindi, Ravinay
AU - Brady, Peter
AU - Yong, Andy
AU - Yan, Tristan
AU - Ng, Martin
AU - Plunkett, Brian
AU - Layland, Jamie
AU - Newcomb, Andrew
AU - Sapontis, James
AU - Smith, Julian
AU - Asrress, Kaleab
AU - El Nakadi, Badih
AU - Noiseux, Nicolas
AU - Peniston, Charles
AU - Chong, Aun Yeong
AU - Glineur, David
AU - Minhas, Kunal
AU - Raab, Michael
AU - Nemec, Petr
AU - Engstroem, Thomas
AU - Thyregod, Gustav
AU - Modrau, Ivy
AU - Rioufol, Gilles
AU - Farhat, Fadi
AU - Park, Seung Jung
AU - Choo, Suk Jung
AU - Kalinauskas, Gintaras
AU - Bruinsma, Brandon
AU - Larsen, Alf Inge
AU - Haaverstad, Rune
AU - Menon, Madhav
AU - El Gamel, Adam
AU - Jagic, Nikola
AU - Sreckovic, Miodrag
AU - Rosic, Milenko
AU - Witt, Nils
AU - Corbascio, Matthias
AU - Ostlund-Papadogeorgos, Nikolaos
AU - Angeras, Oskar
AU - Jeppsson, Anders
AU - Oldroyd, Keith
AU - Berry, Colin
AU - Watkins, Stuart
AU - Al‐Attar, Nawwar
AU - MacCarthy, Philip
AU - Wendler, Olaf
AU - Curzen, Nick
AU - Miskolczi, Szaboles
AU - Sunil, Ohri
AU - Sarma, Jaydeep
AU - Barnard, James
AU - Baker, Thomas
AU - Kharbanda, Rajesh
AU - Sayeed, Rana
PY - 2025/3/12
Y1 - 2025/3/12
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=105002459317&partnerID=8YFLogxK
U2 - 10.1001/jamacardio.2025.0095
DO - 10.1001/jamacardio.2025.0095
M3 - Article
C2 - 40072460
AN - SCOPUS:105002459317
SN - 2380-6583
JO - JAMA Cardiology
JF - JAMA Cardiology
ER -