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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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http://dx.doi.org/10.1001/jamacardio.2025.0095 | DOI Listing |
Obesity (Silver Spring)
September 2025
Eli Lilly and Company, Indianapolis, Indiana, USA.
Objective: SURMOUNT-MAINTAIN aims to evaluate the efficacy and safety of reducing the tirzepatide dose and/or continuing the maximum tolerated dose (MTD) versus placebo in maintaining body weight (BW) reduction achieved with tirzepatide MTD.
Methods: This Phase 3b, multicenter, randomized, parallel-arm, double-blinded, placebo-controlled, 52-week clinical trial is in progress comparing treatment with once weekly tirzepatide (5 mg and/or MTD of 15 mg or 10 mg) versus placebo in achieving BW reduction maintenance from the initial 60-week open-label weight-loss period on tirzepatide MTD, in adults with obesity (BMI ≥ 30 kg/m or ≥ 27 kg/m with ≥ 1 obesity-related comorbidity, excluding type 2 diabetes). The primary endpoint is percent maintenance of BW reduction achieved during the weight-loss period at Week 112 among those who reached a BW plateau (i.
Eur J Intern Med
September 2025
Department of Haematology, Beaumont Hospital, Dublin 9, Ireland. Electronic address:
J Cardiol
September 2025
Department of Cardiology, Tokat Gaziosmanpaşa University, Tokat, Turkey.
Diabetes Res Clin Pract
September 2025
Health Education Department, and Department of Endocrinology and Diabetes, Diabetes Treatment Center, Prince Sultan Military Medical City, Riyadh, Saudi Arabia.
Background: Despite advances, glycemic control in people with type 2 diabetes (PwT2D) treated with oral antidiabetic medications (ADMs) often remains suboptimal. Continuous glucose monitoring (CGM) has shown promise in diabetes management, offering real-time insights into glucose trends. This study evaluates the impact of transitioning from conventional self-monitoring of blood glucose (SMBG) to CGM on glycemic outcomes and self-management in PwT2D receiving oral ADMs.
View Article and Find Full Text PDFDiabetes Metab
September 2025
Paris Diabetology Federation, Paris, France; Institut Necker Enfants Malades, INSERM U1151, CNRS UMR 8253, IMMEDIAB Laboratory, Université Paris Cité, Paris, France; Department of Diabetology and Endocrinology, Bichat Hospital, AP-HP, Paris, France.
Aim: - To investigate the incidences of death and lower limb amputation (LLA) among patients hospitalized with a first diabetic foot ulcer and to identify the associated risk factors.
Methods: - We leveraged medical records from 08/2017 to 10/2023 in the clinical data warehouse of the Greater Paris Hospitals. The primary outcome was the cumulative incidence of death estimated at 12 months.