Loading
Obesity / Diabetes Mellitus, Type 2 / Cardiovascular Diseases · Journal article
American Heart Journal · July 25, 2026
Early or partial results. Treat as a signal, not a conclusion.
BRAVE is an ongoing investigator-initiated, multicenter, open-label RCT designed to compare metabolic/bariatric surgery versus guideline-based medical weight management on major adverse cardiovascular outcomes in adults with obesity and established or high-risk cardiovascular disease. This report presents the rationale, design, and vanguard phase recruitment experience (200 randomized); no efficacy or safety outcome data are available.
Multicenter, open-label randomized controlled trial with blinded endpoint adjudication. Adults with obesity (BMI ≥35 kg/m² or ≥30 kg/m² with type 2 diabetes or age >55 years) and high-risk cardiovascular disease: prior myocardial infarction, coronary intervention, heart failure, atrial fibrillation with elevated CHA₂DS₂-VASc score, cerebrovascular disease, or peripheral arterial disea…. Intervention: Metabolic/bariatric surgery: sleeve gastrectomy, Roux-en-Y gastric bypass, or duodenal switch. Compared with: Guideline-based medical weight management including dietary, behavioral, and pharmacologic therapies. n = 200. 17 centers in Canada, Brazil, Italy, and Spain.
2,514 individuals screened across 17 centers; 444 entered MBS work-up; 200 randomized as of October 2025 Randomized cohort mean age 59.8 years, 37% female, mean BMI 44.0 kg/m² High cardiovascular disease burden: hypertension 82%, diabetes 45%, coronary artery disease 44%, heart failure 39%, atrial fibrillation 48%
No efficacy or safety outcome data reported; vanguard phase only describes recruitment and baseline characteristics
This vanguard phase report does not provide outcome data and therefore has no direct clinical impact. Clinicians should await final efficacy and safety results from the full BRAVE trial before considering changes to current practice regarding metabolic/bariatric surgery in high-risk cardiovascular populations.
This is a vanguard phase report describing trial design, recruitment experiences, and baseline characteristics of 200 randomized participants in an ongoing RCT; no efficacy or safety outcomes are reported.
As stated by the source record.
Quoted from the source exactly as published.
This vanguard phase report does not provide outcome data and therefore has no direct clinical impact. Clinicians should await final efficacy and safety results from the full BRAVE trial before considering changes to current practice regarding metabolic/bariatric surgery in high-risk cardiovascular populations.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
Background. Observational studies suggest that metabolic/bariatric surgery (MBS) reduces mortality and major adverse cardiovascular events in patients with obesity, but adequately powered randomized trials (RCTs) are lacking. The Bariatric Surgery for the Reduction of Cardiovascular Events (BRAVE) trial was designed to address this evidence gap.Methods. BRAVE is an investigator-initiated, multi-center, open-label RCT with blinded endpoint adjudication comparing MBS vs guideline-based medical weight management (MWM) in adults with obesity and high-risk cardiovascular disease (CVD). Eligible participants have a body-mass index ≥35 kg/m² or ≥30 kg/m² with type 2 diabetes or age >55 years, and prior myocardial infarction (MI), coronary intervention, heart failure (HF), atrial fibrillation (AF) with elevated CHA₂DS₂-VASc score, cerebrovascular disease, or peripheral arterial disease. Participants are randomized 1:1 to MBS (sleeve gastrectomy, Roux-en-Y gastric bypass, or duodenal switch) or MWM, which includes dietary, behavioral, and pharmacologic therapies. The primary outcome is the composite of all-cause death, MI, stroke, HF events, coronary revascularization, AF hospitalization, and renal events. A vanguard phase of 200 participants was implemented to optimize recruitment and logistics.Results. As of October 2025, 2,514 individuals have been screened from 17 centers in Canada, Brazil, Italy and Spain, with 444 entered MBS work-up, and 200 have been randomized. The randomized cohort (mean age 59.8 years; 37% female; mean BMI 44.0 kg m⁻²) has high burden of hypertension (82%), diabetes (45%), coronary artery disease (44%), HF (39%), and AF (48%). Recruitment barriers were identified and addressed through targeted education and enhanced patient engagement.Conclusions. BRAVE is the first large RCT evaluating whether MBS safely reduces major cardiovascular events compared with medical therapy in high-risk patients with obesity.Trial registration. ClinicalTrials.gov Identifier: NCT05531474.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.