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Rationale, design, and experiences from the vanguard phase of the bariatric surgery for the reduction of
Jorge A Wong1, David Conen1, Aristithes Doumouras2
1Population Health Research Institute, Hamilton, Ontario, Canada; Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada.
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.
Insights
Metabolic/bariatric surgery (MBS) may reduce cardiovascular events in high-risk obesity patients. The BRAVE trial is the first large randomized controlled trial (RCT) comparing MBS to medical weight management for cardiovascular outcomes.
Area of Science:
- Cardiology
- Metabolic Surgery
- Obesity Medicine
Background:
- Observational studies suggest metabolic/bariatric surgery (MBS) improves outcomes in patients with obesity.
- Randomized trials (RCTs) are needed to confirm the cardiovascular benefits of MBS.
Purpose of the Study:
- The Bariatric Surgery for the Reduction of Cardiovascular Events (BRAVE) trial aims to determine if MBS reduces major adverse cardiovascular events compared to medical weight management.
- This is the first large RCT designed to address this critical evidence gap.
Main Methods:
- BRAVE is a multi-center, open-label RCT comparing MBS to guideline-based medical weight management (MWM) in adults with obesity and high-risk cardiovascular disease (CVD).
- Participants are randomized 1:1 to MBS (sleeve gastrectomy, Roux-en-Y gastric bypass, or duodenal switch) or MWM (dietary, behavioral, pharmacologic therapies).
- The primary outcome is a composite of all-cause death, MI, stroke, HF events, coronary revascularization, AF hospitalization, and renal events.
Main Results:
- As of October 2025, 200 participants have been randomized from 2,514 screened individuals across 17 international centers.
- The randomized cohort (mean age 59.8 years, 37% female, mean BMI 44.0 kg/m²) has a high burden of comorbidities including hypertension, diabetes, coronary artery disease, heart failure (HF), and atrial fibrillation (AF).
- Recruitment barriers were identified and addressed through targeted education and enhanced patient engagement.
Conclusions:
- BRAVE is the first large RCT to evaluate the safety and efficacy of MBS in reducing major cardiovascular events in high-risk patients with obesity.
- The trial will provide crucial evidence to guide clinical practice regarding surgical interventions for cardiovascular risk reduction in this population.
