Rationale, Design, and Experiences from the Vanguard Phase of the Bariatric Surgery for the Reduction of Cardiovascular Events (BRAVE) Trial.
A large international trial is rigorously comparing weight-loss surgery to intensive medical care for people with obesity and heart disease, addressing a critical evidence gap.
BRAVE is an investigator-initiated, multicenter open-label RCT comparing sleeve gastrectomy/Roux-en-Y gastric bypass vs guideline-based medical management in adults with obesity plus established CVD, addressing a critical evidence gap where only observational data existed. The vanguard phase (200 participants across 17 centers in 4 countries) demonstrates feasibility and identifies practical implementation lessons before full-scale enrollment.
What the study was
- Study design
- Randomized controlled trial (design/vanguard report)
- Population
- Adults with obesity (BMI ≥35 or ≥30 with T2D/age>55) and high-risk CVD (prior MI, coronary intervention, HF, AF, cerebrovascular disease, or PAD); N=200 randomized at vanguard; 17 centers in Canada, Brazil, Italy, Spain
- Sample size
- 200
- Category
- Prevention
- Maturity
- Potentially Practice-Changing
- Journal
- American Heart Journal
Why it surfaced
First large RCT design for bariatric surgery vs medical therapy in high-CVD-risk obesity; international multicenter; primary composite endpoint addresses major unmet evidence need; vanguard phase confirms feasibility.
A plain-language summary of published research — not medical advice. Talk to a clinician about your own care.