Overview
The primary objective of this study is to evaluate if, in patients with severe obesity (body mass index (BMI) ≥30 kg/m2) and high-risk cardiovascular disease (CVD), bariatric surgery compared to medical weight management (MWM) safely reduces the risk of major cardiovascular events. The cost-effectiveness of bariatric surgery will also be examined. Separate sub-studies will be performed to examine the relationship between bariatric surgery and mental health, cardiac structure and function, genomics, proteomics and metabolomics.
Eligibility
Inclusion Criteria:
- Body mass index ≥30 kg/m2; OR BMI ≥30 kg/m2 to 34.9 kg/m2 and have type 2 diabetes or are >55 years of age
- Age ≥18 years
- High-risk CVD, defined as the presence of any one of the following:
- High-risk coronary artery disease (CAD) (i.e., history of MI, percutaneous coronary intervention, coronary artery bypass grafting, or stenoses ≥ 50% in 2 or more major coronary arteries)
- Left ventricular ejection fraction (LVEF) < 40%
- Heart failure with preserved ejection fraction (LVEF > 40%) and either HF hospitalization in the last 2-years or N-terminal pro b-type natriuretic peptide (NT-proBNP) > 300 pg/ml or BNP > 100 pg/ml in the past 12 months
- Documented atrial fibrillation (AF) with CHA2DS2-VASc ≥2 stroke risk score
- History of any stroke
- Documented peripheral arterial disease (PAD) (i.e., peripheral revascularization of the iliac, infra-inguinal or carotid arteries; limb or foot amputation for arterial vascular disease; or ≥50% carotid or peripheral artery stenosis)
Exclusion Criteria:
- Hospital admission for HF, myocardial infarction, stroke or coronary revascularization within 30 days of randomization
- Percutaneous coronary intervention with a drug eluting stent within 90 days of randomization.
- Pregnancy
- Contraindication to bariatric surgery
- Prior bariatric surgery, other than gastric banding
- Life expectancy <2 years from non-cardiovascular causes
- Inability to provide informed consent