Bariatric Surgery for the Reduction of CArdioVascular Events Randomized Controlled Trial

Conditions de participation

• Sexe:

  ALL

• Âges admissibles:

  18 and up

Critères de participation

Inclusion Criteria:

1. 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
2. Age ≥18 years
3. High-risk CVD, defined as the presence of any one of the following:

1. 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)
2. Left ventricular ejection fraction (LVEF) \< 40%
3. 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
4. Documented atrial fibrillation (AF) with CHA2DS2-VASc ≥2 stroke risk score
5. History of any stroke
6. 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:

1. Hospital admission for HF, myocardial infarction, stroke or coronary revascularization within 30 days of randomization
2. Percutaneous coronary intervention with a drug eluting stent within 90 days of randomization.
3. Pregnancy
4. Contraindication to bariatric surgery
5. Prior bariatric surgery, other than gastric banding
6. Life expectancy \<2 years from non-cardiovascular causes
7. Inability to provide informed consent