Bariatric Surgery Versus Non-alcoholic Steatohepatitis - BRAVES
Contribution To Literature:
The BRAVES trial showed that bariatric surgery is associated with a reduction in non-alcoholic steatohepatitis (NASH) compared with usual care.
The goal of the trial was to evaluate bariatric surgery compared with usual care among obese patients.
Patients with obesity were randomized to medical care (n = 96) vs. Roux-en-Y gastric bypass (n = 96) versus sleeve gastrectomy (n = 96).
- Total number of enrollees: 288
- Duration of follow-up: 12 months
- Mean patient age: 47 years
- Percentage female: 44%
- Percentage with diabetes: 32%
- Mean body mass index (BMI): 42 kg/m2
- Individuals 25-70 years of age with obesity (BMI 30-55 kg/m2)
- Biopsy-proven NASH
- Coronary event or procedure in previous 6 months
- Liver cirrhosis
- End-stage renal failure
- Substantial alcohol consumption (>20 g/day for women or >30 g/day for men)
- Wilson’s disease
- Parenteral nutrition
- Interfering medications (e.g., amiodarone, methotrexate, tamoxifen, corticosteroids)
The primary outcome, NASH resolution without worsening of fibrosis, was 16% in the medical care group vs. 56% in the Roux-en-Y gastric bypass group vs. 57% in the sleeve gastrectomy group (p < 0.0001).
- Change in BMI: -5.4% in the medical care group vs. -31.5% in Roux-en-Y gastric bypass group vs. -24.0% in sleeve gastrectomy group
- Change in glycemic hemoglobin (HbA1c): -1.5% in the medical care group vs. -10.7% in Roux-en-Y gastric bypass group vs. -3.5% in sleeve gastrectomy group
- Change in low-density lipoprotein cholesterol (LDL-C): -7.3% in the medical care group vs. -24.6% in Roux-en-Y gastric bypass group vs. -5.9% in sleeve gastrectomy group
- Ten (6%) of those who had bariatric-metabolic surgery had severe adverse events
Among obese patients, bariatric surgery was associated with a significant increase in NASH resolution compared with usual care. Among the bariatric surgery group, Roux-en-Y gastric bypass vs. sleeve gastrectomy appeared to be associated with greater improvements in weight loss, HbA1c, and LDL-C. Serious adverse events were infrequent and did not require re-operation.
Verrastro O, Panunzi S, Castagneto-Gissey L, et al. Bariatric–metabolic surgery versus lifestyle intervention plus best medical care in non-alcoholic steatohepatitis (BRAVES): a multicentre, open-label, randomized trial. Lancet 2023;401:1786-97.
Keywords: Bariatric Surgery, Biopsy, Body Mass Index, Cholesterol, LDL, Fibrosis, Diabetes Mellitus, Type 2, Gastrectomy, Gastric Bypass, Glycated Hemoglobin A, Life Style, Lipoproteins, Metabolic Syndrome, Non-alcoholic Fatty Liver Disease, Obesity, Primary Prevention, Weight Loss
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