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.
Description:
The goal of the trial was to evaluate bariatric surgery compared with usual care among obese patients.
Study Design
- Randomized
- Parallel
- Open-label
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
Inclusion criteria:
- Individuals 25-70 years of age with obesity (BMI 30-55 kg/m2)
- Biopsy-proven NASH
Exclusion criteria:
- 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
- Lipodystrophy
- Parenteral nutrition
- Abetalipoproteinemia
- Interfering medications (e.g., amiodarone, methotrexate, tamoxifen, corticosteroids)
Principal Findings:
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).
Secondary outcomes:
- 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
Interpretation:
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.
References:
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.
Editorial Comment: Mahgoub S, Newsome PN. Bariatric–metabolic surgery versus lifestyle intervention in non-alcoholic steatohepatitis. Lancet 2023;401:1747-9.
Clinical Topics: Cardiovascular Care Team, Diabetes and Cardiometabolic Disease, Dyslipidemia, Prevention, Lipid Metabolism, Nonstatins
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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