Bariatric Surgery Versus Non-alcoholic Steatohepatitis - BRAVES

Jun 02, 2023
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Author/Summarized by Author:
Anthony A. Bavry, MD,MPH,FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Fondazione Policlinico Universitario A Gemelli, Policlinico Universitario Umberto I and S Camillo Hospital, Rome, Italy
Date Published:
04/20/2023
Date Updated:
06/02/2023
Original Posted Date:
05/08/2023
References

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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