BRAVES (Roux-en-Y gastric bypass vs. lifestyle modifications)
Trial question
What is the role of Roux-en-Y gastric bypass in patients with MASH?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
47.0% female
53.0% male
N = 192
192 patients (91 female, 101 male).
Inclusion criteria: patients with biopsy-proven MASH.
Key exclusion criteria: coronary event or procedure in the previous 6 months; liver cirrhosis; end-stage renal failure; pregnancy; substantial alcohol consumption; life-threatening non-cardiac disease; Wilson's disease.
Interventions
N=96 Roux-en-Y gastric bypass (use of surgical stapler to create a small and vertically oriented gastric pouch with a volume of 30 mL plus lifestyle modification counseling).
N=96 lifestyle modification (structured lifestyle intervention program including diet and physical activity plus best medical care).
Primary outcome
Proportion of patients achieving histological resolution of metabolic dysfunction-associated steatohepatitis without worsening of fibrosis at 1-year follow-up
56%
16%
56.0 %
42.0 %
28.0 %
14.0 %
0.0 %
Roux-en-Y gastric
bypass
Lifestyle
modification
Significant
increase ▲
NNT = 2
Significant increase in the proportion of patients achieving histological resolution of MASH without worsening of fibrosis at 1-year follow-up (56% vs. 16%; RR 3.6, 95% CI 2.19 to 5.92).
Secondary outcomes
Significantly greater improvement of at least one stage of liver fibrosis without worsening of MASH (37% vs. 23%; RR 1.6, 95% CI 0.12 to 3.08).
No significant difference in worsening of fibrosis (8% vs. 16%; RR 0.48, 95% CI 0.19 to 1.2).
Significantly greater improvement of at least one point in NAFLD activity score at 1-year follow-up (97% vs. 51%; RR 1.9, 95% CI 1.53 to 2.36).
Safety outcomes
No significant differences in pain, fatigue, constipation, diarrhea.
Conclusion
In patients with biopsy-proven MASH, Roux-en-Y gastric bypass was superior to lifestyle modification with respect to the proportion of patients achieving histological resolution of MASH without worsening of fibrosis at 1-year follow-up.
Reference
Ornella Verrastro, Simona Panunzi, Lidia Castagneto-Gissey et al. Bariatric-metabolic surgery versus lifestyle intervention plus best medical care in non-alcoholic steatohepatitis (BRAVES): a multicentre, open-label, randomised trial. Lancet. 2023 May 27;401(10390):1786-1797.
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