Multicentre ESG Randomised Interventional Trial - MERIT

Aug 17, 2022
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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:
Apollo Endosurgery, Mayo Clinic.
Date Published:
07/28/2022
Original Posted Date:
08/17/2022
References

Contribution To Literature:

The MERIT trial showed that endoscopic sleeve gastroplasty (ESG) results in sustained weight loss.

Description:

The goal of the trial was to evaluate ESG compared with control among obese individuals.

Study Design

  • Randomization
  • Parallel
  • Stratification

Obese subjects were randomized to ESG plus lifestyle modification (n = 85) versus lifestyle modification alone (n = 124). Lifestyle modification included a low-calorie diet and physical activity.

After 12 months, subjects in the ESG group could receive re-tightening based on initial suboptimal response. Subjects in the control group could cross over to ESG if they did not reach the primary target weight loss.

  • Total number of enrollees: 209
  • Duration of follow-up: 12 months
  • Mean patient age: 46 years
  • Percentage female: 84%
  • Percentage with diabetics: 33%

Inclusion criteria:

  • Obesity (body mass index 30 to <40 kg/m2)
  • Patients 21–65 years of age
  • History of failure of nonsurgical weight loss methods

Exclusion criteria:

  • Gastrointestinal surgery
  • Gastrointestinal tract inflammatory disease

Principal Findings:

The primary outcome, mean percentage of excess weight loss at 52 weeks, was 49.2% in the ESG group versus 3.2% in the control group (p < 0.0001).

Secondary outcomes:

  • Mean percentage of total bodyweight loss at 52 weeks: 13.6% in the ESG group versus 0.8% in the control group (p < 0.0001)
  • Achieving ≥25% of excess weight loss at 52 weeks: 77% in the ESG group versus 12% in the control group
  • Improvement in 1 or more metabolic comorbidities at 52 weeks: 80% in the ESG versus 45% in the control group

Interpretation:

Among obese individuals, ESG resulted in significant and sustained weight loss at 52 weeks compared with control. Weight loss was sustained at 104 weeks. ESG is a minimally invasive procedure, which uses endoscopic suturing to imbricate most of the stomach. ESG also resulted in improvement in metabolic comorbidities. ESG can be considered a synergistic weight loss intervention among obese individuals.

References:

Dayyeh BK, Bazerbachi F, Vargas EJ, et al. Endoscopic sleeve gastroplasty for treatment of class 1 and 2 obesity (MERIT): a prospective, multicentre, randomised trial. Lancet 2022;400:441-51.

Clinical Topics: Cardiovascular Care Team, Diabetes and Cardiometabolic Disease, Prevention, Diet, Exercise

Keywords: Body Mass Index, Caloric Restriction, Comorbidity, Exercise, Gastroplasty, Life Style, Metabolic Syndrome, Obesity, Primary Prevention, Minimally Invasive Surgical Procedures, Weight Loss


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