Comparative Safety and Effectiveness of Roux-en-Y Gastric Bypass and Sleeve Gastrectomy for Weight Loss and Type 2 Diabetes Across Race and Ethnicity in the PCORnet Bariatric Study Cohort

Abstract

Importance: Bariatric surgery is the most effective treatment for severe obesity; yet it is unclear whether the long-term safety and comparative effectiveness of these operations differ across racial and ethnic groups.

Objective: To compare outcomes of Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) across racial and ethnic groups in the National Patient-Centered Clinical Research Network (PCORnet) Bariatric Study.

Design, setting, and participants: This was a retrospective, observational, comparative effectiveness cohort study that comprised 25 health care systems in the PCORnet Bariatric Study. Patients were adults and adolescents aged 12 to 79 years who underwent a primary (first nonrevisional) RYGB or SG operation between January 1, 2005, and September 30, 2015, at participating health systems. Patient race and ethnicity included Black, Hispanic, White, other, and unrecorded. Data were analyzed from July 1, 2021, to January 17, 2022.

Exposure: RYGB or SG.

Outcomes: Percentage total weight loss (%TWL); type 2 diabetes remission, relapse, and change in hemoglobin A1c (HbA1c) level; and postsurgical safety and utilization outcomes (operations, interventions, revisions/conversions, endoscopy, hospitalizations, mortality, 30-day major adverse events) at 1, 3, and 5 years after surgery.

Results: A total of 36 871 patients (mean [SE] age, 45.0 [11.7] years; 29 746 female patients [81%]) were included in the weight analysis. Patients identified with the following race and ethnic categories: 6891 Black (19%), 8756 Hispanic (24%), 19 645 White (53%), 826 other (2%), and 783 unrecorded (2%). Weight loss and mean reductions in HbA1c level were larger for RYGB than SG in all years for Black, Hispanic, and White patients (difference in 5-year weight loss: Black, -7.6%; 95% CI, -8.0 to -7.1; P < .001; Hispanic, -6.2%; 95% CI, -6.6 to -5.9; P < .001; White, -5.9%; 95% CI, -6.3 to -5.7; P < .001; difference in change in year 5 HbA1c level: Black, -0.29; 95% CI, -0.51 to -0.08; P = .009; Hispanic, -0.45; 95% CI, -0.61 to -0.29; P < .001; and White, -0.25; 95% CI, -0.40 to -0.11; P = .001.) The magnitude of these differences was small among racial and ethnic groups (1%-3% of %TWL). Black and Hispanic patients had higher risk of hospitalization when they had RYGB compared with SG (hazard ratio [HR], 1.45; 95% CI, 1.17-1.79; P = .001 and 1.48; 95% CI, 1.22-1.79; P < .001, respectively). Hispanic patients had greater risk of all-cause mortality (HR, 2.41; 95% CI, 1.24-4.70; P = .01) and higher odds of a 30-day major adverse event (odds ratio, 1.92; 95% CI, 1.38-2.68; P < .001) for RYGB compared with SG. There was no interaction between race and ethnicity and operation type for diabetes remission and relapse.

Conclusions and relevance: Variability of the comparative effectiveness of operations for %TWL and HbA1c level across race and ethnicity was clinically small; however, differences in safety and utilization outcomes were clinically and statistically significant for Black and Hispanic patients who had RYGB compared with SG. These findings can inform shared decision-making regarding bariatric operation choice for different racial and ethnic groups of patients.

Conflict of interest statement

Conflict of Interest Disclosures: Dr Coleman reported receiving grants from Patient-Centered Outcomes Research Institute (PCORI), the National Institutes of Health (NIH), Janssen, and the US Food and Drug Administration outside the submitted work. Mr Wellman reported receiving grants from PCORI during the conduct of the study. Dr Fitzpatrick reported receiving grants from PCORI and the NIH and financial support (salary) from WW (formerly Weight Watchers). Dr Lewis reported receiving honoraria from National Committee for Quality Assurance (NCQA) for serving as a faculty member on a continuing medical education video about the treatment of obesity outside the submitted work. Dr McTigue reported receiving grants from the University of Pittsburgh research contract from PCORI during the conduct of the study. Dr Tobin reported receiving grants from the NIH National Heart, Lung, and Blood Institute, US Department of Health and Human Services Administration for Community Living, and PCORI during the conduct of the study. Dr Clark reported receiving grants from Johns Hopkins School of Medicine during the conduct of the study. Dr Toh reported receiving grants from PCORI during the conduct of the study. Dr Williams reported receiving grants from PCORI during the conduct of the study. Dr Anau reported receiving grants from PCORI during the conduct of the study. Dr Horberg reported receiving grants from PCORI during the conduct of the study. Dr Michalsky reported receiving honorarium from and being a shareholder of Intuitive Surgical outside the submitted work. Dr Cook reported receiving grants from PCORI, the NIH, and the Centers for Disease Control and Prevention outside the submitted work. Dr Arterburn reported receiving grants from PCORI, the NIH, and Sharecare and receiving travel support from the World Congress for Interventional Therapy for Diabetes and the International Federation for the Surgery of Obesity and Metabolic Disorders Latin America Chapter outside the submitted work. Dr Apovian reported receiving grants from Orexigen, Aspire Bariatrics, GI Dynamics, Myos, Takeda, the Vela Foundation, the Dr. Robert C. and Veronica Atkins Foundation, Coherence Lab, Energesis, the NIH, and PCORI; advisory board fees from Altimmune, Cowen and Company, Gelesis, L-Nutra, NeuroBo Pharmaceuticals, Nutrisystem, Zafgen, Sanofi-Aventis, Orexigen, Novo Nordisk, GI Dynamics, Takeda, Scientific Intake, Pain Script Corporation, Riverview School, Rhythm Pharmaceuticals, Xeno Biosciences, Eisai, EnteroMedics, and Bariatrix Nutrition; and having a previous ownership of stock in Science-Smart outside the submitted work. No other disclosures were reported.

Figures

Figure 1.. Percentage Total Weight Loss (%TWL) After Sleeve Gastrectomy (SG) and Roux-en-Y Gastric Bypass (RYGB) for the 3 Largest Racial and Ethnic Groups Across 5 Years of Follow-up in the National Patient-Centered Clinical Research Network Bariatric Study

After bariatric surgery, %TWL is shown for Black (A), Hispanic (B), and White (C) individuals, with the adjusted difference in %TWL shown in (D). Findings for other and unrecorded race and ethnicity are shown in eFigures 1 and 2 in Supplement 1. Findings are presented as mean values (A-C) and the adjusted difference in mean %TWL between bariatric operations (SG − RYGB). Larger differences favor RYGB (D).

Figure 2.. Cumulative Incidence of Operation or Intervention (Primary Safety and Utilization Outcome) After Sleeve Gastrectomy (SG) and Roux-en-Y Gastric Bypass (RYGB) for the 3 Largest Racial and Ethnic Groups (Black, Hispanic, White) in the National Patient-Centered Clinical Research Network Bariatric Study Across 5 Years of Follow-up

Findings for the other and unrecorded race and ethnicity categories are shown in eFigure 7 in Supplement 1. Findings for all other safety and utilization outcomes (revision or conversion, endoscopy, hospitalization, and mortality) are also shown in eFigures 8, 9, 10, and 11 in Supplement 1, respectively.