Dataset Information

Comparing the 5-Year Diabetes Outcomes of Sleeve Gastrectomy and Gastric Bypass: The National Patient-Centered Clinical Research Network (PCORNet) Bariatric Study.

ABSTRACT:

Importance

Bariatric surgery can lead to substantial improvements in type 2 diabetes (T2DM), but outcomes vary across procedures and populations. It is unclear which bariatric procedure has the most benefits for patients with T2DM.

Objective

To evaluate associations of bariatric surgery with T2DM outcomes.

Design, setting, and participants

This cohort study was conducted in 34 US health system sites in the National Patient-Centered Clinical Research Network Bariatric Study. Adult patients with T2DM who had bariatric surgery between January 1, 2005, and September 30, 2015, were included. Data analysis was conducted from April 2017 to August 2019.

Interventions

Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG).

Main outcome and measures

Type 2 diabetes remission, T2DM relapse, percentage of total weight lost, and change in glycosylated hemoglobin (hemoglobin A1c).

Results

A total of 9710 patients were included (median [interquartile range] follow-up time, 2.7 [2.9] years; 7051 female patients [72.6%]; mean [SD] age, 49.8 [10.5] years; mean [SD] BMI, 49.0 [8.4]; 6040 white patients [72.2%]). Weight loss was significantly greater with RYGB than SG at 1 year (mean difference, 6.3 [95% CI, 5.8-6.7] percentage points) and 5 years (mean difference, 8.1 [95% CI, 6.6-9.6] percentage points). The T2DM remission rate was approximately 10% higher in patients who had RYGB (hazard ratio, 1.10 [95% CI, 1.04-1.16]) than those who had SG. Estimated adjusted cumulative T2DM remission rates for patients who had RYGB and SG were 59.2% (95% CI, 57.7%-60.7%) and 55.9% (95% CI, 53.9%-57.9%), respectively, at 1 year and 86.1% (95% CI, 84.7%-87.3%) and 83.5% (95% CI, 81.6%-85.1%) at 5 years postsurgery. Among 6141 patients who experienced T2DM remission, the subsequent T2DM relapse rate was lower for those who had RYGB than those who had SG (hazard ratio, 0.75 [95% CI, 0.67-0.84]). Estimated relapse rates for those who had RYGB and SG were 8.4% (95% CI, 7.4%-9.3%) and 11.0% (95% CI, 9.6%-12.4%) at 1 year and 33.1% (95% CI, 29.6%-36.5%) and 41.6% (95% CI, 36.8%-46.1%) at 5 years after surgery. At 5 years, compared with baseline, hemoglobin A1c was reduced 0.45 (95% CI, 0.27-0.63) percentage points more for patients who had RYGB vs patients who had SG.

Conclusions and relevance

In this large multicenter study, patients who had RYGB had greater weight loss, a slightly higher T2DM remission rate, less T2DM relapse, and better long-term glycemic control compared with those who had SG. These findings can help inform patient-centered surgical decision-making.

SUBMITTER: McTigue KM

PROVIDER: S-EPMC7057171 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ImportanceInstrumental variables can control for selection bias in observational research. However, valid instruments are challenging to identify.ObjectiveTo evaluate regional variation in sleeve gastrectomy following insurance coverage implementation as an instrumental variable in comparative effectiveness research.Design, setting, and participantsThis serial cross-sectional study included adult patients in a national Medicare claims database who underwent sleeve gastrectomy or Roux-en-Y gastric bypass from 2012 to 2017. Data analysis was performed from January to June 2021.ExposuresLaparoscopic sleeve gastrectomy and Roux-en-Y gastric bypass.Main outcomes and measuresThe association of the instrumental variable with treatment (ie, undergoing sleeve gastrectomy), as well as mortality, complications, emergency department visits, hospitalization, reinterventions, and surgical revision.ResultsA total of 76 077 patients underwent bariatric surgery, of whom 44 367 underwent sleeve gastrectomy (mean [SD] age, 56.9 [11.9] years; 32 559 [73.5%] women) and 31 710 underwent gastric bypass (mean (SD) age, 55.9 (11.8) years; 23 750 [74.9%] women). After insurance coverage initiation, there was substantial regional and temporal variation in adoption of sleeve gastrectomy. Prior-year state-level utilization of sleeve gastrectomy was highly associated with undergoing sleeve gastrectomy (Kleibergen-Paap Wald F statistic, 910.3). All but 2 patient characteristics (race and diagnosis of depression) were well-balanced between the top and bottom quartiles of the instrumental variable. Regarding 1-year outcomes, compared with patients undergoing gastric bypass, patients undergoing sleeve gastrectomy had a lower 1-year risk of mortality (0.9%; 95% CI, 0.8%-1.1% vs 1.7%; 95% CI, 1.3%-2.0%), complications (11.6%; 95% CI, 10.9%-12.3% vs 14.1%; 95% CI, 13.0%-15.3%), emergency department visits (48.3%; 95% CI, 46.9%-49.8% vs 53.6%; 95% CI, 52.3%-55.0%), hospitalization (23.4%; 95% CI, 22.4%-24.4% vs 26.5%; 95% CI, 25.1%-28.0%), and reinterventions (8.7%; 95% CI, 8.0%-9.4% vs 12.2%; 95% CI, 11.2%-13.3%). The risk of revision was not different between groups (0.6%; 95% CI, 0.3%-0.8% vs 0.4%; 95% CI, 0.3%-0.6%).Conclusions and relevanceIn this cross-sectional study of patients undergoing bariatric surgery, there was significant geographic variation in the use of sleeve gastrectomy following initiation of insurance coverage, which served as a strong instrument to compare 2 bariatric surgical procedures. This approach could be applied to other areas of health services research to serve as a complement to clinical trials.

Project description:ImportanceBariatric 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.ObjectiveTo 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 participantsThis 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.ExposureRYGB or SG.OutcomesPercentage 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.ResultsA 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 relevanceVariability 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.

Project description:ImportanceData on the long-term health care expenditures associated with bariatric surgery consisting of Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy are lacking.ObjectiveTo compare 4-year health care expenditures after RYGB vs sleeve gastrectomy, identify factors independently associated with 4-year health care expenditures, and compare the procedures in terms of subsequent hospitalizations, bariatric procedures, and all-cause mortality.Design, setting, and participantsIn this propensity score-matched cohort study, all residents of Ontario, Canada, who underwent publicly funded surgery with RYGB (n = 6301) or sleeve gastrectomy (n = 926) from March 1, 2010, to March 31, 2015, and consented to participate in the Ontario Bariatric Registry were eligible for the study. Follow-up was completed on March 31, 2019, and data were analyzed from May 5, 2020, to May 20, 2021.InterventionsRYGB and sleeve gastrectomy.Main outcomes and measuresPublicly funded health care expenditures, subsequent hospitalizations, bariatric procedures, and mortality during the 4 years after RYGB or sleeve gastrectomy.ResultsThe 1:1 matched study cohorts consisted of 1624 patients (812 per cohort) with a mean (SD) age of 48.0 (10.6) years, and 1242 women (76.5%). The mean body mass index (calculated as weight in kilograms divided by height in square meters) was 51.9 (8.3) for the RYGB cohort and 51.9 (8.9) for the sleeve gastrectomy cohort. The 4-year cumulative costs were not statistically significantly different between RYGB and sleeve gastrectomy (mean [SD], $33 682 [$31 169] vs $33 948 [$32 633], respectively; P = .86). Having a history of coronary artery disease was associated with a 35% increase in overall health care expenditures; chronic kidney disease, a 54% increase; and mental health admissions, a 67% increase. There were no statistically significant differences in all-cause mortality between RYGB and sleeve gastrectomy (1.5% vs 2.2%, respectively; P = .26) or the total number of hospitalizations (754 vs 669, respectively; P = .11) during the 4-year follow-up period. However, nonelective hospitalizations occurred more frequently with RYGB vs sleeve gastrectomy (472 vs 339, respectively; P = .002). Roux-en-Y gastric bypass was associated with relatively fewer subsequent bariatric procedures during the 4-year follow-up period (9 vs 40, respectively; P < .001).Conclusions and relevanceIn this Canadian population-based study, key results indicated that 4-year health care expenditures, all-cause mortality, and number of hospital admissions associated with RYGB did not significantly differ from those for sleeve gastrectomy. The rate of subsequent bariatric surgery was lower with RYGB. This study identified important patient-level drivers of health care expenditures that need to be further investigated.