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Original Investigation
September 2, 2019

Association of Metabolic Surgery With Major Adverse Cardiovascular Outcomes in Patients With Type 2 Diabetes and Obesity

Author Affiliations
  • 1Bariatric and Metabolic Institute, Department of General Surgery, Cleveland Clinic, Cleveland, Ohio
  • 2Department of Quantitative Health Sciences, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio
  • 3Kaiser Permanente Washington Health Research Institute, Seattle
  • 4Cleveland Clinic Coordinating Center for Clinical Research, Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio
  • 5Department of Surgery, The Ohio State University Wexner Medical Center, Columbus
JAMA. 2019;322(13):1271-1282. doi:10.1001/jama.2019.14231
Key Points

Question  Is there an association between metabolic surgery and major adverse cardiovascular events (all-cause mortality, coronary artery events, cerebrovascular events, heart failure, nephropathy, and atrial fibrillation) in patients with type 2 diabetes and obesity?

Findings  In this retrospective cohort study of 13 722 patients (including 2287 patients who underwent metabolic surgery and 11 435 matched controls), metabolic surgery was significantly associated with a lower risk of major adverse cardiovascular events (hazard ratio, 0.61).

Meaning  Among patients with type 2 diabetes and obesity, metabolic surgery was significantly associated with a lower risk of incident major adverse cardiovascular events.

Abstract

Importance  Although metabolic surgery (defined as procedures that influence metabolism by inducing weight loss and altering gastrointestinal physiology) significantly improves cardiometabolic risk factors, the effect on cardiovascular outcomes has been less well characterized.

Objective  To investigate the relationship between metabolic surgery and incident major adverse cardiovascular events (MACE) in patients with type 2 diabetes and obesity.

Design, Setting, and Participants  Of 287 438 adult patients with diabetes in the Cleveland Clinic Health System in the United States between 1998 and 2017, 2287 patients underwent metabolic surgery. In this retrospective cohort study, these patients were matched 1:5 to nonsurgical patients with diabetes and obesity (body mass index [BMI] ≥30), resulting in 11 435 control patients, with follow-up through December 2018.

Exposures  Metabolic gastrointestinal surgical procedures vs usual care for type 2 diabetes and obesity.

Main Outcomes and Measures  The primary outcome was the incidence of extended MACE (composite of 6 outcomes), defined as first occurrence of all-cause mortality, coronary artery events, cerebrovascular events, heart failure, nephropathy, and atrial fibrillation. Secondary end points included 3-component MACE (myocardial infarction, ischemic stroke, and mortality) and the 6 individual components of the primary end point.

Results  Among the 13 722 study participants, the distribution of baseline covariates was balanced between the surgical group and the nonsurgical group, including female sex (65.5% vs 64.2%), median age (52.5 vs 54.8 years), BMI (45.1 vs 42.6), and glycated hemoglobin level (7.1% vs 7.1%). The overall median follow-up duration was 3.9 years (interquartile range, 1.9-6.1 years). At the end of the study period, 385 patients in the surgical group and 3243 patients in the nonsurgical group experienced a primary end point (cumulative incidence at 8-years, 30.8% [95% CI, 27.6%-34.0%] in the surgical group and 47.7% [95% CI, 46.1%-49.2%] in the nonsurgical group [P < .001]; absolute 8-year risk difference [ARD], 16.9% [95% CI, 13.1%-20.4%]; adjusted hazard ratio [HR], 0.61 [95% CI, 0.55-0.69]). All 7 prespecified secondary outcomes showed statistically significant differences in favor of metabolic surgery, including mortality. All-cause mortality occurred in 112 patients in the metabolic surgery group and 1111 patients in the nonsurgical group (cumulative incidence at 8 years, 10.0% [95% CI, 7.8%-12.2%] and 17.8% [95% CI, 16.6%-19.0%]; ARD, 7.8% [95% CI, 5.1%-10.2%]; adjusted HR, 0.59 [95% CI, 0.48-0.72]).

Conclusions and Relevance  Among patients with type 2 diabetes and obesity, metabolic surgery, compared with nonsurgical management, was associated with a significantly lower risk of incident MACE. The findings from this observational study must be confirmed in randomized clinical trials.

Trial Registration  ClinicalTrials.gov Identifier: NCT03955952

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