Cardiovascular Outcomes in Bariatric Surgery Patients With Type 2 Diabetes

Cardiovascular Outcomes in Patients With Type 2 Diabetes and Obesity: Comparison of Metabolic Surgery Versus Usual Care

The objective of the analysis was to evaluate the relationship between bariatric surgery and cardiovascular outcomes in obese patients with type 2 diabetes. This is a retrospective matched cohort study of patients with diabetes that underwent bariatric surgery at the Cleveland Clinic between 2004-2017. Each bariatric patient was matched to a non-surgical control with obesity and type 2 diabetes in a 1:5 ratio using data from the Electronic Medical Record (EMR). The maximum observation time was 10 years. Cumulative incidence rates for all-cause mortality and cardiovascular events were calculated at years 1, 3, 5, 7 and 10. Kaplan-Meier curves were created for all the outcomes with all-cause mortality considered as a completing risk.

Study Overview

• Status: Completed
• Conditions: Obesity; Bariatric Surgery Candidate; Type2 Diabetes
• Intervention / Treatment: Procedure: Bariatric Surgery

• Study Type: Observational
• Enrollment (Actual): 13722

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Type 2 diabetes patients with obesity (BMI>=30) between 18-80 years old.

Description

Inclusion Criteria:

• Type II diabetes
• 18-80 years old
• BMI>=30
• HBA1c >6.4 OR taking at lease one (1) diabetes medication (insulin or non-insulin)

Exclusion Criteria:

• History of liver, heart, or lung transplant
• Emergency department admission within 5 days prior
• Cancer diagnosis within 1 year prior
• Any prior ejection fraction <20%
• Non-surgical controls were excluded if they died within 30 days after the index date (date of surgery for the bariatric patients)
• Last follow-up date on or before the index date

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Bariatric Surgery; Patients with type 2 diabetes with BMI >=30 that underwent bariatric surgery	Procedure: Bariatric Surgery; Patients chosen using the following codes: Current Procedural Terminology (CPT): 43633, 43634, 43770, 43775, 43644, 43645, 43659, 43842, 43843, 43844, 43845, 43846, 43847 International Classification of Diseases (ICD): 44.31, 43.82,44.95, 43.89, 44.38, 44.39, 44.68 Healthcare Common Procedure Coding System (HCPCS): S2082, S2085
Non-Surgical Control; Matched non-surgical controls with type 2 diabetes and BMI >=30

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite of All-Cause Mortality and Cardiovascular Outcomes	Time to first occurrence of all-cause mortality, coronary artery disease event, stroke, heart failure, nephropathy, or atrial fibrillation	From index date through a maximum of 10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Major Adverse Cardiovascular Event (MACE-3)	Time to first occurrence of all-cause mortality, myocardial infarction or ischemic stroke	From index date through a maximum of 10 years
All-Cause Mortality	Time to occurrence of death from any cause	From index date through a maximum of 10 years
Incidence of Coronary Disease Events	Time to first occurrence of myocardial infarction, unstable angina, percutaneous coronary intervention, or coronary artery bypass grafting	From index date through a maximum of 10 years
Incidence of Cerebrovascular Events	Time to first occurrence of ischemic or hemorrhagic stroke, carotid stenting or endarterectomy	From index date through a maximum of 10 years
Incidence of Heart Failure	Time to first occurrence of heart failure	From index date through a maximum of 10 years
Development of Nephropathy	Time to first occurrence of nephropathy defined as >=2 measures of estimated Glomerular Filtration Rate (eGFR) <60 ml/min/1.73m^2 separated by at least 90 days without intervening values >=60	From index date through a maximum of 10 years
Incidence of Atrial Fibrillation	Time to first occurrence of atrial fibrillation defined by the following codes: International Classification of Diseases ICD-9: 427.31 ICD-10: i48.0, i48.1, i48.2, i48.91 Current Procedural Terminology (CPT): 93650, 93653, 93656, 93657	From index date through a maximum of 10 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage Change in Body Weight	Percentage change in body weight from index date to years 1, 3 and 5 post-index date	1,3 and 5 years post-index date
Percentage Change in Hemoglobin A1c	Percentage change in hemoglobin A1c from index date to years 1, 3 and 5 post-index date	1,3 and 5 years post-index date
Percentage Change in Systolic Blood Pressure (SBP)	Percentage change in SBP from index date to years 1, 3 and 5 post-index date	1,3 and 5 years post-index date
Percentage Change in Diastolic Blood Pressure (DBP)	Percentage change in DBP from index date to years 1, 3 and 5 post-index date	1,3 and 5 years post-index date
Percentage Change in High Density Lipoprotein (HDL)	Percentage change in HDL from index date to years 1, 3 and 5 post-index date	1,3 and 5 years post-index date
Percentage Change in Low Density Lipoprotein (LDL)	Percentage change in LDL from index date to years 1, 3 and 5 post-index date	1,3 and 5 years post-index date
Percentage Change in Triglycerides	Percentage change in triglycerides from index date to years 1, 3 and 5 post-index date	1,3 and 5 years post-index date

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Phil Schauer, MD, The Cleveland Clinic

Publications and helpful links

General Publications

• Aminian A, Zajichek A, Arterburn DE, Wolski KE, Brethauer SA, Schauer PR, Kattan MW, Nissen SE. Association of Metabolic Surgery With Major Adverse Cardiovascular Outcomes in Patients With Type 2 Diabetes and Obesity. JAMA. 2019 Oct 1;322(13):1271-1282. doi: 10.1001/jama.2019.14231.

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2019
• Primary Completion (Actual): July 12, 2019
• Study Completion (Actual): August 26, 2019

Study Registration Dates

• First Submitted: May 16, 2019
• First Submitted That Met QC Criteria: May 16, 2019
• First Posted (Actual): May 20, 2019

Study Record Updates

• Last Update Posted (Actual): January 2, 2020
• Last Update Submitted That Met QC Criteria: December 27, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Diabetes Mellitus; Diabetes Mellitus, Type 2; Obesity
• Other Study ID Numbers: 19-066

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No