Cardiovascular Outcomes in Bariatric Surgery Patients With Type 2 Diabetes

Study Overview
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Brief Summary
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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.

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

Conditions
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Obesity, Type2 Diabetes, Bariatric Surgery Candidate

Intervention / Treatment
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* Procedure: Bariatric Surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Bariatric Surgery<br>Patients with type 2 diabetes with BMI >=30 that underwent bariatric surgery | Procedure: Bariatric Surgery<br>* 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<br>|
| Non-Surgical Control<br>Matched non-surgical controls with type 2 diabetes and BMI >=30 | |

What is the study measuring?
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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 |