Coronary Artery Revascularization in Diabetes

Study Overview
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Brief Summary
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This is a randomized, multi-site, clinical trial comparing percutaneous coronary stenting (PCI) with drug eluding stents to coronary bypass for angiographically significant coronary artery disease in diabetes. The hypothesis being tested is that a strategy of surgical revascularization is superior to percutaneous intervention in preventing death or myocardial infarction in diabetics with severe ischemic heart disease.

Detailed Description
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Diabetic patients (HbA1c greater than 6.0% if treated or greater than 6.9% untreated) with severe ischemic heart disease and clinical indications for coronary revascularization will be screened and, if agreeable, entered into the study. Qualified patients unwilling to participate in the randomized trial will be approached for participation in a Registry that will collect computerized health data. The study consists of a 4-year accrual period. The median follow-up will be 3.7 years with a maximum of six years and a minimum of two years. Six sites will begin recruitment in the first year followed by nine additional sites for the remaining three years. The study is powered to detect a 40% relative difference between the groups in time to death or MI with a two-sided, type I error of 5% and a power of 90%.

Official Title
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CSP #557 - Coronary Artery Revascularization in Diabetes (VA CARDS)

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Percutaneous coronary intervention (PCI)
* Procedure: Coronary artery bypass graft (CABG)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with diabetes with severe coronary artery disease General Inclusion Criteria Age at least 18 years old Patients with either Type I or Type II diabetes with a documented HbA1c greater than site ULN (If not on diabetic medication must be confirmed by a blood glucose of >126 mg/dL fasting, or >200mg/dL non-fasting); OR on diabetic medication with a documented physician diagnosis of diabetes mellitus. No child bearing potential (if female) Patient competent to provide consent Exclusion Criteria: General Exclusion Criteria Congenital heart disease Coronary bypass surgery within the preceding one year Need for concomitant cardiac surgery AHA Class III decompensated heart failure or AHA Class IV heart failure Undergoing PCI for hemodynamic instability related to acute STEMI History of a hemorrhagic stroke Severe bleeding diathesis History of chronic pancreatitis A severe co-morbid condition that is expected to limit life to less than two years Embolic stroke in the past six months Significant GI bleed within the last one month Lack of adequate surgical conduit Sensitivity to clopidogrel (Plavix) Sensitivity to glycoprotein IIb/IIIa inhibitors Chronic systemic steroid use Participation in another trial with active intervention Patient unable to be adequately followed

Ages Eligible for Study
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Minimum Age: 18 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PCI<br>Percutaneous coronary intervention | Device: Percutaneous coronary intervention (PCI)<br>* percutaneous coronary stenting with drug eluding stents<br>Procedure: Coronary artery bypass graft (CABG)<br>* coronary bypass<br>|
| Active Comparator: CABG<br>Coronary artery bypass graft (CABG) | Procedure: Coronary artery bypass graft (CABG)<br>* coronary bypass<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Hypothesis Being Tested is That a Strategy of Initial Surgical Revascularization is Superior to Percutaneous Intervention in Preventing Death or Myocardial Infarction in Diabetics With Severe Ischemic Heart Disease Assessed up to 4 Years. | Participants were monitored for up to 4 years. This is the number of particiapnts who have died or had at least one myocardial infarction. | Date of Death and non-fatal MI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CABG, Coronary Disease, Diabetes, PCI