Coronary Artery Revascularization in Diabetes (VA CARDS)

US Department of Veterans Affairs (VA)

Status and phase: Terminated; Phase 4

Conditions: Coronary Artery Disease

Treatments: Device: Percutaneous coronary intervention (PCI); Procedure: Coronary artery bypass graft (CABG)

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00326196

557

Details and patient eligibility

About

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.

Full description

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%.

Enrollment: 198 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

Patients with diabetes with severe coronary artery disease General Inclusion Criteria

1. Age at least 18 years old

2. 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.

3. No child bearing potential (if female)

4. Patient competent to provide consent

   Exclusion Criteria:

   General Exclusion Criteria

5. Congenital heart disease

6. Coronary bypass surgery within the preceding one year

7. Need for concomitant cardiac surgery

8. AHA Class III decompensated heart failure or AHA Class IV heart failure

9. Undergoing PCI for hemodynamic instability related to acute STEMI

10. History of a hemorrhagic stroke

11. Severe bleeding diathesis

12. History of chronic pancreatitis

13. A severe co-morbid condition that is expected to limit life to less than two years

14. Embolic stroke in the past six months

15. Significant GI bleed within the last one month

16. Lack of adequate surgical conduit

17. Sensitivity to clopidogrel (Plavix)

18. Sensitivity to glycoprotein IIb/IIIa inhibitors

19. Chronic systemic steroid use

20. Participation in another trial with active intervention

21. Patient unable to be adequately followed

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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198 participants in 2 patient groups

PCI

Active Comparator group

Description:

Percutaneous coronary intervention

Treatment:

Procedure: Coronary artery bypass graft (CABG)

Device: Percutaneous coronary intervention (PCI)

CABG

Active Comparator group

Description:

Coronary artery bypass graft (CABG)

Treatment:

Procedure: Coronary artery bypass graft (CABG)