Coronary Artery Revascularization in Diabetes
- Conditions
- Coronary Artery Disease
- Interventions
- Device: Percutaneous coronary intervention (PCI)Procedure: Coronary artery bypass graft (CABG)
- Registration Number
- NCT00326196
- Lead Sponsor
- US Department of Veterans Affairs
- Brief Summary
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
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%.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 198
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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PCI Percutaneous coronary intervention (PCI) Percutaneous coronary intervention PCI Coronary artery bypass graft (CABG) Percutaneous coronary intervention CABG Coronary artery bypass graft (CABG) Coronary artery bypass graft (CABG)
- Primary Outcome Measures
Name Time Method 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. Date of Death and non-fatal MI Participants were monitored for up to 4 years. This is the number of particiapnts who have died or had at least one myocardial infarction.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (26)
VA Medical Center, Asheville
🇺🇸Asheville, North Carolina, United States
Southern Arizona VA Health Care System, Tucson
🇺🇸Tucson, Arizona, United States
New York Harbor HCS
🇺🇸New York, New York, United States
VA Medical Center, Miami
🇺🇸Miami, Florida, United States
VA Medical Center, DC
🇺🇸Washington, District of Columbia, United States
VA North Texas Health Care System, Dallas
🇺🇸Dallas, Texas, United States
VA Puget Sound Health Care System, Seattle
🇺🇸Seattle, Washington, United States
VA Palo Alto Health Care System
🇺🇸Palo Alto, California, United States
Atlanta VA Medical and Rehab Center, Decatur
🇺🇸Decatur, Georgia, United States
VA Greater Los Angeles HCS, Sepulveda
🇺🇸Sepulveda, California, United States
VA Medical Center, Cleveland
🇺🇸Cleveland, Ohio, United States
VA Medical Center, Memphis
🇺🇸Memphis, Tennessee, United States
Richard Roudebush VA Medical Center, Indianapolis
🇺🇸Indianapolis, Indiana, United States
VA Medical Center, Birmingham
🇺🇸Birmingham, Alabama, United States
VA San Diego Healthcare System, San Diego
🇺🇸San Diego, California, United States
VA Medical Center, San Francisco
🇺🇸San Francisco, California, United States
VA Eastern Colorado Health Care System, Denver
🇺🇸Denver, Colorado, United States
VA Medical Center, Minneapolis
🇺🇸Minneapolis, Minnesota, United States
VA Medical Center, Durham
🇺🇸Durham, North Carolina, United States
VA Medical Center, Oklahoma City
🇺🇸Oklahoma City, Oklahoma, United States
VA South Texas Health Care System, San Antonio
🇺🇸San Antonio, Texas, United States
Zablocki VA Medical Center, Milwaukee
🇺🇸Milwaukee, Wisconsin, United States
VA Boston Healthcare System, Brockton Campus
🇺🇸Brockton, Massachusetts, United States
Michael E. DeBakey VA Medical Center (152)
🇺🇸Houston, Texas, United States
Ralph H Johnson VA Medical Center, Charleston
🇺🇸Charleston, South Carolina, United States
James A. Haley Veterans Hospital, Tampa
🇺🇸Tampa, Florida, United States