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.
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%.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
198
percutaneous coronary stenting with drug eluding stents
coronary bypass
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.
Time frame: Date of Death and non-fatal MI
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
VA Medical Center, Birmingham
Birmingham, Alabama, United States
Southern Arizona VA Health Care System, Tucson
Tucson, Arizona, United States
VA Palo Alto Health Care System
Palo Alto, California, 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 Greater Los Angeles HCS, Sepulveda
Sepulveda, California, United States
VA Eastern Colorado Health Care System, Denver
Denver, Colorado, United States
VA Medical Center, DC
Washington D.C., District of Columbia, United States
VA Medical Center, Miami
Miami, Florida, United States
James A. Haley Veterans Hospital, Tampa
Tampa, Florida, United States
...and 16 more locations