Coronary Artery Disease
Conditions
Keywords
CABG, Coronary Disease, Diabetes, PCI
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%.
Interventions
DEVICEPercutaneous coronary intervention (PCI)
percutaneous coronary stenting with drug eluding stents
PROCEDURECoronary artery bypass graft (CABG)
coronary bypass
Sponsors
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
The study recruitment occured at 23 VA medical centers and thestudy recruitment lasted from 8/25/2006 thru 3/24/2010.
Pre-assignment details
Study participants were were pre-screened by Cath lab. The remaining participants were consented and screened for study eligibility.
Participants by arm
| Arm | Count |
|---|---|
| Percutaneous Coronary Intervention Percutaneous coronary intervention | 101 |
| Coronary Artery Bypass Graft Coronary artery bypass graft (CABG) | 97 |
| Total | 198 |
Baseline characteristics
| Characteristic | Percutaneous Coronary Intervention | Coronary Artery Bypass Graft | Total |
|---|---|---|---|
| Age, Continuous | 62.7 years STANDARD_DEVIATION 7.1 | 62.1 years STANDARD_DEVIATION 7.4 | 62.4 years STANDARD_DEVIATION 7.2 |
| Region of Enrollment United States | 101 participants | 97 participants | 198 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 100 Participants | 96 Participants | 196 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 7 / 101 | 67 / 97 |
| serious Total, serious adverse events | 23 / 101 | 46 / 97 |
Outcome results
Primary
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
Population: The number of participants for analysis was determined by intent to treat principal.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Percutaneous Coronary Intervention | 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. | 21 participants |
| Coronary Artery Bypass Graft | 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. | 16 participants |