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Study to Assess the Benefit and Safety of Rosiglitazone in Preventing Atherosclerosis Progression After Coronary Artery Bypass Surgery in Type 2 Diabetes - VICTORY — Presented at SCAI-ACC i2 Summit/ACC 2008
Description:
The goal of this trial was to evaluate treatment with the PPAR-γ receptor inhibitor rosiglitazone compared with placebo in diabetic patients 1-10 years after coronary artery bypass grafting (CABG).
Hypothesis:
Rosiglitazone will be more effective in preventing atherosclerosis in saphenous vein grafts and native coronary arteries.
Study Design
Study Design:
Patients Screened: 246
Patients Enrolled: 193
Mean Follow Up: 12 months
Mean Patient Age: 65 years
Female: 8
Patient Populations:
• Type 2 diabetic patients
• Canadian Cardiovascular Society angina class I-II
• Left ventricular ejection fraction >35%
• Stable diabetes defined as glycated hemoglobin ≤9%
• CABG 1-10 years prior to enrollment
Primary Endpoints:
Change in plaque volume in a 40 mm segment of saphenous vein graft, as measured by IVUS
Secondary Endpoints:
• Body composition assessed by Dual Energy X-ray Absorptiometry (DEXA)
• Total body water by bioimpedence
• Inflammatory and prothrombotic markers
• Adiponectin and indices of plasma glucose-insulin homeostasis
• Death, myocardial infarction, ischemia-driven revascularization, and hospitalization
Drug/Procedures Used:
Type 2 diabetic patients with prior CABG were randomized to rosiglitazone (n = 98) or placebo (n = 95) after baseline coronary angiography and intravascular ultrasound (IVUS).
Concomitant Medications:
At baseline, for rosiglitazone versus placebo, the use of antiplatelet agents was 100% versus 100%, beta-blockers was 70% versus 67%, angiotensin-converting enzyme inhibitors/angiotensin-receptor blockers was 87% versus 91%, and statins was 94% versus 96%, respectively. By design, no patients received insulin. The predominant antiglycemic agent was metformin, which was used in 77% versus 73%, respectively.
Principal Findings:
Glycated hemoglobin at enrollment was 6.9% in both groups. In the rosiglitazone group, the time since CABG was 3.9 years, and in the placebo group was 3.7 years.
The primary endpoint, saphenous vein graft plaque volume, increased 0.9% in the rosiglitazone group versus 2.8% in the placebo group (p = 0.22). Body weight increased 3 kg in the rosiglitazone group (p = 0.02). Fasting glucose was 116 mg/dl in the rosiglitazone group and 134 mg/dl in the placebo group (p < 0.0001), and high-density lipoprotein cholesterol was 45 mg/dl and 42 mg/dl (p = 0.0032), respectively. There were no deaths in either group; 0 versus 1 myocardial infarction, 1 versus 1 stroke, and 0 versus 2 transient ischemic attacks, for rosiglitizone versus placebo, respectively.
Interpretation:
In optimally treated type 2 diabetic patients remote from CABG, the use of rosiglitazone did not change saphenous vein graft plaque volume; however, this therapy improved fasting glucose and increased high-density lipoprotein cholesterol. In this relatively small study, the incidence of major adverse cardiac events appeared to be similar between the two groups.
References:
Results of a Multicenter Randomized Double-Blind Placebo-Controlled Study to Assess the Benefit and Safety of Rosiglitazone in Preventing Atherosclerosis Progression After Coronary Artery Bypass Surgery in Type 2 Diabetes. Presented by Dr. Olivier Bertrand at the SCAI-ACC i2 Summit/American College of Cardiology Annual Scientific Session, Chicago, IL, March/April 2008.
Keywords: Coronary Artery Disease, Myocardial Infarction, Atherosclerosis, Ischemic Attack, Transient, Diabetes Mellitus, Type 2, Body Weight, Glucose, Glycated Hemoglobin A, PPAR gamma, Coronary Angiography, Saphenous Vein, Stroke Volume, Cholesterol, HDL, Hypoglycemic Agents, Lipoproteins, HDL, Coronary Artery Bypass, Thiazolidinediones, Fasting
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