A multicentre, randomized, double-blind placebo-controlled trial evaluating rosiglitazone for the prevention of atherosclerosis progression after coronary artery bypass graft surgery in patients with type 2 diabetes. Design and rationale of the VeIn-Coronary aTherOsclerosis and Rosiglitazone after bypass surgerY (VICTORY) trial.
BACKGROUND
The number of patients with coronary artery disease and type 2 diabetes will increase dramatically over the next decade. Diabetes has been related to accelerated atherosclerosis and many patients with diabetes will require coronary artery bypass graft (CABG) surgery utilizing saphenous vein grafts. After CABG, accelerated atherosclerosis in saphenous vein grafts leads to graft failure in approximately 50% of cases over a 10-year period. Rosiglitazone, a peroxisome proliferator-activated receptor-gamma agonist, has been shown to improve multiple metabolic parameters in patients with type 2 diabetes. However, its role in the prevention of atherosclerosis progression is uncertain.


METHODS
VeIn-Coronary aTherOsclerosis and Rosiglitazone after bypass surgerY (VICTORY) is a cardiometabolic trial in which patients with type 2 diabetes, one to 10 years after CABG, will be randomly assigned to receive rosiglitazone (up to 8 mg/day) or a placebo after qualifying angiography and intravascular ultrasound of a segment of one vein graft with or without a native anastomosed coronary artery. A comprehensive set of athero-thrombo-inflammatory markers will be serially assessed during the 12-month follow-up period. Body fat distribution and body composition will be assessed by computed tomography and dual energy x-ray absorptiometry, respectively, at baseline, six months and 12 months follow-up. For atherosclerosis progression evaluation, repeat angiography and intravascular ultrasound will be performed after 12 months follow-up. The primary end point of the study will be the change in atherosclerotic plaque volume in a 40 mm or longer segment of one vein graft.


CONCLUSIONS
The VICTORY trial is the first cardiometabolic study to evaluate the antiatherosclerotic and metabolic effects of rosiglitazone in post-CABG patients with type 2 diabetes.
Bertrand
Olivier F
OF
Hôpital Laval, Québec Heart-Lung Institute, Québec, Québec, Canada. olivier.bertrand@crhl.ulaval.ca
Poirier
Paul
P
Rodés-Cabau
Josep
J
Rinfret
Stéphane
S
Title
Lawrence
L
Dzavik
Vladimir
V
Natarajan
Madhu
M
Angel
Juan
J
Batalla
Nuria
N
Alméras
Natalie
N
Costerousse
Olivier
O
De Larochellière
Robert
R
Roy
Louis
L
Després
Jean-Pierre
JP
D000328:Adult; D000368:Aged; D000787:Angina Pectoris / Q000150:complications / Q000175:diagnosis / Q000601:surgery*; D050197:Atherosclerosis / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D001786:Blood Glucose / Q000378:metabolism; D001026:Coronary Artery Bypass / Q000379:methods*; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000150:complications* / Q000188:drug therapy; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications; D011446:Prospective Studies; D011792:Quebec; D000077154:Rosiglitazone; D013030:Spain; D045162:Thiazolidinediones / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome; D014665:Vasodilator Agents
D001786:Blood Glucose; D007004:Hypoglycemic Agents; D045162:Thiazolidinediones; D014665:Vasodilator Agents; D000077154:Rosiglitazone