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Randomized Controlled Trial
. 2009 Sep;25(9):509-15.
doi: 10.1016/s0828-282x(09)70136-9.

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

Olivier F Bertrand  1 , Paul Poirier, Josep Rodés-Cabau, Stéphane Rinfret, Lawrence Title, Vladimir Dzavik, Madhu Natarajan, Juan Angel, Nuria Batalla, Natalie Alméras, Olivier Costerousse, Robert De Larochellière, Louis Roy, Jean-Pierre Després; VICTORY trial investigators
Affiliations
Randomized Controlled Trial

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

Olivier F Bertrand et al. Can J Cardiol. 2009 Sep.

Abstract
in English, French

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.

Study design: 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.

HISTORIQUE:: Le nombre de patients coronariens diabétiques de type 2 augmentera significativement au cours de la prochaine décennie. Le diabète est associé à une athérosclérose accélérée et de nombreux patients coronariens diabétiques nécessiteront une chirurgie de pontage avec utilisation de greffes veineuses saphènes. L’athérosclérose accélérée au sein des pontages veineux amène à leur occlusion dans environ 50% des cas dans les 10 ans suivant la chirurgie. La rosiglitazone, un agoniste du récepteur gamma activé de prolifération des peroxysomes, présente de nombreux effets métaboliques chez le patient diabétique, cependant la possibilité d’une action limitant la progression de l’athérosclérose n’est pas démontrée.

MÉTHODE:: VICTORY est une étude cardiométabolique dans laquelle les patients diabétiques de type 2 ayant eu une opération de pontage aorto-coronaire, un à 10 ans au préalable seront randomisés à la rosiglitazone (jusqu’à 8 mg) ou au placebo après angiographie et échographie intravasculaire d’un greffon veineux ± artère native anastomosée. Une évaluation complète et sériée des marqueurs de l’athérosclérose, de la thrombose et de l’inflammation sera réalisée. La distribution du tissu adipeux et la composition corporelle seront évaluées par tomographie axiale et par absorptiométrie au début de l’étude, après 6 mois et 12 mois de suivi. Pour l’évaluation de la progression de l’athérosclérose, l’angiographie et l’échographie intravasculaire seront répétées après un suivi de 12 mois. L’objectif primaire sera le changement du volume de plaque athérosclérotique dans un segment du greffon veineux ≥ 40 mm.

CONCLUSIONS:: L’essai VICTORY est la première étude cardiométabolique qui évaluera les effets de la rosiglitazone sur l’athérosclérose et le métabolisme chez des patients diabétiques après chirurgie de pontage aorto-coronaire.

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Figures

Figure 1)
Figure 1)
The VeIn-Coronary aTherOsclerosis and Rosiglitazone after Bypass SurgerY (VICTORY) trial design. CT Computed tomography; DEXA Dual energy x-ray absorptiometry; HbA1c Glycosylated hemoglobin
Figure 2)
Figure 2)
Intravascular ultrasound scenarios. SVG Saphenous vein graft
Figure 3)
Figure 3)
Representative results of intravascular ultrasound (IVUS), a computed tomgraphy scan and dual energy x-ray absorptiometry (DEXA) at baseline. A Lumen saphenous vein graft tracings are shown in red, vessel contours in green. B Visceral fat is shown in red, subcutaneous fat in green. C DEXA measurements include total body fat and trunk/leg fat ratio. AT Adipose tissue
See this image and copyright information in PMC

References

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