Clinical InvestigationsInterventional CardiologyPredictive factors for in-stent late loss and coronary lesion progression in patients with type 2 diabetes mellitus randomized to rosiglitazone or placebo
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Selection of patients
The study was a double-blind randomized controlled clinical trial performed at Massachusetts General Hospital (Boston, MA). It was approved by the ethics committee and all patients gave written informed consent. The study was conducted from March 2004 to August 2006.
Patients were eligible for the study if they were >18 years old, were not pregnant, had received a previous diagnosis of DM2 or newly diagnosed DM2 fulfilling the American Diabetes Association criteria, and had stable or unstable
Primary lesions analysis: predictors of late loss
A total of 65 patients were enrolled in the trial with 32 assigned to RSG and 33 to placebo. Baseline demographic characteristics of the overall population and of each treatment group are shown in Table I. With the exception of age and diabetes medications, the 2 groups were similar with respect to the variables examined.
Thirteen (22%) of 65 patients dropped out before 4 months after enrollment. The reasons for discontinuation varied from inability to comply with the frequent follow-up regimen
Discussion
Patients with DM2 are at increased risk for atherosclerotic plaque progression and restenosis after stenting. Indeed, 15% of lesions in this study had RAP and approximately one third of patients underwent target lesion revascularization within 8 months. Although RSG had many favorable effects on serum markers of inflammation, insulin resistance, and adiponectin, it also raised serum LDL cholesterol as well as NT-proBNP and failed to appreciably lower the incidence of either angiographic
Conclusion
In a double-blind randomized controlled clinical trial of patients with DM2 undergoing stent placement, we found that 4 mg oral RSG appears not to lower LL or reduce angiographic progression of NCCL in DM2 and had complex effects on markers of cardiac risk. Given its complexity, the cardiovascular safety of this agent can only be established in prospective studies using hard end points.
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Abstract presented at the American Heart Association Scientific Sessions November 4, 2007, Orlando, FL.
ClinicalTrials.gov identifier: NCT00116792.
The study was funded in part by a research grant to HKG from Abbott Vascular (Santa Clara, CA).