PIoglitazone for PrEvention of Restenosis in Diabetic Patients
Status:
Unknown status
Trial end date:
2011-04-01
Target enrollment:
Participant gender:
Summary
Restenosis requiring reintervention is still a limitation of percutaneous coronary
angioplasty. Despite the use of Drug eluting stent (DES), the rate of restenosis remains 7%
to 16% in diabetic patients, making it a challenging problem in interventional cardiology.
Still, in clinical trials, most of these attempts did not successfully limit neointimal
formation after coronary stenting.
Thiazolidinediones (TZDs), like pioglitazone (pio) or rosiglitazone, are a novel class of
oral antidiabetic agents currently used to treat patients with type 2 diabetes mellitus.
These agents increase insulin sensitivity and, as such, have favorable effects on blood
glucose levels and the lipid profile in treated patients.
Beyond their metabolic action, TZDs have been shown to exhibit antiinflammatory and
antiatherogenic effects in vascular cells in vitro and to limit lesion development in various
animal models of arteriosclerosis.
Moreover, TZDs inhibit VSMC proliferation and migration, 2 critical processes in neointimal
formation after coronary stenting.
Data from rodent models suggest that TZDs limit intimal proliferation after vascular injury,
and in clinical studies with type 2 diabetic coronary artery disease (CAD) patients, TZDs
have been shown to reduce neointimal formation as well as restenosis after coronary stent
implantation.
Still, it remains unclear to what extend these effects depend on the metabolic action of
these drugs and what might mainly be due to the improvement in glycemic control.
Recently a few reports on prevention of restenosis in type 2 diabetic patients (T2DM) with
the use of TZDs as been published. All of them uses BMS as endoprosthetic devices. None of
these evaluated the use of TZDs in combination with DES.
Aim of the study is to evaluate the efficacy of pioglitazone in prevention of in-stent
restenosis after successful implantation of a sirolimus-eluting coronary stent for treatment
of de-novo "complex" coronary vessel disease in patients with T2DM and stable coronary artery
disease.
Study primary end-point are late-loss at 9 months.Secondary end-point include binary
restenosis MACE at 1, 9 and 12 month, stent thrombosis at 12 months.