Abstract 2167: A Strategy Of Intensive Glycemic Control With Pioglitazone Does Not Significantly Reduce In-Stent Neointimal Volume After Percutaneous Coronary Intervention In Type 2 Diabetic Patients.
Background: Despite the advent of drug-eluting stents (DES), diabetic patients remain at high risk of repeat revascularization due to restenosis or disease progression after percutaneous coronary intervention (PCI). As pioglitazone (PIO) may have anti-restenotic and anti-atherosclerotic benefits, the aim of this study was to determine whether PIO could reduce in-stent restenosis and atherosclerosis progression after PCI.
Methods: Fifty type 2 diabetic subjects undergoing PCI were randomized to either: intensive glycemic control (HbA1c <6%) with PIO (30 mg/d × 6 months) plus titration of oral hypoglycemics (PIO group: n=25) vs. conservative glycemic control with titration of oral agents to get HbA1c <7% (CONTROL group: n=25). Intravascular ultrasound (IVUS) was performed immediately after successful PCI and repeated after 6 months. The primary endpoint was the change in in-stent neointimal volume at 6 months; secondary endpoints included change in in-stent neointimal area and change in plaque volume in a 5–10mm reference segment proximal to the stent.
Results: Baseline and procedural variables were comparable in both groups. DES were used in 7 PIO and 11 CONTROL subjects, and bare metal stents (BMS) in the rest. Of the 50 patients, 41 (n=20 PIO and n=21 CONTROL) had analyzable pairs of IVUS to assess the effects of treatment. The PIO group had a trend towards lower HbA1c, insulin resistance and significantly lower glucose levels after 6 months, while lipids were similar in both groups. The change in in-stent neointimal volume and area were not significantly reduced in those receiving PIO vs. CONTROLS. There was a similar lack of benefit of PIO on IVUS parameters in both DES and BMS patients. Atherosclerosis progression in the reference segment was not significantly altered in the PIO group. PIO therapy significantly increased adiponectin levels, but did not significantly alter high-sensitivity C-reactive protein, leptin, matrix metalloproteinase-9, or interleukin-6 levels, compared to CONTROLS. Repeat revascularization at 6 months was similar in both groups.
Conclusions: PIO therapy had no effect on altering in-stent neointimal proliferation or reference segment disease progression after PCI with DES or BMS.