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POPPS: Pioglitazone associated with lower target lesion revascularization rate, fewer cardiac events following bare metal stent

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Pioglitazone was associated with a reduction in restenosis and fewer major adverse cardiac events following percutaneous coronary intervention, study results suggested.

Researchers for the Prevention of In-Stent Neointimal Proliferation by Pioglitazone Study enrolled a total of 97 patients with type 2 diabetes and symptomatic ischemic heart disease undergoing percutaneous coronary intervention (PCI) in the study. Researchers randomly assigned patients to pioglitazone (Actos, Takeda Pharmaceuticals) following placement of a bare metal stent (n=48) or a control group (n=49), and performed angiographic and intravascular ultrasound (IVUS) at baseline and six-month follow-up. The primary endpoints included target lesion revascularization and angiographical restenosis at six months.

According to the study results, the angiographic restenosis rate was 17% in the pioglitazone group vs. 35% in the control group (P=.06) at six month follow-up. The long-term incidence of death and MI did not differ between the study groups, but target lesion revascularization was lower in the pioglitazone group vs. control (12.5% vs. 29.8%, P=.04), as were major adverse cardiac events (13% vs. 31%, P=.01). The percent diameter stenosis and late loss were also significantly lower in the pioglitazone group vs. control. In-stent neointimal volume at six-month follow-up as assessed by IVUS was 48.0 ± 30.2 mm³ in the control group compared with 62.7 ± 29.0 mm³ in the pioglitazone group. Neointimal index was smaller in the pioglitazone group (P=.01).

“Pioglitazone suppresses in-stent neointimal proliferation and therefore reduces angiographical and clinical restenosis six months after PCI in patients with type 2 diabetes,” the researchers concluded. “The additive impact of pioglitazone on restenosis and target lesion revascularization as well as stent thrombosis after placement of drug-eluting stents needs further investigations.”

In an accompanying editorial, Steven E. Nissen, MD, chairman of the department of CV medicine at the Cleveland Clinic, said that despite the study’s limited sample size, a number of important findings could be gleaned from the data.

“Regardless of the mechanisms of benefit, the results of this study are notable,” Nissen wrote. “Systemic therapy to prevent restenosis is not a futile endeavor. The current results must be replicated in a larger trial with greater statistical power and the hypothesis should be explored in a separate study of patients receiving drug-eluting stents.”

Takagi T. J Am Coll Cardiol Intv. 2009;2:524-531.