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A Prospective, Multicenter, Randomized Trial to Assess Efficacy of Pioglitazone on In-Stent Neointimal Suppression in Type 2 Diabetes

POPPS (Prevention of In-Stent Neointimal Proliferation by Pioglitazone Study)

Tsutomu Takagi, MD^_*, Hiroyuki Okura, MD^,_*, Yoshiki Kobayashi, MD, Toru Kataoka, MD, Haruyuki Taguchi, MD, Iku Toda, MD, Koichi Tamita, MD, Atsushi Yamamuro, MD, Yuji Sakanoue, MD^||, Akira Ito, MD^||, Shiro Yanagi, MD^¶, Kenji Shimeno, MD^¶, Katsuhisa Waseda, MD^#, Masao Yamasaki, MD^#, Peter J. Fitzgerald, MD^#, Fumiaki Ikeno, MD^#, Yasuhiro Honda, MD^#, Minoru Yoshiyama, MD, Junichi Yoshikawa, MD^_** for the POPPS Investigators

^_* Division of Cardiology, Takagi Cardiology Clinic, Kyoto, Japan
Division of Cardiology, Bell Land General Hospital, Sakai, Japan
Division of Internal Medicine and Cardiology, Osaka City University School of Medicine, Osaka, Japan
Division of Cardiology, Kobe General Hospital Medical Center, Kobe, Japan
^|| Division of Cardiology, Osaka City Medical Center, Osaka, Japan
^¶ Division of Cardiology, Fuchu Hospital, Izumi, Japan
^# Division of Cardiology, Stanford University Medical Center, Stanford, California
^_** Division of Internal Medicine and Cardiology, Osaka Ekisaikai Hospital, Osaka, Japan

^_* Reprint requests and correspondence: Dr. Hiroyuki Okura, Division of Cardiology, Kawasaki Medical School, 577 Matsushima, Kurashiki 701-0192, Japan (Email: hokura{at}fides.dti.ne.jp).

Objectives: The aim of this study was to clarify whether pioglitazone suppresses in-stent neointimal proliferation and reduces restenosis and target lesion revascularization (TLR) after percutaneous coronary intervention (PCI).

Background: Previous single-center studies have demonstrated the anti-restenotic effect of a peroxisome proliferator-activated receptor gamma agonist, pioglitazone, after PCI.

Methods: A total of 97 patients with type 2 diabetes mellitus (T2DM) undergoing PCI (bare-metal stents only) were enrolled. After PCI, patients were randomly assigned to either the pioglitazone group (n = 48) or the control group (n = 49). Angiographical and intravascular ultrasound (IVUS) imaging were performed at baseline and repeated at 6-month follow-up. Primary end points included angiographical restenosis and TLR at 6 months follow-up. Secondary end point was in-stent neointimal volume by IVUS.

Results: Baseline glucose level and glycosylated hemoglobin (HbA1c) level were similar between the pioglitazone group and the control group. Angiographical restenosis rate was 17% in the pioglitazone group and 35% in control group (p = 0.06). The TLR was significantly lower in pioglitazone group than in control group (12.5% vs. 29.8%, p = 0.04). By IVUS (n = 56), in-stent neointimal volume at 6 months showed a trend toward smaller in the pioglitazone group than in the control group (48.0 ± 30.2 mm³ vs. 62.7 ± 29.0 mm³, p = 0.07). Neointimal index (neointimal volume/stent volume x 100) was significantly smaller in the pioglitazone group than in the control group (31.1 ± 14.3% vs. 40.5 ± 12.9%, p = 0.01).

Conclusions: Pioglitazone treatment might suppress in-stent neointimal proliferation and reduce incidence of TLR after PCI in patients with T2DM.

Key Words: diabetes mellitus • restenosis • stent • ultrasound

Abbreviations and Acronyms   BMS = bare-metal stent(s)   CSA = cross-sectional area   DES = drug-eluting stent(s)   EEM = external elastic membrane   HbA1c = glycosylated hemoglobin   ISR = in-stent restenosis   IVUS = intravascular ultrasound   MI = myocardial infarction   MLD = minimal lumen diameter   PCI = percutaneous coronary intervention   P+M = plaque plus media   TLR = target lesion revascularization   TZDs = thiazolidinediones   T2DM = type 2 diabetes mellitus

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