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)

被引:50
作者
Takagi, Tsutomu [2 ]
Okura, Hiroyuki [1 ]
Kobayashi, Yoshiki [3 ]
Kataoka, Toru [3 ]
Taguchi, Haruyuki [1 ]
Toda, Iku [1 ]
Tamita, Koichi [4 ]
Yamamuro, Atsushi [4 ]
Sakanoue, Yuji [5 ]
Ito, Akira [5 ]
Yanagi, Shiro [6 ]
Shimeno, Kenji [6 ]
Waseda, Katsuhisa [7 ]
Yamasaki, Masao [7 ]
Fitzgerald, Peter J. [7 ]
Ikeno, Fumiaki [7 ]
Honda, Yasuhiro [7 ]
Yoshiyama, Minoru [3 ]
Yoshikawa, Junichi [8 ]
机构
[1] Bell Land Gen Hosp, Div Cardiol, Sakai, Osaka, Japan
[2] Takagi Cardiol Clin, Div Cardiol, Kyoto, Japan
[3] Osaka City Univ, Sch Med, Div Internal Med & Cardiol, Osaka 545, Japan
[4] Kobe Gen Hosp, Med Ctr, Div Cardiol, Kobe, Hyogo, Japan
[5] Osaka City Med Ctr, Div Cardiol, Osaka, Japan
[6] Fuchu Hosp, Div Cardiol, Izumi, Japan
[7] Stanford Univ, Med Ctr, Div Cardiol, Stanford, CA 94305 USA
[8] Osaka Ekisaikai Hosp, Div Internal Med & Cardiol, Osaka, Japan
关键词
diabetes mellitus; restenosis; stent; ultrasound; SIROLIMUS-ELUTING STENTS; MYOCARDIAL-INFARCTION; TISSUE PROLIFERATION; CARDIOVASCULAR EVENTS; NONDIABETIC PATIENTS; CORONARY; IMPLANTATION; RESTENOSIS; TROGLITAZONE; MELLITUS;
D O I
10.1016/j.jcin.2009.04.007
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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 mm(3) vs. 62.7 +/- 29.0 mm(3), 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 neointinnal proliferation and reduce incidence of TLR after PCI in patients with T2DM. (J Am Coll Cardiol Intv 2009;2:524-31) (c) 2009 by the American College of Cardiology Foundation
引用
收藏
页码:524 / 531
页数:8
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