Document Detail

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).
MedLine Citation:
PMID:  19539256     Owner:  NLM     Status:  MEDLINE    
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 neointimal proliferation and reduce incidence of TLR after PCI in patients with T2DM.
Tsutomu Takagi; Hiroyuki Okura; Yoshiki Kobayashi; Toru Kataoka; Haruyuki Taguchi; Iku Toda; Koichi Tamita; Atsushi Yamamuro; Yuji Sakanoue; Akira Ito; Shiro Yanagi; Kenji Shimeno; Katsuhisa Waseda; Masao Yamasaki; Peter J Fitzgerald; Fumiaki Ikeno; Yasuhiro Honda; Minoru Yoshiyama; Junichi Yoshikawa;
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  JACC. Cardiovascular interventions     Volume:  2     ISSN:  1876-7605     ISO Abbreviation:  JACC Cardiovasc Interv     Publication Date:  2009 Jun 
Date Detail:
Created Date:  2009-06-22     Completed Date:  2009-08-27     Revised Date:  2014-09-05    
Medline Journal Info:
Nlm Unique ID:  101467004     Medline TA:  JACC Cardiovasc Interv     Country:  United States    
Other Details:
Languages:  eng     Pagination:  524-31     Citation Subset:  IM    
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MeSH Terms
Angioplasty, Balloon, Coronary / adverse effects,  instrumentation*,  mortality
Blood Glucose / drug effects
Cell Proliferation / drug effects
Coronary Angiography
Coronary Restenosis / etiology,  mortality,  pathology,  prevention & control*
Diabetes Mellitus, Type 2 / blood,  complications,  drug therapy*,  mortality
Heart Diseases / etiology,  prevention & control
Hemoglobin A, Glycosylated / metabolism
Hypoglycemic Agents / therapeutic use*
Middle Aged
Myocardial Ischemia / drug therapy,  etiology,  mortality,  therapy*
Prospective Studies
Prosthesis Design
Thiazolidinediones / therapeutic use*
Time Factors
Treatment Outcome
Tunica Intima / drug effects*,  pathology
Ultrasonography, Interventional
Reg. No./Substance:
0/Blood Glucose; 0/Hemoglobin A, Glycosylated; 0/Hypoglycemic Agents; 0/Metals; 0/Thiazolidinediones; 0/hemoglobin A1c protein, human; X4OV71U42S/pioglitazone
Comment In:
JACC Cardiovasc Interv. 2009 Jun;2(6):532-3   [PMID:  19539257 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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