Document Detail

Predictive factors for in-stent late loss and coronary lesion progression in patients with type 2 diabetes mellitus randomized to rosiglitazone or placebo.
MedLine Citation:
PMID:  19185649     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Type 2 diabetics (DM2) are at increased risk for restenosis as well as nonculprit coronary artery lesion (NCCL) progression. Rosiglitazone (RSG) favorably modifies many of the altered biologic processes in DM2, although recent reports have questioned its safety. We conducted a double-blind randomized trial to assess the effects of RSG versus placebo on in-stent late lumen loss (LL) and angiographic progression of NCCL. METHODS: A total of 65 DM2 were randomized to RSG (4 mg/d) (n = 32) or placebo (n = 33) at the time of stenting and underwent clinical and laboratory analysis at 1 and 4 months and 8-month angiography (n = 46 patients). Rapid angiographic progression (RAP) was defined as > or =20% diameter reduction of preexisting NCCL by quantitative coronary angiography, or a new narrowing > or =30%. RESULTS: Mean LL in RSG (n = 33 lesions) was not different from that of placebo (0.62 +/- 0.59 vs 0.70 +/- 0.67, P = NS). Seven (13.5%) of 52 NCCLs have RAP in RSG versus 9 (16.1%) of 56 in placebo (P = NS). High-sensitivity C-reactive protein (hs-CRP) was the only predictor of RAP. Patients with a 120-day hs-CRP > or =75th percentile had an OR of 7.35 (95% CI 2.35-23) for RAP versus those below. Although RSG treatment also lowered log (hs-CRP) at 4 months (RSG 0.10 +/- 0.37 vs placebo 0.26 +/- 0.49, P = .06), it did not decrease the likelihood of plaque progression while also raising LDL and N-terminal brain naturetic peptide. CONCLUSIONS: Rosiglitazone appears not to lower LL or reduce angiographic progression of NCCL in DM2 and had complex effects on markers of cardiac risk.
Aloke V Finn; Jae S Oh; Michael Hendricks; Maureen Daher; Enrico Cagliero; Raphael M Byrne; Jeffrey Nadelson; Johanna Crimins; Adnan Kastrati; Albert Schömig; Olga Bruskina; Igor Palacios; Michael C John; Herman K Gold
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  American heart journal     Volume:  157     ISSN:  1097-6744     ISO Abbreviation:  Am. Heart J.     Publication Date:  2009 Feb 
Date Detail:
Created Date:  2009-02-02     Completed Date:  2009-02-24     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0370465     Medline TA:  Am Heart J     Country:  United States    
Other Details:
Languages:  eng     Pagination:  383.e1-8     Citation Subset:  AIM; IM    
Department of Internal Medicine, Massachusetts General Hospital, Boston, USA.
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MeSH Terms
Angioplasty, Transluminal, Percutaneous Coronary
Biological Markers / blood
Coronary Angiography
Coronary Restenosis / blood,  etiology*,  prevention & control,  radiography
Coronary Stenosis / blood,  etiology,  prevention & control,  radiography
Diabetes Mellitus, Type 2 / complications*
Diabetic Angiopathies / complications
Disease Progression
Double-Blind Method
Middle Aged
Predictive Value of Tests
Thiazolidinediones / therapeutic use*
Vasodilator Agents / therapeutic use*
Reg. No./Substance:
0/Biological Markers; 0/Thiazolidinediones; 0/Vasodilator Agents; 122320-73-4/rosiglitazone

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

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