Document Detail


Long-term clinical benefit of sirolimus-eluting stent implantation in diabetic patients with de novo coronary stenoses: long-term results of the DIABETES trial.
MedLine Citation:
PMID:  17562666     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
AIMS: Sirolimus stent implantation has been demonstrated to be safe and effective in diabetics; however, the long-term outcomes in this high-risk population remain unknown. The aim of this study was to determine the long-term safety and efficacy of the sirolimus-eluting stent (SES) when compared with the bare metal stent (BMS) in patients included in the DIABETES (DIABETes and sirolimus Eluting Stent) trial. METHODS AND RESULTS: The prospective multicentre DIABETES trial randomized 160 diabetic patients with one or more significant coronary stenoses in one, two, or three vessels to either SES or BMS implantation. One-year dual antiplatelet therapy (aspirin plus clopidogrel) was routinely prescribed. Clinical follow-up was scheduled at 1, 9, 12, and 13 months and 2 years. Baseline clinical and angiographic characteristics were comparable between groups. At 2 years, the rate of target lesion revascularization was significantly lower in the SES group compared with the BMS group (7.7 vs. 35.0%, P < 0.001). However, the total revascularization rate at 2 years increased in both groups due to progression of atherosclerosis in coronary segments remote from the target lesion (rate of atherosclerosis progression: 7.7% in SES group vs. 10% in BMS group; P = 0.7). During dual antiplatelet treatment (1 year), there was no stent thrombosis in the SES group, whereas two patients presented it in the BMS group. However, after clopidogrel withdrawal, three patients allocated to the SES group presented stent thromboses vs. none in the BMS group. CONCLUSION: SES implantation in diabetic patients remains effective at 2-year follow-up. However, clinical efficacy appeared to be reduced by the occurrence of stent thrombosis between 1 and 2 years.
Authors:
Pilar Jiménez-Quevedo; Manel Sabaté; Dominick J Angiolillo; Fernando Alfonso; Rosana Hernández-Antolín; Marcelo SanMartín; Joan Antoni Gómez-Hospital; Camino Bañuelos; Javier Escaned; Raúl Moreno; Cristina Fernández; Francisco Fernández-Avilés; Carlos Macaya;
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2007-06-11
Journal Detail:
Title:  European heart journal     Volume:  28     ISSN:  0195-668X     ISO Abbreviation:  Eur. Heart J.     Publication Date:  2007 Aug 
Date Detail:
Created Date:  2007-08-16     Completed Date:  2008-04-03     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8006263     Medline TA:  Eur Heart J     Country:  England    
Other Details:
Languages:  eng     Pagination:  1946-52     Citation Subset:  IM    
Affiliation:
Servicio de Cardiología Intervencionista, Cardiovascular Institute, San Carlos University Hospital, Madrid 28040, Spain.
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MeSH Terms
Descriptor/Qualifier:
Aged
Aspirin / therapeutic use
Blood Vessel Prosthesis
Coronary Restenosis / prevention & control
Coronary Stenosis / therapy*
Death, Sudden, Cardiac / etiology
Diabetic Angiopathies / therapy*
Drug-Eluting Stents*
Female
Follow-Up Studies
Humans
Immunosuppressive Agents / administration & dosage*
Male
Myocardial Infarction / etiology,  therapy
Myocardial Revascularization / methods
Platelet Aggregation Inhibitors / therapeutic use
Prospective Studies
Prosthesis Failure
Reoperation
Sirolimus / administration & dosage*
Ticlopidine / analogs & derivatives,  therapeutic use
Treatment Outcome
Chemical
Reg. No./Substance:
0/Immunosuppressive Agents; 0/Platelet Aggregation Inhibitors; 50-78-2/Aspirin; 53123-88-9/Sirolimus; 55142-85-3/Ticlopidine; 90055-48-4/clopidogrel

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


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