Document Detail


Randomized evaluation of two drug-eluting stents with identical metallic platform and biodegradable polymer but different agents (paclitaxel or sirolimus) compared against bare stents: 1-year results of the PAINT trial.
MedLine Citation:
PMID:  19670303     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVES: We tested two novel drug-eluting stents (DES), covered with a biodegradable-polymer carrier and releasing paclitaxel or sirolimus, which were compared against a bare metal stent (primary objective). The DES differed by the drug, but were identical otherwise, allowing to compare the anti-restenosis effects of sirolimus versus paclitaxel (secondary objective). BACKGROUND: The efficacy of novel DES with biodegradable polymers should be tested in the context of randomized trials, even when using drugs known to be effective, such as sirolimus and paclitaxel. METHODS: Overall, 274 patients with de novo coronary lesions in native vessels scheduled for stent implantation were randomly assigned (2:2:1 ratio) for the paclitaxel (n = 111), sirolimus (n = 106), or bare metal stent (n = 57) groups. Angiographic follow-up was obtained at 9 months and major cardiac adverse events up to 12 months. RESULTS: Both paclitaxel and sirolimus stents reduced the 9-month in-stent late loss (0.54-0.44 mm, 0.32-0.43 mm, vs. 0.90-0.45 mm respectively), and 1-year risk of target vessel revascularization and combined major adverse cardiac events (P < 0.05 for both, in all comparisons), compared with controls. Sirolimus stents had lower late loss than paclitaxel stents (P < 0.01), but similar 1-year clinical outcomes. There were no differences in the risk of death, infarction, or stent thrombosis among the study groups. CONCLUSION: Both novel DES were effective in reducing neointimal hyperplasia and 1-year re-intervention, compared to bare metal stents. Our findings also suggest that sirolimus is more effective than paclitaxel in reducing angiographic neointima, although this effect was not associated with better clinical outcomes.
Authors:
Pedro A Lemos; Bruno Moulin; Marco A Perin; Ludmilla A R R Oliveira; J Airton Arruda; Valter C Lima; Antonio A G Lima; Paulo R A Caramori; Cesar R Medeiros; Mauricio R Barbosa; Fabio S Brito; Expedito E Ribeiro; Eul??gio E Martinez;
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Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions     Volume:  74     ISSN:  1522-726X     ISO Abbreviation:  Catheter Cardiovasc Interv     Publication Date:  2009 Nov 
Date Detail:
Created Date:  2009-11-02     Completed Date:  2010-01-14     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  100884139     Medline TA:  Catheter Cardiovasc Interv     Country:  United States    
Other Details:
Languages:  eng     Pagination:  665-73     Citation Subset:  IM    
Copyright Information:
Copyright 2009 Wiley-Liss, Inc.
Affiliation:
Catheterization Laboratory, Heart Institute (InCor), University of S??o Paulo Medical School (USP), Sao Paulo, Brazil. pedro.lemos@incor.usp.br
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MeSH Terms
Descriptor/Qualifier:
Aged
Angioplasty, Transluminal, Percutaneous Coronary / adverse effects,  instrumentation*,  mortality
Brazil / epidemiology
Cardiovascular Agents / administration & dosage*
Cardiovascular Diseases / etiology,  mortality,  prevention & control*,  radiography
Coated Materials, Biocompatible*
Coronary Angiography
Coronary Restenosis / etiology,  prevention & control
Coronary Stenosis / mortality,  radiography,  therapy*
Drug-Eluting Stents*
Female
Humans
Hyperplasia
Kaplan-Meiers Estimate
Male
Metals*
Middle Aged
Myocardial Infarction / etiology,  prevention & control
Paclitaxel / administration & dosage*
Proportional Hazards Models
Prosthesis Design
Risk Assessment
Sirolimus / administration & dosage*
Stents*
Thrombosis / etiology,  prevention & control
Time Factors
Treatment Outcome
Chemical
Reg. No./Substance:
0/Cardiovascular Agents; 0/Coated Materials, Biocompatible; 0/Metals; 33069-62-4/Paclitaxel; 53123-88-9/Sirolimus
Investigator
Investigator/Affiliation:
Pedro A Lemos / ; Eul??gio E Martinez / ; Expedito E Ribeiro / ; Valter C Lima / ; Bruno M Machado / ; J Airton Arruda / ; Itamar Ribeiro Oliveira / ; Maur??cio de Rezende Barbosa / ; F??bio S de Brito / ; C??sar R Medeiros / ; Paulo Caramori / ; Marco Antonio Perin / ; Antonio Carlos Carvalho / ; Carlos Augusto Campos / ; Luciano Drager /

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