Document Detail

Thrombosis of second-generation drug-eluting stents in real practice results from the multicenter Spanish registry ESTROFA-2 (Estudio Español Sobre Trombosis de Stents Farmacoactivos de Segunda Generacion-2).
MedLine Citation:
PMID:  20850089     Owner:  NLM     Status:  MEDLINE    
OBJECTIVES: This study sought to evaluate second-generation drug-eluting stent (DES) thrombosis in clinical practice.
BACKGROUND: First-generation DES are associated with a significant incidence of late thrombosis. There is paucity of data regarding real practice late thrombosis incidence and predictors with second-generation DES, zotarolimus-eluting stent (ZES), and everolimus-eluting stents (EES).
METHODS: A prospective, large-scale, non-industry-linked multicenter registry was designed. Complete clinical-procedural data and systematic follow-up of all patients treated with these stents was reported in a dedicated registry supported by the Spanish Working Group on Interventional Cardiology.
RESULTS: From 2005 to 2008, 4,768 patients were included in 34 centers: 2,549 treated with ZES, and 2,219 with EES. The cumulative incidence of definite/probable thrombosis for ZES was 1.3% at 1 year and 1.7% at 2 years and for EES 1.4% at 1 year and 1.7% at 2 years (p = 0.8). The increment of definite thrombosis between the first and second year was 0.2% and 0.25%, respectively. In a propensity score analysis, the incidence remained very similar. Ejection fraction (adjusted hazard ratio [HR]: 0.97; 95% confidence interval [CI]: 0.95 to -0.99; p = 0.008), stent diameter (adjusted HR: 0.37; 95% CI: 0.17to 0.81; p = 0.01) and bifurcations (adjusted HR: 2.1; 95% CI: 1.14 to 3.7; p = 0.02) emerged as independent predictors of thrombosis. In the subgroup of patients with bifurcations, the use of ZES was independently associated with a higher thrombosis rate (adjusted HR: 4; 95% CI: 1.1 to 13; p = 0.03).
CONCLUSIONS: In a real practice setting, the incidence of thrombosis at 2 years with ZES and EES was low and quite similar. The incidence of very late thrombosis resulted lower than was reported in registries of first-generation DES. In the subset of bifurcations, the use of ZES significantly increased the risk of thrombosis.
José M de la Torre Hernández; Fernando Alfonso; Federico Gimeno; Jose A Diarte; Ramón Lopez-Palop; Armando Pérez de Prado; Fernando Rivero; Juan Sanchis; Mariano Larman; Jose F Diaz; Jaime Elizaga; Javier Martín Moreiras; Alfredo Gomez Jaume; José M Hernández; Josepa Mauri; Angel Sánchez Recalde; Juan A Bullones; Jose R Rumoroso; Bruno García Del Blanco; Jose A Baz; Francisco Bosa; Javier Botas; Felipe Hernández;
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Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study    
Journal Detail:
Title:  JACC. Cardiovascular interventions     Volume:  3     ISSN:  1876-7605     ISO Abbreviation:  JACC Cardiovasc Interv     Publication Date:  2010 Sep 
Date Detail:
Created Date:  2010-09-20     Completed Date:  2011-03-01     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:  911-9     Citation Subset:  IM    
Copyright Information:
Copyright © 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
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MeSH Terms
Coronary Restenosis / epidemiology*,  etiology
Coronary Thrombosis / epidemiology*,  etiology
Drug-Eluting Stents / adverse effects*
Follow-Up Studies
Prospective Studies
Prosthesis Failure
Risk Factors
Spain / epidemiology
Juan C Fernández Guerrero / ; José Moreu / ; Rafael Melgares / ; José M Vázquez / ; Adolfo Rincon / ; Jose D Cascon / ; Antonio Serra / ; Iñigo Lozano / ; Ramiro Trillo / ; Jesús M Jiménez Mazuecos / ; Eduardo Pinar /

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