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)
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, ESTROFA-2 Study Group, 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, 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, ESTROFA-2 Study Group, 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
Abstract
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.
Copyright © 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Source: PubMed