Thrombosis of Second-Generation Drug-Eluting Stents in Real Practice Results From the Multicenter Spanish Registry ESTROFA-2 (Estudio Espanol Sobre Trombosis de Stents Farmacoactivos de Segunda Generacion-2)

被引:31
作者
de la Torre Hernandez, Jose M. [1 ]
Alfonso, Fernando [2 ]
Gimeno, Federico [7 ]
Diarte, Jose A. [8 ]
Lopez-Palop, Ramon [9 ]
Perez de Prado, Armando [10 ]
Rivero, Fernando [3 ]
Sanchis, Juan [11 ]
Larman, Mariano [12 ]
Diaz, Jose F. [13 ,16 ]
Elizaga, Jaime [4 ]
Martin Moreiras, Javier [14 ]
Gomez Jaume, Alfredo [15 ]
Hernandez, Jose M.
Mauri, Josepa [18 ]
Sanchez Recalde, Angel [5 ]
Bullones, Juan A. [17 ]
Rumoroso, Jose R. [19 ]
Garcia del Blanco, Bruno [20 ]
Baz, Jose A. [21 ]
Bosa, Francisco [22 ]
Botas, Javier [23 ]
Hernandez, Felipe [6 ]
机构
[1] Hosp Univ Marques Valdecilla, Unidad Hemodinam & Cardiol Intervencionista, Inst Formac & Invest Marques Valdecilla, Intervent Cardiol Dept, Santander 39012, Spain
[2] Hosp Clinico San Carlos, Intervent Cardiol Dept, Madrid, Spain
[3] Hosp La Princesa, Intervent Cardiol Dept, Madrid, Spain
[4] Hosp Gregorio Maranon, Intervent Cardiol Dept, Madrid, Spain
[5] Hosp La Paz, Intervent Cardiol Dept, Madrid, Spain
[6] Hosp 12 Octubre, Intervent Cardiol Dept, E-28041 Madrid, Spain
[7] Hosp Clin Valladolid, Intervent Cardiol Dept, Valladolid, Spain
[8] Hosp Miguel Servet, Intervent Cardiol Dept, Zaragoza, Spain
[9] Hosp San Juan Alicante, Intervent Cardiol Dept, Alicante, Spain
[10] Hosp Leon, Intervent Cardiol Dept, Leon, Spain
[11] Hosp Clin Valencia, Intervent Cardiol Dept, Valencia, Spain
[12] Policlin Guipuzcoa, Intervent Cardiol Dept, San Sebastian, Spain
[13] Hosp Juan Ramon Jimenez, Intervent Cardiol Dept, Huelva, Spain
[14] Hosp Clin Salamanca, Intervent Cardiol Dept, Salamanca, Spain
[15] Hosp Son Dureta, Intervent Cardiol Dept, Palma de Mallorca, Spain
[16] Hosp Virgen La Victoria, Intervent Cardiol Dept, Malaga, Spain
[17] Hosp Carlos Haya, Intervent Cardiol Dept, Malaga, Spain
[18] Hosp Badalona Germans Trias & Pujol, Intervent Cardiol Dept, Badalona, Spain
[19] Hosp Galdacano, Intervent Cardiol Dept, Bilbao, Spain
[20] Hosp Vail dHebron, Intervent Cardiol Dept, Barcelona, Spain
[21] Hosp Meixoeiro, Intervent Cardiol Dept, Vigo, Spain
[22] Hosp Clin Tenerife, Intervent Cardiol Dept, Santa Cruz de Tenerife, Spain
[23] Fdn Alcorcon, Intervent Cardiol Dept, Alcorcon, Spain
关键词
coronary; stents; thrombosis; CORONARY-ARTERY-DISEASE; LARGE 2-INSTITUTIONAL COHORT; ROUTINE CLINICAL-PRACTICE; ENDEAVOR-II; FOLLOW-UP; TRIAL; OUTCOMES; LESIONS; SAFETY; EFFICACY;
D O I
10.1016/j.jcin.2010.06.010
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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% Cl: 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. (J Am Coll Cardiol Intv 2010;3:911-9) (C) 2010 by the American College of Cardiology Foundation
引用
收藏
页码:911 / 919
页数:9
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