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
相关论文
共 24 条
[21]   Safety and efficacy of sirolimus- and paclitaxel-eluting coronary stents [J].
Stone, Gregg W. ;
Moses, Jeffrey W. ;
Ellis, Stephen G. ;
Schofer, Joachim ;
Dawkins, Keith D. ;
Morice, Marie-Claude ;
Colombo, Antonio ;
Schampaert, Erick ;
Grube, Eberhard ;
Kirtane, Ajay J. ;
Cutlip, Donald E. ;
Fahy, Martin ;
Pocock, Stuart J. ;
Mehran, Roxana ;
Leon, Martin B. .
NEW ENGLAND JOURNAL OF MEDICINE, 2007, 356 (10) :998-1008
[22]   Randomized Comparison of Everolimus-Eluting and Paclitaxel-Eluting Stents Two-Year Clinical Follow-Up From the Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions (SPIRIT) III Trial [J].
Stone, Gregg W. ;
Midei, Mark ;
Newman, William ;
Sanz, Mark ;
Hermiller, James B. ;
Williams, Jerome ;
Farhat, Naim ;
Caputo, Ronald ;
Xenopoulos, Nicholas ;
Applegate, Robert ;
Gordon, Paul ;
White, Roseann M. ;
Sudhir, Krishnankutty ;
Cutlip, Donald E. ;
Petersen, John L. .
CIRCULATION, 2009, 119 (05) :680-686
[23]  
STONE GW, 2009, TRANSC THER SEPT SAN
[24]   Incidence and correlates of drug-eluting stent thrombosis in routine clinical practice -: 4-year results from a large 2-institutional cohort study [J].
Wenaweser, Peter ;
Daemen, Joost ;
Zwahlen, Marcel ;
van Domburg, Ron ;
Jueni, Peter ;
Vaina, Sophia ;
Hellige, Gerrit ;
Tsuchida, Keiichi ;
Morger, Cyrill ;
Boersma, Eric ;
Kukreja, Neville ;
Meier, Bernhard ;
Serruys, Patrick W. ;
Windecker, Stephan .
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 2008, 52 (14) :1134-1140