CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY
Drug-Eluting Stent ThrombosisResults From the Multicenter Spanish Registry ESTROFA (Estudio ESpañol sobre TROmbosis de stents FArmacoactivos)
José M. de la Torre-Hernández, MD, PhD*,*,
Fernando Alfonso, MD, PhD ,
Felipe Hernández, MD ,
Jaime Elizaga, MD ,
Marcelo Sanmartin, MD, PhD||,
Eduardo Pinar, MD¶,
Iñigo Lozano, MD, PhD#,
Jose M. Vazquez, MD**,
Javier Botas, MD, PhD,
Armando Perez de Prado, MD,
Jose M. Hernández, MD, PhD,
Juan Sanchis, MD, PhD||||,
Juan M. Ruiz Nodar, MD, PhD¶¶,
Alfredo Gomez-Jaume, MD, PhD##,
Mariano Larman, MD***,
Jose A. Diarte, MD, PhD,
Javier Rodríguez-Collado, MD,
Jose R. Rumoroso, MD, PhD,
Jose R. Lopez-Minguez, MD||||||,
Josepa Mauri, MD¶¶¶ for the ESTROFA Study Group
* Hospital Marques de Valdecilla, Santander, Spain
Hospital Clinico San Carlos, Madrid, Spain
Hospital 12 de Octubre, Madrid, Spain
Hospital Gregorio Marañon, Madrid, Spain
|| Hospital do Meixoeiro, Vigo, Spain
¶ Hospital Virgen de la Arrixaca, Murcia, Spain
# Hospital Central de Asturias, Oviedo, Spain
** Hospital Juan Canalejo, La Coruña, Spain
Hospital Fundación Alcorcon, Alcorcon, Spain
Hospital de Leon, Leon, Spain
Hospital Virgen de la Victoria, Malaga, Spain
|||| Hospital Clínico, Valencia, Spain
¶¶ Hospital General, Alicante, Spain
## Hospital Son Dureta, Palma de Mallorca, Spain
*** Policlínica Guipúzcoa, San Sebastián, Spain
Hospital Miguel Servet, Zaragoza, Spain
Hospital Clinico, Salamanca, Spain
Hospital de Galdacano, Bilbao, Spain
|||||| Hospital Infanta Cristina, Badajoz, Spain
¶¶¶ Hospital Germans Trias i Pujol, Badalona, Spain.
Manuscript received July 16, 2007;
revised manuscript received October 17, 2007,
accepted October 22, 2007.
* Reprint requests and correspondence: Dr. José M. de la Torre Hernández, Unidad de Hemodinámica y Cardiología Intervencionista, Hospital Universitario Marqués de Valdecilla, Avda. Valdecilla s/n, 39008 Santander, Spain. (Email: he1thj{at}humv.es).
Objectives: This study sought to assess the incidence, predictors, and outcome of drug-eluting stent (DES) thrombosis in real-world clinical practice.
Background: The DES thromboses in randomized trials could not be comparable to those observed in clinical practice, frequently including off-label indications.
Methods: We designed a large-scale, nonindustry-linked multicentered registry, with 20 centers in Spain. The participant centers provided follow-up data for their patients treated with DES, reporting a detailed standardized form in the event of any angiography-documented DES-associated thrombosis occurring.
Results: Of 23,500 patients treated with DES, definite stent thrombosis (ST) developed in 301: 24 acute, 125 subacute, and 152 late. Of the late, 62 occurred >1 year (very late ST). The cumulative incidence was 2% at 3 years. Antiplatelet treatment had been discontinued in 95 cases (31.6%). No differences in incidences were found among stent types. Independent predictors for subacute ST analyzed in a subgroup of 14,120 cases were diabetes, renal failure, acute coronary syndrome, ST-segment elevation myocardial infarction, stent length, and left anterior descending artery stenting, and for late ST were ST-segment elevation myocardial infarction, stenting in left anterior descending artery, and stent length. Mortality at 1-year follow-up was 16% and ST recurrence 4.6%. Older age, left ventricular ejection fraction <45%, nonrestoration of Thrombolysis In Myocardial Infarction flow grade 3, and additional stenting were independent predictors for mortality.
Conclusions: The cumulative incidence of ST after DES implantation was 2% at 3 years. No differences were found among stent types. Patient profiles differed between early and late ST. Short-term prognosis is poor, especially when restoration of normal flow fails.
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Abbreviations and Acronyms
| | BMS = bare-metal stent(s) | | DES = drug-eluting stent(s) | | LAD = left anterior descending artery | | PES = paclitaxel-eluting stent(s) | | SES = sirolimus-eluting stent(s) | | ST = stent thrombosis | | STEMI = ST-segment elevation myocardial infarction |
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