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CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY

Drug-Eluting Stent Thrombosis

Results 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.

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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