Drug-eluting stent thrombosis: results from the multicenter Spanish registry ESTROFA (Estudio ESpañol sobre TROmbosis de stents FArmacoactivos)
José M de la Torre-Hernández, Fernando Alfonso, Felipe Hernández, Jaime Elizaga, Marcelo Sanmartin, Eduardo Pinar, Iñigo Lozano, Jose M Vazquez, Javier Botas, Armando Perez de Prado, Jose M Hernández, Juan Sanchis, Juan M Ruiz Nodar, Alfredo Gomez-Jaume, Mariano Larman, Jose A Diarte, Javier Rodríguez-Collado, Jose R Rumoroso, Jose R Lopez-Minguez, Josepa Mauri, ESTROFA Study Group, José M de la Torre-Hernández, Fernando Alfonso, Felipe Hernández, Jaime Elizaga, Marcelo Sanmartin, Eduardo Pinar, Iñigo Lozano, Jose M Vazquez, Javier Botas, Armando Perez de Prado, Jose M Hernández, Juan Sanchis, Juan M Ruiz Nodar, Alfredo Gomez-Jaume, Mariano Larman, Jose A Diarte, Javier Rodríguez-Collado, Jose R Rumoroso, Jose R Lopez-Minguez, Josepa Mauri, ESTROFA Study Group
Abstract
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.
Source: PubMed