Drug-eluting stent thrombosis: results from the multicenter Spanish registry ESTROFA (Estudio ESpañol sobre TROmbosis de stents FArmacoactivos).
OBJECTIVE
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.
de la Torre-Hernández
José M
JM
Hospital Marques de Valdecilla, Santander, Spain. he1thj@humv.es
Alfonso
Fernando
F
Hernández
Felipe
F
Elizaga
Jaime
J
Sanmartin
Marcelo
M
Pinar
Eduardo
E
Lozano
Iñigo
I
Vazquez
Jose M
JM
Botas
Javier
J
Perez de Prado
Armando
A
Hernández
Jose M
JM
Sanchis
Juan
J
Nodar
Juan M Ruiz
JM
Gomez-Jaume
Alfredo
A
Larman
Mariano
M
Diarte
Jose A
JA
Rodríguez-Collado
Javier
J
Rumoroso
Jose R
JR
Lopez-Minguez
Jose R
JR
Mauri
Josepa
J
D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D003327:Coronary Disease / Q000628:therapy; D003328:Coronary Thrombosis / Q000453:epidemiology / Q000209:etiology* / Q000628:therapy; D018572:Disease-Free Survival; D054855:Drug-Eluting Stents / Q000009:adverse effects*; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009203:Myocardial Infarction / Q000503:physiopathology / Q000628:therapy; D017239:Paclitaxel / Q000008:administration & dosage; D016016:Proportional Hazards Models; D012042:Registries; D020123:Sirolimus / Q000008:administration & dosage; D013318:Stroke Volume
D017239:Paclitaxel; D020123:Sirolimus