Thrombosis of second-generation drug-eluting stents in real practice results from the multicenter Spanish registry ESTROFA-2 (Estudio Español Sobre Trombosis de Stents Farmacoactivos de Segunda Generacion-2).
OBJECTIVE
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% CI: 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.
de la Torre Hernández
José M
JM
Interventional Cardiology Department, Unidad de Hemodinámica y Cardiología Intervencionista, Hospital Universitario Marques de Valdecilla, Instituto de Formación e Investigación Marqués de Valdecilla, Santander, Spain. he1thj@humv.es
Alfonso
Fernando
F
Gimeno
Federico
F
Diarte
Jose A
JA
Lopez-Palop
Ramón
R
Pérez de Prado
Armando
A
Rivero
Fernando
F
Sanchis
Juan
J
Larman
Mariano
M
Diaz
Jose F
JF
Elizaga
Jaime
J
Moreiras
Javier Martín
JM
Gomez Jaume
Alfredo
A
Hernández
José M
JM
Mauri
Josepa
J
Recalde
Angel Sánchez
AS
Bullones
Juan A
JA
Rumoroso
Jose R
JR
Del Blanco
Bruno García
BG
Baz
Jose A
JA
Bosa
Francisco
F
Botas
Javier
J
Hernández
Felipe
F
D000368:Aged; D023903:Coronary Restenosis / Q000453:epidemiology* / Q000209:etiology; D003328:Coronary Thrombosis / Q000453:epidemiology* / Q000209:etiology; D054855:Drug-Eluting Stents / Q000009:adverse effects*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D008297:Male; D011446:Prospective Studies; D011475:Prosthesis Failure; D012042:Registries; D012307:Risk Factors; D013030:Spain / Q000453:epidemiology