Unrestricted use of endeavor resolute zotarolimus-eluting stent in daily clinical practice: a prospective registry.
BACKGROUND
To evaluate the safety and efficacy of unrestricted Endeavor Resolute zotarolimus-eluting stent (ZES) use. Furthermore, we sought to evaluate clinical outcomes associated with on- and off-label use of Resolute ZES.


METHODS
The current study was a prospective, single-center registry. The primary endpoint was major adverse cardiac events (MACE), defined as the composite of death, myocardial infarction (MI), and target-vessel revascularization (TVR). Secondary endpoints were death, MI, TVR, and stent thrombosis (ST).


RESULTS
A total of 370 patients were prospectively enrolled. Off-label Resolute ZES use was performed in 311 patients (84%). At a mean follow-up of 17.3 ± 6 months, MACE occurred in 31 patients (8.5%), death in 15 (4.1%), MI in 10 (2.7%), and TVR in 19 (5.2%). Definite, probable, and possible ST occurred in 9 patients (2.5%). Off-label Resolute ZES implantation, as compared to on-label use, was not associated with an increased risk of MACE (9.4% vs 3.4%; P=.13), death (4.9% vs 0%; P=.14), MI (3.3% vs 0%; P=.38), and TVR (5.5% vs 3.4%; P=.75). On multivariable analysis, previous revascularization (P=.008), but not off-label Resolute ZES implantation (P=.07), was associated with MACE.


CONCLUSIONS
In daily clinical practice, Resolute ZES was mostly implanted in patients with off-label indications and associated with a relatively low rate of MACE and TVR.
Department of Clinical Medicine, Cardiovascular Sciences and Immunology, Federico II University, Via S. Pansini, 5. 80131. Naples, Italy.
Gennaro
G
Galasso
Raffaele
R
Piccolo
Salvatore
S
Cassese
Giovanni
G
Esposito
Plinio
P
Cirillo
Dario
D
Leosco
Antonio
A
Rapacciuolo
Domenico
D
Sirico
Chiara
C
De Biase
Tullio
T
Niglio
Federico
F
Piscione
D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000379:methods* / Q000401:mortality; D015331:Cohort Studies; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000453:epidemiology; D054855:Drug-Eluting Stents; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D016015:Logistic Models; D008297:Male; D015999:Multivariate Analysis; D056687:Off-Label Use; D011446:Prospective Studies; D011475:Prosthesis Failure; D012042:Registries; D018570:Risk Assessment; D020123:Sirolimus / Q000031:analogs & derivatives* / Q000494:pharmacology; D018709:Statistics, Nonparametric; D015996:Survival Rate; D016896:Treatment Outcome
C489443:zotarolimus; D020123:Sirolimus