Unrestricted Use of Endeavor Resolute Zotarolimus-Eluting Stent in Daily Clinical Practice: A Prospective Registry

作者：Galasso Gennaro; Piccolo Raffaele; Cassese Salvatore; Esposito Giovanni; Cirillo Plinio; Leosco Dario; Rapacciuolo Antonio; Sirico Domenico; De Biase Chiara; Niglio Tullio; Piscione Federico^*

来源：Journal of Invasive Cardiology, 2012, 24(6): 251-255.

• zotarolimus-eluting stent
• Endeavor Resolute
• percutaneous coronary intervention
• off-label
• drug-eluting stent

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.

• 出版日期2012-6