Unrestricted Use of Endeavor Resolute Zotarolimus-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.
Drug-eluting stents (DES) represented a breakthrough technology in the invasive treatment of patients with coronary artery disease. Several randomized trials have shown a significant reduction in restenosis, as well as in the need of reintervention, in patients treated with DESs as compared to bare-metal stents. Nevertheless, concerns have been recently raised about DES safety: several large registries documented that "off-label" DES use, namely DES implantation with indications that have not been tested in first pivotal trials, is associated with a higher incidence of adverse clinical events as compared to "on-label" patients, which have relatively more favorable clinical features and lesion characteristics. Unfortunately, these findings derived from the evaluation of "first-generation" DESs, such as sirolimus- and paclitaxel-eluting stents. To date, insufficient data are available regarding clinical outcomes associated with the use of a "second-generation" zotarolimus-eluting stent (ZES), namely the Endeavor Resolute ZES (Medtronic Vascular). The Resolute ZES employs BioLink polymer technology instead of the phosphorylcholine coating of the first marketed Endeavor ZES, which aims to extend drug elution, thus ensuring better performance even in the treatment of more challenging coronary lesions.
Therefore, the purpose of this study was to perform a prospective registry evaluating the safety and efficacy of unrestricted Resolute ZES use in a cohort of real-world patients. Furthermore, we sought to evaluate clinical outcomes associated with on- and off-label use of the Resolute ZES.
Abstract and Introduction
Abstract
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.
Introduction
Drug-eluting stents (DES) represented a breakthrough technology in the invasive treatment of patients with coronary artery disease. Several randomized trials have shown a significant reduction in restenosis, as well as in the need of reintervention, in patients treated with DESs as compared to bare-metal stents. Nevertheless, concerns have been recently raised about DES safety: several large registries documented that "off-label" DES use, namely DES implantation with indications that have not been tested in first pivotal trials, is associated with a higher incidence of adverse clinical events as compared to "on-label" patients, which have relatively more favorable clinical features and lesion characteristics. Unfortunately, these findings derived from the evaluation of "first-generation" DESs, such as sirolimus- and paclitaxel-eluting stents. To date, insufficient data are available regarding clinical outcomes associated with the use of a "second-generation" zotarolimus-eluting stent (ZES), namely the Endeavor Resolute ZES (Medtronic Vascular). The Resolute ZES employs BioLink polymer technology instead of the phosphorylcholine coating of the first marketed Endeavor ZES, which aims to extend drug elution, thus ensuring better performance even in the treatment of more challenging coronary lesions.
Therefore, the purpose of this study was to perform a prospective registry evaluating the safety and efficacy of unrestricted Resolute ZES use in a cohort of real-world patients. Furthermore, we sought to evaluate clinical outcomes associated with on- and off-label use of the Resolute ZES.
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