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Clinical Outcomes After Unrestricted Implantation of Everolimus-Eluting Stents

Azeem Latib, MB BCh^_*,, Luca Ferri, MD^_*, Alfonso Ielasi, MD^_*, Cosmo Godino, MD^_*,, Alaide Chieffo, MD^_*, Valeria Magni, MD^_*, Giorgio Bassanelli, MD^_*, Andrew S.P. Sharp, MD, Robert Gerber, MD, Iassen Michev, MD^_*,, Mauro Carlino, MD^_*, Flavio Airoldi, MD^_*, Giuseppe M. Sangiorgi, MD, Matteo Montorfano, MD^_*, Antonio Colombo, MD^_*,,_*

^_* Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy
Interventional Cardiology Unit, EMO Centro Cuore Columbus, Milan, Italy
Division of Cardiology, University of Cape Town, Cape Town, South Africa

^_* Reprint requests and correspondence: Dr. Antonio Colombo, EMO-GVM Centro Cuore Columbus, 48 Via M. Buonarroti, 20145 Milan, Italy (Email: info{at}emocolumbus.it).

Objectives: The aim of this study was to evaluate the efficacy and safety of unrestricted everolimus-eluting stent (EES) implantation in a contemporary cohort of real-world patients.

Background: The randomized SPIRIT (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions) trials have evaluated the performance of EES, resulting in their approval by the Food and Drug Administration, but data regarding unselected usage, including off-label indications are lacking.

Methods: Consecutive patients treated with EES (either PROMUS, Boston Scientific Corp., Natick, Massachusetts, or XIENCE-V, Abbott Vascular Devices, Santa Clara, California) between October 2006 and February 2008 were analyzed. End points were cardiac death, myocardial infarction (MI), ischemic-driven target lesion revascularization (TLR), stent thrombosis (ST), and major adverse cardiac events (MACE) (a composite of cardiac death, MI, TLR) during follow-up.

Results: We identified 345 patients (573 lesions) treated with EES. The majority of patients (71.9%) were treated for 1 off-label or untested indication. Clinical follow-up was completed in 99%. At a median follow-up of 378 days (interquartile range 334 to 473), MACE occurred in 36 (10.6%) patients, TLR in 27 (7.9%), MI in 7 (2.1%), and cardiac death in 7 (2.1%). Definite and probable ST was observed in 3 (0.9%) cases. Off-label EES implantation was not associated with a statistically significant increased risk of MACE (12.2% vs. 6.3%, p = 0.17), TLR (9.3% vs. 4.2%, p = 0.18), or ST (0.8% vs. 1.1%, p = 1.0). On multivariable analysis, previous bypass surgery (p = 0.002) and diabetes (p = 0.03) were associated with MACE.

Conclusions: In unrestricted daily practice, EES were implanted predominantly for off-label indications and associated with a relative low rate of MACE and TLR.

Key Words: drug-eluting stent • everolimus-eluting stent • off-label • outcomes • real world

Abbreviations and Acronyms   BMS = bare-metal stent(s)   CI = confidence interval   DES = drug-eluting stent(s)   EES = everolimus-eluting stent(s)   FDA = Food and Drug Administration   IVUS = intravascular ultrasound   MACE = major adverse cardiac events   MI = myocardial infarction   ST = stent thrombosis   TLR = target lesion revascularization   TVR = target vessel revascularization

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