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3-Year Clinical Follow-Up of the XIENCE V Everolimus-Eluting Coronary Stent System in the Treatment of Patients With De Novo Coronary Artery Lesions

The SPIRIT II Trial (Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients with de novo Native Coronary Artery Lesions)

Scot Garg, MBChB^_*, Patrick Serruys, MD, PhD^_*,_*, Yoshinobu Onuma, MD^_*, Cécile Dorange, MSc, Susan Veldhof, RN, Karine Miquel-Hébert, PhD, Krishnankutty Sudhir, MD, PhD, Jean Boland, MD, Kurt Huber, MD^||, Eulogio Garcia, MD^¶, Jan A.M. te Riele, MD^# on behalf of the SPIRIT II Investigators

^_* Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands
Abbott Vascular, Diegem, Belgium
Abbott Vascular, Santa Clara, California
C.H.R. La Citadelle, Liege, Belgium
^|| Wilhelminenspital der Stadt, Vienna, Austria
^¶ University Hospital Gregorio Maranon, Madrid, Spain
^# Amphia Hospital, Breda, the Netherlands

^_* Reprint requests and correspondence: Prof. Patrick Serruys, Ba583a, Thoraxcenter, Erasmus MC,'s-Gravendijkwal 230, 3015 CE Rotterdam, the Netherlands (Email: p.w.j.c.serruys{at}erasmusmc.nl).

Objectives: This paper reports the 3-year clinical outcomes of the XIENCE V (Abbott Vascular, Santa Clara, California) everolimus-eluting stent (EES) compared with the TAXUS (Boston Scientific, Natick, Massachusetts) paclitaxel-eluting stent (PES) in the randomized SPIRIT II (Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients with de novo Native Coronary Artery Lesions) study.

Background: The Xience V EES is a new-generation drug-eluting stent (DES) that might offer advantages over the first-generation DES in terms of improved clinical outcomes and a better safety profile.

Methods: The SPIRIT II trial was a multicenter, prospective, randomized, single-blind, clinical trial, randomizing 300 patients with de novo coronary artery lesions in a ratio of 3:1 to either EES or PES. The primary end point was in-stent late loss at 180 days.

Results: At 3-year clinical follow-up cardiac death was numerically lower with EES than PES (0.5% vs. 4.3%, p = 0.056). The observed rate of myocardial infarction was 3.6% for EES and 7.2% for PES (p = 0.31). The rate of ischemia-driven target lesion revascularization was 4.6% and 10.1% for EES and PES, respectively (p = 0.14). Overall, there was a trend for lower major adverse cardiovascular events in the EES group compared with PES (7.2% vs. 15.9%, p = 0.053). The rate of stent thrombosis was low and comparable in both groups (EES 1.0% vs. PES 2.9%).

Conclusions: The present study reports the favorable 3-year clinical outcomes of the EES, which are consistent with the results from other studies of the EES with shorter follow-up.

Key Words: angioplasty • everolimus-eluting stent • paclitaxel-eluting stent

Abbreviations and Acronyms   ARC = Academic Research Consortium   BMS = bare-metal stent(s)   CABG = coronary artery bypass graft   CI = confidence interval   CK-MB = creatinine kinase-myocardial band   DES = drug-eluting stent(s)   DS = diameter stenosis   EES = everolimus-eluting stent(s)   HR = hazard ratio   ID-TLR = ischemia-driven target lesion revascularization   IVUS = intravascular ultrasound   MACE = major adverse cardiovascular events   MI = myocardial infarction   PCI = percutaneous coronary intervention   PES = paclitaxel-eluting stent(s)   RR = relative risk   SES = sirolimus-eluting stent(s)   ULN = upper limit of normal   TVF = target vessel failure   TVR = target vessel revascularization

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