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Original Articles

Two-Year Clinical, Angiographic, and Intravascular Ultrasound Follow-Up of the XIENCE V Everolimus-Eluting Stent in the Treatment of Patients With De Novo Native Coronary Artery Lesions

The SPIRIT II Trial

Bimmer E. Claessen, MD; Marcel A. Beijk, MD; Victor Legrand, MD; Witold Ruzyllo, MD; Antonio Manari, MD; Olivier Varenne, MD, PhD; Maarten J. Suttorp, MD, PhD; Jan G.P. Tijssen, PhD; Karine Miquel-Hebert, PhD; Susan Veldhof, RN; Jose P.S. Henriques, MD, PhD; Patrick W. Serruys, MD, PhD and Jan J. Piek, MD, PhD

From the Department of Cardiology (B.E.C., M.A.B., J.G.P.T., J.P.S.H., J.J.P.), Academic Medical Center, University of Amsterdam, The Netherlands; C.H.U. de Liege Sart Tilman (V.L.), Liege, Belgium; National Institute of Cardiology in Warsaw (W.R.), Warsaw, Poland; Azienda Ospedaliera Santa Maria Nuova (A.M.), Reggio Emilia, Italy; Hopital Cochin (O.V.), Paris, France; St. Antonius Ziekenhuis (M.J.S.), Nieuwegein, The Netherlands; Abbott Vascular (K.M.-H., S.V.), Diegem, Belgium; and Thoraxcenter (P.W.S.), Erasmus Medical Center, Rotterdam, The Netherlands.

Correspondence to Bimmer E.P.M. Claessen, Department of Cardiology, Academic Medial Center, Meibergdreef 9 Room B2-223, 1105 AZ Amsterdam, The Netherlands. E-mail B.E.Claessen{at}amc.uva.nl

Received October 28, 2008; accepted June 10, 2009.

Background— This article reports the 2-year clinical, angiographic, and intravascular ultrasound outcomes of the everolimus-eluting stent (EES) compared with the paclitaxel-eluting stent (PES) in the randomized SPIRIT II trial.

Methods and Results— This was a prospective, single-blind clinical trial in which a total of 300 patients with de novo native coronary artery lesions were randomized to either EES or PES in a 3:1 fashion. Clinical follow-up was planned at 2 years in all patients. A subset of 152 patients underwent serial angiographic and intravascular ultrasound analyses at 6 months and 2 years. After 2 years, target lesion failure (cardiac death, myocardial infarction, and ischemia-driven target lesion revascularization) rates were 6.6% and 11% in EES and PES, respectively (P=0.31). At 6 months, a significant reduction in angiographic in-stent late loss and percentage volume obstruction measured by intravascular ultrasound was observed in the EES group. However, at 2-year follow-up, a late increased intimal hyperplasia growth after implantation of an EES was observed. There were no significant differences between EES and PES for in-stent late loss (EES, 0.33±0.37 mm versus PES, 0.34±0.34 mm; P=0.84) and percentage volume obstruction (EES, 5.18±6.22% versus PES, 5.80±6.31%; P=0.65) at 2 years. The incidence of stent thrombosis was low and comparable in both groups (EES, 0.9%; PES, 1.4%).

Conclusions— Although the previously reported angiographic and clinical superiority of the EES has vanished over time, this report confirms and extends the previously demonstrated noninferiority in terms of in-stent late loss of the EES when compared with the PES up to 2-year follow-up. There were no significant differences between EES and PES in clinical, angiographic and intravascular ultrasound outcomes at 2 years.

Key Words: stents • angioplasty • IVUS

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