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

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115 Scopus citations

Abstract

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. (Circ Cardiovasc Intervent. 2009;2:339-347.)

Original languageEnglish
Pages (from-to)339-347
Number of pages9
JournalCirculation: Cardiovascular Interventions
Volume2
Issue number4
DOIs
StatePublished - Aug 2009
Externally publishedYes

Keywords

  • Angioplasty
  • IVUS
  • Stents

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