Web of Science: 2 citations, Scopus: 2 citations, Google Scholar: citations
A randomized multicenter trial comparing the XIENCE everolimus eluting stent with the CYPHER sirolimus eluting stent in the treatment of female patients with de novo coronary artery lesions: The SPIRIT WOMEN study
Franzone, Anna (Department of Cardiology. Bern University Hospital)
Zaugg, Serge (Department of Clinical Research. University of Bern)
Piccolo, Raffaele (Department of Cardiology. Bern University Hospital)
Modena, Maria Grazia (Institute of Cardiology. Policlinico Hospital, University of Modena and Reggio Emilia)
Mikhail, Ghada W. (Imperial College Healthcare NHS Trust)
Mauri Ferré, Josepa (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Strasser, Ruth (University of Dresden, Department of Internal Medicine and Cardiology)
Grinfeld, Liliana (Hospital Italiano, Invasive Cardiology Unit, Buenos Aires)
Heg, Dik (Department of Clinical Research. University of Bern)
Jüni,Peter (Department of Medicine and Institute of Health Policy, Management and Evaluation. University of Toronto)
Windecker, Stephan (Department of Cardiology. Bern University Hospital)
Morice, Marie-Claude (Institut Cardiovasculaire Paris Sud)

Date: 2017
Abstract: Background. The comparative performance of different drug-eluting stents (DES) among female patients has not been assessed in a randomized manner. Objectives. The SPIRIT Women Clinical Evaluation trial compared the durable polymer everolimus-eluting XIENCE stent (DP-EES) with the durable polymer sirolimus-eluting Cypher stent (DPSES) in women undergoing percutaneous coronary intervention (PCI). Methods. A total of 455 female patients with stable CAD were randomly assigned to receive DP-EES (n = 304) or DP-SES (n = 151). The powered angiographic outcome of the trial was in-stent late lumen loss (LLL) at 9 months after the index procedure. Secondary angiographic end points included in-segment LLL, in-stent and in-segment binary restenosis and percentdiameter stenosis. The primary clinical outcome was a composite of all-cause death, myocardial infarction (MI) or target vessel revascularization (TVR). Results. At 9-month follow-up, in-stent LLL was 0. 19±0. 38 mm and 0. 11±0. 37 mm in patients assigned to DP-EES and DP-SES, respectively. The one-sided upper 95% CI of the difference in in-stent LLL between the groups of 0. 08 mm was 0. 15 and therefore within the prespecified non-inferiority margin of 0. 17 mm (p for non-inferiority = 0. 013). However, the test for superiority showed a borderline significant difference in terms of LLL between DP-EES and DP-SES (p for superiority = 0. 044). There were no significant differences in binary restenosis (2. 0% vs. 0. 72%, p = 0. 44) and percent diameter stenosis (14. 97±12. 17 vs. 13. 36 ±10. 82, p = 0. 19). The rate of definite stent thrombosis at 12 months was lower in patients treated with DP-EES (0% vs. 2. 0%, p = 0. 036). Conclusions. Among women undergoing PCI, DP-EES was associated with a small but probably clinically relevant increase in in-stent LLL at 9 months as compared to DP-SES and with a lower risk of definite stent thrombosis at 12 months.
Rights: Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original. Creative Commons
Language: Anglès
Document: publishedVersion
Published in: PloS one, Vol. 12 Núm. 8 (august 2017) , p. 1, ISSN 1932-6203

DOI: 10.1371/journal.pone.0182632
PMID: 28796809

16 p, 1.9 MB

The record appears in these collections:
Research literature > UAB research groups literature > Research Centres and Groups (scientific output) > Health sciences and biosciences > Institut d'Investigació en Ciencies de la Salut Germans Trias i Pujol (IGTP)
Articles > Published articles

 Record created 2018-10-25, last modified 2020-08-08

   Favorit i Compartir