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.
<h4>Background</h4>The comparative performance of different drug-eluting stents (DES) among female patients has not been assessed in a randomized manner.<h4>Objectives</h4>The SPIRIT Women Clinical Evaluation trial compared the durable polymer everolimus-eluting XIENCE stent...
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2017-01-01
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| author | Anna Franzone Serge Zaugg Raffaele Piccolo Maria Grazia Modena Ghada W Mikhail Josepa Mauri Ferré Ruth Strasser Liliana Grinfeld Dik Heg Peter Jüni Stephan Windecker Marie-Claude Morice |
| author_facet | Anna Franzone Serge Zaugg Raffaele Piccolo Maria Grazia Modena Ghada W Mikhail Josepa Mauri Ferré Ruth Strasser Liliana Grinfeld Dik Heg Peter Jüni Stephan Windecker Marie-Claude Morice |
| author_sort | Anna Franzone |
| collection | DOAJ |
| description | <h4>Background</h4>The comparative performance of different drug-eluting stents (DES) among female patients has not been assessed in a randomized manner.<h4>Objectives</h4>The SPIRIT Women Clinical Evaluation trial compared the durable polymer everolimus-eluting XIENCE stent (DP-EES) with the durable polymer sirolimus-eluting Cypher stent (DP-SES) in women undergoing percutaneous coronary intervention (PCI).<h4>Methods</h4>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 percent diameter stenosis. The primary clinical outcome was a composite of all-cause death, myocardial infarction (MI) or target vessel revascularization (TVR).<h4>Results</h4>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 pre-specified 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).<h4>Conclusions</h4>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.<h4>Trial registration</h4>ClinicalTrials.gov NCT01182428. https://clinicaltrials.gov/. |
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| spelling | doaj-art-df70fd5756ee4b3e92001be0af0146662025-08-20T02:03:53ZengPublic Library of Science (PLoS)PLoS ONE1932-62032017-01-01128e018263210.1371/journal.pone.0182632A 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.Anna FranzoneSerge ZauggRaffaele PiccoloMaria Grazia ModenaGhada W MikhailJosepa Mauri FerréRuth StrasserLiliana GrinfeldDik HegPeter JüniStephan WindeckerMarie-Claude Morice<h4>Background</h4>The comparative performance of different drug-eluting stents (DES) among female patients has not been assessed in a randomized manner.<h4>Objectives</h4>The SPIRIT Women Clinical Evaluation trial compared the durable polymer everolimus-eluting XIENCE stent (DP-EES) with the durable polymer sirolimus-eluting Cypher stent (DP-SES) in women undergoing percutaneous coronary intervention (PCI).<h4>Methods</h4>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 percent diameter stenosis. The primary clinical outcome was a composite of all-cause death, myocardial infarction (MI) or target vessel revascularization (TVR).<h4>Results</h4>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 pre-specified 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).<h4>Conclusions</h4>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.<h4>Trial registration</h4>ClinicalTrials.gov NCT01182428. https://clinicaltrials.gov/.https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0182632&type=printable |
| spellingShingle | Anna Franzone Serge Zaugg Raffaele Piccolo Maria Grazia Modena Ghada W Mikhail Josepa Mauri Ferré Ruth Strasser Liliana Grinfeld Dik Heg Peter Jüni Stephan Windecker Marie-Claude Morice 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. PLoS ONE |
| title | 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. |
| title_full | 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. |
| title_fullStr | 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. |
| title_full_unstemmed | 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. |
| title_short | 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. |
| title_sort | 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 |
| url | https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0182632&type=printable |
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