Six-month IVUS and two-year clinical outcomes in the EVOLVE FHU trial: A randomised evaluation of a novel bioabsorbable polymer-coated, everolimus-eluting stent

Ian T. Meredith*, Stefan Verheye, Neil J. Weissman, Paul Barragan, Douglas Scott, Mariano Valdés Chávarri, Nick E.J. West, Henning Kelbaek, Robert Whitbourn, Darren L. Walters, Jacek Kubica, Leif Thuesen, Monica Masotti, Adrian Banning, Iwar Sjogren, Rod H. Stables, Dominic J. Allocco, Keith D. Dawkins

*Corresponding author af dette arbejde

    Publikation: Bidrag til tidsskriftArtikelForskningpeer review

    Abstrakt

    Aims: The EVOLVE FHU trial demonstrated non-inferiority of six-month late loss with two dose formulations of SYNERGY, a novel bioabsorbable polymer everolimus-eluting stent (EES) compared with the durable polymer PROMUS Element (PE) EES. The current analysis describes the six-month IVUS and clinical results through two years from the EVOLVE FHU trial. Methods and results: EVOLVE recruited 291 patients from 29 centres. At six months, IVUS-assessed in-stent net volume obstruction was 3.40±5.06% for PROMUS Element (PE) vs. 2.68±4.60% for SYNERGY (p=0.34) and 3.09±4.29% for SYNERGY 1/2 dose (p=0.68 vs. PE). There were no significant differences between groups for any other measured IVUS parameter including resolved, persistent, and late-acquired incomplete stent apposition (ISA). At two years, target lesion failure (TLF) was 6.1% for PE vs. 5.5% for SYNERGY (p=0.87) and 5.2% for SYNERGY 1/2 dose (p=0.81). There were no significant differences between groups for cardiac death, repeat revascularisation, MI or stent thrombosis through two years. Conclusions: At six months, everolimus delivered from an ultrathin bioabsorbable abluminal polymer resulted in equivalent net volume obstruction and ISA compared with a permanent polymer EES. There were no significant differences between PE and either SYNERGY stent for any major cardiac endpoint through two years. Clinical trials number: NCT01135225.

    OriginalsprogEngelsk
    Sider (fra-til)308-315
    Antal sider8
    TidsskriftEuroIntervention
    Vol/bind9
    Udgave nummer3
    DOI
    StatusUdgivet - 1 jul. 2013

    Fingeraftryk

    Udforsk hvilke forskningsemner 'Six-month IVUS and two-year clinical outcomes in the EVOLVE FHU trial: A randomised evaluation of a novel bioabsorbable polymer-coated, everolimus-eluting stent' indeholder.

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