Endeavour zotarolimus-eluting stent reduces stent thrombosis and improves clinical outcomes compared with cypher sirolimus-eluting stent: 4-year results of the PROTECT randomized trial

William Wijns, Ph. Gabriel Steg, Laura Mauri, Volkhard Kurowski, Keyur Parikh, Runlin Gao, Christoph Bode, John P. Greenwood, Erik Lipsic, Farqad Alamgir, Tessa Rademaker-Havinga, Eric Boersma, Peter Radke, Frank van Leeuwen, Edoardo Camenzind*, PROTECT Steering Comm Investigator

*Bijbehorende auteur voor dit werk

    OnderzoeksoutputAcademicpeer review

    45 Citaten (Scopus)

    Samenvatting

    Aims To compare the long-term clinical safety between two drug-eluting stents with different healing characteristics in the Patient Related Outcomes with Endeavour (E-ZES) vs. Cypher (C-SES) Stenting Trial (PROTECT). At 3 years, there was no difference in the primary outcome of definite or probable stent thrombosis or in the other main secondary clinical outcomes consisting of the composite of death or myocardial infarction (MI). Prespecified 4-year clinical follow-up was analysed.

    Methods and results Patient Related OuTcomes with Endeavour vs. Cypher Stenting Trial was a prospective, open-label randomized-controlled superiority trial powered to look at differences in long-term clinical safety, including stent thrombosis. Dual antiplatelet therapy (DAPT) was prescribed for >= 3 months and up to 12 months based on current guidelines. Patient Related Outcomes with Endeavour vs. Cypher Stenting Trial enrolled 8791 patients undergoing elective or emergency PCI to E-ZES or C-SES. There was no difference in DAPT usage between the two groups up to 4 years. At 4-year follow-up, the primary outcome occurred in 1.6% of E-ZES vs. 2.6% of C-SES patients [HR 0.63 (95% CI 0.46-0.85), P = 0.003]. The composite of all-cause death or large MI occurred in 6.7% of E-ZES vs. 8.0% of C-SES-treated patients [HR 0.84 (95% CI 0.71-0.98), P = 0.024].

    Conclusions Drug-eluting coronary stents with different healing characteristics demonstrated different late safety profiles: after 4 years, compared with C-SES, E-ZES reduced the risk of stent thrombosis and the risk of the composite end points of death or MI. Appropriately powered large-scale trials with long-term follow-up are critical to determine clinical safety and efficacy of permanently implanted coronary stents.

    Originele taal-2English
    Pagina's (van-tot)2812-2820
    Aantal pagina's9
    TijdschriftEuropean Heart Journal
    Volume35
    Nummer van het tijdschrift40
    DOI's
    StatusPublished - 21-okt-2014

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