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*

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

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Abstract

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.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].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 endpoints 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. This trial is registered with ClinicalTrials.gov, number NCT00476957.Published on behalf of the European Society of Cardiology. All rights reserved. ? The Author 2014. For permissions please email: journals.permissions@oup.com.
Original languageEnglish
Pages (from-to)2812-2820
JournalEuropean Heart Journal
Volume35
Issue number40
DOIs
Publication statusPublished - 21 Oct 2014

Keywords

  • Drug-eluting stent
  • Late stent thrombosis
  • Myocardial infarction
  • Endothelialization
  • Sirolimus
  • Zotarolimus

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