Four-year clinical outcome following randomised use of zotarolimus-eluting stents versus everolimus-eluting stents in all-comers: Insights from the DUTCH PEERS trial

M. Lowik, L.C. van der Heijden, M.M. Kok, P. Zocca, P.W. Danse, G.A.J. Jessurun, R.W.M. Hautvast, M. Hartmann, M.G. Stoel, G.C.M. Linssen, C.J.M. Doggen, C. von Birgelen

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Abstract

Background: The DUTCH PEERS (TWENTE II) trial (clinicaltrials.gov NCT01331707) is a randomised, multicenter, single-blinded, investigator initiated all-comers trial. All coronary syndromes were permitted with no limit for lesion length, reference size, or number of lesions or diseased vessels to be treated. In total, 1811 patients were 1:1 randomised to cobalt chromium-based zotarolimuseluting stents (ZES) versus platinum chromium-based everolimus-eluting stents (EES). These durable polymer-based drug-eluting stents (DES) were developed to facilitate device deliverability and to improve stent apposition to the vessel wall. Purpose: We assessed the 4-year clinical outcome of the DUTCH PEERS trial in terms of safety and efficacy.

Methods: Clinical outcome was assessed by means of follow-up data of the trial participants. The primary endpoint target vessel failure (TVF) is a composite of cardiac death, target vessel-related myocardial infarction (MI) or target vessel revascularization. Secondary endpoints included the individual components of the TVF and the incidence of definite-or-probable stent thrombosis. Endpoints were analyzed by the logrank test by comparing the time to the endpoint, using the Kaplan-Meier method. Independent contract research organizations performed the study monitoring and clinical event adjudication.

Results: The 4-year clinical follow-up data were available in 1802 patients (99.5%; 4 patients were lost to follow-up and 5 withdrew consent). The ZES and EES groups showed favourable outcomes with a similar incidence of TVF (12.1% vs. 12.1%; Logrank p=0.95). The rates of the individual components of TVF were also similar for both stent arms: cardiac death (3.9% vs. 3.7%; Logrank p=0.78); target vessel-related MI (3.2% vs. 2.5%; Logrank p=0.38); and target vessel revascularization (6.8% vs. 7.5%; Logrank p=0.55), respectively. In addition, the incidence of definite-or-probable stent thrombosis was similar for patients treated with ZES versus EES (1.5% vs. 1.2%; Logrank p=0.67).

Conclusion: At 4-year follow-up, ZES and EES showed similar and sustained results in terms of safety and efficacy for treating all-comer patients.
Original languageEnglish
Pages (from-to)620
Number of pages1
JournalEuropean heart journal
Volume38
Issue numberSupplement 1
DOIs
Publication statusPublished - 29 Aug 2017

Keywords

  • Kaplan Meier method
  • Adult
  • Adverse device effect
  • Blood vessel wall
  • Clinical assessment
  • Clinical outcome
  • Conference abstract
  • Controlled study
  • Everolimus eluting coronary stent
  • Female
  • Follow up
  • Heart death
  • Heart infarction
  • Human
  • Incidence
  • Log rank test
  • Major clinical study
  • Male
  • Monitoring
  • Multicenter study
  • Organization
  • Outcome assessment
  • Polymer
  • Randomized controlled trial (RCT)
  • Single blind procedure
  • Stent thrombosis
  • Syndrome
  • Target vessel revascularization
  • Treatment failure
  • Unclassified drug
  • Zotarolimus eluting coronary stent
  • 22/4 OA procedure

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