Safety of second-generation drug-eluting stents three years after randomised use in the TWENTE trial

Marije M. Löwik, Ming Kai Lam, Hanim Sen, Kenneth Tandjung, K. Gert van Houwelingen, Frits H.A.F. de Man, Martin G. Stoel, J. (Hans) W. Louwerenburg, Gerard C.M. Linssen, Carine J.M. Doggen, Clemens von Birgelen

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Abstract

Aims: To assess three-year clinical outcome following randomised use of the second-generation Resolute zotarolimus-eluting stent (ZES) and the XIENCE V everolimus-eluting stent (EES). For Resolute ZES and randomised use, outcome data ≥3 years are relatively scarce.

Methods and results: The TWENTE trial examined 1,391 patients with stable angina or non-ST-elevation acute coronary syndromes, of whom 21.6% were diabetics, 70.1% had complex B2 or C lesions and 77.4% had “off-label” indications for DES use. Three-year follow-up data were obtained in 1,381 patients (99.3%; 10 withdrawals). Adverse clinical events were independently adjudicated. The primary endpoint target vessel failure (TVF), a composite of cardiac death, target vessel-related myocardial infarction and clinically indicated target vessel revascularisation, was 12.1% for Resolute ZES and 13.4% for XIENCE V EES (p=0.50). Cardiac death rates were 1.9% vs. 3.5% (p=0.06); the other individual components of TVF also showed no significant between-group differences. The rates of definite-or-probable stent thrombosis (1.4% vs. 1.6%, p=0.82) and very late stent thrombosis (0.6% vs. 0.4%, p=1.0) did not differ between the groups.

Conclusions: Three-year follow-up data of patients included in the randomised TWENTE trial demonstrated similar and sustained safety and efficacy of Resolute ZES and XIENCE V EES
Original languageEnglish
Pages (from-to)1276-1279
JournalEuroIntervention
Volume10
Issue number11
DOIs
Publication statusPublished - 19 Aug 2015

Keywords

  • METIS-307076
  • IR-93177
  • Co-Cr EES
  • Co-Cr R-ZES
  • Coronary revascularisation
  • Everolimus-eluting stent(s)
  • Long-term outcome
  • Long-term result(s)
  • Percutaneous Coronary Intervention (PCI)
  • Randomised study
  • Second-generation drug-eluting stent(s)
  • Stent(s)
  • Stent thrombosis
  • Zotarolimus-eluting stent(s)

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    Löwik, M. M., Lam, M. K., Sen, H., Tandjung, K., van Houwelingen, K. G., de Man, F. H. A. F., ... von Birgelen, C. (2015). Safety of second-generation drug-eluting stents three years after randomised use in the TWENTE trial. EuroIntervention, 10(11), 1276-1279. https://doi.org/10.4244/EIJY14M08_11