Long-term clinical outcomes after bioresorbable and permanent polymer drug-eluting stent implantation: Final five-year results of the CENTURY II randomised clinical trial

William Wijns, Mariano Valdes-Chavarri, Gert Richardt, Raul Moreno, Andres Iniguez-Romo, Emanuele Barbato, Didier Carrie, Kenji Ando, Béla Merkely, Ran Kornowski, Hélène Eltchaninoff, Sinisa Stojkovic, Shigeru Saito

Research output: Contribution to journalArticlepeer-review

Abstract

Aims: The aim of this study was to establish the long-term safety and efficacy of a sirolimus-eluting stent with bioresorbable polymer (BP-SES; Ultimaster) by comparison with an everolimus-eluting stent with permanent polymer (PP-EES; XIENCE). Methods and results: CENTURY II (Clinical Evaluation of New Terumo Drug-Eluting Coronary Stent System in the Treatment of Patients with Coronary Artery Disease) is a large-scale, prospective, multicentre, randomised single-blind, controlled, non-inferiority trial conducted at 58 study sites globally, including Europe, Japan and Korea, powered to prove non-inferiority for freedom from target lesion failure (TLF: cardiac death, target vessel-related myocardial infarction [MI] and target lesion revascularisation) at nine months. Patients requiring a percutaneous coronary intervention (PCI) were randomised (1:1) to BP-SES (n=551) or PP-EES (n=550). Freedom from TLF at five years was 90.0% in the BP-SES and 91.1% in the PP-EES group (p=0.54). The patient-oriented composite endpoint (all death, any MI, any revascularisation) was 24.1 and 25.6% (p=0.57) with BP-SES and PP-EES, respectively. The very late stent thrombosis rate from one to five years was especially low at 0.2% in both arms. Conclusions: This randomised clinical trial showed that the BP-SES stent was non-inferior to the benchmark PP-EES stent for TLF. Safety and efficacy measures were comparable up to five-year follow-up after PCI.

Original languageEnglish
Pages (from-to)e343-e351
JournalEuroIntervention
Volume14
Issue number3
DOIs
StatePublished - Jun 2018

Keywords

  • Clinical trials
  • Drug-eluting stent
  • Multiple vessel disease
  • Single vessel disease

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