Comparison of 3 biodegradable polymer and durable polymer-based drug-eluting stents in all-comers (BIO-RESORT): Rationale and study design of the randomized TWENTE III multicenter trial

Ming Kai Lam, Hanim Sen, Kenneth Tandjung, K. Gert van Houwelingen, Arie G. de Vries, Peter W. Danse, Carl E. Schotborgh, Martijn Scholte, Marije M. Löwik, Gerard C.M. Linssen, Maarten J. IJzerman, Jacobus Adrianus Maria van der Palen, Carine J.M. Doggen, Clemens von Birgelen

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23 Citations (Scopus)
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Abstract

Aim: To evaluate the safety and efficacy of 2 novel drug-eluting stents (DES) with biodegradable polymer-based coatings versus a durable coating DES.

Methods and Results: BIO-RESORT is an investigator-initiated, prospective, patient-blinded, randomized multicenter trial in 3540 Dutch all-comers with various clinical syndromes, requiring percutaneous coronary interventions (PCI) with DES implantation. Randomization (stratified for diabetes mellitus) is being performed in a 1:1:1 ratio between ORSIRO sirolimus-eluting stent with circumferential biodegradable coating, SYNERGY everolimus-eluting stent with abluminal biodegradable coating, and RESOLUTE INTEGRITY zotarolimus-eluting stent with durable coating. The primary endpoint is the incidence of the composite endpoint target vessel failure at 1 year, consisting of cardiac death, target vessel-related myocardial infarction, or clinically driven target vessel revascularization. Power calculation assumes a target vessel failure rate of 8.5% with a 3.5% non‐inferiority margin, giving the study a power of 85% (α level .025 adjusted for multiple testing). The impact of diabetes mellitus on post-PCI outcome will be evaluated. The first patient was enrolled on December 21, 2012.

Conclusions: BIO-RESORT is a large, prospective, randomized, multicenter trial with three arms, comparing two DES with biodegradable coatings versus a reference DES with a durable coating in 3540 all-comers. The trial will provide novel insights into the clinical outcome of modern DES and will address the impact of known and so far undetected diabetes mellitus on post-PCI outcome
Original languageEnglish
Pages (from-to)445-451
JournalAmerican heart journal
Volume167
Issue number4
DOIs
Publication statusPublished - 2014

Keywords

  • METIS-303307
  • IR-90443

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