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

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• 作者：Ming Kai Lam ; MD^a ; ⁱ ; Hanim Sen ; MD^a ; ⁱ ; Kenneth Tandjung ; MD^a ; K. Gert van Houwelingen ; MD^a ; Arie G. de Vries ; MD^b ; Peter W. Danse ; MD ; PhD^c ; Carl E. Schotborgh ; MD^d ; Martijn Scholte ; MD^b ; Marije M. Lö ; wik ; PhD^a ; Gerard C.M. Linssen ; MD ; PhD^e ; Maarten J. IJzerman ; PhD^f ; Job van der Palen ; PhD^g ; ^h ; Carine J.M. Doggen ; PhD^f ; Clemens von Birgelen ; MD ; PhD^a ; ^f ; ^{c.vonbirgelen@mst.nl" class="auth_mail}
• 刊名：American Heart Journal
• 出版年：April, 2014
• 年：2014
• 卷：167
• 期：4
• 页码：445-451
• 全文大小：556 K

文摘

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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鈥恑nferiority margin, giving the study a power of 85% (伪 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.