Randomized comparison of biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents for percutaneous coronary revascularization: rationale and design of the BIOSCIENCE trial.

Abstract

BACKGROUND:

Biodegradable polymers for release of antiproliferative drugs from metallic drug-eluting stents aim to improve long-term vascular healing and efficacy. We designed a large scale clinical trial to compare a novel thin strut, cobalt-chromium drug-eluting stent with silicon carbide-coating releasing sirolimus from a biodegradable polymer (O-SES, Orsiro; Biotronik, Bülach, Switzerland) with the durable polymer-based Xience Prime/Xpedition everolimus-eluting stent (EES) (Xience Prime/Xpedition stent, Abbott Vascular, IL) in an all-comers patient population.

DESIGN:

The multicenter BIOSCIENCE trial (NCT01443104) randomly assigned 2,119 patients to treatment with biodegradable polymer sirolimus-eluting stents (SES) or durable polymer EES at 9 sites in Switzerland. Patients with chronic stable coronary artery disease or acute coronary syndromes, including non-ST-elevation and ST-elevation myocardial infarction, were eligible for the trial if they had at least 1 lesion with a diameter stenosis >50% appropriate for coronary stent implantation. The primary end point target lesion failure (TLF) is a composite of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization within 12 months. Assuming a TLF rate of 8% at 12 months in both treatment arms and accepting 3.5% as a margin for noninferiority, inclusion of 2,060 patients would provide more than 80% power to detect noninferiority of the biodegradable polymer SES compared with the durable polymer EES at a 1-sided type I error of 0.05. Clinical follow-up will be continued through 5 years.

CONCLUSION:

The BIOSCIENCE trial will determine whether the biodegradable polymer SES is noninferior to the durable polymer EES with respect to TLF.

• Authors: Thomas Pilgrim, Marco Roffi, David Tüller, Olivier Muller, André Vuilliomenet, Stéphane Cook, Daniel Weilenmann, Christoph Kaiser, Peiman Jamshidi, Dik Heg, Peter Jüni, Stephan Windecker
• Journal: American heart journal (Am Heart J) Vol. 168 Issue 3 Pg. 256-61 (Sep 2014) ISSN: 1097-6744 [Electronic] United States
• PMID: 25173535 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: Copyright © 2014 Mosby, Inc. All rights reserved.

Chemical References

• Everolimus
• Sirolimus

Topics

• Absorbable Implants
• Acute Coronary Syndrome (therapy)
• Coronary Artery Disease (therapy)
• Drug-Eluting Stents
• Everolimus
• Humans
• Percutaneous Coronary Intervention
• Research Design
• Sirolimus (administration & dosage, analogs & derivatives)