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Open Access Study protocol

Comparison of everolimus-eluting and biolimus-eluting coronary stents with everolimus-eluting bioresorbable scaffold: study protocol of the randomized controlled EVERBIO II trial

Diego Arroyo, Mario Togni, Serban Puricel, Baeriswyl Gerard, Lehmann Sonja, Noé Corpataux, Hélène Villeneuve, Estelle Boute, Jean-Christophe Stauffer, Jean-Jacques Goy and Stéphane Cook*

Author Affiliations

Department of Cardiology, University & Hospital, Fribourg, Switzerland

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Trials 2014, 15:9  doi:10.1186/1745-6215-15-9

Published: 7 January 2014

Abstract

Background

Second-generation everolimus-eluting stents (EES) and third generation biolimus-eluting stents (BES) have been shown to be superior to first-generation paclitaxel-eluting stents (PES) and second-generation sirolimus-eluting stents (SES). However, neointimal proliferation and very late stent thrombosis is still an unresolved issue of drug-eluting stent (DES) implantation overall. The Absorb™ (Abbott Vascular, Abbott Park, IL, USA) is the first CE approved DES with a bioresorbable vascular scaffold (BVS) thought to reduce long-term complication rates. The EVERBIO II trial was set up to compare the BVS safety and efficacy with both EES and BES in all patients viable for inclusion.

Methods/Design

The EVERBIO II trial is a single-center, assessor-blinded, randomized trial. The study population consists of all patients aged ≥18 years old undergoing percutaneous coronary intervention. Exclusion criterion is where the lesion cannot be treated with BVS (reference vessel diameter >4.0 mm). A total of 240 patients will be enrolled and randomly assigned into 3 groups of 80 with either BVS, EES or BES implantation. All patients will undergo a follow-up angiography study at 9 months. Clinical follow-up for up to 5 years will be conducted by telephone. The primary endpoint is in-segment late lumen loss at 9 months measured by quantitative coronary angiography. Secondary endpoints are patient-oriented major adverse cardiac event (MACE) (death, myocardial infarction and target-vessel revascularization), device-oriented MACE (cardiac death, myocardial infarction and target-lesion revascularization), stent thrombosis according to ARC and binary restenosis at follow-up 12 months angiography.

Discussion

EVERBIO II is an independent, randomized study, aiming to compare the clinical efficacy, angiographic outcomes and safety of BVS, EES and BES in all comer patients.

Trial registration

The trial listed in clinicaltrials.gov as NCT01711931.

Keywords:
Biolimus-eluting stent; Bioresorbable vascular scaffold (BVS); Coronary artery disease; Drug-eluting stent; Everolimus-eluting stent; Late lumen loss; Percutaneous coronary intervention