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

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.

Figures

Figure 1
Figure 1
Study algorithm. BES: biolimus-eluting stent, BVS: biovascular scaffold, EES: everolimus-eluting stent, OCT: optical coherence tomography, PCI: percutaneous coronary intervention. aPrimary endpoint: late lumen loss at 9-month angiography study. bSecondary endpoints: patient oriented (death, myocardial infarction, target vessel revascularization), device oriented (cardiac death, myocardial infarction, target-lesion revascularization), stent thrombosis, binary restenosis at 9-month angiography study.

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