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

Arroyo, Diego Andoni; Togni, Mario; Puricel, Serban-George; Baeriswyl, Gérard; Lehmann, Sonja; Goy, Jean-Jacques; Stauffer, Jean-Christophe; Cook, Stéphane (2014). Comparison of everolimus- and biolimus-eluting stents with everolimus-eluting bioresorbable vascular scaffold stents: study protocol of the randomized controlled EVERBIO II. Trials, 15(9), p. 9. BioMed Central 10.1186/1745-6215-15-9

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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.

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