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

doi:10.1186/1745-6215-15-9

Diego Arroyo, Jean-Christophe Stauffer + Show 9 more

Open Access

https://doi.org/10.1186/1745-6215-15-9

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Abstract

BackgroundSecond-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/DesignThe 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.DiscussionEVERBIO 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 registrationThe trial listed in clinicaltrials.gov as NCT01711931.

Highlights

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)
The persistent polymer within the vessel lumen has been held responsible for ongoing endothelial inflammation, incomplete endothelialization and subsequent atherosclerosis, all leading to late complications such as restenosis and stent thrombosis [2]
Substantial efforts have been made during the last decade to develop bioresorbable materials such as transient polymers or temporary ‘scaffolds’

Summary

Discussion

DES have revolutionized percutaneous coronary interventions by significantly reducing clinically relevant restenosis and ‘target-lesion’ revascularization [17,18,19,20], numerous reports have since demonstrated an increased incidence of late stent thrombosis (LST) [21,22,23]. The AbsorbTM BVS is the first, fully bioresorbable coronary scaffold to have been launched for clinical use with CE approval. It uses a poly-L-lactide polymer that undergoes a fourstage bioresorption through hydration, depolymerization, polymer fragmentation and dissolution over 2 years via the Krebs cycle [26].

Background

Methods/Design

Findings