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

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.

Reducing attrition within clinical trials: The communication of retention and withdrawal within patient information leaflets

“…The recruitment and retention of patients are acknowledged as major challenges in the delivery of clinical trials and represent key methodological research priorities [ 1 , 2 ].…”

Identifying research priorities for effective retention strategies in clinical trials

“…Research into site training is supported by the results of recent workshops reviewing recruitment and retention strategies [ 16 , 23 ]. Anecdotal evidence suggests that coordinated approaches with local sites and strong clinical buy-in can help to retain patient populations perceived to be at risk of attrition [ 23 ].…”

“…If there was no response, attempts were made to identify contact details for other senior staff such as deputy directors, operational directors, senior trial managers or senior statisticians. Fifty-nine strategies to reduce missing data were collated from the Cochrane review and the published results of previous surveys [ 16 , 17 ]. Registered CTUs were asked to identify which of these strategies they had used within their trials either during the initial design or later in response to specific challenges.…”

Percutaneous coronary intervention vs coronary artery bypass grafting for left main coronary artery disease? A systematic review and meta‐analysis of randomized controlled trials

“…Biolimus‐eluting stent (BES) was used in NOBLE trial. BES uses abluminal bioresorbable polymer coating . It is currently approved and marketed outside of United States …”