Evidence map›Paper›PMID 24398143›Full record

Trial reportTrials2014

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 1 more

2 registry-linked trialsOpen access · goldAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
3.8field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01472705 completednot on this map

Long-Term Comparison of Everolimus-Eluting and Biolimus-Eluting Stents in All-Comer Patients

TypeobservationalSponsorUniversity of FreiburgRan2010 to 2011Enrolled814ConditionsCoronary Artery Disease
NCT01711931 phase4completednot on this map

Comparison of Everolimus- and Biolimus-Eluting Stents With Everolimus-Eluting Bioresorbable Vascular Scaffold Stents

TypeinterventionalSponsorUniversity of FreiburgRan2012 to 2013Enrolled240ConditionsCoronary Artery DiseaseArmsImplantation of everolimus-eluting bioresorbable vascular scaffold stent, Implantation of everolimus-eluting stents, Implantation of biolimus-eluting stents
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 21 citations in OpenAlex.

  1. Five-year angiographic, OCT and clinical outcomes of a randomized comparison of everolimus and biolimus-eluting coronary stents with everolimus-eluting bioresorbable vascular scaffolds.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2022
    Trial
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 1 institution in 1 country.

Diego Arroyo
Mario Togni
Serban Puricel
Baeriswyl Gerard
Lehmann Sonja
Noé Corpataux
Hélène Villeneuve
Estelle Boute
Jean-Christophe Stauffer
Jean-Jacques Goy
Stéphane CookDepartment of Cardiology, University & Hospital, Fribourg, Switzerland. stephane.cook@unifr.ch.
University of Fribourg · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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. 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 registrationThe trial listed in clinicaltrials.gov as NCT01711931.

Indexed as

Absorbable ImplantsDrug-Eluting StentsResearch DesignTissue ScaffoldsCardiovascular AgentsClinical ProtocolsCoronary AngiographyCoronary Artery DiseaseCoronary RestenosisCoronary ThrombosisEverolimusHumansMyocardial InfarctionPercutaneous Coronary InterventionProsthesis DesignSirolimusCardiovascular AgentsEverolimusSirolimusumirolimus

Identifiers

PMID24398143
PMCPMC3926690
OpenAlexW2096568100

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.