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Everolimus- Versus Biolimus-Eluting Stents in All-Comers (EverBio)

This study has been completed.
Information provided by (Responsible Party):
Stéphane Cook, Prof, University of Freiburg Identifier:
First received: August 30, 2011
Last updated: December 1, 2015
Last verified: December 2015
This study sought to investigate safety and efficacy of biolimus-eluting stents (BES) with biodegradable polymer as compared with everolimus-eluting stents (EES) with durable polymer through 3 years of follow-up.

Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long-Term Comparison of Everolimus-Eluting and Biolimus-Eluting Stents in All-Comer Patients

Resource links provided by NLM:

Further study details as provided by Stéphane Cook, Prof, University of Freiburg:

Primary Outcome Measures:
  • Composite of Death, Myocardial Infarction and Target Vessel Revascularization [ Time Frame: up to 24 months ]
    The primary outcome is the above mentioned composite of adverse events in order to measure their cumulative incidence (i.e. the rate of occurrence of such events in the study population over a predefined time periode).

Secondary Outcome Measures:
  • Cardiovascular death [ Time Frame: up to 24 months ]
  • Any Revascularization [ Time Frame: up to 24 months ]

Enrollment: 814
Study Start Date: November 2010
Study Completion Date: November 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
everolimus-eluting stents (EES)
Second-generation everolimus-eluting stents (EES) have been shown to be superior to the first-generation paclitaxel eluting stents (PES) in terms of safety and efficacy.
biolimus-eluting stents (BES)
Third generation biolimus-eluting stents (BES) have been shown to be superior to the PES and non inferior to first-generation sirolimus eluting stents in terms of safety and efficacy.

Detailed Description:
A group of 814 consecutive patients undergoing percutaneous coronary intervention (PCI) was enrolled between 2007 and 2010, of which 527 were treated with EES and 287 with BES implantation. Clinical outcome was compared in 200 pairs using propensity score matching. The primary endpoint was a composite of death, myocardial infarction (MI) and target vessel revascularisation (TVR) at two-year follow-up.

Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All consecutive patients treated at our institution with at least one BES or EES

Inclusion Criteria:

  • all patients with at least one BES or EES for de novo stenosis

Exclusion Criteria:

  • patients with at least one non-study stent
  • patients with both study stent
  • patients with life expectancy < 3 years
  Contacts and Locations
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Please refer to this study by its identifier: NCT01472705

Cardiology, university Fribourg Medical Center
Fribourg, Switzerland, 1708
Sponsors and Collaborators
University of Freiburg
Study Chair: Stéphane P Cook, MD University Fribourg
Study Director: Mario Togni, MD University Fribourg
Principal Investigator: Markus Oberhänsli, MD University Fribourg
  More Information

Responsible Party: Stéphane Cook, Prof, Principal Investigator, University of Freiburg Identifier: NCT01472705     History of Changes
Other Study ID Numbers: 003-REP-CER-FR
Study First Received: August 30, 2011
Last Updated: December 1, 2015

Keywords provided by Stéphane Cook, Prof, University of Freiburg:
drug-eluting coronary stent
percutaneous coronary intervention

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents processed this record on August 22, 2017