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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01472705
Recruitment Status : Completed
First Posted : November 16, 2011
Last Update Posted : December 3, 2015
Information provided by (Responsible Party):
Stéphane Cook, Prof, University of Freiburg

Brief Summary:
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.

Condition or disease
Coronary Artery Disease

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.

Study Type : Observational
Actual Enrollment : 814 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long-Term Comparison of Everolimus-Eluting and Biolimus-Eluting Stents in All-Comer Patients
Study Start Date : November 2010
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.

Primary Outcome Measures :
  1. 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 :
  1. Cardiovascular death [ Time Frame: up to 24 months ]
  2. Any Revascularization [ Time Frame: up to 24 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Publications of Results:
Responsible Party: Stéphane Cook, Prof, Principal Investigator, University of Freiburg Identifier: NCT01472705     History of Changes
Other Study ID Numbers: 003-REP-CER-FR
First Posted: November 16, 2011    Key Record Dates
Last Update Posted: December 3, 2015
Last Verified: December 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