Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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: May 27, 2014
Last verified: May 2014

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.

Percutaneous Coronary Intervention

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 University of Freiburg:

Primary Outcome Measures:
  • Composite of Death, Myocardial Infarction and Target Vessel Revascularization [ Time Frame: up to 24 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
  • Any Revascularization [ Time Frame: up to 24 months ] [ Designated as safety issue: Yes ]

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

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: May 27, 2014
Health Authority: Switzerland: Swissmedic

Keywords provided by University of Freiburg:
drug-eluting coronary stent
percutaneous coronary intervention
Propensity score matching with the null hypothesis that the primary end point occurs >3% in BES versus the EES group

Additional relevant MeSH terms:
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs processed this record on March 03, 2015