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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stéphane Cook, Prof, University of Freiburg
ClinicalTrials.gov Identifier:
NCT01472705
First received: August 30, 2011
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

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
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)
Groups/Cohorts
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.

  Eligibility

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

Criteria

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 ClinicalTrials.gov identifier: NCT01472705

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

Publications:
Responsible Party: Stéphane Cook, Prof, Principal Investigator, University of Freiburg
ClinicalTrials.gov 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:
Everolimus
Sirolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents

ClinicalTrials.gov processed this record on August 28, 2014