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: December 1, 2015
Last verified: December 2015
  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
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 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.

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.
  Eligibility

Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
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: December 1, 2015
Health Authority: Switzerland: Swissmedic

Keywords provided by 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
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Everolimus
Sirolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents

ClinicalTrials.gov processed this record on July 24, 2016