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Completed

NCT Number: NCT01472705

Everolimus- Versus Biolimus-Eluting Stents in All-Comers

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cardiology, university Fribourg Medical Center

Fribourg, Canton of Fribourg, 1708, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  1. Cardiovascular death

    Time frame: up to 24 months

  2. Any Revascularization

    Time frame: up to 24 months

Sponsors and collaborators

Lead sponsor

University of Freiburg

Other

Registry information

Official study title

Long-Term Comparison of Everolimus-Eluting and Biolimus-Eluting Stents in All-Comer Patients

Acronym: EverBio

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Nov 16, 2011
Registry last updated
Dec 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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