MedPath

Everolimus- Versus Biolimus-Eluting Stents in All-Comers

Completed
Conditions
Coronary Artery Disease
Registration Number
NCT01472705
Lead Sponsor
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
814
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Composite of Death, Myocardial Infarction and Target Vessel Revascularizationup 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
NameTimeMethod
Cardiovascular deathup to 24 months
Any Revascularizationup to 24 months

Trial Locations

Locations (1)

Cardiology, university Fribourg Medical Center

🇨🇭

Fribourg, Switzerland

© Copyright 2025. All Rights Reserved by MedPath