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Clinical Trials/NCT01472705
NCT01472705
Completed
Not Applicable

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

University of Freiburg1 site in 1 country814 target enrollmentNovember 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
University of Freiburg
Enrollment
814
Locations
1
Primary Endpoint
Composite of Death, Myocardial Infarction and Target Vessel Revascularization
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2010
End Date
November 2011
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Stéphane Cook, Prof

Principal Investigator

University of Freiburg

Eligibility 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

Outcomes

Primary Outcomes

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

  • Cardiovascular death(up to 24 months)
  • Any Revascularization(up to 24 months)

Study Sites (1)

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