Everolimus- Versus Biolimus-Eluting Stents in All-Comers

Coronary Artery Disease Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01472705
• Other study ID #: 003-REP-CER-FR
• Status: Completed
• Phase: N/A
• First received: August 30, 2011
• Last updated: December 1, 2015
• Start date: November 2010
• Est. completion date: November 2011

Study information

• Verified date: December 2015
• Source: University of Freiburg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 814
• Est. completion date: November 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 120 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
Switzerland	Cardiology, university Fribourg Medical Center	Fribourg

Sponsors (1)

Lead Sponsor	Collaborator
University of Freiburg

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

Arroyo D, Togni M, Puricel S, Gerard B, Sonja L, Corpataux N, Villeneuve H, Boute E, Stauffer JC, Goy JJ, Cook S. Comparison of everolimus-eluting and biolimus-eluting coronary stents with everolimus-eluting bioresorbable scaffold: study protocol of the r — View Citation

Puricel S, Oberhänsli M, Guntern P, Lehmann S, Goy JJ, Arroyo D, Villeneuve H, Baeriswyl G, Stauffer JC, Togni M, Cook S. Long-term comparison of everolimus-eluting and biolimus-eluting stents. EuroIntervention. 2013 Jul;9(3):336-44. doi: 10.4244/EIJV9I3A — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of Death, Myocardial Infarction and Target Vessel Revascularization	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).	up to 24 months	Yes
Secondary	Cardiovascular death		up to 24 months	Yes
Secondary	Any Revascularization		up to 24 months	Yes