Everolimus- Versus Biolimus-Eluting Stents in All-Comers

NCT01472705 | Completed

• 1 other identifier: 003-REP-CER-FR
• Study Type: observational
• Target: 814
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

drug-eluting coronary stent; percutaneous coronary intervention

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Cardiovascular death

  up to 24 months

• Any Revascularization

  up to 24 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All consecutive patients treated at our institution with at least one BES or EES

You may qualify if:

• all patients with at least one BES or EES for de novo stenosis

You may not qualify if:

• patients with at least one non-study stent
• patients with both study stent
• patients with life expectancy \< 3 years

Sponsors & Collaborators

• University of Freiburg: lead

Study Sites (1)

Cardiology, university Fribourg Medical Center

Fribourg, Canton of Fribourg, 1708, Switzerland

Location

Related Publications (2)

• Puricel S, Oberhansli 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/EIJV9I3A55.

  PMID: 23482296 RESULT

• 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 randomized controlled EVERBIO II trial. Trials. 2014 Jan 7;15:9. doi: 10.1186/1745-6215-15-9.

  PMID: 24398143 RESULT

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Stéphane P Cook, MD

  University Fribourg

  STUDY CHAIR

• Mario Togni, MD

  University Fribourg

  STUDY DIRECTOR

• Markus Oberhänsli, MD

  University Fribourg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 30, 2011
• First Posted: November 16, 2011
• Study Start: November 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2011
• Last Updated: December 3, 2015

Record last verified: 2015-12

Locations

CH (1)