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Everolimus- Versus Biolimus-Eluting Stents in All-Comers

NCT ID: NCT01472705

Last Updated: 2015-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

814 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-11-30

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Freiburg

OTHER

Sponsor Role lead

Responsible Party

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Stéphane Cook, Prof

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stéphane P Cook, MD

Role: STUDY_CHAIR

University Fribourg

Mario Togni, MD

Role: STUDY_DIRECTOR

University Fribourg

Markus Oberhänsli, MD

Role: PRINCIPAL_INVESTIGATOR

University Fribourg

Locations

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Cardiology, university Fribourg Medical Center

Fribourg, Canton of Fribourg, Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type RESULT
PMID: 23482296 (View on PubMed)

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.

Reference Type RESULT
PMID: 24398143 (View on PubMed)

Other Identifiers

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003-REP-CER-FR

Identifier Type: -

Identifier Source: org_study_id