Comparison of Everolimus- and Biolimus-Eluting Stents With Everolimus-Eluting Bioresorbable Vascular Scaffold Stents

Conditions

Coronary Artery Disease

Keywords

percutaneous coronary intervention, bioresorbable vascular scaffold stents, everolimus, biolimus

Brief summary

The purpose of this study is to compare the efficacy and safety of everolimus- and biolimus-bluting stents with everolimus-eluting bioresorbable vascular scaffold stents. The null hypothesis to be rejected is that there is no significant difference with regard to lumen late loss at 9 months and a clinical end point of death, myocardial infarction and TVR at 12 months between everolimus-eluting and biolimus-eluting stents and everolimus-eluting bioresorbable vascular scaffold stents.

Samir Bengueddache, Malica Cook, Sonja Lehmann, Diego Fernández Arroyo, Mario Togni et al. (7 authors)

Frontiers in Cardiovascular Medicine2024-09-103 citations

10.3389/fcvm.2024.1426348

Vascular response to everolimus- and biolimus-eluting coronary stents versus everolimus-eluting bioresorbable scaffolds--an optical coherence tomography substudy of the EVERBIO II trial.

Kallinikou Z, Arroyo D, Togni M, Lehman S, Corpataux N, Cook M, Müller O, Baeriswyl G, Stauffer JC, Goy JJ, Puricel SG, Cook S.

2016-01-144 citations

10.4414/smw.2016.14274

Comparison of everolimus- and biolimus-eluting coronary stents with everolimus-eluting bioresorbable vascular scaffolds.

Puricel S, Arroyo D, Corpataux N, Baeriswyl G, Lehmann S, Kallinikou Z, Muller O, Allard L, Stauffer JC, Togni M, Goy JJ, Cook S.

2015-03-01150 citations

10.1016/j.jacc.2014.12.017

Satisfactory Angiographic and Clinical Outcomes with the Everolimus-Eluting BVS

T. Rizzo, Stephen L. Cook

MD Conference Express2014-10-01

10.1177/155989771430015

Comparison of everolimus-eluting and biolimus-eluting coronary stents with everolimus-eluting bioresorbable scaffold: study protocol of the randomized controlled EVERBIO II trial.

Arroyo D, Togni M, Puricel S, Gerard B, Sonja L, Corpataux N, Villeneuve H, Boute E, Stauffer JC, Goy JJ, Cook S.

2014-01-0711 citations

10.1186/1745-6215-15-9

Interventions

DEVICEImplantation of everolimus-eluting bioresorbable vascular scaffold stent

DEVICEImplantation of everolimus-eluting stents

DEVICEImplantation of biolimus-eluting stents

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

No

Inclusion criteria

* elective PCI * ability and willingness to provide written informed consent

Exclusion criteria

* ST-elevation myocardial infarction in the previous 48 hours * moderate to severe renal failure (defined as creatinine clearance of 30-60 ml/min and \<30ml/min respectively) * known or presumed hypersensitivity to heparin, antiplatelet drugs and hypersensitivity to contrast dye incontrollable with premedication

Design outcomes

Primary

Measure	Time frame	Description
Lumen Late Loss	9 months	as assessed by quantitative coronary angiogram

Secondary

Measure	Time frame	Description
Device-oriented major adverse cardiac events	6 months, 1, 2, 5 years	The composite of cardiac death, myocardial infarction (not clearly attributable to a nontarget vessel) and target lesion revascularization
Patient-oriented major adverse cardiac events	6 months, 1, 2, 5 years	The composite of all-cause mortality, any myocardial infarction and any revascularization

Other

Measure	Time frame	Description
Stent thrombosis	up to 5 years	possible, probable and definite stent thrombosis
Periprocedural Complications (occurring <48 hours after the Intervention)	Periprocedural	Type 4A MI Dissection Perforation

Countries

Switzerland

Outcome results

None listed