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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Everolimus-eluting bioresorbable vascular scaffold stents | Active Comparator |
| |
| Everolimus-eluting stent | Active Comparator |
| |
| Biolimus-eluting stent | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantation of everolimus-eluting bioresorbable vascular scaffold stent | Device |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Lumen Late Loss | as assessed by quantitative coronary angiogram | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Device-oriented major adverse cardiac events | The composite of cardiac death, myocardial infarction (not clearly attributable to a nontarget vessel) and target lesion revascularization | 6 months, 1, 2, 5 years |
| Patient-oriented major adverse cardiac events |
| Measure | Description | Time Frame |
|---|---|---|
| Stent thrombosis | possible, probable and definite stent thrombosis | up to 5 years |
| Periprocedural Complications (occurring <48 hours after the Intervention) | Type 4A MI Dissection Perforation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stéphane Cook, Professor | University of Freiburg | Study Chair |
| Mario Togni, Professor | University of Freiburg | Study Director |
| Serban Puricel, MD | University of Freiburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fribourg Cantonal Hospital | Fribourg | 1708 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24398143 | 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. | |
| 39323753 |
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| Implantation of everolimus-eluting stents |
| Device |
|
| Implantation of biolimus-eluting stents | Device |
|
The composite of all-cause mortality, any myocardial infarction and any revascularization |
| 6 months, 1, 2, 5 years |
| Periprocedural |
| Bengueddache S, Cook M, Lehmann S, Arroyo D, Togni M, Puricel S, Cook S. Ten-year clinical outcomes of everolimus- and biolimus-eluting coronary stents vs. everolimus-eluting bioresorbable vascular scaffolds-insights from the EVERBIO-2 trial. Front Cardiovasc Med. 2024 Sep 10;11:1426348. doi: 10.3389/fcvm.2024.1426348. eCollection 2024. |
| 26766027 | Derived | Kallinikou Z, Arroyo D, Togni M, Lehman S, Corpataux N, Cook M, Muller O, Baeriswyl G, Stauffer JC, Goy JJ, Puricel SG, Cook S. Vascular response to everolimus- and biolimus-eluting coronary stents versus everolimus-eluting bioresorbable scaffolds--an optical coherence tomography substudy of the EVERBIO II trial. Swiss Med Wkly. 2016 Jan 14;146:w14274. doi: 10.4414/smw.2016.14274. eCollection 2016. |
| 25720622 | Derived | Puricel S, Arroyo D, Corpataux N, Baeriswyl G, Lehmann S, Kallinikou Z, Muller O, Allard L, Stauffer JC, Togni M, Goy JJ, Cook S. Comparison of everolimus- and biolimus-eluting coronary stents with everolimus-eluting bioresorbable vascular scaffolds. J Am Coll Cardiol. 2015 Mar 3;65(8):791-801. doi: 10.1016/j.jacc.2014.12.017. |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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