Six-month IVUS and two-year clinical outcomes in the EVOLVE FHU trial: a randomised evaluation of a novel bioabsorbable polymer-coated, everolimus-eluting stent

Meredith, Ian T., Verheye, Stefan, Weissman, Neil J., Barragan, Paul, Scott, Douglas, Chavarri, Mariano Valdes, West, Nick E. J., Kelbaek, Henning, Whitbourn, Robert, Walters, Darren L., Kubica, Jacek, Thuesen, Leif, Masotti, Monica, Banning, Adrian, Sjogren, Iwar, Stables, Rod H., Allocco, Dominic J. and Dawkins, Keith D. (2013) Six-month IVUS and two-year clinical outcomes in the EVOLVE FHU trial: a randomised evaluation of a novel bioabsorbable polymer-coated, everolimus-eluting stent. EuroIntervention, 9 3: 308-315. doi:10.4244/EIJV9I3A52

Attached Files (Some files may be inaccessible until you login with your UQ eSpace credentials)
Name Description MIMEType Size Downloads

Author Meredith, Ian T.
Verheye, Stefan
Weissman, Neil J.
Barragan, Paul
Scott, Douglas
Chavarri, Mariano Valdes
West, Nick E. J.
Kelbaek, Henning
Whitbourn, Robert
Walters, Darren L.
Kubica, Jacek
Thuesen, Leif
Masotti, Monica
Banning, Adrian
Sjogren, Iwar
Stables, Rod H.
Allocco, Dominic J.
Dawkins, Keith D.
Title Six-month IVUS and two-year clinical outcomes in the EVOLVE FHU trial: a randomised evaluation of a novel bioabsorbable polymer-coated, everolimus-eluting stent
Journal name EuroIntervention   Check publisher's open access policy
ISSN 1774-024X
1969-6213
Publication date 2013-07-01
Year available 2013
Sub-type Article (original research)
DOI 10.4244/EIJV9I3A52
Open Access Status
Volume 9
Issue 3
Start page 308
End page 315
Total pages 8
Place of publication Toulouse, France
Publisher Europa Edition
Language eng
Formatted abstract
Aims: The EVOLVE FHU trial demonstrated non-inferiority of six-month late loss with two dose formulations of SYNERGY, a novel bioabsorbable polymer everolimus-eluting stent (EES) compared with the durable polymer PROMUS Element (PE) EES. The current analysis describes the six-month IVUS and clinical results through two years from the EVOLVE FHU trial.

Methods and results: EVOLVE recruited 291 patients from 29 centres. At six months, IVUS-assessed in-stent net volume obstruction was 3.40±5.06% for PROMUS Element (PE) vs. 2.68±4.60% for SYNERGY (p=0.34) and 3.09±4.29% for SYNERGY 1/2 dose (p=0.68 vs. PE). There were no significant differences between groups for any other measured IVUS parameter including resolved, persistent, and late-acquired incomplete stent apposition (ISA). At two years, target lesion failure (TLF) was 6.1% for PE vs. 5.5% for SYNERGY (p=0.87) and 5.2% for SYNERGY 1/2 dose (p=0.81). There were no significant differences between groups for cardiac death, repeat revascularisation, MI or stent thrombosis through two years.

Conclusions: At six months, everolimus delivered from an ultrathin bioabsorbable abluminal polymer resulted in equivalent net volume obstruction and ISA compared with a permanent polymer EES. There were no significant differences between PE and either SYNERGY stent for any major cardiac endpoint through two years. Clinical trials number: NCT01135225.
Keyword Bioabsorbable polymer
Coronary stenosis
Drug-eluting stents
Everolimus
Transluminal percutaneous coronary intervention
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ
Additional Notes Need to be registered to access.

Document type: Journal Article
Sub-type: Article (original research)
Collections: Official 2014 Collection
School of Medicine Publications
 
Versions
Version Filter Type
Citation counts: TR Web of Science Citation Count  Cited 20 times in Thomson Reuters Web of Science Article | Citations
Scopus Citation Count Cited 18 times in Scopus Article | Citations
Google Scholar Search Google Scholar
Created: Fri, 29 Nov 2013, 03:44:03 EST by System User on behalf of Medicine - Prince Charles Hospital