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.
abstract: OBJECTIVE
  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.
  
  
  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 ½ 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 ½ 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.
authors.affiliation: MonashHeart, Clayton, Victoria, Australia. ian.meredith@myheart.id.au
authors.forename: Ian T
authors.initials: IT
authors.lastname: Meredith
authors.forename: Stefan
authors.initials: S
authors.lastname: Verheye
authors.forename: Neil J
authors.initials: NJ
authors.lastname: Weissman
authors.forename: Paul
authors.initials: P
authors.lastname: Barragan
authors.forename: Douglas
authors.initials: D
authors.lastname: Scott
authors.forename: Mariano
authors.initials: M
authors.lastname: Valdés Chávarri
authors.forename: Nick E J
authors.initials: NE
authors.lastname: West
authors.forename: Henning
authors.initials: H
authors.lastname: Kelbæk
authors.forename: Robert
authors.initials: R
authors.lastname: Whitbourn
authors.forename: Darren L
authors.initials: DL
authors.lastname: Walters
authors.forename: Jacek
authors.initials: J
authors.lastname: Kubica
authors.forename: Leif
authors.initials: L
authors.lastname: Thuesen
authors.forename: Monica
authors.initials: M
authors.lastname: Masotti
authors.forename: Adrian
authors.initials: A
authors.lastname: Banning
authors.forename: Iwar
authors.initials: I
authors.lastname: Sjögren
authors.forename: Rod H
authors.initials: RH
authors.lastname: Stables
authors.forename: Dominic J
authors.initials: DJ
authors.lastname: Allocco
authors.forename: Keith D
authors.initials: KD
authors.lastname: Dawkins
mesh_terms: D001315:Australia; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D016009:Chi-Square Distribution; D020099:Coated Materials, Biocompatible; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000209:etiology; D003328:Coronary Thrombosis / Q000000981:diagnostic imaging / Q000209:etiology; D003331:Coronary Vessels / Q000000981:diagnostic imaging*; D054855:Drug-Eluting Stents; D005060:Europe; D000068338:Everolimus; D006801:Humans; D053208:Kaplan-Meier Estimate; D009203:Myocardial Infarction / Q000000981:diagnostic imaging / Q000209:etiology; D009520:New Zealand; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D011108:Polymers; D011237:Predictive Value of Tests; D011474:Prosthesis Design; D012307:Risk Factors; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D013997:Time Factors; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional
chemical_list: D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible; D011108:Polymers; D000068338:Everolimus; D020123:Sirolimus