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 article

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 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: Meredith, I; Verheye, S; Weissman, N; Barragan, P; Scott, D

• Journal: EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
• Volume: 9
• Issue: 3
• Pages: 308-315
• Publication date: 2013-07-01
• DOI: 10.4244/eijv9i3a52
• EISSN: 1969-6213
• ISSN: 1774-024X
• Language: English
• Keywords: Kaplan-Meier Estimate; Humans; Predictive Value of Tests; Polymers; Prosthesis Design; Coronary Vessels; Treatment Outcome; Myocardial Infarction; Time Factors; Chi-Square Distribution; Australia; Coronary Restenosis; Coronary Thrombosis; New Zealand; Coronary Artery Disease; Europe; Coronary Angiography; Sirolimus; Risk Factors; Drug-Eluting Stents; Ultrasonography, Interventional; Coated Materials, Biocompatible; Cardiovascular Agents; Percutaneous Coronary Intervention