TY  - BOOK
AU  - Weissman, Neil J
TI  - 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
SN  - 1774-024X
PY  - 2013///
KW  - *Cardiovascular Agents/ad [Administration & Dosage]
KW  - *Coated Materials, Biocompatible
KW  - *Coronary Artery Disease/th [Therapy]
KW  - *Coronary Vessels/us [Ultrasonography]
KW  - *Drug-Eluting Stents
KW  - *Percutaneous Coronary Intervention/is [Instrumentation]
KW  - *Polymers
KW  - *Sirolimus/aa [Analogs & Derivatives]
KW  - *Ultrasonography, Interventional
KW  - Australia
KW  - Chi-Square Distribution
KW  - Coronary Angiography
KW  - Coronary Artery Disease/di [Diagnosis]
KW  - Coronary Artery Disease/mo [Mortality]
KW  - Coronary Restenosis/et [Etiology]
KW  - Coronary Restenosis/us [Ultrasonography]
KW  - Coronary Thrombosis/et [Etiology]
KW  - Coronary Thrombosis/us [Ultrasonography]
KW  - Europe
KW  - Humans
KW  - Kaplan-Meier Estimate
KW  - Myocardial Infarction/et [Etiology]
KW  - Myocardial Infarction/us [Ultrasonography]
KW  - New Zealand
KW  - Percutaneous Coronary Intervention/ae [Adverse Effects]
KW  - Percutaneous Coronary Intervention/mo [Mortality]
KW  - Predictive Value of Tests
KW  - Prosthesis Design
KW  - Risk Factors
KW  - Sirolimus/ad [Administration & Dosage]
KW  - Time Factors
KW  - Treatment Outcome
KW  - MedStar Heart & Vascular Institute
KW  - Comparative Study
KW  - Journal Article
KW  - Multicenter Study
KW  - Randomized Controlled Trial
KW  - Research Support, Non-U.S. Gov't
N2  - 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; 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; 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
UR  - http://dx.doi.org/10.4244/EIJV9I3A52
ER  -