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.
Citation: Eurointervention. 9(3):308-15, 2013 Jul.PMID: 23872647Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Comparative Study | Journal Article | Multicenter Study | Randomized Controlled Trial | Research Support, Non-U.S. Gov'tSubject headings: *Cardiovascular Agents/ad [Administration & Dosage] | *Coated Materials, Biocompatible | *Coronary Artery Disease/th [Therapy] | *Coronary Vessels/us [Ultrasonography] | *Drug-Eluting Stents | *Percutaneous Coronary Intervention/is [Instrumentation] | *Polymers | *Sirolimus/aa [Analogs & Derivatives] | *Ultrasonography, Interventional | Australia | Chi-Square Distribution | Coronary Angiography | Coronary Artery Disease/di [Diagnosis] | Coronary Artery Disease/mo [Mortality] | Coronary Restenosis/et [Etiology] | Coronary Restenosis/us [Ultrasonography] | Coronary Thrombosis/et [Etiology] | Coronary Thrombosis/us [Ultrasonography] | Europe | Humans | Kaplan-Meier Estimate | Myocardial Infarction/et [Etiology] | Myocardial Infarction/us [Ultrasonography] | New Zealand | Percutaneous Coronary Intervention/ae [Adverse Effects] | Percutaneous Coronary Intervention/mo [Mortality] | Predictive Value of Tests | Prosthesis Design | Risk Factors | Sirolimus/ad [Administration & Dosage] | Time Factors | Treatment OutcomeYear: 2013ISSN:- 1774-024X
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Journal Article | MedStar Authors Catalog | Article | 23872647 | Available | 23872647 |
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.
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