Primary endpoint results of the EVOLVE trial: a randomized evaluation of a novel bioabsorbable polymer-coated, everolimus-eluting coronary stent
| Autor: | Ian T, Meredith, Stefan, Verheye, Christophe L, Dubois, Joseph, Dens, Jean, Fajadet, Didier, Carrié, Simon, Walsh, Keith G, Oldroyd, Olivier, Varenne, Seif, El-Jack, Raul, Moreno, Anita A, Joshi, Dominic J, Allocco, Keith D, Dawkins |
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| Rok vydání: | 2011 |
| Předmět: |
Male
Sirolimus Polymers Drug-Eluting Stents Coronary Artery Disease Middle Aged Coronary Angiography Prosthesis Design Electrocardiography Treatment Outcome Coated Materials Biocompatible Absorbable Implants Humans Female Single-Blind Method Everolimus Prospective Studies Angioplasty Balloon Coronary Immunosuppressive Agents Follow-Up Studies |
| Zdroj: | Journal of the American College of Cardiology. 59(15) |
| ISSN: | 1558-3597 |
| Popis: | This study sought to compare the safety and efficacy of 2 dose formulations of SYNERGY, a novel bioabsorbable polymer everolimus-eluting stent (EES) (Boston Scientific Corp., Natick, Massachusetts) compared with the durable polymer PROMUS Element EES (Boston Scientific Corp.).Durable polymer coatings on drug-eluting stents have been associated with chronic inflammation and impaired healing. Bioabsorbable polymer-coated drug-delivery systems may reduce the risk of late adverse events, including stent thrombosis, and thus the need for prolonged dual-antiplatelet therapy.A total of 291 patients with a de novo lesion ≤28 mm in length, in a coronary artery of ≥2.25 to ≤3.5 mm diameter, were enrolled in the EVOLVE study, a prospective, randomized, single-blind, noninferiority trial. Patients were randomly assigned in a 1:1:1 ratio to PROMUS Element, SYNERGY, or SYNERGY half dose. The primary clinical endpoint was the 30-day rate of target lesion failure, defined as cardiac death or myocardial infarction related to the target vessel, or target lesion revascularization. The primary angiographic endpoint was 6-month in-stent late loss measured by quantitative coronary angiography.The 30-day primary clinical endpoint of target lesion failure occurred in 0%, 1.1%, and 3.1% of patients in the PROMUS Element, SYNERGY, and SYNERGY half dose groups, respectively. The 6-month in-stent late loss was 0.15 ± 0.34 mm for PROMUS Element, 0.10 ± 0.25 mm for SYNERGY, and 0.13 ± 0.26 mm for SYNERGY half dose (SYNERGY, difference -0.06, upper 95.2% confidence limit: 0.02, p for noninferiority0.001; SYNERGY half dose, difference -0.03, upper 95.2% confidence limit: 0.05, p for noninferiority0.001). Clinical event rates remained low and comparable between groups, with no stent thromboses in any group at 6 months.The EVOLVE trial confirms the effective delivery of everolimus by a unique directional bioabsorbable polymer system utilizing the SYNERGY stent. (A Prospective Randomized Multicenter Single-Blind Noninferiority Trial to Assess the Safety and Performance of the Evolution Everolimus-Eluting Monorail Coronary Stent System [Evolution Stent System] for the Treatment of a De Novo Atherosclerotic Lesion [EVOLVE]; NCT01135225). |
| Databáze: | OpenAIRE |
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