Final, 5-year results from the EVOLVE Trial evaluating the Boston Scientific (NYSE: BSX) SYNERGY Stent support long-term safety and efficacy for the treatment of patients with de novo coronary artery disease.
The final 5 year results of the EVOLVE Trial reinforce earlier findings of sustained performance of the SYNERGY™ Bioabsorbable Polymer Drug-Eluting Stent System, with no stent thrombosis (ST), a very low target lesion revascularisation (TLR) rate (1.1%) and no significant differences between SYNERGY and control for the key endpoints of target lesion failure (TLF), cardiac death, or myocardial infarction (MI).
These data demonstrate excellent long term outcomes with the SYNERGY stent, which is designed to deliver more rapid and complete arterial healing and to reduce the risk of complications associated with long-term polymer exposure.
The study results were presented today at EuroPCR by Professor Ian Meredith, Ph.D.
The EVOLVE Trial is a prospective, randomised, single-blind first human use study of 291 patients with de novo native coronary lesions that was conducted at 29 sites in Europe, Australia and New Zealand. EVOLVE evaluated the non-inferiority of the SYNERGY Stent to a durable polymer control stent. The EVOLVE Trial is part of a rigorous clinical program, which also includes EVOLVE II, a global, multi-centre, randomised, single-blind, non-inferiority pivotal trial. Boston Scientific is continuing to advance the robust clinical program supporting the SYNERGY Stent with the currently enrolling EVOLVE Short Dual Anti- Platelet Therapy (DAPT) Study.
About the SYNERGY Bioabsorbable Polymer Stent
The SYNERGY Stent is the only bioabsorbable polymer stent available to patients in the United States. It features ultrathin stent struts with an abluminal bioabsorbable drug/polymer coating technology that is absorbed shortly after drug elution is complete at three months, thereby eliminating long-term polymer exposure. The SYNERGY Stent received CE Mark in 2012 and was approved for use in the U.S. in 2015 and in Japan in early 2016.
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Source: Boston Scientific