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Biolimus still comparable to everolimus in year 2 of stent match-up
Date:3/31/2014

WASHINGTON (March 31, 2014) A new stent covered with biodegradable coating continues to show statistical equivalence to Japan's market leader in cumulative second-year data and subgroup analyses, according to research from the NEXT trial presented at the American College of Cardiology's 63rd Annual Scientific Session. NEXT is the largest head-to-head randomized study of these two stents the novel biolimus-releasing model with the degradable coating (BES) and the everolimus-releasing standard with a durable polymer (EES).

Polymer coatings contain the drugs in drug-eluting stents, and slowly release agents to keep the stent clear of new lesions called intima neointima formations that lead to target lesion revascularization a second procedure to restore blood flow to the blocked artery after a stent is in place. Drug-releasing stents have become standard treatment, but the permanent polymer that holds the helpful drug can cause late clinical problems.

First year results for 3,235 patients randomly assigned to BES (1,617 patients; 2,059 lesions) or EES (1,618 patients; 2,010 lesions) demonstrated statistically equivalent outcomes for the efficacy endpoint of target lesion revascularization and the composite safety endpoint of death from all causes and heart attack. The track record of non-inferiority continued with year-two data: BES 7.8 percent compared to EES 7.7 percent for safety endpoints; BES 6.2 percent compared to EES 6 percent for the efficacy endpoint. Landmark analysis at one year showed no difference in safety (BES 2.5 percent vs. EES 2.4 percent) or efficacy (BES 2 percent vs. EES 1.5 percent). Subgroup analysis for target lesion revascularization in patients with diabetes, insulin-treated diabetes, patients 75 years or older, hemodialysis, and multi-vessel angioplasty revealed no significant differences in cumulative incidence.

"Recent network meta-analyses suggested that drug-eluting stents with a biodegradable polymer
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Contact: Beth Casteel
bcasteel@acc.org
202-375-6275
American College of Cardiology
Source:Eurekalert

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