Publisher： John Wiley & Sons Inc
E-ISSN： 1755-5922|33|6|367-371
ISSN： 1755-5914
Source： CARDIOVASCULAR THERAPEUTICS (ELECTRONIC), Vol.33, Iss.6, 2015-12, pp. : 367-371
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Abstract
SummaryAimsTo evaluate the outcomes of patients treated with a new drug‐eluting stent formulation with low doses of sirolimus, built in an ultra‐thin‐strut platform coated with biodegradable abluminal coating.MethodsThis study is a randomized trial that tested the main hypothesis that the angiographic late lumen loss of the novel sirolimus‐eluting stent is noninferior compared with commercially available biolimus‐eluting stent. A final study population comprising 170 patients with one or two de novo lesions was randomized in the ratio 2:1 for sirolimus‐eluting stent or biolimus‐eluting stent, respectively. The primary endpoint was 9‐month angiographic in‐stent late lumen loss. Adverse clinical events were prospectively collected for 1 year.ResultsAfter 9 months, the novel sirolimus‐eluting stent was shown noninferior compared with the biolimus stent for the primary endpoint (angiographic in‐stent late lumen loss: 0.20 ± 0.29 mm vs. 0.15 ± 0.20 mm, respectively; P value for noninferiority <0.001). The 1‐year incidence of death, myocardial infarction, repeat revascularization, and stent thrombosis remained low and not significantly different between the groups.ConclusionsThe present randomized trial demonstrates that the tested novel sirolimus‐eluting stent was angiographically noninferior in comparison with a last‐generation biolimus‐eluting stent.
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