Metallic Limus‐Eluting Stents Abluminally Coated with Biodegradable Polymers: Angiographic and Clinical Comparison of a Novel Ultra‐Thin Sirolimus Stent Versus Biolimus Stent in the DESTINY Randomized Trial
Summary Aims To 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. Methods This study is a randomized trial that tested the main hypothesis that the angiog...
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Veröffentlicht in: | Cardiovascular therapeutics 2015-12, Vol.33 (6), p.367-371 |
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Format: | Artikel |
Sprache: | eng |
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Zusammenfassung: | Summary
Aims
To 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.
Methods
This 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.
Results
After 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 |
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ISSN: | 1755-5914 1755-5922 |
DOI: | 10.1111/1755-5922.12159 |