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Comparison of sirolimus eluting stent with bioresorbable polymer to everolimus eluting stent with permanent polymer in bifurcation lesions: Results from CENTURY II trial.

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Orvin, Katia Carrie, Didier Richardt, Gert Desmet, Walter Assali, Abid Rahim Dangoisse, Vincent [UCL] Kornowski, Ran

(eng) OBJECTIVE: To demonstrate the safety and efficacy of a new sirolimus eluting stent with bioresorbable polymer, Ultimaster, (BP-SES) compared with everolimus-eluting, permanent polymer, Xience stent (PP-EES) in bifurcation lesions with respect to the freedom from Target Lesion Failure at 1-year. METHODS: Within 1,119 patients enrolled in the CENTURY II randomized controlled multicenter trial, 194 patients were treated for bifurcation lesions and randomized to either BP-SES (n = 95) or PP-EES (n = 99). The primary endpoint was freedom from target lesion failure (TLF) composite endpoint [cardiac death, MI not clearly attributable to a non-target vessel, and clinically driven target lesion revascularization (TLR)] at 1-year. RESULTS: Baseline patient demographic, angiographic, and stenting characteristics were similar in both study arms. A single stent technique with provisional or "cross over" stenting were the most widely used in both arms (93.2% BP-SES vs. 92.4% PP-EES). Freedom from TLF at 1-year was 94.7% for BP-SES and 91.9% for PP-EES (P for noninferiority 0.031). The rate of clinically driven target lesion revascularization (TLR) at 1-year was 3.2% for BP-SES and 3.0% for PP-EES (P = 0.95). There were no significant differences detected in any of the individual clinical endpoints or other secondary clinical endpoints between the study arms at 1-year follow up. CONCLUSIONS: The new bioresorbable polymer sirolimus-eluting stent showed safety and efficacy profiles similar to durable polymer everolimus-eluting in the treatment of patients with bifurcation lesions at 1-year follow up. © 2015 Wiley Periodicals, Inc.

Document type Article de périodique (Journal article) – Article de recherche
Access type Accès restreint
Publication date 2016
Language Anglais
Journal information "Catheterization and Cardiovascular Interventions" - Vol. 87, no. 6, p. 1092-1100 (2016)
Peer reviewed yes
Publisher JohnWiley & Sons, Inc. ((United States) New York, NY)
issn 1522-1946
e-issn 1522-726X
Publication status Publié
Affiliations UCL - SSS/IREC/CARD - Pôle de recherche cardiovasculaire
UCL - (MGD) Service de cardiologie
Keywords Sirolimus eluting stent ; Cobalt-chromium stent ; Complex lesions ; Coronary bifurcation ; Drug eluting stent
Links
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Bibliographic reference Orvin, Katia ; Carrie, Didier ; Richardt, Gert ; Desmet, Walter ; Assali, Abid Rahim ; et. al. Comparison of sirolimus eluting stent with bioresorbable polymer to everolimus eluting stent with permanent polymer in bifurcation lesions: Results from CENTURY II trial.. In: Catheterization and Cardiovascular Interventions, Vol. 87, no. 6, p. 1092-1100 (2016)
Permanent URL http://hdl.handle.net/2078.1/171775