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

Orvin, Katia;Carrie, Didier;Richardt, Gert;Desmet, Walter;Kornowski, Ran;et.al.
(2016) Catheterization and Cardiovascular Interventions — Vol. 87, n° 6, p. 1092-1100 (2016)

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Authors
  • Orvin, Katia
    Author
  • Carrie, Didier
    Author
  • Richardt, Gert
    Author
  • Desmet, Walter
    Author
  • Dangoisse, VincentUCLouvain
    Author
  • Kornowski, Ran
    Author
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Abstract
(en) 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.
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Orvin, K., Carrie, D., Richardt, G., Desmet, W., Assali, A. R., Werner, G., Ikari, Y., Fujii, K., Goicolea, J., Dangoisse, V., Manari, A., Saito, S., Wijns, W., & Kornowski, R. (2016). Comparison of sirolimus eluting stent with bioresorbable polymer to everolimus eluting stent with permanent polymer in bifurcation lesions: Results from CENTURY II trial. Catheterization and Cardiovascular Interventions, 87(6), 1092-1100. https://doi.org/10.1002/ccd.26150 (Original work published 2016)