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Randomized comparison of biolimus-eluting stents with biodegradable polymer versus everolimus-eluting stents with permanent polymer coatings assessed by optical coherence tomography

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Abstract

We sought to compare the healing patterns of biolimus-eluting stents with biodegradable polymer (BP-BES, Nobori) versus everolimus-eluting stents with permanent polymer (PP-EES, Xience) using intravascular optical coherence tomography (OCT). A total of 34 patients undergoing treatment of de novo coronary lesions were randomly assigned to receive BP-BES (n = 15) or PP-EES (n = 19). Stent tissue coverage and apposition as well as the incidence of peri-strut low intensity area (PLIA) were assessed by OCT at 6–8 months. Generalized linear mixed models were used to account for clustered data. OCT imaging was available for 17 lesions with 2,805 struts in the BP-BES group and 22 lesions with 3,890 struts in the PP-EES group. BP-BES as compared to PP-EES showed similar rates of uncovered struts (479 vs. 588, odds ratio (OR) 1.54 (95 % CI 0.63–3.79), P = 0.34) and malapposed struts (46 vs. 32 struts, OR 1.64 [95 % CI 0.21–12.5], P = 0.64). Three lesions with BP-BES (17.6 %) versus 5 lesions with PP-EES (22.7 %) had >30 % uncovered struts (P = 0.78). The proportion of patients with PLIA was similar in both groups (BP-BES 41.2 % vs. PP-EES 36.4 %, OR 1.11 [95 % CI 0.43–2.87], P = 0.83). New generation BP-BES as compared to PP-EES showed similar stent coverage and apposition as assessed by OCT at 6–8 months. In addition, PLIA—possible markers of delayed arterial healing—were observed with similar frequency in both groups.

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Acknowledgments

This work was founted by the European Commission under the Seventh Framework Program (PRESTIGE project grant 260309) and supported by a research Grant for supplying OCT catheters from Terumo Europe.

Conflict of interest

Dr. Kastrati reports received lecture fees from Abbott, Astra-Zeneca, Biotronik, Biosensors, MSD, The Medicines and St. Jude Medical. Dr. Mehilli reports received lecture fees form Abbott, Biotronik and Terumo. The remaining authors report no conflicts of interest.

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Authors and Affiliations

  1. Deutsches Herzzentrum, Technische Universität, Lazarettstrasse 36, 80636, Munich, Germany

    Tomohisa Tada, Adnan Kastrati, Robert A. Byrne, Rezarta Cuni, Lamin A. King, Salvatore Cassese, Michael Joner, Jürgen Pache & Albert Schömig

  2. DZHK (German Centre for Cardiovascular Research), Partner Site Munich Heart Alliance, Munich, Germany

    Tomohisa Tada, Adnan Kastrati, Robert A. Byrne, Lamin A. King, Salvatore Cassese, Michael Joner, Jürgen Pache, Steffen Massberg, Albert Schömig & Julinda Mehilli

  3. Institut für Medizinische Statistik und Epidemiologie, Technische Universität, Munich, Germany

    Tibor Schuster

  4. 1. Medizinische Klinik, Klinikum Rechts der Isar, Technische Universität, Munich, Germany

    Albert Schömig

  5. Munich University Clinic, Department of Cardiology, Ludwig-Maximilian University, Munich, Germany

    Steffen Massberg & Julinda Mehilli

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  1. Tomohisa Tada
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  2. Adnan Kastrati
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  3. Robert A. Byrne
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  8. Michael Joner
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Correspondence to Tomohisa Tada.

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Tada, T., Kastrati, A., Byrne, R.A. et al. Randomized comparison of biolimus-eluting stents with biodegradable polymer versus everolimus-eluting stents with permanent polymer coatings assessed by optical coherence tomography. Int J Cardiovasc Imaging 30, 495–504 (2014). https://doi.org/10.1007/s10554-014-0376-1

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  • DOI: https://doi.org/10.1007/s10554-014-0376-1

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