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Safety and efficacy outcomes of first and second generation durable polymer drug eluting stents and biodegradable polymer biolimus eluting stents in clinical practice: comprehensive network meta-analysis

BMJ 2013; 347 doi: https://doi.org/10.1136/bmj.f6530 (Published 06 November 2013) Cite this as: BMJ 2013;347:f6530
  1. Eliano P Navarese, assistant professor of medicine and director of research1,
  2. Kenneth Tandjung, resident2,
  3. Bimmer Claessen, resident3,
  4. Felicita Andreotti, aggregate professor of medicine4,
  5. Mariusz Kowalewski, research fellow1,
  6. David E Kandzari, professor of medicine5,
  7. Dean J Kereiakes, professor of medicine6,
  8. Ron Waksman, professor of medicine7,
  9. Laura Mauri, professor of medicine8,
  10. Ian T Meredith, professor of medicine9,
  11. Aloke V Finn, assistant professor of medicine10,
  12. Hyo-Soo Kim, professor of medicine11,
  13. Jacek Kubica, professor of medicine1,
  14. Harry Suryapranata, professor of medicine12,
  15. Toni Mustahsani Aprami, profesor of medicine13,
  16. Giuseppe Di Pasquale, cardiologist14,
  17. Clemens von Birgelen, professor of medicine215,
  18. Elvin Kedhi, interventional cardiologist16
  1. 1Department of Cardiology and Internal Medicine, Ludwik Rydygier Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland
  2. 2Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, Netherlands
  3. 3Department of Cardiology, Academisch Medisch Centrum, Universiteit van Amsterdam, Netherlands
  4. 4Department of Cardiovascular Science, Catholic University, Rome, Italy
  5. 5Piedmont Heart Institute, Atlanta, GA, USA
  6. 6Department of Cardiology, Christ Hospital Heart and Vascular Center/Lindner Research Center, Cincinnati, OH, USA
  7. 7Division of Cardiology, MedStar Washington Hospital Center, Washington DC, USA
  8. 8Department of Cardiology, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA
  9. 9Department of Cardiology, MonashHeart, Monash Medical Centre and Monash University, Melbourne, Australia
  10. 10Department of Cardiology, Emory University School of Medicine, Atlanta, USA
  11. 11Division of Cardiology, Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea
  12. 12Department of Cardiology, UMC St Radboud, Nijmegen, Netherlands
  13. 13Department of Cardiology, Padjadjaran University Hospital Hasan Sadikin, Bandung, Indonesia
  14. 14Unità Ospedaliera di Cardiologia, Ospedale Maggiore, Bologna, Italy
  15. 15Health Technology and Services Research, MIRA-Institute for Biomedical Technology and Technical Medicine, University of Twente, Enschede, Netherlands
  16. 16Department of Cardiology, Isala Klinieken, 8025 AB Zwolle, Netherlands
  1. Correspondence to: E Kedhi ekedhi{at}yahoo.com
  • Accepted 8 October 2013

Abstract

Objectives To investigate the safety and efficacy of durable polymer drug eluting stents (DES) and biodegradable polymer biolimus eluting stents (biolimus-ES).

Design Network meta-analysis of randomised controlled trials.

Data sources and study selection Medline, Google Scholar, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) database search for randomised controlled trials comparing at least two of durable polymer sirolimus eluting stents (sirolimus-ES) and paclitaxel eluting stents (paclitaxel-ES), newer durable polymer everolimus eluting stents (everolimus-ES), Endeavor and Resolute zotarolimus eluting stents (zotarolimus-ES), and biodegradable polymer biolimus-ES.

Primary outcomes Safety (death, myocardial infarction, definite or probable stent thrombosis) and efficacy (target lesion and target vessel revascularisation) assessed at up to one year and beyond.

Results 60 randomised controlled trials were compared involving 63 242 patients with stable coronary artery disease or acute coronary syndrome treated with a DES. At one year, there were no differences in mortality among devices. Resolute and Endeavor zotarolimus-ES, everolimus-ES, and sirolimus-ES, but not biodegradable polymer biolimus-ES, were associated with significantly reduced odds of myocardial infarction (by 29-34%) compared with paclitaxel-ES. Compared with everolimus-ES, biodegradable polymer biolimus-ES were associated with significantly increased odds of myocardial infarction (by 29%), while Endeavor zotarolimus-ES and paclitaxel-ES were associated with significantly increased odds of stent thrombosis. All investigated DES were similar with regards to efficacy endpoints, except for Endeavor zotarolimus-ES and paclitaxel-ES, which were associated with significantly increased the odds of target lesion and target vessel revascularisations compared with other devices. Direction of results beyond one year did not diverge from the findings for up to one year follow-up. Bayesian probability curves showed a gradient in the magnitude of effect, with everolimus-ES and Resolute zotarolimus-ES offering the highest safety profiles.

Conclusions The newer durable polymer everolimus-ES and Resolute zotarolimus-ES and the biodegradable polymer biolimus-ES maintain the efficacy of sirolimus-ES; however, for safety endpoints, differences become apparent, with everolimus-ES and Resolute zotarolimus-ES emerging as the safest stents to date.

Footnotes

  • Contributors: EK and EPN designed the analysis. EPN, KT, BC, and MK and EK collected and abstracted the data. EPN carried out the statistical analysis; EPN and EK drafted the manuscript. All authors analysed and interpreted the data and critically revised the manuscript for important intellectual content. The contents of this study are solely the responsibility of the authors and do not necessarily represent the official view of their institutions or any other party. EPN and EK are guarantors.

  • Funding: This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.

  • Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare that DEK has received research/grant support from Boston Scientific, Medtronic, and Abbott Vascular and has served as consultant for Boston Scientific, Medtronic, and Micell Technologies; DJK has received grant/research support from, been a consultant to, and served on the advisory board for Abbott Vascular and Boston Scientific; CvB is a consultant to and/or has received lecture fees or travel expenses from Abbott Vascular, Boston Scientific, and Medtronic; The Cardiology Research Department of Thoraxcentrum Twente has received educational and/or research grants from Abbott Vascular, Biotronik, Boston Scientific, and Medtronic; AVF has sponsored research agreements with Boston Scientific and Medtronic Vascular and serves on the advisory board for Medtronic Vascular; EK is a consultant to and/or has received lecture fees or travel expenses from Abbott Vascular, and Medtronic; The Maasstad Cardiology Department (previous working place) has received educational and/or research grants funded by Abbott Vascular, Boston Scientific, Terumo Europe, and Medtronic; ITM serves as a consultant to Boston Scientific and Medtronic. All the other authors report no conflict of interest related to the present article.

  • Ethical approval: Not required.

  • Data sharing: No additional data available

  • Declaration of transparency: The lead author (the manuscript’s guarantor) affirms that the manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned (and, if relevant, registered) have been explained.

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