Article Text

First-generation versus second-generation drug-eluting stents in current clinical practice: updated evidence from a comprehensive meta-analysis of randomised clinical trials comprising 31 379 patients
  1. Eliano Pio Navarese1,2,13,
  2. Mariusz Kowalewski3,13,
  3. David Kandzari4,13,
  4. Alexandra Lansky5,
  5. Bartosz Górny3,13,
  6. Łukasz Kołtowski6,13,
  7. Ron Waksman7,
  8. Sergio Berti1,13,
  9. Giuseppe Musumeci8,13,
  10. Ugo Limbruno9,
  11. Rene J van der Schaaf10,
  12. Malte Kelm2,13,
  13. Jacek Kubica11,13 and
  14. Harry Suryapranata12
  1. 1Invasive Cardiology, National Research Council Institute of Clinical Physiology (CNR-IFC), Pisa, Italy
  2. 2Department of Internal Medicine, Division of Cardiology, Pulmonology and Vascular Medicine, Heinrich-Heine-University, Düsseldorf, Germany
  3. 310th Military Research Hospital and Polyclinic, Bydgoszcz, Poland
  4. 4Piedmont Heart Institute, Atlanta, Georgia, USA
  5. 5Department of Cardiology, Yale Medical School, New Haven, Connecticut, USA
  6. 61st Department of Cardiology, Teaching Hospital, Medical University of Warsaw, Warsaw, Poland
  7. 7Division of Cardiology, MedStar Washington Hospital Center, Washington DC, USA
  8. 8Department of Cardiology, Ospedali Riuniti di Bergamo, Bergamo, Italy
  9. 9Department of Cardiology, Ospedale della Misericordia, Grosseto, Italy
  10. 10Department of Cardiology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherland
  11. 11Department of Cardiology and Internal Medicine, Ludwik Rydygier Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland
  12. 12Department of Cardiology, Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands
  13. 13Systematic Investigation and Research on Interventions and Outcomes (SIRIO) MEDICINE Research Network
  1. Correspondence to Dr Eliano Pio Navarese; eliano.navarese{at}alice.it

Abstract

Background First-generation drug-eluting stents (DES) have become the most widely used devices worldwide for management of coronary artery disease. As remote follow-up data were becoming available, concerns emerged in regard to their long-term safety. Second-generation DES were designed to overcome safety issues, but the results of randomised clinical trials remain conflicting.

Methods We compared the safety and efficacy of first-generation versus second-generation Food and Drug Administration approved DES; the following devices were included: first-generation sirolimus-eluting stent (SES) and paclitaxel-eluting stents (PES); second-generation everolimus-eluting stent (EES), zotarolimus-eluting stent Endeavor and ZES-Resolute (ZES-R). Prespecified safety end points comprised ≤1 and >1 year: overall and cardiac mortality, myocardial infarction (MI), definite/definite or probable ST; efficacy end points were target lesion revascularisation and target vessel revascularisation. Composite end points were analysed as well.

Results 33 randomised controlled trials involving 31 379 patients with stable coronary artery disease or acute coronary syndrome undergoing DES implantation were retrieved. No differences in mortality among devices were found. In the overall class comparison, second-generation DES were associated with a 22% reduction of odds of MI at short-term OR 0.77 (95% CI 0.68 to 0.89) p=0.0002; EES reduced the odds of definite-probable ST compared with PES: OR 0.33 (95% CI 0.15 to 0.73) p=0.006; First-generation SES along with second-generation EES and ZES-R showed similar efficacy in decreasing the odds of repeat revascularisation.

Conclusions Second-generation EES and ZES-R offer similar levels of efficacy compared with first-generation SES, but are more effective than PES; however, only second-generation EES significantly reduced the incidence of MI and ST, and therefore should be perceived as the safest DES to date.

  • CORONARY ARTERY DISEASE
  • EBM
  • INTERVENTIONAL CARDIOLOGY

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 3.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/3.0/

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