title: Short and long-term safety and efficacy of polymer-free vs. durable polymer drug-eluting stents. A comprehensive meta-analysis of randomized trials including 6178 patients.
abstract: BACKGROUND
  The efficacy and safety of polymer-free drug-eluting stents (DESs) in clinical practice is currently subject of debate; randomized trials (RCTs) conducted so far provided conflicting results or were underpowered to definitively address this question; we aimed to investigate the efficacy and safety profile of polymer-free vs. durable polymer DES by a comprehensive meta-analysis of RCTs.
  
  
  METHODS
  MEDLINE, Google Scholar, EMBASE and Cochrane databases were searched for RCTs comparing polymer-free to durable polymer DES. Safety endpoints at short-term (≤ 1 year) and long-term follow-up (>1-year) were: death, myocardial infarction (MI) and stent thrombosis (ST); main efficacy endpoints were: target lesion revascularization (TLR) and target vessel revascularization (TVR).
  
  
  RESULTS
  Eight RCTs including 6178 patients were included. No significant differences in mortality were observed between polymer-free and durable polymer DESs at both short- and long-follow up (OR [95% CI] = 0.79 [0.58-1.08], p = 0.14; and 0.80 [0.58-1.10], p = 0.17 respectively); polymer free and durable polymer DESs provided comparable short and long-term MI rates; at short-term: OR [95% CI] = 1.13 [0.83-1.54], p = 0.44 and at long-term: OR [95% CI] = 1.27 [0.87-1.85], p = 0.22. Similarly, these two different devices proved equally effective in regards to ST, TLR and TVR over the short and long follow-up period.
  
  
  CONCLUSIONS
  Polymer-free DESs are as safe and effective as durable polymer DES; however, there is no evidence of any additional benefits provided by this new technology.
authors: Department of Cardiology, Radboud University Medical Center, Nijmegen, The Netherlands; Systematic Investigation and Research on Interventions and Outcomes (SIRIO) MEDICINE Research Network. Electronic address: eliano.navarese@alice.it.
authors: Eliano P
authors: EP
authors: Navarese
authors: 10th Military Research Hospital and Polyclinic, Bydgoszcz, Poland; Systematic Investigation and Research on Interventions and Outcomes (SIRIO) MEDICINE Research Network.
authors: Mariusz
authors: M
authors: Kowalewski
authors: Interventional Cardiology Unit, Ospedale Fatebenefratelli, Milan, Italy.
authors: Bernardo
authors: B
authors: Cortese
authors: Department of Cardiology, Piedmont Heart Institute, Atlanta, GA, USA.
authors: David
authors: D
authors: Kandzari
authors: University of Bristol, School of Social and Community Medicine, Bristol, UK.
authors: Sofia
authors: S
authors: Dias
authors: Department of Cardiology, Medical University of Silesia, Katowice, Poland.
authors: Wojtek
authors: W
authors: Wojakowski
authors: Department of Cardiovascular Sciences, Catholic University of the Sacred Heart, Rome, Italy.
authors: Antonino
authors: A
authors: Buffon
authors: Department of Cardiology, Yale Medical School, New Haven, CT, USA.
authors: Alexandra
authors: A
authors: Lansky
authors: Department of Cardiology, Texas Heart Institute of St. Luke's Episcopal Hospital, Houston, TX, USA.
authors: Paolo
authors: P
authors: Angelini
authors: Department of Cardiology, MedStar Washington Hospital Center, Washington, DC, USA.
authors: Rebecca
authors: R
authors: Torguson
authors: Department of Cardiology and Internal Medicine, Ludwik Rydygier Collegium Medicum, Nicolaus Copenicus University, Bydgoszcz, Poland; Systematic Investigation and Research on Interventions and Outcomes (SIRIO) MEDICINE Research Network.
authors: Jacek
authors: J
authors: Kubica
authors: Department of Internal Medicine, Division of Cardiology, Pulmonology and Vascular Medicine, Heinrich-Heine-University, Düsseldorf, Germany.
authors: Malte
authors: M
authors: Kelm
authors: Department of Cardiology, Radboud University Medical Center, Nijmegen, The Netherlands.
authors: Menko-Jan
authors: MJ
authors: de Boer
authors: Department of Cardiology, MedStar Washington Hospital Center, Washington, DC, USA.
authors: Ron
authors: R
authors: Waksman
authors: Department of Cardiology, Radboud University Medical Center, Nijmegen, The Netherlands.
authors: Harry
authors: H
authors: Suryapranata
mesh_terms: D054855:Drug-Eluting Stents / Q000009:adverse effects*; D006801:Humans; D009203:Myocardial Infarction / Q000401:mortality; D011108:Polymers / Q000009:adverse effects; D011341:Probucol / Q000008:administration & dosage; D016032:Randomized Controlled Trials as Topic; D020123:Sirolimus / Q000008:administration & dosage; D015607:Stents / Q000009:adverse effects; D013927:Thrombosis / Q000517:prevention & control; D016896:Treatment Outcome
chemical_list: D011108:Polymers; D011341:Probucol; D020123:Sirolimus
keywords: Durable polymer drug-eluting stents; Meta-analysis; Polymer-free drug-eluting stents; Randomized trials