title: Polymer-free drug-eluting stent in unselected patient population: a single center experience.
abstract: OBJECTIVE
  To evaluate the clinical performance of the Cre8™ polymer-free drug-eluting-stent in unselected real-life population.
  
  
  BACKGROUND
  Inflammation plays a key role in the multi-factorial process eventually leading to target vessel failure (TVF) after drug-eluting-stent (DES) implantation. The local chronic inflammatory reaction in the vessel wall at the site of stent implantation is, at least in part, attributed to interaction between the polymer coating of DES and vessel wall components. The belief that elimination of the polymer will reduce the occurrence of short and long-term TVF has led to the field of polymer-free DES development.
  
  
  RESULTS
  In this prospective, open-labeled, single-center, uncontrolled trial we enrolled consecutive patients undergoing PCI to receive the Cre8™ stent. The only exclusion criteria were in-stent restenosis and target vessel diameter <2.5mm. Primary end points were cardiac death and target vessel failure (TVF) at 1-year. Overall, 215 patients were enrolled, in which 318 Cre8 stents were implanted. Study population was characterized by a high prevalence of comorbidities including 38% of diabetics. More than 50% presented with acute coronary syndromes. During 1-year of follow-up there were 1 case of sudden death and 1 case of non-cardiac death, as well as 2 cases of TVF.
  
  
  CONCLUSIONS
  In this small single-center trial of unselected real-life population, the polymer-free Cre8™ DES appears to be effective, as it was associated with very low rates of target-vessel-failure up to 1-year follow-up.
authors.affiliation: Department of Cardiology, Tel-Aviv Medical Center, Tel-Aviv, Israel and the Sackler Faculty of Medicine, Tel-Aviv University, Tel Aviv, Israel. Electronic address: maayan.konigstein@gmail.com.
authors.forename: Maayan
authors.initials: M
authors.lastname: Konigstein
authors.affiliation: Department of Cardiology, Tel-Aviv Medical Center, Tel-Aviv, Israel and the Sackler Faculty of Medicine, Tel-Aviv University, Tel Aviv, Israel.
authors.forename: Shmuel
authors.initials: S
authors.lastname: Banai
authors.affiliation: Department of Cardiology, Tel-Aviv Medical Center, Tel-Aviv, Israel and the Sackler Faculty of Medicine, Tel-Aviv University, Tel Aviv, Israel.
authors.forename: Itzhak
authors.initials: I
authors.lastname: Herz
authors.affiliation: Department of Cardiology, Tel-Aviv Medical Center, Tel-Aviv, Israel and the Sackler Faculty of Medicine, Tel-Aviv University, Tel Aviv, Israel.
authors.forename: Samuel
authors.initials: S
authors.lastname: Bazan
authors.affiliation: Department of Cardiology, Tel-Aviv Medical Center, Tel-Aviv, Israel and the Sackler Faculty of Medicine, Tel-Aviv University, Tel Aviv, Israel.
authors.forename: Miri
authors.initials: M
authors.lastname: Revivo
authors.affiliation: Department of Cardiology, Tel-Aviv Medical Center, Tel-Aviv, Israel and the Sackler Faculty of Medicine, Tel-Aviv University, Tel Aviv, Israel.
authors.forename: Amir
authors.initials: A
authors.lastname: Halkin
authors.affiliation: Department of Cardiology, Tel-Aviv Medical Center, Tel-Aviv, Israel and the Sackler Faculty of Medicine, Tel-Aviv University, Tel Aviv, Israel.
authors.forename: Gad
authors.initials: G
authors.lastname: Keren
authors.affiliation: Department of Cardiology, Tel-Aviv Medical Center, Tel-Aviv, Israel and the Sackler Faculty of Medicine, Tel-Aviv University, Tel Aviv, Israel.
authors.forename: Ariel
authors.initials: A
authors.lastname: Finkelstein
authors.affiliation: Department of Cardiology, Tel-Aviv Medical Center, Tel-Aviv, Israel and the Sackler Faculty of Medicine, Tel-Aviv University, Tel Aviv, Israel.
authors.forename: Yaron
authors.initials: Y
authors.lastname: Arbel
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002317:Cardiovascular Agents / Q000627:therapeutic use*; D023903:Coronary Restenosis / Q000628:therapy; D003328:Coronary Thrombosis / Q000628:therapy; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention; D011108:Polymers; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D011108:Polymers
keywords: Drug-eluting-stent; Polymer; Restenosis; Stent thrombosis; Target-vessel failure