title: A clinical evaluation of the ProNOVA XR polymer-free sirolimus eluting coronary stent system in the treatment of patients with de novo coronary artery lesions (EURONOVA XR I study).
abstract: OBJECTIVE
  Evaluation of safety and efficacy of ProNOVA XR, a new generation of polymer-free sirolimus eluting stents (SES), utilizing a pharmaceutical excipient for timed release of sirolimus from the XR platform.
  
  
  RESULTS
  Safety and efficacy of ProNOVA XR coronary stent system was examined in EURONOVA prospective, single arm, multi-center registry of 50 patients with de novo native coronary lesions up to 28 mm in length in arteries between 2.25 and 4 mm. At 6-month, in-stent late lumen loss by QCA was 0.45 ± 0.41 mm and in-stent neointimal volume obstruction in the IVUS sub-study was 14 ± 11%. One-year clinical follow-up revealed a favorable safety profile, with 2% of in-hospital MACE and 6.4% of MACE from hospital discharge up to 12 months (including 1 cardiac death >30 days after stent implantation and 2 TLRs). According to the ARC definition, there was no definite or probable stent thrombosis and 1 possible stent thrombosis (2%) up to 12 months of clinical follow-up.
  
  
  CONCLUSIONS
  In this preliminary evaluation, ProNOVA XR polymer-free sirolimus eluting stent system appeared safe with an early promise of adequate effectiveness in the treatment of de novo coronary lesions in up to 12 months of clinical, angiographic and IVUS follow-up.
authors.affiliation: Department of Interventional Cardiology, Jagiellonian University, Krakow, Poland; Department of Invasive Cardiology, Electrotherapy and Angiology, Intercard, Nowy Targ, Poland. Electronic address: jlegutko@kcri.org.
authors.forename: Jacek
authors.initials: J
authors.lastname: Legutko
authors.forename: Wojciech
authors.initials: W
authors.lastname: Zasada
authors.forename: Grzegorz L
authors.initials: GL
authors.lastname: Kałuża
authors.forename: Grzegorz
authors.initials: G
authors.lastname: Heba
authors.forename: Lukasz
authors.initials: L
authors.lastname: Rzeszutko
authors.forename: Jacek
authors.initials: J
authors.lastname: Jakala
authors.forename: Jacek
authors.initials: J
authors.lastname: Dragan
authors.forename: Artur
authors.initials: A
authors.lastname: Klecha
authors.forename: Dawid
authors.initials: D
authors.lastname: Giszterowicz
authors.forename: Wojciech
authors.initials: W
authors.lastname: Dobrowolski
authors.forename: Lukasz
authors.initials: L
authors.lastname: Partyka
authors.forename: Swaminathan
authors.initials: S
authors.lastname: Jayaraman
authors.forename: Dariusz
authors.initials: D
authors.lastname: Dudek
mesh_terms: D015897:Comorbidity; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000188:drug therapy*; D054855:Drug-Eluting Stents; D005079:Excipients / Q000494:pharmacology; D005260:Female; D006801:Humans; D019344:Lactic Acid / Q000494:pharmacology; D008297:Male; D008875:Middle Aged; D011100:Polyglycolic Acid / Q000494:pharmacology; D000077182:Polylactic Acid-Polyglycolic Acid Copolymer; D011446:Prospective Studies; D020123:Sirolimus / Q000008:administration & dosage*; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional
chemical_list: D005079:Excipients; D000077182:Polylactic Acid-Polyglycolic Acid Copolymer; D011100:Polyglycolic Acid; D019344:Lactic Acid; D020123:Sirolimus
keywords: DES; EEM; IVUS; PF; QCA; external elastic membrane; polymer-free