title: 9-Month Clinical and Angiographic Outcomes of the COBRA Polyzene-F NanoCoated Coronary Stent System.
abstract: The aim of this study was to assess the safety and effectiveness of the COBRA Polyzene-F NanoCoated Coronary Stent System (CeloNova Biosciences, San Antonio, Texas) for the treatment of de novo coronary artery lesions.
  
  
  
  Polyzene-F-coated coronary stents have shown reduced thrombogenicity and inflammation in preclinical studies.
  
  
  
  Patients with de novo coronary artery lesions meeting eligibility criteria were enrolled in a nonrandomized, prospective clinical trial. The primary endpoint was target vessel failure (TVF) (defined as a composite of cardiac death, myocardial infarction, or clinically driven target vessel revascularization) at 9 months. A pre-specified subset was planned for routine repeat angiographic follow-up at 9 months. The powered secondary endpoint was mean late lumen loss (LL). The comparator was a performance goal derived from meta-analysis of historical bare-metal stent trials of 19.62% for TVF and 1.1 mm for LL. Other secondary endpoints were clinically driven target lesion revascularization and definite or probable stent thrombosis.
  
  
  
  Of 296 enrolled patients, 287 (97%) completed primary endpoint analysis; 130 were planned for angiographic follow-up and 115 (88%) completed. At 9 months, TVF had occurred in 33 patients (11.5%; upper 95% confidence boundary: 15.07%), including 1 (0.3%) cardiac death, 20 (7.0%) myocardial infarctions (17 periprocedural), and 17 (5.9%) target vessel revascularizations. LL was 0.84 ± 0.48 mm (upper 95% confidence boundary: 0.92). Target lesion revascularization occurred in 13 patients (4.6%). There were no stent thrombosis events.
  
  
  
  The COBRA Polyzene-F stent met performance goals for TVF and LL at 9 months. There was an excellent safety profile, with infrequent late myocardial infarction and no stent thrombosis.
authors.affiliation: Cardiology Division, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts. Electronic address: dcutlip@bidmc.harvard.edu.
authors.forename: Donald E
authors.initials: DE
authors.lastname: Cutlip
authors.affiliation: Christiana Health Care System, Newark, Delaware.
authors.forename: Kirk N
authors.initials: KN
authors.lastname: Garratt
authors.affiliation: Clinical Research Center, Soroka University Medical Center, Beersheba, Israel.
authors.forename: Victor
authors.initials: V
authors.lastname: Novack
authors.affiliation: North Shore University Hospital, Manhasset, New York.
authors.forename: Mark
authors.initials: M
authors.lastname: Barakat
authors.affiliation: GCS ES Axium Rambot, Aix-en-Provence, France.
authors.forename: Perwaiz
authors.initials: P
authors.lastname: Meraj
authors.affiliation: University of Latvia, Riga, Latvia.
authors.forename: Luc
authors.initials: L
authors.lastname: Maillard
authors.affiliation: Baylor Heart and Vascular Hospital at Baylor University Medical Center, Dallas, Texas.
authors.forename: Andrejs
authors.initials: A
authors.lastname: Erglis
authors.affiliation: GCS ES Axium Rambot, Aix-en-Provence, France.
authors.forename: Rajiv
authors.initials: R
authors.lastname: Jauhar
authors.affiliation: Cardiology Division, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts.
authors.forename: Jeffrey J
authors.initials: JJ
authors.lastname: Popma
authors.affiliation: Department of Cardiology, Heart Center at the Isar, Munich, Germany.
authors.forename: Robert
authors.initials: R
authors.lastname: Stoler
authors.affiliation: CeloNova BioSciences, San Antonio, Texas.
authors.forename: Sigmund
authors.initials: S
authors.lastname: Silber
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation*; D020099:Coated Materials, Biocompatible; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000628:therapy*; D023903:Coronary Restenosis / Q000000981:diagnostic imaging* / Q000209:etiology; D003328:Coronary Thrombosis / Q000000981:diagnostic imaging / Q000209:etiology; D003331:Coronary Vessels / Q000000981:diagnostic imaging*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D053758:Nanoparticles; D009943:Organophosphorus Compounds / Q000737:chemistry; D011108:Polymers / Q000737:chemistry*; D011237:Predictive Value of Tests; D011446:Prospective Studies; D011474:Prosthesis Design; D012307:Risk Factors; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D020099:Coated Materials, Biocompatible; D009943:Organophosphorus Compounds; D011108:Polymers
keywords: restenosis; stent(s); thrombosis