title: First-in-man 1-year clinical outcomes of the Catania Coronary Stent System with Nanothin Polyzene-F in de novo native coronary artery lesions: the ATLANTA (Assessment of The LAtest Non-Thrombogenic Angioplasty stent) trial.
abstract: OBJECTIVE
  This study sought to assess safety and efficacy of implantation of the Catania Coronary Stent System with Nanothin Polyzene-F (CeloNova BioSciences, Newnan, Georgia) in human coronary arteries with clinical data and comprehensive intracoronary imaging.
  
  
  BACKGROUND
  Novel approaches to modify stents (e.g., bioactive agents, coatings) have been developed to address the limitations of bare-metal and drug-eluting stents (e.g., restenosis, target lesion revascularization [TLR], late thrombosis).
  
  
  METHODS
  This first-in-man study using the Catania stent is a prospective, single center, nonrandomized, single-arm study of 55 patients with symptomatic ischemic heart disease with de novo, obstructive lesions of native coronary arteries.
  
  
  RESULTS
  Acute angiographic success was 100%. A core laboratory analyzed quantitative coronary angiography and intravascular ultrasound data immediately after stenting and at 6-month follow-up. Late lumen loss was 0.60 +/- 0.48 mm and the percent neointimal hyperplasia volume was 27.9 +/- 16.1%. In 15 of 55 randomly selected patients, 1,904 cross-sections (19,028 struts) were analyzed at 6 months by optical coherence tomography. Overall, 99.5% of struts were covered. Only 29 of 19,028 struts (0.15%) were malapposed. Binary angiographic restenosis was 6.8%. No death, myocardial infarction, or Academic Research Consortium-defined stent thrombosis was observed at 12 months. The incidence of TLR at 12 months was clinically driven TLR 3.6% (2 of 55) and nonclinically driven TLR 7.3% (4 of 55).
  
  
  CONCLUSIONS
  This first-in-man showed an excellent early and mid-term safety profile and high-level efficacy of the new Catania stent in the treatment of de novo coronary lesions in a fairly complex population. Polyzene-F coated stents may be an alternative to both bare-metal and drug-eluting stents with reduced late loss, restenosis, and the TLR without long-term dual antiplatelet therapy.
authors.affiliation: Cardiology Department, Ferrarotto Hospital, University of Catania, Catania, Italy. tambucor@unict.it
authors.forename: Corrado
authors.initials: C
authors.lastname: Tamburino
authors.forename: Alessio
authors.initials: A
authors.lastname: La Manna
authors.forename: Maria Elena
authors.initials: ME
authors.lastname: Di Salvo
authors.forename: Giorgio
authors.initials: G
authors.lastname: Sacchetta
authors.forename: Davide
authors.initials: D
authors.lastname: Capodanno
authors.forename: Roxana
authors.initials: R
authors.lastname: Mehran
authors.forename: George
authors.initials: G
authors.lastname: Dangas
authors.forename: Thierry
authors.initials: T
authors.lastname: Corcos
authors.forename: Francesco
authors.initials: F
authors.lastname: Prati
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation / Q000706:statistics & numerical data*; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000175:diagnosis* / Q000473:pathology / Q000628:therapy; D003331:Coronary Vessels / Q000473:pathology*; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D013318:Stroke Volume; D013997:Time Factors; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional; D016277:Ventricular Function, Left