title: Safety and Feasibility of Treatment with Rivaroxaban for Non-Canonical Indications: A Case Series Analysis.
abstract: OBJECTIVE
  The new oral anticoagulants (NOACs) are used for the prevention of thromboembolic complications in patients with non-valvular atrial fibrillation (AF) and those at risk of deep venous thrombosis. Their rapid onset of action and predictable pharmacokinetic and pharmacodynamic profiles make them the optimal alternative to warfarin in the treatment of these two categories of patients. Unfortunately, however, NOACs cannot be used in patients with valvular AF or valvular cardiac prostheses. Although mechanical valves are effectively a contraindication to NOAC use due to several pathophysiological mechanisms that promote the use of warfarin rather than NOACs, few data exist regarding the use of such new pharmacological compounds on patients with cardiac biological valves or those who have undergone mitral repair or tubular aortic graft implantation.
  
  
  METHODS
  Our case series involved 27 patients [mean age 70 ± 10 years; mean CHA2DS2-VASc (Congestive heart failure, Hypertension, Age ≥75 years (doubled), Diabetes mellitus, Stroke/transient ischemic attack (doubled), Vascular disease, Age 65-74 years, Sex category): 6 ± 1.4; and mean HAS-BLED (Hypertension, Abnormal renal and liver function, Stroke, Bleeding, Labile international normalized ratios, Elderly, Drugs or alcohol): 4 ± 1] with AF and biological prostheses, repaired mitral valves, or tubular aortic graft who were treated with the factor Xa inhibitor rivaroxaban due to inefficacy or adverse effects of warfarin.
  
  
  RESULTS
  The mean left ventricular ejection fraction was 48 ± 9 %, the left atrial diameter was 46.5 ± 7 mm, and the estimated glomerular filtration rate was 45 ± 21 mL/min/1.73 m(2). The mean duration of treatment was 15 ± 2 months. No relevant complications or recurrent thromboembolic events occurred. Three patients had recurrent nose bleeding and two had hematuria that led to reduction of the rivaroxaban dose by the treating physician to 15 mg once a day after 4 months of therapy. No further bleeding episode was recorded after escalating the dose.
  
  
  CONCLUSIONS
  Rivaroxaban is a valuable treatment option for patients with biological prostheses, repaired mitral valves, or a tubular aortic graft in order to prevent thromboembolic complications.
authors.affiliation: Salvatore Maugeri Foundation I.R.C.C.S., Telese Terme, Benevento, Italy.
authors.forename: Domenico
authors.initials: D
authors.lastname: Acanfora
authors.affiliation: Salvatore Maugeri Foundation I.R.C.C.S., Telese Terme, Benevento, Italy.
authors.forename: Chiara
authors.initials: C
authors.lastname: Acanfora
authors.affiliation: Section of Cardiovascular Diseases, Department of Emergency and Organ Transplantation, School of Medicine, University of Bari, Piazza G. Cesare 11, 70124, Bari, Italy.
authors.forename: Pietro
authors.initials: P
authors.lastname: Scicchitano
authors.affiliation: Salvatore Maugeri Foundation I.R.C.C.S., Telese Terme, Benevento, Italy.
authors.forename: Marialaura
authors.initials: M
authors.lastname: Longobardi
authors.affiliation: Salvatore Maugeri Foundation I.R.C.C.S., Telese Terme, Benevento, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Furgi
authors.affiliation: San Francesco Hospital, Telese Terme, Benevento, Italy.
authors.forename: Gerardo
authors.initials: G
authors.lastname: Casucci
authors.affiliation: Salvatore Maugeri Foundation I.R.C.C.S., Telese Terme, Benevento, Italy.
authors.forename: Bernardo
authors.initials: B
authors.lastname: Lanzillo
authors.affiliation: Section of Cardiovascular Diseases, Department of Emergency and Organ Transplantation, School of Medicine, University of Bari, Piazza G. Cesare 11, 70124, Bari, Italy.
authors.forename: Ilaria
authors.initials: I
authors.lastname: Dentamaro
authors.affiliation: Section of Cardiovascular Diseases, Department of Emergency and Organ Transplantation, School of Medicine, University of Bari, Piazza G. Cesare 11, 70124, Bari, Italy.
authors.forename: Annapaola
authors.initials: A
authors.lastname: Zito
authors.affiliation: Department of Geriatrics, Campus Bio-Medico University, Rome, Italy.
authors.forename: Raffaele Antonelli
authors.initials: RA
authors.lastname: Incalzi
authors.affiliation: Section of Cardiovascular Diseases, Department of Emergency and Organ Transplantation, School of Medicine, University of Bari, Piazza G. Cesare 11, 70124, Bari, Italy. marcomatteo.ciccone@uniba.it.
authors.forename: Marco Matteo
authors.initials: MM
authors.lastname: Ciccone
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000627:therapeutic use*; D001281:Atrial Fibrillation / Q000150:complications; D005260:Female; D005343:Fibrinolytic Agents / Q000627:therapeutic use; D006333:Heart Failure / Q000503:physiopathology; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D006973:Hypertension / Q000188:drug therapy; D019934:International Normalized Ratio; D008297:Male; D008875:Middle Aged; D000069552:Rivaroxaban / Q000627:therapeutic use*; D020521:Stroke / Q000517:prevention & control*; D013923:Thromboembolism / Q000517:prevention & control*; D014859:Warfarin / Q000627:therapeutic use
chemical_list: D000925:Anticoagulants; D005343:Fibrinolytic Agents; D014859:Warfarin; D000069552:Rivaroxaban