title: The use of direct oral anticoagulants in 56 patients with antiphospholipid syndrome.
abstract: BACKGROUND
  Antiphospholipid syndrome (APS) is a common acquired thrombophilia associated with a high thrombotic risk, in which vitamin K antagonists (VKA) represent the mainstay of therapy. Case series involving up to 35 patients with APS suggested limited efficacy and safety of direct oral anticoagulants (DOACs).
  
  
  METHODS
  In the prospective case series we followed 56 consecutive patients with APS (44 women and 12 men, aged from 22 to 64years), including 33 (60%) associated with systemic lupus erythematosus (SLE) and 16 (28.6%) with triple APS who were treated with DOACs due to their preferences or unstable anticoagulation with VKA. DOACs were started at least 3months since the thromboembolic event in patients with D-dimer below 500ng/ml.
  
  
  RESULTS
  Forty-nine (87.5%) patients were treated with rivaroxaban, 4 (7.3%) with dabigatran and 3 (5.4%) with apixaban. During follow-up of 2 to 43 (mean 22) months, 6 (10.7%, 5.8 per 100 patient-years) patients (4 women and 2 men, 4 with triple positive APS) experienced recurrent thrombosis, including deep vein thrombosis (n=4, including 2 episodes preceded by nonadherence), superficial vein thrombosis (n=1) and non-ST elevation myocardial infarction (n=1). The recurrence rate of VTE on DOACs was 5.8 per 100 patient-years. Two patients (3.6%) experienced severe bleeding.
  
  
  CONCLUSIONS
  This case-series suggests that DOACs are safe in patients with APS. These findings need to be confirmed in larger studies.
authors.affiliation: Institute of Cardiology, Jagiellonian University Medical College, Krakow, Poland.
authors.forename: Katarzyna
authors.initials: K
authors.lastname: Malec
authors.affiliation: Innovative Laboratory Diagnostic Center, John Paul II Hospital, Krakow, Poland.
authors.forename: Tadeusz
authors.initials: T
authors.lastname: Góralczyk
authors.affiliation: Institute of Cardiology, Jagiellonian University Medical College, Krakow, Poland; Innovative Laboratory Diagnostic Center, John Paul II Hospital, Krakow, Poland. Electronic address: mmundas@cyf-kr.edu.pl.
authors.forename: Anetta
authors.initials: A
authors.lastname: Undas
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000925:Anticoagulants / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016736:Antiphospholipid Syndrome / Q000150:complications* / Q000188:drug therapy; D000069604:Dabigatran / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011720:Pyrazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011728:Pyridones / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000069552:Rivaroxaban / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D013927:Thrombosis / Q000209:etiology* / Q000517:prevention & control*; D014812:Vitamin K / Q000037:antagonists & inhibitors; D055815:Young Adult
chemical_list: D000925:Anticoagulants; D011720:Pyrazoles; D011728:Pyridones; D014812:Vitamin K; C522181:apixaban; D000069552:Rivaroxaban; D000069604:Dabigatran
keywords: Antiphospholipid syndrome; Apixaban; Dabigatran; Direct oral anticoagulants; Rivaroxaban; Thrombosis