title: Direct oral anticoagulants: an alternative treatment for thrombotic antiphospholipid syndrome?
abstract: Background Direct oral anticoagulants (DOACs) demonstrate a lower risk-benefit ratio than vitamin K antagonists (VKAs) for secondary thromboprophylaxis of thrombotic events. But there are no data on the efficacy of DOACs for the prevention of thrombotic recurrence in patients with antiphospholipid syndrome (APS). In this study, we evaluated the efficacy of DOACs to prevent recurrences of thrombotic events in patients with APS. Methods This was a single-center pilot, using a multi-step Fleming design. If seven or fewer patients presented treatment failure with rivaroxaban, the study could conclude efficacy. Results A total of 23 patients were included. APS involved the veins only ( n = 19), arteries only ( n = 2) or both ( n = 1) and 1 patient exhibited catastrophic antiphospholipid syndrome (CAPS). Overall, two patients were positive for lupus anticoagulant, anti-beta-2 glycoprotein I antibodies and anticardiolipid antibodies (triple positivity). The mean duration of follow up was 35.6 (range, 29-40) months. A total of six treatment failures were reported: one patient, with triple positivity, developed bilateral distal pulmonary embolism (PE) after 20 months of treatment with rivaroxaban, two patients refused to take rivaroxaban, the treatment was stopped in three other patients: two with adverse effects and one with chronic iron-deficiency anemia. Conclusions Rivaroxaban may represent an alternative for secondary thromboprophylaxis for thrombo-embolism in patients with APS, in particular, those with poor international normalized ratio (INR) control and those who are not at the highest risk of recurrent thrombosis, such as those with triple positivity.
authors.affiliation: 1 Department of Internal Medicine, CHU Clermont-Ferrand, Clermont-Ferrand, France.
authors.forename: A S
authors.initials: AS
authors.lastname: Resseguier
authors.affiliation: EA 4681 PEPRADE, University Clermont Auvergne, Clermont-Ferrand, France.
authors.forename: B
authors.initials: B
authors.lastname: Pereira
authors.affiliation: 2 Biostatistics Unit, Délégation Recherche Clinique & Innovation, University Hospital Clermont-Ferrand, France.
authors.forename: V
authors.initials: V
authors.lastname: Rieu
authors.affiliation: 2 Biostatistics Unit, Délégation Recherche Clinique & Innovation, University Hospital Clermont-Ferrand, France.
authors.forename: G
authors.initials: G
authors.lastname: Le Guenno
authors.affiliation: 2 Biostatistics Unit, Délégation Recherche Clinique & Innovation, University Hospital Clermont-Ferrand, France.
authors.forename: V
authors.initials: V
authors.lastname: Grobost
authors.affiliation: 1 Department of Internal Medicine, CHU Clermont-Ferrand, Clermont-Ferrand, France.
authors.forename: M
authors.initials: M
authors.lastname: Ruivard
mesh_terms: D000284:Administration, Oral; D000328:Adult; D017153:Antibodies, Anticardiolipin / Q000276:immunology; D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use*; D016736:Antiphospholipid Syndrome / Q000150:complications / Q000188:drug therapy* / Q000276:immunology; D015331:Cohort Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D016682:Lupus Coagulation Inhibitor / Q000276:immunology; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011655:Pulmonary Embolism / Q000209:etiology / Q000517:prevention & control; D000069552:Rivaroxaban / Q000009:adverse effects / Q000627:therapeutic use*; D013927:Thrombosis / Q000209:etiology / Q000517:prevention & control*; D055815:Young Adult; D053482:beta 2-Glycoprotein I / Q000276:immunology
chemical_list: D017153:Antibodies, Anticardiolipin; D000925:Anticoagulants; D016682:Lupus Coagulation Inhibitor; D053482:beta 2-Glycoprotein I; D000069552:Rivaroxaban
keywords: Anticoagulation; antiphospholipid syndrome; thrombosis