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Rivaroxaban vs warfarin in high-risk patients with antiphospholipid syndrome

Vittorio Pengo, Gentian Denas, Giacomo Zoppellaro, Seena Padayattil Jose, Ariela Hoxha, Amelia Ruffatti, Laura Andreoli, Angela Tincani, Caterina Cenci, Domenico Prisco, Tiziana Fierro, Paolo Gresele, Arturo Cafolla, Valeria De Micheli, Angelo Ghirarduzzi, Alberto Tosetto, Anna Falanga, Ida Martinelli, Sophie Testa, Doris Barcellona, Maria Gerosa and Alessandra Banzato

Key Points

  • Direct anticoagulants are currently used in patients with thromboembolism, irrespective of the presence of antiphospholipid antibodies.

  • This trial shows an increased rate of events with rivaroxaban compared with warfarin in patients with antiphospholipid syndrome.

Publisher's Note: There is a Blood Commentary on this article in this issue.

Abstract

Rivaroxaban is an effective and safe alternative to warfarin in patients with atrial fibrillation and venous thromboembolism. We tested the efficacy and safety of rivaroxaban compared with warfarin in high-risk patients with thrombotic antiphospholipid syndrome. This is a randomized open-label multicenter noninferiority study with blinded end point adjudication. Rivaroxaban, 20 mg once daily (15 mg once daily based on kidney function) was compared with warfarin (international normalized ratio target 2.5) for the prevention of thromboembolic events, major bleeding, and vascular death in patients with antiphospholipid syndrome. Only high-risk patients triple positive for lupus anticoagulant, anti-cardiolipin, and anti–β2-glycoprotein I antibodies of the same isotype (triple positivity) were included in the study. The trial was terminated prematurely after the enrollment of 120 patients (59 randomized to rivaroxaban and 61 to warfarin) because of an excess of events among patients in the rivaroxaban arm. Mean follow-up was 569 days. There were 11 (19%) events in the rivaroxaban group, and 2 (3%) events in the warfarin group. Thromboembolic events occurred in 7 (12%) patients randomized to rivaroxaban (4 ischemic stroke and 3 myocardial infarction), whereas no event was recorded in those randomized to warfarin. Major bleeding occurred in 6 patients: 4 (7%) in the rivaroxaban group and 2 (3%) in the warfarin group. No death was reported. The use of rivaroxaban in high-risk patients with antiphospholipid syndrome was associated with an increased rate of events compared with warfarin, thus showing no benefit and excess risk. This trial was registered at www.clinicaltrials.gov as #NCT02157272.

  • Submitted April 30, 2018.
  • Accepted July 3, 2018.
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