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Apixaban vs. Warfarin in Patients with Thrombotic Antiphospholipid Antibody Syndrome
Direct oral anticoagulants (DOACs) have replaced warfarin as the anticoagulant of choice in most clinical situations. However, warfarin has remained as the recommended anticoagulant for patients with antiphospholipid antibody syndrome (APS), based on superiority over the DOAC rivaroxaban. Apixaban has not been studied.
To determine whether apixaban 2.5 mg twice daily would be safe and effective compared with warfarin (targeting an international normalized ratio of 2–3) in thrombotic APS patients, investigators conducted a prospective, randomized, controlled trial. The primary outcome was a composite including thrombosis (arterial and venous) and vascular death.
Key result were as follows:
- 48 patients were enrolled (including 83.3% women) with a mean age of 47.3 years; 35.4% had a prior history of arterial thrombosis, and vascular comorbidities such as smoking (20.8%), hypertension (14.6%), diabetes (16.7%), and dyslipidemia (16.7%) were reported in the cohort.
- There were 6 thrombotic events (all cerebrovascular accidents) in the apixaban group (318 events per 1000 person-years) versus 0 with warfarin.
- There were no bleeding events with apixaban, and 1 with warfarin.
- Patient satisfaction scores were higher with apixaban.
This study reports additional discouraging data regarding use of DOACs in patients with APS. The authors note flaws in their study, including early termination, a small sample size (200 patients were intended to be enrolled), and protocol modifications — the two most notable being an increase in apixaban to 5 mg twice daily after three thrombotic events had been noted and the exclusion of patients with prior arterial thrombosis. This study highlights the challenges in obtaining high-quality data for rare nonmalignant hematological diseases. However, until a study without the stated limitations can be conducted, hematologists will have to discourage use of apixaban for APS.
Woller SC et al.
Title: Apixaban compared with warfarin to prevent thrombosis in thrombotic antiphospholipid syndrome: A randomized trial.
Source: Blood Adv 2021 Oct 18; [e-pub]. (Abstract/FREE Full Text)