AI Article Synopsis

  • Thrombotic antiphospholipid syndrome (TAPS) causes blood clots in various vessels, requiring patients to take anticoagulants, traditionally warfarin.
  • A study compared the effectiveness of apixaban, a newer anticoagulant that doesn’t need monitoring, against warfarin over 12 months in TAPS patients.
  • Results showed more strokes in patients on apixaban (6 out of 23) compared to none on warfarin (0 out of 25), leading to the conclusion that apixaban may not be a suitable substitute for warfarin in preventing clots in TAPS patients.

Article Abstract

Thrombotic antiphospholipid syndrome (TAPS) is characterized by venous, arterial, or microvascular thrombosis. Patients with TAPS merit indefinite anticoagulation, and warfarin has historically been the standard treatment. Apixaban is an oral factor Xa inhibitor anticoagulant that requires no dose adjustment or monitoring. The efficacy and safety of apixaban compared with warfarin for TAPS patients remain unknown. This multicenter prospective randomized open-label blinded endpoint study assigned anticoagulated TAPS patients to apixaban or warfarin (target international normalized ratio 2-3) for 12 months. The primary efficacy outcome was clinically overt thrombosis and vascular death. Apixaban was first given at 2.5 mg twice daily. Two protocol changes were instituted based on recommendations from the data safety monitoring board. After the twenty-fifth patient was randomized, the apixaban dose was increased to 5 mg twice daily, and after the thirtieth patient was randomized, subjects with prior arterial thrombosis were excluded. Primary outcomes were adjudicated by independent experts blinded to treatment allocation. Patients randomized between 23 February 2015 and 7 March 2019 to apixaban (n = 23) or warfarin (n = 25) were similar. Among the components of the primary efficacy outcome, only stroke occurred in 6 of 23 patients randomized to apixaban compared with 0 of 25 patients randomized to warfarin. The study ended prematurely after the forty-eighth patient was enrolled. Conclusions from our study are limited due to protocol modifications and low patient accrual. Despite these limitations, our results suggest that apixaban may not be routinely substituted for warfarin to prevent recurrent thrombosis (especially strokes) among patients with TAPS. This trial was registered at www.clinicaltrials.gov as #NCT02295475.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8941474PMC
http://dx.doi.org/10.1182/bloodadvances.2021005808DOI Listing

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