A randomized clinical trial of high-intensity warfarin vs. conventional antithrombotic therapy for the prevention of recurrent thrombosis in patients with the antiphospholipid syndrome (WAPS).

摘要: Summary. Background: The optimal intensity of oral anticoagulation for the prevention recurrent thrombosis in patients with antiphospholipid antibody syndrome is uncertain. Retrospective studies show that only high-intensity [target international normalized ratio (INR) >3.0] effective but a recent randomized clinical trial comparing high (INR range 3.0–4.0) vs. moderate 2.0– 3.0) intensities failed to confirm this assumption. Methods: We conducted which 109 (APS) and previous were given either warfarin 3.0–4.5, 54 patients) or standard antithrombotic therapy (warfarin, INR 2.0–3.0 52 aspirin alone, 100 mg day )1 three determine whether intensive superior treatment preventing symptomatic thromboembolism without increasing bleeding risk. Results: enrolled followed up median time 3.6 years. Mean during follow-up was 3.2 (SD 0.6) group 2.5 0.3) (P < 0.0001) conventional warfarin. Recurrent observed six (11.1%) assigned receive highintensity 55 (5.5%) [hazard group, 1.97; 95% confidence interval (CI) 0.49–7.89]. Major minor occurred 15 (two major) (27.8%) eight (three (14.6%) (hazard 2.18; CI 0.92–5.15). Conclusions: High-intensity not APS associated an increased rate hemorrhagic complications.