Thrombosis recurrence and major bleeding in non-anticoagulated thrombotic antiphospholipid syndrome patients: Prospective study from antiphospholipid syndrome alliance for clinical trials and international networking (APS ACTION) clinical database and repository ("Registry").
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Yelnik Cecile M, Erton Zeynep Belce, Drumez Elodie, Cheildze Dachi, de Andrade Danieli, Clarke Ann, Tektonidou Maria G, Sciascia Savino, Pardos-Gea Jose, Pengo Vittorio, Ruiz-Irastorza Guillermo, Belmont H Michael, Pedrera Chary Lopez, Fortin Paul R, Wahl Denis, Gerosa Maria, Kello Nina, Signorelli Flavio, Atsumi Tatsuya, Ji Lanlan, Efthymiou Maria, Branch D Ware, Nalli Cecilia, Rodriguez-Almaraz Esther, Petri Michelle, Cervera Ricard, Shi Hui, Zuo Yu, Artim-Esen Bahar, Pons-Estel Guillermo, Willis Rohan, Barber Megan R W, Skeith Leslie, Bertolaccini Maria Laura, Cohen Hannah, Roubey Robert, Erkan Doruk
Аннотация
OBJECTIVES: To prospectively evaluate the risk of thrombosis recurrence and major bleeding in non-anticoagulated TAPS patients, compared to anticoagulated TAPS, and secondly, to identify different features between those two groups.
PATIENTS/METHODS: Using an international registry, we identified non-anticoagulated TAPS patients at baseline, and matched them with anticoagulated TAPS patients based on gender, age, type of previous thrombosis, and associated autoimmune disease. Thrombosis recurrence and major bleeding were prospectively analyzed using Kaplan-Meier method and compared using a marginal Cox's regression model.
RESULTS: As of June 2022, 94 (14 %) of the 662 TAPS patients were not anticoagulated; and 93 of them were matched with 181 anticoagulated TAPS patients (median follow-up 5 years [interquartile range 3 to 8]). The 5-year thrombosis recurrence and major bleeding rates were 12 % versus 10 %, and 6 % versus 7 %, respectively (hazard ratio [HR] 1.38, 95 % confidence interval [CI] 0.53 to 3.56, p = 0.50 and HR 0.53; 95 % CI 0.15 to 1.86; p = 0.32, respectively). Non-anticoagulated patients were more likely to receive antiplatelet therapy (p < 0.001), and less likely to have more than one previous thrombosis (p < 0.001) and lupus anticoagulant positivity (p = 0.01).
CONCLUSION: Fourteen percent of the TAPS patients were not anticoagulated at recruitment. Their recurrent thrombosis risk did not differ compared to matched anticoagulated TAPS patients, supporting the pressing need for risk-stratified secondary thrombosis prevention trials in APS investigating strategies other than anticoagulation.