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A Cohort Study to Assess Risk of Cutaneous Small Vessel Vasculitis Among Users of Different Oral Anticoagulants

    Basic Details

    Cutaneous small vessel vasculitis (CSVV) was identified as a safety signal among patients treated with Direct Oral Anticoagulants (DOAC). This study aimed to determine if CSVV risk differed among patients with atrial fibrillation (Afib) who newly initiated warfarin or a DOAC.

    We identified enrollees aged ≥21 years diagnosed with Afib who newly initiated rivaroxaban, dabigatran, apixaban, and warfarin in the Sentinel Distributed Database from October 19, 2010, to February 29, 2020. We selected and followed patients who did not have evidence of the following in the 183 days prior to initiating treatment: CSVV diagnosis, dispensing of other study drugs, select autoimmune diseases or autoimmune medications, cancer diagnoses or chemotherapeutic treatment, kidney dialysis or transplant, alternative anticoagulation indications, or an institutional (nursing home, hospice, hospital) stay on the treatment initiation date (index date) until CSVV outcome or pre-specified censoring. We conducted 1:1 propensity score matching in six comparisons.


    Adebola Ajao, Austin Cosgrove, Efe Eworuke, Mohamed Mohamoud, Rongmei Zhang, Oren Shapira, Joy Kolonoski, John G. Connolly

    Corresponding Author

    Adebola Ajao; Division of Epidemiology, Office of Pharmacovigilance and Epidemiology, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD.