Abstract 16274: Risk of Bleeding in Patients With Non-Valvular Atrial Fibrillation Exposed to Apixaban With or Without Selective Serotonin Reuptake Inhibitors (SSRIs) or Serotonin-norepinephrine Reuptake Inhibitors (SNRIs)

Abstract

Background: Patients with NVAF treated with direct oral anticoagulants (DOACs) are often also treated with SSRI/SNRI for co-existing conditions. Whether the concomitant use of SSRI/SNRI with DOAC such as apixaban would impart additional bleeding risk over that of apixaban alone has not been well studied. Objective: To assess the risk of major bleeding (MB) in patients with NVAF treated with apixaban alone and in concomitant with SSRI/SNRI in a real-world setting. Methods: We identified patients with NVAF, and newly prescribed with apixaban or co-administered with SSRI/SNRI (Apix+SSRI/SNRI) in a large US administrative claims database (1JAN2013-31DEC2017). Patients treated with Apix+SSRI/SNRI were matched by propensity score (PSM) with those treated with apixaban only. Cox model was used to estimate the hazard ratios (HRs) of overall and individual MB (GI bleeding, intracranial hemorrhage [ICH], or other bleeding requiring hospitalization) across matched cohorts. Additionally, we applied inverse probability treatment weighting (IPTW) and covariates balancing PS (CBPS) methods to adjust for unbalanced covariates despite matching on PS. Results: We identified 32,225 and 6,101 patients with NVAF newly prescribed with apixaban and co-administered with Apix+SSRI/SNRI. Before PSM, Apix+SSRI/SNRI patients were older, had higher baseline CHA 2 DS 2 -VASc and HAS-BLED scores, more comorbidities, and received a lower dosage of apixaban. PS matched 6,035 patients in each group. The adjusted HR (95% CI) of overall MB, with Apix+SSRI/SNRI relative to apixaban alone was 1.42 (0.94-2.15). For GI bleeding HR was 1.26 (0.74-2.15), 3.94 (0.78-19.77) for ICH, and 1.39 (0.66-2.93) for other bleeding leading to hospitalization. The estimated associations between co-administration of apixaban with SSRI/SNRI and MB were less strong with IPTW and CBPS analyses. None of the HR point estimates was statistically significant. Conclusion: In this real-world study of patients with NVAF, patients co-administered with apix+SSRI/SNRI did not show significant increased risks of MB compared with those on apixaban alone. The findings do not suggest apixaban used concomitantly with SSRI/SNRI would impart additional risk of MB over that of apixaban alone in patients with NVAF.