ABSTRACT
BACKGROUND: Evidence supporting venous thromboembolism (VTE) prophylaxis with direct oral anticoagulants (DOACs) in patients with nephrotic syndrome (NS) is limited to case reports. OBJECTIVE: The purpose of this study was to compare bleeding and thromboembolic events in this population. METHODS: A retrospective cohort study was conducted in adults with NS initiated on a DOAC or warfarin for VTE prophylaxis between January 2013 and July 2021 within the Ochsner Health System. Patients with study drug exposure within the preceding 7 days, acute VTE within the preceding 6 months, or ≤7 days of study drug exposure were excluded. The primary outcome was the composite rate of major bleeding and clinically relevant nonmajor bleeding. Secondary outcomes included time to major bleeding and rate of new thromboembolic events. This study was approved by the Ochsner Health System Institutional Review Board. RESULTS: Twenty-five DOAC and 19 warfarin patients were included. The primary outcome occurred in 8% vs 26.3% (P = 0.21) of patients treated with a DOAC or warfarin, respectively, and was driven by major bleeding (4% vs 21%, P = 0.25). Other secondary outcomes were similar between cohorts. The study was limited by a small sample size. CONCLUSION AND RELEVANCE: Use of DOACs for VTE prophylaxis resulted in a nonstatistically significant, but clinically relevant lower rate of major bleeding compared to warfarin. This study provides comparative data showing safe and effective use of DOACs in patients with NS. Prospective, randomized studies are needed to confirm results.
Subject(s)
Nephrotic Syndrome , Venous Thromboembolism , Adult , Humans , Warfarin/adverse effects , Venous Thromboembolism/drug therapy , Venous Thromboembolism/prevention & control , Prospective Studies , Retrospective Studies , Anticoagulants/adverse effects , Administration, OralABSTRACT
BACKGROUND: Evidence for direct oral anticoagulants (DOACs) in patients with cirrhosis is limited. Few patients with Child-Turcotte-Pugh (CTP) class B and C cirrhosis have been studied. OBJECTIVE: To compare major bleeding rates in patients with cirrhosis receiving a DOAC versus warfarin. METHODS: A retrospective cohort study was conducted in adults with cirrhosis receiving a DOAC versus warfarin for venous thromboembolism, portal-vein thrombosis, or atrial fibrillation. The primary outcome was the rate of major bleeding. Secondary outcomes included time to major bleeding, clinically relevant nonmajor bleeding, all bleeding, gastrointestinal bleeding, intracranial bleeding, and new thromboembolic events. The study was approved by the Ochsner Health System Institutional Review Board. RESULTS: A total of 44 patients receiving a DOAC and 41 patients receiving warfarin were included. Major bleeding occurred in 4 patients receiving a DOAC and 6 patients receiving warfarin (9.1% vs 14.6%; P = 0.881). Rates of major bleeding were similar in 24 DOAC and 17 warfarin patients with CTP Class B (4.2% vs 17.6%; P = 0.37) and 8 DOAC and 9 warfarin patients with CTP Class C (37.5% vs 11.1%; P = 0.41) cirrhosis. Secondary bleeding and efficacy outcomes were similar between cohorts. The study was limited by a small sample size. CONCLUSION AND RELEVANCE: Treatment with DOACs in patients with cirrhosis was associated with a similar rate of major bleeding compared with warfarin. Inclusion of CTP class C patients in future studies remains valuable to evaluate safety and efficacy of DOACs in this population.
Subject(s)
Atrial Fibrillation , Thrombosis , Venous Thromboembolism , Adult , Humans , Administration, Oral , Anticoagulants/adverse effects , Atrial Fibrillation/complications , Atrial Fibrillation/drug therapy , Gastrointestinal Hemorrhage/chemically induced , Gastrointestinal Hemorrhage/drug therapy , Gastrointestinal Hemorrhage/epidemiology , Liver Cirrhosis/complications , Liver Cirrhosis/drug therapy , Retrospective Studies , Thrombosis/drug therapy , Venous Thromboembolism/drug therapy , Warfarin/adverse effectsABSTRACT
BACKGROUND: Because of a lack of comparative data on anticoagulant use in the advanced chronic kidney disease (CKD) population, guidelines recommend warfarin for atrial fibrillation and venous thromboembolism (VTE) treatment in these patients. However, apixaban has specific dosing recommendations in CKD leading to use in clinical practice. OBJECTIVE: To evaluate major bleeding, stroke, and thromboembolism rates in patients with CKD stage 4, stage 5, and dialysis on apixaban or warfarin therapy. METHODS: This was a retrospective cohort study of patients with advanced CKD receiving apixaban or warfarin. The primary outcome was the occurrence of major bleeding at 3 months after enrollment. Secondary outcomes included occurrence of major bleeding, occurrence of ischemic stroke, and recurrence of VTE at 3 to 6 and 6 to 12 months. RESULTS: A total of 604 patients were included in the analysis. The percentage of apixaban and warfarin patients with a major bleed at 0 to 3, 3 to 6, and 6 to 12 months were 8.3% versus 9.9% ( P=0.48), 1.4% versus 4% ( P=0.07), and 1.5% versus 8.4% ( P<0.001), respectively. There were no differences in rates of ischemic stroke or recurrent VTE at any time period. Conclusion and Relevance: Patients with advanced CKD taking apixaban had similar bleeding rates at 3 months compared with those taking warfarin. However, those who continued therapy had higher major bleeding rates with warfarin between 6 and 12 months. This study provides knowledge on the effects of a direct oral anticoagulant in a population that was excluded from all major trials.
