A Multicentric prospective Real-World Experience of Direct Oral Anticoagulants use in prophylaxis of Venous Thromboembolism in Nephrotic syndrome

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Abstract

Introduction : Patients with nephrotic syndrome (NS), particularly with severe hypoalbuminia are at significantly increased risk for venous thromboembolism (VTE). Although vitamin K antagonists (VKAs) have traditionally been used for prophylaxis. Evidence supporting direct oral anticoagulants (DOACs) for primary prophylaxis in NS remains scarce, with a lack of prospective real-world data. Methods : We conducted a prospective multicentric cohort study across eight tertiary centers in India, enrolling adults (≥ 18 years) with NS and severe hypoalbuminemia (albumin < 2.4 g/dL for Membranous nephropathy; <2.0 g/dL for other etiologies). All patients received apixaban 5 mg once daily as primary VTE prophylaxis until albumin levels improved beyond 2.4 g/dL. The primary composite outcome included VTE occurrence and major or clinically significant bleeding events. Patients were followed until anticoagulation discontinuation. Results : A total of 212 patients were analyzed (mean age 36.9 ± 14.0 years, 52% male). Median proteinuria was 9.0 g/day and mean serum albumin 1.68 ± 0.49 g/dL; mean serum creatinine was 1.5 ± 0.54 mg/dL. Most patients were categorized as low (80%) or intermediate (20%) bleeding risk by GN tool. Membranous nephropathy was the most common etiology (45%). Immunosuppressive therapy included corticosteroids (81%), rituximab (25.9%), and cyclophosphamide (28.3%). The mean duration of apixaban therapy was 3 months. No venous or arterial thromboembolic events occurred, and minor bleeding was observed in 4 patients (3.5%), all resolving without transfusion or hospitalization. Overall apixaban was well tolerated. Conclusion : This large multicenter prospective study showed that apixaban prophylaxis appears safe, well-tolerated, and potentially effective in preventing VTE among high-risk NS patients. Larger randomized trials are needed to validate findings and optimize dosing, but current data support the rational integration of DOACs into NS thromboprophylaxis protocols.

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