Venous Thromboembolism in Severe Renal Insufficiency: 20 Years of Contemporary Management and Clinical Outcomes.

backgroundPatients with severe renal insufficiency have been systematically excluded from randomized trials of anticoagulation for venous thromboembolism (VTE), leaving uncertainty regarding their management in clinical practice.

objectivesThe purpose of this study was to describe the clinical profile, temporal trends in management, and phase-specific outcomes of patients with acute VTE and severe renal insufficiency.

methodsWe analyzed 5,763 patients with acute VTE and creatinine clearance < 30 mL/min enrolled in Registro Informatizado de Enfermedad TromboEmbólica (2005-2024). Baseline characteristics, anticoagulant strategies, and 90-day outcomes were evaluated across 4 calendar periods and during the early (days 0-10) and late (days 11-90) treatment phases.

resultsMean age was 81 years; 69% were women, 56% presented with pulmonary embolism (PE), 16% had creatinine clearance <15 mL/min, and 3.6% were receiving hemodialysis. Over time, severe renal dysfunction and hemodialysis became more frequent. Initial treatment remained predominantly low-molecular-weight heparin, whereas vitamin K antagonist use declined and direct oral anticoagulant use increased. At 90 days, recurrent VTE occurred in 1.3% of patients, major bleeding in 5.1%, and 20% died. During the first 10 days, fatal PE exceeded fatal bleeding (2.0% vs 0.3%), whereas during days 11 to 90 fatal bleeding exceeded fatal PE (0.7% vs 0.3%).

conclusionsPatients with VTE and severe renal insufficiency are elderly, medically complex, and experience high short-term mortality. The relative balance between fatal PE and fatal bleeding changes over time, with fatal PE predominating early and fatal bleeding thereafter, while real-world management frequently differs from product labels and guideline recommendations.