Assuntos
Anticorpos Monoclonais Humanizados/uso terapêutico , Agentes de Reversão Anticoagulante/provisão & distribuição , Fator Xa/provisão & distribuição , Hospitais/estatística & dados numéricos , Proteínas Recombinantes/provisão & distribuição , Agentes de Reversão Anticoagulante/uso terapêutico , Estudos Transversais , Fator Xa/uso terapêutico , Humanos , Proteínas Recombinantes/uso terapêutico , Centros de Traumatologia/estatística & dados numéricos , Estados UnidosRESUMO
[Figure: see text].
Assuntos
Agentes de Reversão Anticoagulante/economia , Fatores de Coagulação Sanguínea/economia , Análise Custo-Benefício , Fator Xa/economia , Hemorragias Intracranianas/induzido quimicamente , Proteínas Recombinantes/economia , Idoso , Agentes de Reversão Anticoagulante/uso terapêutico , Fatores de Coagulação Sanguínea/uso terapêutico , Canadá , Fator Xa/uso terapêutico , Inibidores do Fator Xa/efeitos adversos , Feminino , Humanos , Expectativa de Vida , Masculino , Cadeias de Markov , Anos de Vida Ajustados por Qualidade de Vida , Proteínas Recombinantes/uso terapêutico , Acidente Vascular Cerebral/prevenção & controleRESUMO
BACKGROUND: Lack of data on balancing bleeding and thrombosis risk causes uncertainty about restarting anticoagulants after major bleeding. Anticoagulant reversal trials offer prospectively gathered data after major bleeding with well-documented safety events and restarting behavior. OBJECTIVES: To examine the relationship of restarting anticoagulation with thrombosis, rebleeding, and death. METHODS: This is a posthoc analysis of a prospective factor Xa inhibitor reversal study at 63 centers in North America and Europe. We compared outcomes of restarted patients with those not restarted using landmark and time-dependent Cox proportional hazards models. Outcomes included thrombotic and bleeding events and death and a composite of all three. RESULTS: Of 352 patients enrolled, oral anticoagulation was restarted in 100 (28%) during 30-day follow-up. Thirty-four (9.7%) had thrombotic events, 15 (4.3%) had bleeding events (after day 3), and 49 (14%) died. In the landmark analysis comparing patients restarted within 14 days to those not, restarting was associated with decreased thrombotic events (hazard ratio [HR] = 0.112; 95% confidence interval [CI]: 0.001-0.944; p = 0.043) and increased rebleeding (HR = 8.39; 95% CI: 1.13-62.29; p = 0.037). The time-dependent Cox model showed evidence for a reduction in a composite (thrombotic events, bleeding, and death) attempting to capture net benefit (HR = 0.384; 95% CI: 0.161-0.915; p = 0.031). CONCLUSION: This analysis provides modest evidence that restarting anticoagulation in factor Xa inhibitor-associated major bleeding patients is correlated with reduced risk of thrombotic events and increased risk of rebleeding. There is low-level evidence of net benefit for restarting. A randomized trial of restarting would be appropriate.