Restart of Anticoagulant Therapy and Risk of Thrombosis, Rebleeding, and Death after Factor Xa Inhibitor Reversal in Major Bleeding Patients.
Thromb Haemost
; 121(8): 1097-1106, 2021 08.
Article
em En
| MEDLINE
| ID: mdl-33634446
ABSTRACT
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.
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Base de dados:
MEDLINE
Assunto principal:
Trombose
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Proteínas Recombinantes
/
Fator Xa
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Inibidores do Fator Xa
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Reversão da Anticoagulação
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Agentes de Reversão Anticoagulante
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Hemorragia
Idioma:
En
Ano de publicação:
2021
Tipo de documento:
Article