Efficacy and safety of the drugs used to reverse direct oral anticoagulants: a systematic review and meta‐analysis

Luz, Luís Teodoro da; Marchand, Mylene; Nascimento, Bartolomeu; Tien, Homer; Nathens, Avery B.; Shah, Prakesh S.

doi:10.1111/trf.14096

Cited by 14 publications

(8 citation statements)

References 55 publications

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“…2,3,18,32,33 Quando se considera esta opção, interrompe-se a TAC com VKAs 4-6 dias antes, com substituição por heparina, e retoma-se a TAC habitual 48-72h após a intervenção (Nível Ib, Classe IIb). 21 2.3) Regime Terapêutico com DOACs: A TAC com DOACs 7 deve ser mantida durante procedimentos cirúrgicos, 2,8,23,32,[34][35][36][37][38][39][40][41] todavia o risco de hemorragia inerente à intervenção deve ser considerado. Isto é, deve aceder-se à função renal do doente para perceber a que nível a suspensão temporária da terapia pode ser considerada (Tabela 2).…”

Section: Resultsunclassified

Normas de orientação clínica dos pacientes hipocoagulados em medicina dentária

Mata¹,

Mendonça²,

Caramês³

et al. 2018

j.rpemd

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On-line a 12 de december de 2018 O aumento da prevalência de pacientes hipocoagulados recorrendo à consulta de Medicina Dentária pressiona a necessidade de consciencialização dos profissionais de saúde para uma abordagem correcta dos mesmos. Objetiva-se desta forma o desenvolvimento e disseminação de Normas de Orientação Clínica Nacionais, baseadas em evidência, para pacientes hipocoagulados, com indicação para cirurgia na cavidade oral. Foram criteriosamente focadas um número de perguntas visando classificar e avaliar procedimentos de risco em pacientes hipocoagulados no contexto pré, peri e pós-operatório. Efetuou-se uma pesquisa da literatura (Pu-bMed e Cochrane Library) com subsequente avaliação da qualidade da evidência (sistemas Robis e Agree II) por vários avaliadores e finalmente destilaram-se as devidas recomendações clínicas consubstanciadas pelo respetivo nível de evidência e classe de recomendação. (Rev

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Section: Resultsunclassified

Normas de orientação clínica dos pacientes hipocoagulados em medicina dentária

Mata¹,

Mendonça²,

Caramês³

et al. 2018

j.rpemd

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“…However, the mortality results were not adjusted for confounding, and the comparator group's death rate is unknown. Several systematic reviews (33)(34)(35) have reported mainly on low-quality, single-arm cohort studies.…”

Section: Reversal Of Doacs With Pccmentioning

confidence: 99%

American College of Gastroenterology-Canadian Association of Gastroenterology Clinical Practice Guideline: Management of Anticoagulants and Antiplatelets During Acute Gastrointestinal Bleeding and the Periendoscopic Period

et al. 2022

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We conducted systematic reviews of predefined clinical questions and used the Grading of Recommendations, Assessment, Development and Evaluations approach to develop recommendations for the periendoscopic management of anticoagulant and antiplatelet drugs during acute gastrointestinal (GI) bleeding and the elective endoscopic setting. The following recommendations target patients presenting with acute GI bleeding: For patients on warfarin, we suggest against giving fresh frozen plasma or vitamin K; if needed, we suggest prothrombin complex concentrate (PCC) compared with fresh frozen plasma administration; for patients on direct oral anticoagulants (DOACs), we suggest against PCC administration; if on dabigatran, we suggest against the administration of idarucizumab, and if on rivaroxaban or apixaban, we suggest against andexanet alfa administration; for patients on antiplatelet agents, we suggest against platelet transfusions; and for patients on cardiac acetylsalicylic acid (ASA) for secondary prevention, we suggest against holding it, but if the ASA has been interrupted, we suggest resumption on the day hemostasis is endoscopically confirmed. The following recommendations target patients in the elective (planned) endoscopy setting: For patients on warfarin, we suggest continuation as opposed to temporary interruption (1–7 days), but if it is held for procedures with high risk of GI bleeding, we suggest against bridging anticoagulation unless the patient has a mechanical heart valve; for patients on DOACs, we suggest temporarily interrupting rather than continuing these; for patients on dual antiplatelet therapy for secondary prevention, we suggest temporary interruption of the P2Y12 receptor inhibitor while continuing ASA; and if on cardiac ASA monotherapy for secondary prevention, we suggest against its interruption. Evidence was insufficient in the following settings to permit recommendations. With acute GI bleeding in patients on warfarin, we could not recommend for or against PCC administration when compared with placebo. In the elective periprocedural endoscopy setting, we could not recommend for or against temporary interruption of the P2Y12 receptor inhibitor for patients on a single P2Y12 inhibiting agent. We were also unable to make a recommendation regarding same-day resumption of the drug vs 1–7 days after the procedure among patients prescribed anticoagulants (warfarin or DOACs) or P2Y12 receptor inhibitor drugs because of insufficient evidence.

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“…Although reversal agents should be preferred, the role of PCCs in DOAC reversal has been evaluated. A meta-analysis (four cohort studies in patients taking DOACs and eight RCTs in healthy volunteers) showed that PCCs provided partial or no reversal of anticoagulation inpatient clotting assays and partial DOAC reversal in healthy volunteer clotting assays, though further clinical evidence is warranted [38]. A multicenter, observational, registry-based study found that 4F-PCC treatment demonstrated similar mortality and neurological outcomes, and no VTE events, in patients with VKA-associated (n = 28) or FXa inhibitor-associated (n = 14) ICH [39].…”

Section: Nonspecific Prohemostatic Agentsmentioning

confidence: 99%

Reversal agents for direct oral anticoagulants: considerations for hospital physicians and intensivists

Desai

Cornutt

2019

Hospital Practice

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Direct oral anticoagulants (DOACs) include dabigatran etexilate, a direct thrombin inhibitor, and specific inhibitors of activated coagulation factor X (FXa; e.g. apixaban, betrixaban, edoxaban, rivaroxaban). DOACs are associated with lower rates of major and fatal bleeding events compared with warfarin. Clinicians may need to achieve rapid reversal of anticoagulation effects of the DOACs in an emergency setting. Idarucizumab and andexanet alfa, which reverse the anticoagulant effects of dabigatran and FXa inhibitors, respectively, are DOAC reversal agents available in the US. Other reversal agents (e.g. ciraparantag for heparins, DOACs) are in development. Alternative nonspecific agents (e.g. fresh frozen plasma, prothrombin complex concentrate) are available. Nonspecific prohemostatic agents can counteract the anticoagulant action of DOACs in emergency situations, when specific reversal agents are unavailable. However, specific reversal agents are efficacious and safe and should be preferred when available. In this review, we discuss practical issues in the initiation of DOAC therapy, situations where reversal may be needed, coagulation assays, reversal agents, and post-reversal complications in the context of published evidence and guidelines.

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Efficacy and safety of the drugs used to reverse direct oral anticoagulants: a systematic review and meta‐analysis

Abstract: Clotting assays are partially reversed by PCC in healthy volunteers. Idarucizumab and andexanet alfa have solid laboratory reversal effect and potential to be clinically efficacious and safe. However, clinical evidence is still lacking for all agents.

Cited by 14 publications

References 55 publications

Normas de orientação clínica dos pacientes hipocoagulados em medicina dentária

Normas de orientação clínica dos pacientes hipocoagulados em medicina dentária

American College of Gastroenterology-Canadian Association of Gastroenterology Clinical Practice Guideline: Management of Anticoagulants and Antiplatelets During Acute Gastrointestinal Bleeding and the Periendoscopic Period

Reversal agents for direct oral anticoagulants: considerations for hospital physicians and intensivists

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