Reversal and removal of oral antithrombotic drugs in patients with active or perceived imminent bleeding

Author:

Cao Davide123ORCID,Amabile Nicolas4ORCID,Chiarito Mauro25ORCID,Lee Victoria T6,Angiolillo Dominick J7,Capodanno Davide8ORCID,Bhatt Deepak L9,Mack Michael J10,Storey Robert F11,Schmoeckel Michael12,Gibson C Michael13,Deliargyris Efthymios N14,Mehran Roxana1ORCID

Affiliation:

1. Center for Interventional Cardiovascular Research and Clinical Trials, The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai , One Gustave L. Levy Place, Box 1030, New York, NY 10029-6574 , USA

2. Department of Biomedical Sciences, Humanitas University , Pieve Emanuele-Milan , Italy

3. Department of Cardiology, Humanitas Gavazzeni , Bergamo , Italy

4. Department of Cardiology, Institut Mutualiste Montsouris , Paris , France

5. Department of Cardiology, IRCCS Humanitas Research Hospital , Rozzano-Milan , Italy

6. PAVmed Inc. , New York, NY , USA

7. Division of Cardiology, University of Florida College of Medicine , Jacksonville, FL , USA

8. Division of Cardiology, Azienda Ospedaliero Universitaria Policlinico ‘G. Rodolico-San Marco’, University of Catania , Catania , Italy

9. Mount Sinai Heart, Icahn School of Medicine at Mount Sinai , New York, NY , USA

10. Department of Cardiac Surgery, Baylor Scott and White Health , Plano, TX , USA

11. Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield , Sheffield , UK

12. Department of Cardiac Surgery, Asklepios Klinik St. Georg , Hamburg , Germany

13. Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School , Boston, MA , USA

14. CytoSorbents Corporation , Princeton, NJ , USA

Abstract

Abstract Remarkable progress has been made in the pharmacological management of patients with cardiovascular disease, including the frequent use of antithrombotic agents. Nonetheless, bleeding complications remain frequent and potentially life-threatening. Therapeutic interventions relying on prompt antithrombotic drug reversal or removal have been developed to assist clinicians in treating patients with active bleeding or an imminent threat of major bleeding due to urgent surgery or invasive procedures. Early phase studies on these novel strategies have shown promising results using surrogate pharmacodynamic endpoints. However, the benefit of reversing/removing antiplatelet or anticoagulant drugs should always be weighed against the possible prothrombotic effects associated with withdrawal of antithrombotic protection, bleeding, and surgical trauma. Understanding the ischemic-bleeding risk tradeoff of antithrombotic drug reversal and removal strategies in the context of urgent high-risk settings requires dedicated clinical investigations, but challenges in trial design remain, with relevant practical, financial, and ethical implications.

Publisher

Oxford University Press (OUP)

Subject

Cardiology and Cardiovascular Medicine

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