title: Management of bleeding complications in patients with cancer on DOACs.
abstract: There has been a concern that major bleeding events (MBE) on direct-acting oral anticoagulants (DOACs) will be more difficult to manage than on vitamin K antagonists. Patients with cancer and DOAC-associated bleeding may be even more of a challenge to manage. We therefore reviewed the literature on bleeding in patients with cancer on DOACs. In addition, we performed an analysis of individual patient data from 5 phase III trials on treatment with dabigatran with focus on those with cancer. In 6 randomized trials the risk of MBE in patients with cancer was similar on treatment with DOACs compared to vitamin K antagonists. Bleeding was in the majority of patients managed with supportive therapy alone. In the individual patient data analysis there were no significant differences in use of hemostatic products, transfusion of red cells, effectiveness of management, bleeding-related mortality or 30-day all-cause mortality between patients with cancer treated with dabigatran or with warfarin. Local hemostatic therapy, including resection of the cancer site was more common in patients with gastrointestinal bleeding with cancer than among those without cancer. We conclude that management of bleeding in patients with cancer and on a DOAC does not pose a greater challenge than management of bleeding in patients without cancer.
authors.affiliation: Department of Medicine and Thrombosis and Atherosclerosis Research Institute, McMaster University, Hamilton, ON, Canada; Coagulation Unit, Hematology Center, Karolinska Hospital and Karolinska Institutet, Stockholm, Sweden. Electronic address: schulms@mcmaster.ca.
authors.forename: Sam
authors.initials: S
authors.lastname: Schulman
authors.affiliation: Department of Medicine and Thrombosis and Atherosclerosis Research Institute, McMaster University, Hamilton, ON, Canada; Department of Medicine, University of Calgary, Calgary, AB, Canada.
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Shrum
authors.affiliation: Coagulation Unit, Hematology Center, Karolinska Hospital and Karolinska Institutet, Stockholm, Sweden; Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.
authors.forename: Ammar
authors.initials: A
authors.lastname: Majeed
mesh_terms: D000925:Anticoagulants / Q000009:adverse effects* / Q000627:therapeutic use*; D000069604:Dabigatran / Q000009:adverse effects / Q000627:therapeutic use; D006470:Hemorrhage / Q000139:chemically induced* / Q000150:complications / Q000628:therapy*; D006801:Humans; D009369:Neoplasms / Q000150:complications*; D054556:Venous Thromboembolism / Q000150:complications* / Q000188:drug therapy*; D014812:Vitamin K / Q000037:antagonists & inhibitors; D014859:Warfarin / Q000009:adverse effects / Q000627:therapeutic use
chemical_list: D000925:Anticoagulants; D014812:Vitamin K; D014859:Warfarin; D000069604:Dabigatran
keywords: Bleeding; Cancer; Factor Xa inhibitor; Thrombin inhibitor