Oral anticoagulants-related bleeding: what happens in the emergency room? The Galeno study

Abstract

There are no real-world data on the modalities and outcomes of managing major or life-threatening bleeding related to oral anticoagulants in the emergency room (ER). The primary endpoint of this prospective observational study was to evaluate the therapeutic regimen ER physicians started to manage bleeding and 30-day mortality. The secondary endpoint was to evaluate the appropriateness of DOACs prescription and hospital admissions. Data were collected using RedCap. Patient's general characteristics, laboratory test results, therapy started in the ER to manage bleeding, patient transfer to another hospital department or discharge home, and 30-day mortality were recorded. A total of 526 consecutive patients were enrolled, 67% treated with DOACs and 33% with VKAs. Reversal of oral anticoagulants was successfully performed in a minority of patients, while in a percentage ranging from 30.5% for dabigatran to 60.2% for VKAs, patients did not receive any treatment, even if necessary. Thirty-day mortality was 11% and 17% for patients treated with DOACs and VKAs, respectively. Major bleeding conferred a higher risk of death (OR = 2.95, 1.42-6.16). Compared with VKAs, DOACs therapy reduced the risk of death by 57% (OR = 0.43, 0.26-0.72). Excessive doses were administered to 10.8%, 13%, 18%, and 19% of patients treated with rivaroxaban, edoxaban, apixaban, and dabigatran, respectively. In these patients, major bleeding occurred in a percentage ranging from 66.7% to 94.7% depending on the drug administered. Overall, 25.8% of patients, treated primarily with DOACs, were discharged. The management of oral anticoagulant-related major or life-threatening bleeding in the ER appears poor.

Keywords: Anticoagulants; Antidotes; Emergency service; Hemorrhage; Inappropriate prescribing.