Abstract
The management of major bleeding in patients treated with direct oral anticoagulants (DOACs) is still not well established. START-Events, a branch of the START registry (Survey on anTicoagulated pAtients RegisTer) (NCT02219984), aims to describe the actual management of bleeding or recurrent thrombotic events in routine clinical practice. We here present the results of the management of bleeding patients. The START-Event registry is a prospective, observational, multicenter, international study. Baseline characteristics (demographic, clinical, risk factors) of patients, laboratory data at admission and during follow-up, site of bleeding, therapeutic strategies, and outcomes at the time of hospital discharge and after 6 months were recorded on a web-based case report form. Between January 2015 and December 2016, 117 patients with major bleeding events were enrolled. Non-valvular atrial fibrillation (NVAF) was the indication for treatment in 84% (62% males); 53 patients had intracranial bleeding (13 fatal), 42 had gastrointestinal bleeding (1 fatal), and 22 had bleeding in other sites. Therapeutic interventions for the management of bleeding were performed in 71% of patients. Therapeutic strategies with/without surgery or invasive procedures included: fluid replacement or red blood cells transfusion, prothrombin complex concentrates (3 or 4 factors), antifibrinolytic drugs, and the administration of idarucizumab. Creatinine, blood cell count, and PT/aPTT were the most frequent tests requested, while specific DOAC measurements were performed in 23% of patients. Mortality during hospitalization was 11.9%, at 6-month follow-up 15.5%. Our data confirm a high heterogeneity in the management of bleeding complications in patients treated with DOACs.
Highlights
In the past few years, direct oral anticoagulants (DOACs) have been introduced in clinical practice for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NAVF), and for the prevention and treatment of venous thromboembolism (VTE) [1].Hospital, Geneva, Switzerland 7 Ospedale Mauriziano Torino, Turin, Italy 8 UZ Gasdthuisberg, Louvain, Belgium 9 Department of Cardiac, Thoracic and Vascular Sciences, University of Padua, Padua, Italy 10 Thrombosis Centre, AOU Careggi, Florence, Italy1 3 Vol.:(0123456789)Internal and Emergency Medicine (2018) 13:1051–1058At present, available drugs include dabigatran, a selective anti-factor IIa molecule and three direct factor Xa inhibitors: apixaban, edoxaban, and rivaroxaban
We describe the management of major bleeding with respect to therapeutic strategies, laboratory testing, and other supportive measures, and we describe the adherence to currently available guidelines and recommendations in clinical practice
All participating centers are asked to report in the registry all available clinical and laboratory data collected in consecutive patients aged more than 18 years presenting with major bleeding or thromboembolic complications
Summary
In phase III clinical studies, all these agents have shown non-inferiority or superiority compared with vitamin K antagonists (VKA) in terms of efficacy and safety [2,3,4,5,6]. Due to their pharmacological characteristics (i.e., rapid onset of action, short half-life, predictable anticoagulant effect in standard conditions, low food/drug interactions without any important need for restrictions, metabolism, and elimination), the DOACs allow fixed dose administration, and do not require laboratory monitoring [7, 8]. The efficacy and safety of the administration of procoagulant factors, which are suggested by international guidelines [8, 11] for patients on direct Factor Xa inhibitors, is uncertain [19]
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