Management of major bleeding and outcomes in patients treated with direct oral anticoagulants: results from the START-Event registry

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.

Drug–Drug Interactions between Direct Oral Anticoagulants and Hepatitis C Direct-Acting Antiviral Agents: Looking for Evidence Through a Systematic Review

“…Lastly, little information was available in the literature on how to manage potential DDIs between DOACs and DAAs in clinical practice; the only study available was a small observational study showing heterogeneity in the approaches used by clinicians to handle DDIs between DOACs and DAAs [ 41 ]. Therefore, our results further highlight the lack of data available and the urgent conduction of targeted studies.…”

Clinical and endoscopic features of severe acute gastrointestinal bleeding in elderly patients treated with direct oral anticoagulants: a multicentre study

“…19 Studies published by the French pharmacovigilance database (FPVD), the ORANGE study from the UK, the Dutch subset of the European XANTUS registry and the international START-Event registry showed similar data with GI bleeding representing 37%, 44%, 36.8% and 35.9%, respectively, of all bleeding events under DOAC therapy. 20–23…”

“…15,24 It is also very similar to patients’ demographic characteristics of cohorts and pivotal RCTs of DOACs in NVAF, while for RCTs of DOACs in VTE, patients were younger (55 years). 21,22,25,26…”

Dabigatran Plasma Measurement to Guide the Management of Acute Bleeding and Thrombotic Complications

“…DOACs are now widely prescribed in clinical practice and, consequently, an increase in bleeding and thromboembolic complications is expected, which clinicians will have to manage correctly. However, the management of these conditions has not been properly standardized, clinicians lack experience [6] and only some case reports and case series have been reported in the literature [7] .…”