Major bleeding with vitamin K antagonists or direct oral anticoagulants in real-life

Becattini, Cecilia; Franco, Laura; Beyer‐Westendorf, Jan; Masotti, Luca; Nitti, Cinzia; Vanni, Simone; Manina, Giorgia; Cattinelli, Sergio; Cappelli, Roberto; Sbrojavacca, Rodolfo; Pomero, Fulvio; Marten, Sandra; Agnelli, Giancarlo

doi:10.1016/j.ijcard.2016.11.117

Cited by 51 publications

(41 citation statements)

References 42 publications

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“…Most deaths in ICH patients (13/14; 92.8%) occur within the first 72 h from hospital admission. ICH-related mortality is 26.4%, similar to what is recently reported in the literature [27]. As shown in previous studies [27][28][29], ICH mortality in DOACs seems lower than in AVK, but, in any case, it concerns nearly one-fourth of total ICH in DOAC-treated patients.…”

Section: Discussionsupporting

confidence: 88%

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

Testa

Ageno

Antonucci³

et al. 2018

Intern Emerg Med

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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.

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Section: Discussionsupporting

confidence: 88%

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

Testa

Ageno

Antonucci³

et al. 2018

Intern Emerg Med

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“…Clinical trials have shown that both vitamin K antagonists and DOACs reduce stroke and mortality in AF patients . Utilization of DOACs for stroke prevention in NVAF and their effectiveness and safety in clinical practice have been assessed in several European countries . However, little is known about their use beyond clinical trial conditions, especially in patients with hepatic or renal impairment.…”

Section: Introductionmentioning

confidence: 99%

“…5,6 Utilization of DOACs for stroke prevention in NVAF and their effectiveness and safety in clinical practice have been assessed in several European countries. [7][8][9][10][11][12][13] However, little is known about their use beyond clinical trial conditions, especially in patients with hepatic or renal impairment. Findings from 2 studies from USA and Australia showed that inappropriate dosing occurred among patients with renal failure, and there is still uncertainty about appropriate dosing in these patients.…”

Section: Introductionmentioning

confidence: 99%

Incidence of direct oral anticoagulant use in patients with nonvalvular atrial fibrillation and characteristics of users in 6 European countries (2008–2015): A cross‐national drug utilization study

Ibáñez

Sabaté

Vidal

et al. 2019

Brit J Clinical Pharma

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AimsTo estimate the incidence of direct oral anticoagulant drug (DOAC) use in patients with nonvalvular atrial fibrillation and to describe user and treatment characteristics in 8 European healthcare databases representing 6 European countries.MethodsLongitudinal drug utilization study from January 2008 to December 2015. A common protocol approach was applied. Annual period incidences and direct standardisation by age and sex were performed. Dose adjustment related to change in age and by renal function as well as concomitant use of potentially interacting drugs were assessed.ResultsA total of 186 405 new DOAC users (age ≥18 years) were identified. Standardized incidences varied from 1.93–2.60 and 0.11–8.71 users/10 000 (2011–2015) for dabigatran and rivaroxaban, respectively, and from 0.01–8.12 users/10 000 (2012–2015) for apixaban. In 2015, the DOAC incidence ranged from 9 to 28/10 000 inhabitants in SIDIAP (Spain) and DNR (Denmark) respectively. There were differences in population coverage among the databases. Only 1 database includes the total reference population (DNR) while others are considered a population representative sample (CPRD, BIFAP, SIDIAP, EGB, Mondriaan). They also varied in the type of drug data source (administrative, clinical). Dose adjustment ranged from 4.6% in BIFAP (Spain) to 15.6% in EGB (France). Concomitant use of interacting drugs varied between 16.4% (SIDIAP) and 70.5% (EGB). Cardiovascular comorbidities ranged from 25.4% in Mondriaan (The Netherlands) to 82.9% in AOK Nordwest (Germany).ConclusionOverall, apixaban and rivaroxaban increased its use during the study period while dabigatran decreased. There was variability in patient characteristics such as comorbidities, potentially interacting drugs and dose adjustment. (EMA/2015/27/PH).

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“…Clinical outcomes were consistent with previous findings. Two multi‐centre cohort studies reported a lower 30‐day mortality with DOACs compared to VKAs, after major bleeding and in the absence of specific DOAC reversal agents . However, in the present study, thromboembolic events were also considered and sample size was small.…”

Section: Discussionmentioning

confidence: 99%

Preventability of serious thromboembolic and bleeding events related to the use of oral anticoagulants: a prospective study

Sennesael

Larock²,

Devalet³

et al. 2018

Brit J Clinical Pharma

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Major bleeding with vitamin K antagonists or direct oral anticoagulants in real-life

Cited by 51 publications

References 42 publications

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

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

Incidence of direct oral anticoagulant use in patients with nonvalvular atrial fibrillation and characteristics of users in 6 European countries (2008–2015): A cross‐national drug utilization study

Preventability of serious thromboembolic and bleeding events related to the use of oral anticoagulants: a prospective study

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