Clinical impact and course of major bleeding with edoxaban versus vitamin K antagonists

Brekelmans, Marjolein P. A.; Bleker, Suzanne M.; Bauersachs, Rupert; Boda, Zoltán; Büller, Harry R.; Choi, Youngsook; Gallus, Alexander; Grosso, Michael; Oh, Doyeun; Raskob, Gary E.; Schwocho, Lee; Cohen, Alexander T.

doi:10.1160/th15-11-0892

Cited by 16 publications

(25 citation statements)

References 22 publications

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“… 13 A safety analysis for the major bleeding events in the Hokusai-VTE study described no significant difference in severity or clinical course in major bleeding with edoxaban compared to enoxaparin/warfarin. 22 Of the major bleeding events in the trial, 54% related to edoxaban were considered milder at the time of presentation compared to 42% of bleeding events with VKA, however, not statistically significant. More severe clinical presentation was also numerically less in the edoxaban group (46%) than the VKA group (58%) but not statistically significant (OR 0.62; 95% CI 0.30–1.27; P =0.19).…”

Section: Evaluation Of Bleeding Events From Randomized Clinical Trialmentioning

confidence: 87%

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Evaluation of bleeding in patients receiving direct oral anticoagulants

Hellenbart¹,

Faulkenberg²,

Finks³

2017

VHRM

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Direct oral anticoagulants (DOACs) are recognized by evidence-based treatment guidelines as the first-line option for the treatment of venous thromboembolism and prevention of stroke and systemic embolism in nonvalvular atrial fibrillation. As use of these anticoagulants has become favored over the past several years, reported bleeding-related adverse drug events with these agents has increased. In randomized clinical trials, all DOACs have a reduced risk for intracranial hemorrhage, while major and other bleeding results have varied among the agents compared to vitamin K antagonists. We have reviewed the bleeding incidence and severity from randomized and real-world data in patients receiving DOACs in an effort to provide the clinician with a critical review of bleeding and offer practical considerations for avoiding adverse events with these anticoagulants.

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Section: Evaluation Of Bleeding Events From Randomized Clinical Trialmentioning

confidence: 87%

“…However, there was a nonsignificant trend toward milder presentation and course in the edoxaban group. 22 …”

Section: Evaluation Of Bleeding Events From Randomized Clinical Trialmentioning

confidence: 99%

Evaluation of bleeding in patients receiving direct oral anticoagulants

Hellenbart¹,

Faulkenberg²,

Finks³

2017

VHRM

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“…All major bleeding events were classified using two classification schemes that were developed and published previously . The first classification was used to assess the severity of the major bleeding event at presentation (Table S2A).…”

Section: Methodsmentioning

confidence: 99%

“…The second classification was used to assess the applied procedures and interventions for treatment and the clinical outcome of the bleeding event (Table S2B). Both classification schemes consist of four different categories, with one being the mildest and four the most severe …”

Section: Methodsmentioning

confidence: 99%

Clinical outcome of patients with a vitamin K antagonist‐associated bleeding treated with prothrombin complex concentrate

Brekelmans

Abdoellakhan

Scheres

et al. 2018

Research and Practice in Thrombosis and Haemostasis

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Essentials Data on clinical outcome of vitamin K antagonist (VKA)‐associated bleeding is scarce.Cohort study of patients with VKA bleeds treated with prothrombin complex concentrate (PCC).Effective haemostasis was achieved in 68% of patients with a VKA‐associated bleeding.Thromboembolism rates were low and mortality rates high at 30 days after PCC administration. BackgroundVitamin K antagonists (VKA) are used for the treatment of thromboembolism. Patients with severe VKA‐associated bleeding require immediate restoration of haemostasis. Clinical studies on the effect of prothrombin complex concentrate (PCC) are heterogeneous with respect to outcome of bleeding.ObjectiveTo evaluate the clinical outcome of patients treated with PCC for VKA‐associated bleeding.MethodsWe performed a cohort study of consecutive patients who received PCC for VKA‐related bleeding in five Dutch hospitals. Data were collected by chart review on the bleeding event, international normalized ratio (INR), haemostatic efficacy, thromboembolic (TE) complications, and mortality. The primary outcome was effective haemostasis, assessed by an adaptation of the Sarode criteria with a surrogate outcome for patients with ICH without repeat CT.ResultsOne hundred patients were included. Mean age was 74 years, 54% were male and 79% received VKA for atrial fibrillation. Most patients presented with ICH (41%) or GI bleeding (36%). Effective haemostasis was achieved in 67/98 (68%) patients using the adapted classification. Surrogate outcomes were applied for 32 patients and data for two patients was missing. Median pre‐treatment INR was 3.9 (IQR 2.9‐5.8). One hour after PCC infusion, the INR was available for 50 patients and of these, 35 (70%) had an INR ≤1.4. TE complications occurred in five patients and 22 died (60% bleeding‐related) within 30 days.Conclusion PCC achieved effective haemostasis in 68% of evaluable patients with VKA‐associated bleeding. TE complication rates were low, but mortality rates were high, due to the large number of patients with ICH.

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“…and L.J.S.) using predefined criteria (Supporting Information Table S1), as previously described 12, 13, 14. In short, the first classification assessed the severity of the abnormal vaginal bleeding event at the moment of presentation.…”

Section: Methodsmentioning

confidence: 99%

Abnormal vaginal bleeding in women of reproductive age treated with edoxaban or warfarin for venous thromboembolism: a post hoc analysis of the Hokusai‐VTE study

Scheres

Brekelmans

Ageno

et al. 2018

BJOG

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ObjectiveTo investigate the characteristics and outcome of abnormal vaginal bleeding in women receiving edoxaban or warfarin for treatment of venous thromboembolism (VTE).Design and settingPost hoc analysis of the Hokusai‐VTE study, a multicentre, randomised, double‐blind trial comparing edoxaban with warfarin for acute symptomatic VTE.PopulationWomen below 50 years receiving edoxaban or warfarin for treatment of VTE.MethodsWe collected data on diagnostic measures, treatment, and clinical outcome of abnormal vaginal bleeding events.Main outcome measuresOccurrence of major and clinically relevant nonmajor (CRNM) abnormal vaginal bleeding events.ResultsIn all, 628 women aged under 50 years were treated with edoxaban and 665 with warfarin. The rate of abnormal vaginal bleeding was 15/100 person‐years (py) (95% CI 11–19) in women receiving edoxaban and 9/100 py (95% CI 6–12) in the warfarin group (hazard ratio: 1.7, 95% CI 1.1–2.5). Major abnormal vaginal bleeding occurred in eight (1.3%) women on edoxaban and in three (0.9%) women receiving warfarin [odds ratio (OR) 2.8; 95% CI 0.8–10.8], and CRNM abnormal vaginal bleeding occurred in 53 (8.4%) women treated with edoxaban and in 37 (5.6%) on warfarin therapy (OR 1.6, 95% CI 1.0–2.4). Over 85% of all vaginal bleeds were characterised by heavy menstrual bleeding. Major bleeds frequently required treatment, and in more than 75% of patients anticoagulant therapy was adjusted. The severity of clinical presentation and course of major and CRNM bleeds was mild in most patients.ConclusionsAbnormal vaginal bleeding occurred more frequently in women treated with edoxaban than with warfarin. Reassuringly, most events could be managed conservatively and had a mild outcome.Tweetable abstractAbnormal vaginal bleeding occurred more frequently in women treated with edoxaban than with warfarin.

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Clinical impact and course of major bleeding with edoxaban versus vitamin K antagonists

Cited by 16 publications

References 22 publications

Evaluation of bleeding in patients receiving direct oral anticoagulants

Evaluation of bleeding in patients receiving direct oral anticoagulants

Clinical outcome of patients with a vitamin K antagonist‐associated bleeding treated with prothrombin complex concentrate

Abnormal vaginal bleeding in women of reproductive age treated with edoxaban or warfarin for venous thromboembolism: a post hoc analysis of the Hokusai‐VTE study

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