Rates, management and outcome of bleeding complications during edoxaban therapy in daily care – results from the DRESDEN NOAC REGISTRY

Beyer‐Westendorf, Jan; Marten, Sandra; Naue, Christiane; Tittl, Luise; Hänsel, Ulrike; Beyer-Westendorf, Ines; Mizera, Heike; Schreier, Thomas; Festerling, E. G.; Reitter, Antje; Spindler, Marianne; Bornhäuser, Martin

doi:10.1016/j.thromres.2020.03.021

Cited by 7 publications

(4 citation statements)

References 36 publications

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“…Bleeding associated with edoxaban in standard clinical practice has been shown to mainly consist of minor or clinical relevant non major bleeding. 18 We also demonstrated similar bleeding risks in our sensitivity analysis restricted to bleeding events leading to hospitalization, HR of 1.06 (95% CI 0.77 to 1.47) compared with the relative risk of 0.90 (95% CI 0.82 to 0.98) in the ENGAGE-AF-TIMI 48 trial comparing edoxaban with warfarin. 19 In the present study, we show a significant reduction in all-cause mortality and the composite of ''all-cause mortality and thromboembolism''.…”

Section: Discussionsupporting

confidence: 68%

Comparative effectiveness and safety of edoxaban versus warfarin in patients with atrial fibrillation: A nationwide cohort study

Nielsen

Soegaard

Jensen

et al. 2021

International Journal of Stroke

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Background and purpose: The effectiveness and safety of edoxaban 60 mg and 30 mg for stroke prevention compared with warfarin in patients with atrial fibrillation (AF) has not been well-described in a nationwide cohort of Caucasian patients treated in standard clinical practice. Methods: We used Danish nationwide registries to identify patients with AF during June 2016 and November 2018 who were treated with edoxaban or warfarin and computed rates per 100 person-years of thromboembolic, all-cause mortality, and bleeding events using an inverse probability of treatment weighting approach to account for baseline confounding. We used weighted pooled logistic regression to compute hazard ratios (HRs) with 95% confidence intervals (CIs) comparing events between edoxaban 60 mg and warfarin users; edoxaban 30 mg was not included in formal comparisons. Results: We identified 6451 AF patients, mean age was 72 years and 40% were females. A total of 1772 patients were treated with edoxaban 60 mg, 537 with edoxaban 30 mg, and 4142 with warfarin. The median CHA2DS2-VASc score was similar between warfarin and edoxaban 60 mg with a score of 3 (interquartile range [IQR] 2-4). In the inverse probability of treatment-weighted pseudo-population, the thromboembolic event rate for edoxaban 60 mg was 0.95 and 1.0 for warfarin, corresponding weighted HR of 1.00 (95% confidence intervals [CI] 0.59, 1.71). Edoxaban 60 mg users were associated with lower rates of all-cause mortality (3.93) compared to warfarin (6.04), with a HR of 0.64 (95% CI 0.47 to 0.88). The event rates for bleeding were 3.36 and 3.14, respectively; HR 1.09 (95% CI 0.77, 1.57) Conclusion: Edoxaban 60 mg is a safe and effective treatment compared with warfarin for stroke prevention in routine clinical care for white European patients with AF, with non-significantly different risks for stroke and clinically relevant bleeding, but lower all-cause mortality.â

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Section: Discussionsupporting

confidence: 68%

Comparative effectiveness and safety of edoxaban versus warfarin in patients with atrial fibrillation: A nationwide cohort study

Nielsen

Soegaard

Jensen

et al. 2021

International Journal of Stroke

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“…Bleeding risk evaluated with VTE-BLEED score (<2 and ≥2) which included active cancer, uncontrolled hypertension, male gender, anemia, history of major or CRNM bleeding, age >60, and renal dysfunction (CrCl< 60 ml/min) also did not have an impact on the effectiveness of edoxaban in reducing recurrent VTE at 12 month in the ETNA-VTE-Global study but the mortality rates and bleeding incidences were higher in the patients with high VTEBLEED scores [72]. A prospective analysis of the Dresden DOAC registry reported 891 bleeding events in 996 patients treated with edoxaban for SPAF or treatment of VTE (minor: 53.2%, CRNM: 41.9%, major: 4.9%) [73]. Authors reported that the rate of major bleeding associated with edoxaban use was consistent with those reported in the phase 3 trials and there was no difference between edoxaban and other DOACs regarding bleeding patterns, management, and outcomes [73].…”

Section: Treatment Of Vtementioning

confidence: 99%

“…A prospective analysis of the Dresden DOAC registry reported 891 bleeding events in 996 patients treated with edoxaban for SPAF or treatment of VTE (minor: 53.2%, CRNM: 41.9%, major: 4.9%) [73]. Authors reported that the rate of major bleeding associated with edoxaban use was consistent with those reported in the phase 3 trials and there was no difference between edoxaban and other DOACs regarding bleeding patterns, management, and outcomes [73]. In 2021, Bavalia et al published the quality of life results of 251 patients treated with edoxaban or warfarin for PE in the Hokusai-VTE trial at 7 years after randomization.…”

Section: Treatment Of Vtementioning

confidence: 99%

Edoxaban in cardiovascular medicine from scientific evidence to clinical practice

Budak¹,

Gencpinar²,

Dogan³

et al. 2022

Turk J Vasc Surg

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Direct oral anticoagulants have become a reasonable treatment option replacing warfarin in preventing stroke in patients with non-valvular atrial fibrillation and in treating and preventing venous thromboembolism. This article aims to summarize the rationale behind the development of direct oral anticoagulants and to review the key pharmacological properties, clinical and reallife data of the factor Xa inhibitor edoxaban, that may contribute to improving patient outcomes in cardiovascular clinical practice.

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“…ПОАК предлагают возможность более удобного контроля лечения без необходимости постоянного мониторинга показателей свертываемости крови [1]. Однако, с другой стороны, оценка риска геморрагических осложнений у пациентов с ФП, принимающих ПОАК, требует изучения в условиях рандомизированных клинических исследований (РКИ) и реальной клинической практики [6,7]. На сегодняшний день медицинское сообщество делает акцент на безопасность антикоагулянтной терапии при безусловной важности эффективности оральных антикоагулянтов в отношении профилактики инсульта как цели их назначения, а также надежности фармакокинетики ПОАК при использовании их в комбинации с другими лекарственными препаратами.…”

Section: поак: новые возможности и новые рискиunclassified

Potential for anticoagulant therapy in the most vulnerable groups of patients

2021

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Patients with atrial fibrillation (AF) often have comorbidities or characteristics (senile age, chronic kidney disease, high risk of coronary events, cognitive impairment) that can affect the patient's prognosis and that must be taken into account when prescribing therapy for stroke prevention. However, there are groups of patients with a high risk of bleeding, which cause concern to the doctor about possible hemorrhagic events. Direct Oral Anticoagulant (DOAC) Xarelto® (rivaroxaban) compared with other DOACs confirmed a favorable safety profile in the widest patient population: from children to senile patients. Moreover, high safety indicators in the treatment with rivaroxaban were obtained in vulnerable, from the point of view of hemorrhagic risks, patients with AF with various risk factors: those with a high risk of bleeding according to HAS-BLED scores, elderly patients, patients with chronic kidney disease, including advanced stages, as well as with anemia. It is important to remember that bleeding is not the only undesirable outcome for an elderly patient with AF. To ensure the most favorable prognosis of his life and health, it is necessary to level the maximum possible number of risks. The use of rivaroxaban may make it possible to approach the therapy of an elderly patient with AF in a comprehensive manner: to prevent stroke with a proven safety profile, while simultaneously reducing the risks of coronary events and renal complications, as well as contributing to the formation of high adherence — a necessary condition for obtaining the expected results of therapy.

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Rates, management and outcome of bleeding complications during edoxaban therapy in daily care – results from the DRESDEN NOAC REGISTRY

Cited by 7 publications

References 36 publications

Comparative effectiveness and safety of edoxaban versus warfarin in patients with atrial fibrillation: A nationwide cohort study

Comparative effectiveness and safety of edoxaban versus warfarin in patients with atrial fibrillation: A nationwide cohort study

Edoxaban in cardiovascular medicine from scientific evidence to clinical practice

Potential for anticoagulant therapy in the most vulnerable groups of patients

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