Risk of bleeding in hospitalized patients on anticoagulant therapy: Prevalence and potential risk factors

Dreijer, Albert R; Diepstraten, Jeroen; Brouwer, Rolf E.; Kragten, E.; Leebeek, Frank W.G.; Kruip, Marieke J.H.A.; Bemt, Patricia M. L. A. van den

doi:10.1016/j.ejim.2019.01.008

Cited by 11 publications

(15 citation statements)

References 30 publications

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“…The major bleeding rate in the standard monitoring group was higher than what was previously reported in hospitalized patients receiving an oral anticoagulant 20 and is concerning given the degree of morbidity and mortality associated with FxaI-related major bleeding. 21 There are several potential explanations for the high rate of bleeding observed.…”

Section: Discussioncontrasting

confidence: 53%

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Apixaban and Rivaroxaban Anti-Xa Level Monitoring Versus Standard Monitoring in Hospitalized Patients With Acute Kidney Injury

et al. 2021

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Background: Oral direct factor Xa inhibitors (FxaIs) are renally eliminated; thus, acute kidney injury (AKI) may increase the risk for drug accumulation and bleeding. There is minimal data describing the effects of AKI on FxaI anti-Xa levels or clinical outcomes. Objective: To compare anti-Xa level monitoring with standard monitoring in patients who experience AKI on apixaban or rivaroxaban. Methods: This retrospective study included patients admitted within a large hospital system from May 2016 to October 2020. Patients were included if they received apixaban or rivaroxaban prior to AKI. Patients were stratified into 1 of 2 groups: those with anti-Xa level monitoring or those who received standard monitoring. The primary outcome was major bleeding as defined by the International Society of Thrombosis and Haemostasis. Results: A total of 196 patients were included in the final analysis. Major bleeding occurred in 2 patients who received anti-Xa level monitoring, compared with 14 patients who received standard monitoring (2.1% vs 14%; P < 0.01). Variables identified as predictors of major bleeding included a documented history of liver disease (adjusted odds ratio = 3.17; 95% CI = 1.04-9.67; P = 0.04) and antiplatelet use (adjusted odds ratio = 4.18; 95% CI = 1.28-13.7; P = 0.02). Conclusion and Relevance: This is the first study to demonstrate that anti-Xa level monitoring was associated with a significant reduction in major bleeding compared with standard monitoring in patients with AKI who received apixaban or rivaroxaban. The optimal management of antithrombotic medications in patients with AKI and recent exposure to an FxaI requires further investigation.

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Section: Discussioncontrasting

confidence: 53%

“…However, the prevalence of antiplatelet use seen within this study is consistent with previous studies investigating in-hospital anticoagulant use and could be reflective of real-world practice because many patients with an indication for anticoagulation may also have comorbid conditions that warrant antiplatelet therapy. 20…”

Section: Discussionmentioning

confidence: 99%

Apixaban and Rivaroxaban Anti-Xa Level Monitoring Versus Standard Monitoring in Hospitalized Patients With Acute Kidney Injury

et al. 2021

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“…Female sex was found to be significantly associated with bleeding events in hospitalized patients treated with different types of anticoagulants. 1 Conversely, female sex was not a significant factor for bleeding in outpatients treated with VKAs (vitamin k antagonists) in the historical ISCOAT cohort, 2 as well as in a more recent cohort 3 and other studies. 4 Furthermore, female sex was not included among the risk factors (RFs) for bleeding in international guidelines regarding VKA use.…”

Section: Introductionmentioning

confidence: 79%

Do women with venous thromboembolism bleed more than men during anticoagulation? Data from the real-life, prospective START-Register

Palareti¹,

Legnani²,

Antonucci³

et al. 2021

Therapeutic Advances in Drug Safety

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Background: Venous thromboembolism (VTE) is a frequent and serious disease that requires immediate and long-term anticoagulant treatment, which is inevitably associated with a risk of bleeding complications. Some studies, though not all, reported a higher risk of bleeding in female patients treated with either old anticoagulants [vitamin k antagonists (VKAs)] or recent anticoagulants [direct oral anticoagulants (DOACs)]. Furthermore, analyses of clinical trials reported an abnormal vaginal bleeding in women of reproductive age treated with DOACs. This study aimed at comparing the risk of bleeding in an inception cohort of VTE women and men included in a prospective observational registry. Methods: Baseline characteristics and bleeding events occurring during anticoagulation in patients of both sexes, included in the START-Register after a first VTE, were analyzed. Results: In all, 1298 women were compared with 1290 men. Women were older and more often had renal diseases; their index events were often provoked (often by hormonal contraception and pregnancy), and more frequently presented as isolated pulmonary embolism (PE). The rate of bleeding was similar in women (2.9% patient-years) and men (2.1% patient-years), though it was higher when uterine bleeds were included (3.5% patient-years, p = 0.0141). More bleeds occurred in VKA- than DOAC-treated patients (6.4% versus 2.6%, respectively; p = 0.0013). At multivariate analysis, age ⩾ 75 years was associated with higher prevalence of bleeds. Conclusion: The occurrence of bleeding was not different between women and men during anticoagulation after VTE. Only after inclusion of vaginal/uterine bleeds, the rate of bleeding was higher in women. The incidence of bleeding was higher in women treated with VKAs. Plain Language Summary The risk of bleeding in women anticoagulated for deep vein thrombosis or pulmonary embolism is not higher than that in men, except for vaginal bleeding Background: The occurrence of a venous thromboembolic event (VTE, including deep vein thrombosis and pulmonary embolism) necessarily requires a period of at least 3–6 months of treatment with anticoagulant drugs [either vitamin k antagonists (VKA) or, more recently, direct oral anticoagulants (DOACs)]. Anticoagulation therapy, however, is associated with a risk of bleeding that is influenced by several factors. Sex is one of these factors as some authors have hypothesized that women are at higher risk than men. Furthermore, some studies have recently found more vaginal bleeding in VTE women treated with a DOAC compared with those who received VKAs. Methods: The present study aimed to compare the frequency of bleeds occurring in women and in men who were treated with DOACs or VKAs for a first VTE event and followed in real-life conditions. Since the beginning of their anticoagulant treatment, the patients were included in a prospective, multicenter, observational registry (the START-Register), and bleeding events were recorded. Results: A total of 1298 women were compared with 1290 men. Women were older and more often were affected by renal diseases; their VTE events were often associated with risk factors (especially hormonal contraception and pregnancy) and presented as isolated pulmonary embolism. The rate of all bleeding events (including major, non-major but clinically relevant, and minor bleeds) was higher in women (3.5% patient-years) than in men (2.1% patient-years, p = 0.0141); however, the difference was no longer statistically significant after exclusion of uterine bleeds (2.9% patient years). More bleeding occurred in women receiving VKA as anticoagulant drug compared with those treated with a DOAC (6.4% versus 2.6%, respectively; p = 0.0013). At multivariate analysis, age ⩾ 75 years was associated with higher prevalence of bleeds. Conclusion: In conclusion, we found that in real-life conditions, the rate of bleeding events occurring during anticoagulation after a VTE episode is not higher in women than in men. Only after inclusion of vaginal bleeds, the rate of bleeding was higher in women. More bleeds (including vaginal bleeding) occurred in women treated with VKA than DOACs.

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“…The bleeding rate in COVID-19 patients with thrombosis was significantly higher than reported bleeding rates for hospitalized nonCOVID-19 patients on anticoagulants, 12.3% versus 7.2% (p<0.05) . 5,9 The majority of bleeding events occurred after a noted thrombosis (58.8%), on therapeutic dosing of anticoagulation (64.7%), in the ICU (70.6%), and were WHO grade 4 (58.8%) as seen in Table 2. Only 17.6% of COVID-19 patients with thrombosis who had bleeding had thrombocytopenia defined as platelet count < 100x10 3 ul at the time of bleeding.…”

Section: Accepted Manuscriptmentioning

confidence: 99%

Prevention of Thromboembolic Events in Patients with COVID-19

Warrior

Behrens

Thomas

et al. 2021

TH Open

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Background: COVID-19 has developed into a global pandemic with respiratory compromise and systemic coagulopathy causing significant morbidity and mortality. Methods: A retrospective analysis was performed on all COVID-19 patients hospitalized between March and June 2020. Findings: Of 1265 COVID-19 positive hospitalized patients identified, 138 (10.9%) had a thromboembolism. Mortality rate in COVID-19 patients with thrombosis was 31.9%, significantly higher than COVID-19 patients who did not have thrombosis 10% (p<0.0001). The incidence of thrombosis was significantly less in those who received steroids at 14% as compared to other COVID-19 therapies: tocilizumab 25% (p=0.0031), hydroxychloroquine 42% (p<0.0001), and remdesivir 72% (p<0.0001). There was no difference in mortality in patients who had prophylactic enoxaparin 40.5% than therapeutic enoxaparin 51.7% (p= 0.3491). Adjusting for demographics, a logistics model showed no mortality difference in patients who had either dosing of anticoagulation (p=0.5810). The bleeding rate was 12.3%, significantly higher than reported bleeding rates for hospitalized nonCOVID-19 patients on anticoagulants at 7.2% (p<0.05). Interpretation: Our study shows the incidence of thrombosis in hospitalized COVID-19 patients was higher than the general population. The lowest incidence of thrombosis occurred in COVID-19 patients who received steroids. There was no mortality difference in patients who received prophylactic versus therapeutic anticoagulation prior to thrombosis, but there was a high incidence of bleeding events. Funding: No outside funding was used

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Risk of bleeding in hospitalized patients on anticoagulant therapy: Prevalence and potential risk factors

Cited by 11 publications

References 30 publications

Apixaban and Rivaroxaban Anti-Xa Level Monitoring Versus Standard Monitoring in Hospitalized Patients With Acute Kidney Injury

Apixaban and Rivaroxaban Anti-Xa Level Monitoring Versus Standard Monitoring in Hospitalized Patients With Acute Kidney Injury

Do women with venous thromboembolism bleed more than men during anticoagulation? Data from the real-life, prospective START-Register

Prevention of Thromboembolic Events in Patients with COVID-19

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