Bleeding Risk Assessment in Patients with Venous Thromboembolism

Nopp, Stephan; Ay, Cihan

doi:10.1055/a-1339-9987

Cited by 11 publications

(8 citation statements)

References 75 publications

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“…Bleeding risk assessment poses a special challenge to the treating physician when deciding on anticoagulation modalities during HD or anticoagulation for treatment and prevention of thromboembolic events. Therefore, different models have been proposed to assess bleeding risk in clinical practice in the general patient population (40,41). However, potentially due to the heterogeneity in bleeding type and causality of bleeding events, risk prediction performs only poorly to moderately across different diseases and clinical settings (24,42).…”

Section: Discussionmentioning

confidence: 99%

“…Currently existing bleeding risk scores were selected from recent reviews on bleedings risk assessment tools in various diseases. 23 24 25 Seven bleeding risk prediction scores potentially applicable to the HD setting were identified and evaluated. The HAS-BLED, 26 ATRIA, 27 ORBIT, 28 OBRI, 29 and mORBI 30 scores were calculated based on the variables collected at study inclusion for each patient as defined in their original development studies.…”

Section: Methodsmentioning

confidence: 99%

“…Currently existing bleeding risk scores were selected from recent reviews on bleedings risk assessment tools in various diseases (23)(24)(25). Seven bleeding risk prediction scores…”

Section: Bleeding Risk Assessment Toolsmentioning

confidence: 99%

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Bleeding Risk Assessment in End-Stage Kidney Disease: Validation of Existing Risk Scores and Evaluation of a Machine Learning-Based Approach

et al. 2022

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Background Patients with end-stage kidney disease (ESKD) on hemodialysis (HD) are at increased risk for bleeding. However, despite relevant clinical implications regarding dialysis modalities or anticoagulation, no bleeding risk assessment strategy has been established in this challenging population. Methods Analyses on bleeding risk assessment models were performed in the population-based Vienna InVestigation of Atrial fibrillation and thromboemboLism in patients on hemoDialysIs (VIVALDI) study including 625 patients. In this cohort study, patients were prospectively followed for a median observation period of 3.5 years for the occurrence of major bleeding. First, performances of existing bleeding risk scores (i.e., HAS-BLED, HEMORR2HAGES, ATRIA, and four others) were evaluated in terms of discrimination and calibration. Second, four machine learning-based prediction models that included clinical, dialysis-specific, and laboratory parameters were developed and tested using Monte-Carlo cross-validation. Results Of 625 patients (median age: 66 years, 38% women), 89 (14.2%) developed major bleeding, with a 1-year, 2-year, and 3-year cumulative incidence of 6.1% (95%CI 4.2-8.0), 10.3% (95%CI 8.0-12.8), and 13.5% (95%CI 10.8-16.2), respectively. C-statistics of seven contemporary bleeding risk scores ranged between 0.54 and 0.59 indicating poor discriminatory performance. The HAS-BLED score showed the highest C-statistics of 0.59 (95% 0.53-0.56). Similarly, all four machine learning-based predictions models performed poorly in internal validation (C-statistics ranging from 0.49-0.55). Conclusions Existing bleeding risk scores and a machine learning approach including common clinical parameters fail to assist in bleeding risk prediction of patients on HD. Therefore, new approaches, including novel biomarkers, to improve bleeding risk prediction in patients on HD are needed.

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Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

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Bleeding Risk Assessment in End-Stage Kidney Disease: Validation of Existing Risk Scores and Evaluation of a Machine Learning-Based Approach

et al. 2022

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“…52 Another study of patients with VTE ≥65 years receiving VKA 53 evaluating 10 clinical bleeding risk scores (VTE-BLEED, 68 RIETE, 70 ACCP, 25 Seiler, 71 Kuijer, 69 Kearon, OBRI, 61 62 ATRIA, 50 HAS-BLED, 59 HEMORR 2 HAGES 57 ) showed c-statistics ranging from 0.47 (OBRI 61 62 ) to 0.70 (Seiler 71 ) for major bleeding and 0.52 (OBRI 61 62 ) to 0.67 (HEMORR 2 HAGES 57 ) for clinically relevant bleeding. A recent review of bleeding risk assessment in patients with VTE 93 concluded that the HAS-BLED or RIETE scores are beneficial in identifying patients at high bleeding risk (HBR) during early-phase OAC treatment, with VTE-BLEED advantageous in identifying low-risk patients who could benefit from extended OAC for secondary prophylaxis.…”

Section: Systematic Reviewmentioning

confidence: 99%

Assessment and Mitigation of Bleeding Risk in Atrial Fibrillation and Venous Thromboembolism: Executive Summary of a European and Asia-Pacific Expert Consensus Paper

et al. 2022

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While there is a clear clinical benefit of oral anticoagulation in patients with atrial fibrillation (AF) and venous thromboembolism (VTE) in reducing the risks of thromboembolism, major bleeding events (especially intracranial bleeds) may still occur and be devastating. The decision for initiating and continuing anticoagulation is often based on a careful assessment of both thromboembolism and bleeding risk. The more common and validated bleeding risk factors have been used to formulate bleeding risk stratification scores, but thromboembolism and bleeding risk factors often overlap. Also, many factors that increase bleeding risk are transient and modifiable, such as variable international normalized ratio values, surgical procedures, vascular procedures, or drug–drug and food–drug interactions. Bleeding risk is also not a static “one-off” assessment based on baseline factors but is dynamic, being influenced by aging, incident comorbidities, and drug therapies. In this executive summary of a European and Asia-Pacific Expert Consensus Paper, we comprehensively review the published evidence and propose a consensus on bleeding risk assessments in patients with AF and VTE, with a view to summarizing “best practice” when approaching antithrombotic therapy in these patients. We address the epidemiology and size of the problem of bleeding risk in AF and VTE, and review established bleeding risk factors and summarize definitions of bleeding. Patient values and preferences, balancing the risk of bleeding against thromboembolism, are reviewed, and the prognostic implications of bleeding are discussed. We propose consensus statements that may help to define evidence gaps and assist in everyday clinical practice.

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“…The first group represents patients with an increased risk of bleeding (e.g., patients with kidney impairment, prior history of bleedings, cancer, or the elderly). Notably, bleeding risk assessment is challenging and no single approach has been proved to be consistently superior ( 30 ). Thus, the decision to initiate or continue anticoagulation remains at the discretion of the treating physician based on an individual assessment of risk of thrombosis and bleeding.…”

Section: Introductionmentioning

confidence: 99%

Factor XI Inhibitors for Prevention and Treatment of Venous Thromboembolism: A Review on the Rationale and Update on Current Evidence

Nopp

Kraemmer

2022

Front. Cardiovasc. Med.

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Although anticoagulation therapy has evolved from non-specific drugs (i.e., heparins and vitamin K antagonists) to agents that directly target specific coagulation factors (i.e., direct oral anticoagulants, argatroban, fondaparinux), thrombosis remains a leading cause of death worldwide. Direct oral anticoagulants (i.e., factor IIa- and factor Xa-inhibitors) now dominate clinical practice because of their favorable pharmacological profile and ease of use, particularly in venous thromboembolism (VTE) treatment and stroke prevention in atrial fibrillation. However, despite having a better safety profile than vitamin K antagonists, their bleeding risk is not insignificant. This is true for all currently available anticoagulants, and a high bleeding risk is considered a contraindication to anticoagulation. As a result, ongoing research focuses on developing future anticoagulants with an improved safety profile. Several promising approaches to reduce the bleeding risk involve targeting the intrinsic (or contact activation) pathway of coagulation, with the ultimate goal of preventing thrombosis without impairing hemostasis. Based on epidemiological data on hereditary factor deficiencies and preclinical studies factor XI (FXI) emerged as the most promising candidate target. In this review, we highlight unmet clinical needs of anticoagulation therapy, outlay the rationale and evidence for inhibiting FXI, discuss FXI inhibitors in current clinical trials, conduct an exploratory meta-analysis on their efficacy and safety, and provide an outlook on the potential clinical application of these novel anticoagulants.

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Bleeding Risk Assessment in Patients with Venous Thromboembolism

Cited by 11 publications

References 75 publications

Bleeding Risk Assessment in End-Stage Kidney Disease: Validation of Existing Risk Scores and Evaluation of a Machine Learning-Based Approach

Bleeding Risk Assessment in End-Stage Kidney Disease: Validation of Existing Risk Scores and Evaluation of a Machine Learning-Based Approach

Assessment and Mitigation of Bleeding Risk in Atrial Fibrillation and Venous Thromboembolism: Executive Summary of a European and Asia-Pacific Expert Consensus Paper

Factor XI Inhibitors for Prevention and Treatment of Venous Thromboembolism: A Review on the Rationale and Update on Current Evidence

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