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1.
Medicine (Baltimore) ; 103(28): e38697, 2024 Jul 12.
Article in English | MEDLINE | ID: mdl-38996155

ABSTRACT

It has been shown that patients' knowledge about venous thromboembolism (VTE) and its therapy is suboptimal, which might reduce compliance and worsen prognosis. We investigated whether low VTE patients' knowledge affects their clinical outcomes during long-term follow-up. We evaluated 151 consecutive patients (51.8 ±â€…15.7 years) after unprovoked VTE, who were recruited from the outpatient clinic (Krakow, Poland). All patients received anticoagulant treatment, mostly with direct oral anticoagulants (n = 113, 74.8%). The modified Jessa Atrial fibrillation Knowledge Questionnaire (JAKQ-VTE; 16 questions) was used to assess the knowledge of VTE and anticoagulant therapy. During a median follow-up of 58.0 months, VTE recurrence, major bleeding, and anticoagulation withdrawal were recorded. The median percentage of correct responses was 62.5% (12.5-100%) and was inversely correlated with age (P < .01). Diabetic patients and those with positive family history of VTE had lower overall scoring compared to the remainder (both P < .05). Major bleeding (n = 10, 6.6%) and anticoagulation withdrawal (n = 28, 18.5%), but not VTE recurrence (n = 12, 7.9%), were associated with lower overall scoring compared to the remainder (48.8% ±â€…12.5% vs 63.8% ±â€…16.3%, P = .003 and 55.3% ±â€…14.7% vs 64.4% ±â€…16.3%, P = .040, respectively). Major bleeding was independently associated with the female sex (hazard ratio [HR] 6.18; 95% confidence interval [CI] 1.15-33.19, P = .034), younger age (HR per 10 years 0.55; 95% CI 0.34-0.90, P = .016), OAC therapy discontinuation (HR 6.69; 95% CI 1.62-27.70), and lower overall scoring of JAKQ-VTE (HR 0.60 per 10 percentage points; 95% CI 0.40-0.92, P = .019). Insufficient knowledge about VTE and anticoagulant treatment predisposes to a higher risk of major bleeding and therapy discontinuation, but not VTE recurrence in unprovoked VTE patients during long-term follow-up.


Subject(s)
Anticoagulants , Health Knowledge, Attitudes, Practice , Hemorrhage , Venous Thromboembolism , Humans , Venous Thromboembolism/drug therapy , Middle Aged , Female , Male , Anticoagulants/adverse effects , Anticoagulants/administration & dosage , Anticoagulants/therapeutic use , Hemorrhage/chemically induced , Aged , Adult , Recurrence , Risk Factors , Cohort Studies , Surveys and Questionnaires
2.
Nat Commun ; 15(1): 5657, 2024 Jul 05.
Article in English | MEDLINE | ID: mdl-38969649

ABSTRACT

Given the existing uncertainty regarding the effectiveness and safety of switching from low-molecular-weight heparin (LMWH) to direct oral anticoagulants (DOACs) in patients with cancer-associated venous thrombosis (CAT), we conducted a comprehensive population-based cohort study utilizing electronic health database in Hong Kong. A total of 4356 patients with CAT between 2010 and 2022 were included, with 1700 (39.0%) patients switching to DOAC treatment. Compared to continuous LMWH treatment, switching to DOACs was associated with a significantly lower risk of hospitalization due to venous thromboembolism (HR: 0.49 [95% CI = 0.35-0.68]) and all-cause mortality (HR: 0.67 [95% CI = 0.61-0.74]), with no significant difference in major bleeding (HR: 1.04 [95% CI = 0.83-1.31]) within six months. These findings provide reassurance regarding the effectiveness and safety of switching from LMWH to DOACs among patients with CAT, including vulnerable patient groups.


Subject(s)
Anticoagulants , Hemorrhage , Heparin, Low-Molecular-Weight , Neoplasms , Venous Thrombosis , Humans , Neoplasms/drug therapy , Neoplasms/complications , Heparin, Low-Molecular-Weight/administration & dosage , Heparin, Low-Molecular-Weight/adverse effects , Heparin, Low-Molecular-Weight/therapeutic use , Female , Male , Middle Aged , Aged , Anticoagulants/administration & dosage , Anticoagulants/therapeutic use , Anticoagulants/adverse effects , Venous Thrombosis/drug therapy , Administration, Oral , Hong Kong/epidemiology , Hemorrhage/chemically induced , Treatment Outcome , Venous Thromboembolism/drug therapy , Venous Thromboembolism/etiology , Cohort Studies , Hospitalization/statistics & numerical data , Drug Substitution , Aged, 80 and over
4.
Pediatr Blood Cancer ; 71(9): e31140, 2024 Sep.
Article in English | MEDLINE | ID: mdl-38956808

ABSTRACT

BACKGROUND: Direct oral anticoagulants (DOACs) have had significant impact on the management of venous thromboembolism (VTE) in adults, but these agents were not approved for use in pediatric patients until 2021. Our objective was to analyze the characteristics of pediatric patients treated with DOACs prior to and following U.S. Food and Drug Administration (FDA) approval for children and evaluate their impact on hospital outcomes. PROCEDURE: We utilized the Epic Cosmos dataset (Cosmos), a de-identified dataset of over 220 million patients, to identify patients aged 1-18 years admitted with a first-occurrence diagnosis of VTE between January 1, 2017 and June 30, 2023. Patients were grouped by anticoagulation received (unfractionated heparin, low molecular weight heparin, and/or DOACs). RESULTS: Among 5138 eligible patients, 18.1% received DOACs as all or part of their anticoagulation treatment, while 81.9% received heparin therapies alone. Patients treated with DOACs were older than patients treated with heparin monotherapy at 17.4 and 13.0 years, respectively. Non-DOAC patients were more likely to have chronic conditions and were less likely to have pulmonary embolism. Patients treated with DOACs demonstrated shorter overall length of stay and duration of intensive care unit (ICU) admission. CONCLUSIONS: DOACs remain infrequently utilized in pediatric patients, especially in those under 13 years old. Initiation on heparin therapy and transition to DOACs remains common, with 80.6% of DOAC patients receiving heparin during their hospitalization. While DOAC monotherapy is not currently endorsed as first-line therapy for DVT or PE in children, it is being used clinically. Further research is needed to clarify the impact of DOAC use on patient adherence, VTE recurrence, and healthcare cost.


Subject(s)
Anticoagulants , Venous Thromboembolism , Humans , Child , Adolescent , Male , Female , Child, Preschool , Infant , Venous Thromboembolism/drug therapy , Administration, Oral , Anticoagulants/therapeutic use , Hospitalization , United States , Follow-Up Studies , Factor Xa Inhibitors/therapeutic use , Prognosis
6.
Clin Interv Aging ; 19: 1103-1116, 2024.
Article in English | MEDLINE | ID: mdl-38915432

ABSTRACT

Background: Rivaroxaban, a non-vitamin K antagonist oral anticoagulant, has become widely used for the management of venous thromboembolism (VTE) in adult patients. However, few trials have explored the efficacy and safety of rivaroxaban in VTE patients over 80 years of age. This necessitates further real-world studies of rivaroxaban across elderly populations. Methods: We performed a retrospective single center study involving extremely aged VTE sufferers treated with rivaroxaban. The sample comprised 121 patients newly initiated on rivaroxaban diagnosed between January 2018 and January 2020. Patients were followed up for no less than 2 years. The effectiveness outcome was the disappearance of thromboembolism. The safety outcome was the incidence of major bleeding events. Comorbidities and complications were recorded throughout the entire study. Results: The efficacy outcome occurred in 114 of 121 patients (94.21%) and the safety outcome occurred in 12 of 121 patients (9.91%). Increased hemorrhages were observed in patients with infection (15.15% vs 7.80%), but no significant difference was observed due to limited sample size (P=0.3053). Patients with an age-adjusted Charlson comorbidity index score higher than 6 points exhibited higher bleeding rates (14.08% vs 4.00%; P=0.0676) and lower thrombus cure rates (88.73% vs 100%; P=0.0203). Key conclusions: Patients with infection should be more careful of bleeding events during rivaroxaban therapy. An age-adjusted Charlson comorbidity index score higher than 6, which predicted poor survival, indicated inferior safety and efficacy of rivaroxaban. Aim: To investigate the efficacy and safety of Rivaroxaban in an aged venous thromboembolism patient population under real-world conditions.


Subject(s)
Factor Xa Inhibitors , Hemorrhage , Rivaroxaban , Venous Thromboembolism , Humans , Rivaroxaban/adverse effects , Rivaroxaban/therapeutic use , Retrospective Studies , Male , Female , Venous Thromboembolism/drug therapy , Aged, 80 and over , Factor Xa Inhibitors/adverse effects , Factor Xa Inhibitors/therapeutic use , Hemorrhage/chemically induced , Cross-Sectional Studies , Treatment Outcome , Comorbidity
7.
Clin Appl Thromb Hemost ; 30: 10760296241261364, 2024.
Article in English | MEDLINE | ID: mdl-38870350

ABSTRACT

OBJECTIVE: To examine the effectiveness of rivaroxaban compared to enoxaparin in patients diagnosed with cancer and venous thromboembolism. METHODS: A search of Pub Med, Scopus, and Google Scholar, from inception through April 2023 was conducted. Articles comparing rivaroxaban with enoxaparin in patients with cancer and VTE/PE/DVT were included. Review Manager Version 5.2 was utilised for the analysis of the following outcomes; VTE, PE, DVT, major bleeding, and mortality. RESULTS: A total of 8 articles and 2276 patients were included in the final analysis. Pooled analysis showed that rivaroxaban had a statistically insignificant reduced association with VTE occurrence (RR:0.83, 95% CI:0.58-1.18, P:0.3) as well as a statically insignificant reduction in major bleeding (RR:0.79, 95% CI:0.53-1.18, P:0.25). Analysis showcased that there was an insignificant reduction of mortality rivaroxaban as compared to enoxaparin (RR:0.74, 95% CI: 0.46-1.20, P:0.23). CONCLUSION: Rivaroxaban can serve as a viable alternative to enoxaparin, with no appreciable drawbacks, for preventing and managing VTE in patients with malignancy.


Subject(s)
Enoxaparin , Neoplasms , Rivaroxaban , Venous Thromboembolism , Humans , Anticoagulants/therapeutic use , Enoxaparin/therapeutic use , Hemorrhage/chemically induced , Neoplasms/complications , Neoplasms/drug therapy , Recurrence , Rivaroxaban/therapeutic use , Venous Thromboembolism/prevention & control , Venous Thromboembolism/etiology , Venous Thromboembolism/drug therapy
8.
Pediatr Blood Cancer ; 71(9): e31131, 2024 Sep.
Article in English | MEDLINE | ID: mdl-38899913

ABSTRACT

Adolescent venous thromboembolism (VTE) has unique challenges in management, complications, and compliance to anticoagulants. Direct oral anticoagulants (DOACs) have been approved for pediatric VTE management, with an increasing use especially in adolescents. Primary objective is to evaluate the safety and efficacy of DOAC therapy in adolescent VTE. Secondary objectives include adverse events, bleeding events, and overall mortality. A SR protocol was registered in PROSPERO 2022 (CRD42022363928). Databases were searched from inception to September 22, 2022. Studies with children aged 10-18 years, VTE diagnosis, DOAC therapy, randomized control trials (RCTs), cohort, and relevant study types were included. Studies including prophylaxis, non-DOAC therapy, arterial thrombosis, age outliers, non-relevant study types were excluded. Findings are reported in accordance to PRISMA 2020. Nine reports from five studies, published between 2016 and 2022, were included. Rivaroxaban was the most common DOAC. VTE recurrence was 0.02% in the rivaroxaban phase III trial and one patient in the dabigatran phase IIb/III trial. Complete/partial thrombus resolution (CR/PR) was 76.6% in the rivaroxaban phase III trial, and 83.9% in the dabigatran phase IIb/III trial. CR/PR was found to be 68.4% in Dhaliwal et al. study and 83.3% in Hassan et al. study. Major bleeding occurred in one patient. Headache and gastrointestinal symptoms were commonly seen. All-cause mortality occurred in a patient due to cancer progression. DOAC therapy in adolescent VTE had CR/PR in two-thirds of the patients, with low incidence of VTE recurrence and major bleeding. As there are only two randomized controlled trial (RCTs), future adolescents' studies are required to validate our results.


Subject(s)
Anticoagulants , Venous Thromboembolism , Humans , Adolescent , Venous Thromboembolism/drug therapy , Administration, Oral , Anticoagulants/therapeutic use , Anticoagulants/administration & dosage , Anticoagulants/adverse effects , Child , Prognosis
9.
Rev Med Interne ; 45(5): 289-299, 2024 May.
Article in French | MEDLINE | ID: mdl-38806295

ABSTRACT

Patients with cancer are at significantly increased risk of venous thromboembolism (VTE), due both to the impact of malignant disease itself and to the impact of certain anticancer drugs on haemostasis. This is true both for first episode venous thromboembolism and recurrence. The diagnosis and management of VTE recurrence in patients with cancer poses particular challenges, and these are reviewed in the present article, based on a systematic review of the relevant scientific literature published over the last decade. Furthermore, it is uncertain whether diagnostic algorithms for venous thromboembolism, validated principally in untreated non-cancer patients, are also valid in anticoagulated cancer patients: the available data suggests that clinical decision rules and D-dimer testing perform less well in this clinical setting. In patients with cancer, computed tomography pulmonary angiography and venous ultrasound appear to be the most reliable diagnostic tools for diagnosis of pulmonary embolism and deep vein thrombosis respectively. Options for treatment of venous thromboembolism include low molecular weight heparins (at a therapeutic dose or an increased dose), fondaparinux or oral direct factor Xa inhibitors. The choice of treatment should take into account the nature (pulmonary embolism or VTE) and severity of the recurrent event, the associated bleeding risk, the current anticoagulant treatment (type, dose, adherence and possible drug-drug interactions) and cancer progression.


Subject(s)
Anticoagulants , Neoplasms , Recurrence , Venous Thromboembolism , Humans , Venous Thromboembolism/diagnosis , Venous Thromboembolism/etiology , Venous Thromboembolism/drug therapy , Neoplasms/complications , Anticoagulants/therapeutic use , Anticoagulants/adverse effects , Anticoagulants/administration & dosage , France/epidemiology
10.
Vasc Endovascular Surg ; 58(6): 633-639, 2024 Aug.
Article in English | MEDLINE | ID: mdl-38706248

ABSTRACT

OBJECTIVE: This systematic review and network meta-analysis aimed to evaluate the efficacy and safety of direct oral anticoagulants (DOACs) in adults aged 75 and over undergoing acute venous thromboembolism (VTE) treatment. METHODS: PubMed, Embase and the CENTRAL were searched up to 25 December 2023. The incidence of VTE recurrence and bleeding events was assessed. Employing a frequentist network meta-analysis approach, interventions not directly compared could be indirectly assessed through the 95% confidence interval (CI), enhancing the interpretability of the search results. The surface under the cumulative ranking curves (SUCRA) was utilized to generate the relative ranking probabilities for each group. RESULTS: Our study, analysing 6 randomised controlled trials with 3665 patients, compares direct oral anticoagulants (DOACs) and vitamin K antagonists (VKAs) in adults aged 75 and over with acute venous thromboembolism. Edoxaban reduces VTE recurrence risk compared with VKAs (risk ratio [RR] .50, 95% CI 0.27 - .95), while apixaban significantly decreases bleeding risk compared with VKAs (RR .23, 95% CI 0.08 - .69), edoxaban (RR .28, 95% CI 0.09 - .86) and rivaroxaban (RR .28, 95% CI 0.09 - .86). Despite low overall evidence quality, apixaban consistently ranks highest for both efficacy and safety. Findings underscore the nuanced efficacy-safety balance in this population, emphasizing cautious interpretation due to evidence limitations. CONCLUSION: Apixaban emerges as a favourable choice for acute VTE treatment in the elderly, displaying reduced bleeding risk compared to other treatments while maintaining comparable efficacy. Future studies should explore diverse anticoagulants efficacy and safety in older populations. Additionally, clinical prediction models tailored to geriatric cohorts are crucial for guiding treatment duration decisions.


Subject(s)
Factor Xa Inhibitors , Hemorrhage , Network Meta-Analysis , Randomized Controlled Trials as Topic , Recurrence , Venous Thromboembolism , Humans , Venous Thromboembolism/drug therapy , Venous Thromboembolism/diagnosis , Venous Thromboembolism/blood , Aged , Hemorrhage/chemically induced , Administration, Oral , Risk Factors , Treatment Outcome , Age Factors , Female , Male , Aged, 80 and over , Risk Assessment , Factor Xa Inhibitors/adverse effects , Factor Xa Inhibitors/administration & dosage , Anticoagulants/adverse effects , Anticoagulants/administration & dosage , Acute Disease
11.
Thromb Res ; 239: 109027, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38735165

ABSTRACT

Venous thromboembolism (VTE) in pediatric patients is an uncommon but serious diagnosis that has an array of therapeutic options and challenges. An assessment of the existing literature on management of pediatric patients with VTE was conducted. The interventions reviewed include anticoagulation, thrombolysis, thrombectomy, inferior vena cava (IVC) filters, and venous stenting. For each intervention, a discussion of mechanism of action, indications, contraindications, and potential complications was performed. While anticoagulants are considered the first-line pediatric VTE treatment, many drugs remain investigational in this patient population and treatment recommendations are extrapolated from adult practice. Thrombolysis may be indicated in cases of acute thrombosis requiring more rapid clot resolution but presents a greater bleeding risk than anticoagulation. Similarly, thrombectomy also provides rapid clot resolution and offers a larger therapeutic window and usage in more mature thrombi than thrombolysis. In select patient groups, IVC filters may be indicated in the prevention of PE but present with inherent thrombogenicity and risk of migration. The data regarding pediatric VTE treatment options, monitoring, and long term outcomes is limited compared to the adult population. The relatively few clinical trials including pediatric patients have a relatively small sample size and are heterogenous with regards to predisposing factors that further exacerbate generalizability. Additional research is needed to help construct and evaluate a robust treatment algorithm for pediatric patients with VTE.


Subject(s)
Anticoagulants , Endovascular Procedures , Venous Thromboembolism , Humans , Venous Thromboembolism/drug therapy , Venous Thromboembolism/therapy , Anticoagulants/therapeutic use , Child , Endovascular Procedures/methods , Thrombolytic Therapy/methods , Thrombectomy/methods , Vena Cava Filters
12.
Thromb Res ; 239: 109036, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38776611

ABSTRACT

Adherence to guideline recommendations for venous thromboembolism prophylaxis (VTE) in hospitalized medical patients is suboptimal despite national policies and institutional interventions. The aim of this quality improvement project was to improve adherence to guidelines and decrease the overuse of VTE prophylaxis in order to reduce the institutional cost for heparins. A multidisciplinary anticoagulation stewardship program (ACSP) using the audit and feedback strategy was implemented on the medicine inpatient units at a teaching hospital in Canada. The primary outcome measure was a comparison, pre and post introduction of the ACSP, of the costs per 6-month period for prophylactic dose enoxaparin and unfractionated heparin on the medicine units. The balancing measures were the 90-day VTE rate and major bleeding rate during the hospitalization. Six months after the implementation of the ACSP, the cost was decreased by >50 % without any observed negative impact on patient safety. This study demonstrates the potential for anticoagulation stewardship programs to optimize the use of VTE prophylaxis and reduce the associated costs and risks.


Subject(s)
Anticoagulants , Guideline Adherence , Hospitalization , Venous Thromboembolism , Humans , Venous Thromboembolism/prevention & control , Venous Thromboembolism/drug therapy , Venous Thromboembolism/economics , Anticoagulants/therapeutic use , Female , Male , Practice Guidelines as Topic , Middle Aged , Aged , Hemorrhage/chemically induced , Heparin/therapeutic use , Heparin/economics , Canada
13.
Thromb Res ; 239: 109037, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38781706

ABSTRACT

INTRODUCTION: Approximately 10 % of all diagnosed pulmonary embolism are isolated to the subsegmental vessels. The risk of recurrent venous thromboembolism (VTE) in patients with an acute subsegmental pulmonary embolism (SSPE) managed with or without anticoagulant therapy remains poorly understood. METHODS: This is an observational cohort study including consecutive adult patients diagnosed with acute isolated SSPE between June 01, 2019, and August 31, 2022. We excluded patients with a concomitant diagnosis of deep vein thrombosis and those who had an indication for long-term anticoagulation. The primary outcome was objectively confirmed recurrent VTE. RESULTS: Overall, 118 patients with acute SSPE were included in the analysis. The mean (± standard deviation [SD]) age of the participants was 59 ± 17 years and 44 % of them had active cancer. Mean (±SD) duration of follow-up was 438 ± 426 days. Seventy-seven patients (65 %) were initially treated with anticoagulation, whereas 41 patients (35 %) were not. Of the 77 patients receiving anticoagulant therapy, 23 (30 %) received extended-duration anticoagulation (beyond 3 months) for secondary prevention. Overall, recurrent VTE events occurred in 6/118 (5 %, 95 % CI 2.4 to 10.7) patients. Four events (4/77 = 5.2 %, 95 % CI 2.0 to 12.6) occurred in initially treated patients. Two recurrent VTE occurred in patients initially left untreated (2/41 = 4.9 %, 95 % CI 1.4 to 16.1). Half of the recurrent VTE occurred in patients with active cancer. CONCLUSIONS: Most patients diagnosed with an acute SSPE received anticoagulation. The incidence of recurrent VTE detected over time was relatively high, especially in patients with cancer.


Subject(s)
Hemorrhage , Pulmonary Embolism , Recurrence , Venous Thromboembolism , Humans , Pulmonary Embolism/epidemiology , Pulmonary Embolism/drug therapy , Pulmonary Embolism/etiology , Middle Aged , Male , Female , Venous Thromboembolism/drug therapy , Venous Thromboembolism/epidemiology , Hemorrhage/etiology , Risk Factors , Aged , Anticoagulants/therapeutic use , Cohort Studies , Adult , Acute Disease
14.
Clin Appl Thromb Hemost ; 30: 10760296241256368, 2024.
Article in English | MEDLINE | ID: mdl-38798129

ABSTRACT

INTRODUCTION: Venous thromboembolism (VTE) is a serious, frequent, and preventable medical complication in hospitalized patients. Although the efficacy of prophylaxis (pharmacological and/or mechanical) has been demonstrated, compliance with prophylaxis is poor at international and national levels. AIM: To determine the indication and use of pharmacological thromboprophylaxis in hospitalized patients in Uruguay. METHODS: An observational, descriptive, cross-sectional, multicentre study involving 31 nationwide healthcare facilities was conducted. Baseline characteristics associated with hospital admission, the percentage of the population with an indication for thromboprophylaxis, and the percentage of patients receiving pharmacological thromboprophylaxis were assessed. The VTE risk was determined using the Padua score for medical patients; the Caprini score for surgical patients; the Royal College of Obstetricians and Gynaecologists (RCOG) guidelines for pregnant-postpartum patients. RESULTS: 1925 patients were included, representing 26% of hospitalized patients in Uruguay. 71.9% of all patients were at risk of VTE. Of all patients at risk of VTE, 58.6% received pharmacological thromboprophylaxis. The reasons for not receiving thromboprophylaxis were prescribing omissions in 16.1% of cases, contraindication in 15.9% and 9.4% of patients were already anticoagulated for other reasons. Overall, just 68% of patients were "protected" against VTE. Recommendations of major thromboprophylaxis guidelines were followed in 70.1% of patients at risk. CONCLUSIONS: Despite the progress made in adherence to thromboprophylaxis indications, nonadherence remains a problem, affecting one in six patients at risk of VTE in Uruguay.


Subject(s)
Hospitalization , Venous Thromboembolism , Humans , Venous Thromboembolism/prevention & control , Venous Thromboembolism/drug therapy , Venous Thromboembolism/etiology , Uruguay , Female , Male , Cross-Sectional Studies , Middle Aged , Adult , Risk Factors , Aged , Guideline Adherence/statistics & numerical data , Pregnancy , Anticoagulants/therapeutic use
15.
Pediatr Blood Cancer ; 71(9): e31033, 2024 Sep.
Article in English | MEDLINE | ID: mdl-38702920

ABSTRACT

BACKGROUND: The optimal enoxaparin dosing for treatment of venous thromboembolism (VTE) in pediatric patients with obesity remains uncertain. We described the mean enoxaparin dose required to attain anti-factor Xa (anti-Xa) levels of 0.5-1 unit/mL in pediatric patients with obesity. METHODS: Pediatric patients with obesity (body mass index [BMI] ≥95th percentile) who received treatment dose of enoxaparin from 2013 to 2022 and had at least one appropriately timed anti-Xa level were retrospectively evaluated. Daily enoxaparin dose required to achieve an anti-Xa level of 0.5-1 unit/mL was reviewed and compared by the severity of obesity. The correlation coefficients between enoxaparin dose requirement and BMI, BMI percentile, and weight were measured by Spearman's rank correlation coefficient. RESULTS: Pediatric patients with obesity (n = 89) required a mean enoxaparin dose of 0.8 ± 0.18 mg/kg twice daily to attain a therapeutic anti-Xa level. Children with BMI 95th-99th percentile and weight ≤100 kg achieved the target level on a significantly higher weight-based enoxaparin dose compared to BMI greater than 99th percentile (0.95 ± 0.15 vs. 0.75 ± 0.15 mg/kg twice daily; p < .001) and weight greater than 100 kg (0.95 ± 0.14 vs. 0.7 ± 0.12 mg/kg twice daily; p < .001). BMI, BMI percentile, and weight showed a moderate to strong negative correlation with enoxaparin dose requirement. CONCLUSIONS: Pediatric patients with obesity required a lower weight-based dose of enoxaparin to achieve a therapeutic anti-Xa than the recommended starting dose of 1 mg/kg twice daily for treatment of VTE. Among obesity indices, weight showed the strongest negative correlation with total daily enoxaparin requirement.


Subject(s)
Anticoagulants , Enoxaparin , Venous Thromboembolism , Humans , Enoxaparin/administration & dosage , Venous Thromboembolism/drug therapy , Venous Thromboembolism/etiology , Female , Child , Male , Retrospective Studies , Adolescent , Anticoagulants/administration & dosage , Anticoagulants/therapeutic use , Pediatric Obesity/complications , Pediatric Obesity/drug therapy , Child, Preschool , Body Mass Index , Factor Xa Inhibitors/administration & dosage , Factor Xa Inhibitors/therapeutic use , Follow-Up Studies , Obesity/complications , Obesity/drug therapy , Prognosis
16.
J Thromb Haemost ; 22(8): 2234-2246, 2024 Aug.
Article in English | MEDLINE | ID: mdl-38762019

ABSTRACT

BACKGROUND: The duration of anticoagulation for a first episode of unprovoked venous thromboembolism (VTE) should balance the likelihood of VTE recurrence against the risk of major bleeding. OBJECTIVES: Analyze rates and case-fatality rates (CFRs) of recurrent VTE and major bleeding after discontinuing anticoagulation in patients with a first unprovoked VTE after at least 3 months of anticoagulation. METHODS: We compared the rates and CFRs in patients of the Registro Informatizado Enfermedad Trombo Embólica (RIETE) and Contemporary management and outcomes in patients with venous thromboembolism registries. We used logistic regression models to identify predictors for recurrent pulmonary embolism (PE) and major bleeding. RESULTS: Of 8261 patients with unprovoked VTE in RIETE registry, 4012 (48.6%) had isolated deep vein thrombosis (DVT) and 4250 had PE. Follow-up (median, 318 days) showed 543 recurrent DVTs, 540 recurrent PEs, 71 major bleeding episodes, and 447 deaths. The Contemporary management and outcomes in patients with venous thromboembolism registry yielded similar results. Corresponding CFRs of recurrent DVT, PE, and major bleeding were 0.4%, 4.6%, and 24%, respectively. On multivariable analyses, initial PE presentation (hazard ratio [HR], 3.03; 95% CI, 2.49-3.69), dementia (HR, 1.47; 95% CI, 1.01-2.13), and anemia (HR, 0.72; 95% CI, 0.57-0.91) predicted recurrent PE, whereas older age (HR, 2.11; 95% CI, 1.15-3.87), inflammatory bowel disease (HR, 4.39; 95% CI, 1.00-19.3), and anemia (HR, 2.24; 95% CI, 1.35-3.73) predicted major bleeding. Prognostic scores were formulated, with C statistics of 0.63 for recurrent PE and 0.69 for major bleeding. CONCLUSION: Recurrent DVT and PE were frequent but had low CFRs (0.4% and 4.6%, respectively) after discontinuing anticoagulation. On the contrary, major bleeding was rare but had high CFR (24%). A few clinical factors may predict these outcomes.


Subject(s)
Anticoagulants , Hemorrhage , Pulmonary Embolism , Recurrence , Registries , Venous Thromboembolism , Humans , Hemorrhage/chemically induced , Anticoagulants/adverse effects , Anticoagulants/administration & dosage , Anticoagulants/therapeutic use , Female , Male , Venous Thromboembolism/drug therapy , Venous Thromboembolism/mortality , Venous Thromboembolism/diagnosis , Middle Aged , Aged , Pulmonary Embolism/drug therapy , Pulmonary Embolism/mortality , Treatment Outcome , Time Factors , Risk Factors , Venous Thrombosis/drug therapy , Venous Thrombosis/mortality , Venous Thrombosis/diagnosis , Aged, 80 and over , Adult , Risk Assessment , Logistic Models
17.
Tex Heart Inst J ; 51(1)2024 May 15.
Article in English | MEDLINE | ID: mdl-38748549

ABSTRACT

BACKGROUND: Current venous thromboembolism guidelines recommend using direct oral anticoagulants (DOACs) over warfarin regardless of obesity status; however, evidence remains limited for the safety and efficacy of DOAC use in patients with obesity. This retrospective analysis sought to demonstrate the safety and efficacy of DOACs compared with warfarin in a diverse population of patients with obesity in light of current prescribing practices. METHODS: A retrospective cohort study was conducted at a large academic health system between July 2014 and September 2019. Adults with an admission diagnosis of deep vein thrombosis (DVT) or pulmonary embolism, with weight greater than 120 kg or a body mass index greater than 40, and who were discharged on an oral anticoagulant were included. Outcomes included occurrence of a thromboembolic event (DVT, pulmonary embolism, or ischemic stroke), bleeding event requiring hospitalization, and all-cause mortality within 12 months following index admission. RESULTS: Out of 787 patients included, 520 were in the DOAC group and 267 were in the warfarin group. Within 12 months of index hospitalization, thromboembolic events occurred in 4.23% of patients in the DOAC group vs 7.12% of patients in the warfarin group (hazard ratio, 0.6 [95% CI, 0.32-1.1]; P = .082). Bleeding events requiring hospitalization occurred in 8.85% of DOAC patients vs 10.1% of warfarin patients (hazard ratio, 0.93 [95% CI, 0.57-1.5]; P = .82). A DVT occurred in 1.7% and 4.9% of patients in the DOAC and warfarin groups, respectively (hazard ratio, 0.35 [95% CI, 0.15-0.84]; P = .046). CONCLUSION: No significant differences could be determined between DOACs and warfarin for cumulative thromboembolic or bleeding events, pulmonary embolism, ischemic stroke, or all-cause mortality. The risk of DVT was lower with apixaban and rivaroxaban. Regardless of patient weight or body mass index, physicians prescribed DOACs more commonly than warfarin.


Subject(s)
Anticoagulants , Obesity , Venous Thromboembolism , Warfarin , Humans , Retrospective Studies , Female , Male , Warfarin/adverse effects , Warfarin/administration & dosage , Warfarin/therapeutic use , Obesity/complications , Anticoagulants/adverse effects , Anticoagulants/administration & dosage , Anticoagulants/therapeutic use , Middle Aged , Venous Thromboembolism/epidemiology , Venous Thromboembolism/drug therapy , Administration, Oral , Aged , Treatment Outcome , Factor Xa Inhibitors/adverse effects , Factor Xa Inhibitors/administration & dosage , Factor Xa Inhibitors/therapeutic use , Hemorrhage/chemically induced , Hemorrhage/epidemiology , Follow-Up Studies
18.
Am J Nurs ; 124(6): 40-46, 2024 Jun 01.
Article in English | MEDLINE | ID: mdl-38780339

ABSTRACT

BACKGROUND: Unfractionated heparin (UFH) is a high-risk medication that can cause bleeding and/or thrombotic complications if not managed appropriately. Between January and July 2019, our institution experienced a high number of patient safety events related to UFH infusion for the treatment of venous thromboembolism (VTE). PURPOSE: The aim of this quality improvement (QI) initiative was to prevent these safety events by improving compliance with our institution's nurse-driven VTE UFH infusion protocol. METHODS: Baseline data for patients on the VTE UFH protocol were collected to identify improvement opportunities. Compliance with eight standards of care related to the VTE UFH infusion protocol was measured. Time to first therapeutic activated partial thromboplastin time (aPTT) was recorded to assess the benefit of improved compliance. INTERVENTIONS: Institutional policy updates were made to clarify the management of UFH infusions and documentation in the electronic health record. A multidisciplinary workgroup implemented order set changes, nursing communication orders, UFH infusion reports, and a nursing education module to promote compliance with the protocol. RESULTS: The overall rate of compliance with the VTE UFH infusion protocol increased from 79.4% at baseline to 85.2% following implementation of the QI initiative, and the median time to first therapeutic aPTT decreased from 831.5 minutes to 808 minutes over the same period. CONCLUSIONS: A multidisciplinary initiative to address improvement opportunities in a nurse-driven UFH protocol for VTE treatment increased compliance with the protocol and decreased the time to first therapeutic aPTT.


Subject(s)
Anticoagulants , Guideline Adherence , Heparin , Quality Improvement , Venous Thromboembolism , Humans , Venous Thromboembolism/drug therapy , Venous Thromboembolism/nursing , Venous Thromboembolism/prevention & control , Heparin/administration & dosage , Heparin/therapeutic use , Heparin/adverse effects , Anticoagulants/administration & dosage , Anticoagulants/therapeutic use , Anticoagulants/adverse effects , Guideline Adherence/statistics & numerical data , Infusions, Intravenous , Female , Male , Middle Aged , Patient Safety/standards
19.
Thromb Res ; 238: 1-10, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38636204

ABSTRACT

Patients aged ≥65 years not only account for the majority of patients with atrial fibrillation (AF) and venous thromboembolism (VTE), they are also at a higher risk of morbidity, mortality, and undertreatment than younger patients. Several age-related physiological changes with effects on drug pharmacokinetics/-dynamics and blood vessel fragility as well as the higher prevalence of geriatric conditions such as frailty, multimorbidity, polypharmacy, fall risk, dementia, and malnutrition make older persons more vulnerable to disease- and anticoagulation-related complications. Moreover, because older patients with AF/VTE are underrepresented in oral anticoagulation (OAC) trials, evidence on OAC in older adults with AF/VTE is mainly based on subgroup analyses from clinical trials and observational studies. A growing body of such limited evidence suggests that direct oral anticoagulants (DOACs) may be superior in terms of efficacy and safety compared to vitamin K antagonists in older persons with AF/VTE and that specific DOACs may have a differing risk-benefit profile. In this narrative review, we summarize the evidence on epidemiology of AF/VTE, impact of age-related physiological changes, efficacy/safety of OAC, specifically considering individuals with common geriatric conditions, and review OAC guideline recommendations for older adults with AF/VTE. We also propose a research agenda to improve the evidence basis on OAC older individuals with AF/VTE, including the conduct of advanced age-specific and pragmatic studies using less restrictive eligibility criteria and patient-reported health outcomes, in order to compare the effectiveness and safety of different DOACs, and investigate lower-dose regimens and optimal OAC durations in older patients.


Subject(s)
Anticoagulants , Venous Thromboembolism , Humans , Anticoagulants/therapeutic use , Anticoagulants/adverse effects , Aged , Administration, Oral , Venous Thromboembolism/drug therapy , Venous Thromboembolism/prevention & control , Atrial Fibrillation/drug therapy , Aged, 80 and over , Male , Female
20.
Thromb Res ; 238: 52-59, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38669963

ABSTRACT

BACKGROUND: D-dimer testing may help deciding the duration of anticoagulation in subjects at high risk of venous thromboembolism (VTE) recurrence. Two management studies on this issue have been published (DULCIS in 2014 and APIDULCIS in 2022). They had similar designs but had important different results. Aim of this article is to compare their results. METHODS: Both studies were finalized to extend anticoagulation [with vitamin K anticoagulants (VKAs) in DULCIS or apixaban 2.5 mg BID (kindly provided by BMS-Pfizer Collaboration) in APIDULCIS] only in patients with positive D-dimer results. RESULTS: More D-dimer assays resulted positive in APIDULCIS than in DULCIS (61.1 % vs 47.7 %, respectively; p < 0.0001). While only 4 (0.5 %) refused low dose apixaban in APIDULCIS, the 22.6 % of patients with positive D-dimer refused to resume VKAs in DULCIS; their rates of recurrence were 187 and 8.8 per 100 person-years, respectively (incidence rate ratio [IRR]: 21.2). The incidence of bleeding was low in those receiving apixaban vs those who resumed VKAs (0.4 vs 2.3 per 100 person-years, respectively; IRR 0.17;). While the recurrence rate was low and similar in the studies in subjects who resumed anticoagulation, it was significantly higher in APIDULCIS than in DULCIS in those who stopped anticoagulation for negative D-dimer (5.6 vs 3.0 per 100 person-years, respectively; IRR 1.9). CONCLUSION: The low dose Apixaban for extended VTE treatment is effective and safe, and well accepted by patients. Why subjects who stopped anticoagulation for negative D-dimer had a higher recurrence rate in APIDULCIS than in DULCIS remains to be explained.


Subject(s)
Anticoagulants , Fibrin Fibrinogen Degradation Products , Recurrence , Venous Thromboembolism , Humans , Fibrin Fibrinogen Degradation Products/analysis , Venous Thromboembolism/drug therapy , Venous Thromboembolism/blood , Female , Male , Anticoagulants/therapeutic use , Middle Aged , Aged , Pyrazoles/therapeutic use , Pyridones/therapeutic use , Risk Factors , Vitamin K/antagonists & inhibitors
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