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1.
J Med Case Rep ; 18(1): 243, 2024 May 11.
Article En | MEDLINE | ID: mdl-38730499

BACKGROUND: An ascending aortic thrombus is exceedingly rare. Two instances have been reported in the setting of lung cancer, but only after cisplatin use, which is associated with hypercoagulability. We present the first case of a patient with lung cancer who developed an ascending aortic thrombus without structural risk factors or chemotherapy use. CASE: A 60-year-old white female with significant smoking history presented with several weeks of malaise. A chest computed tomography scan revealed a 2.2-cm right upper lobe mass. As an outpatient, right hilar lymph node immunohistochemistry (IHC) samples via endobronchial ultrasound confirmed thyroid transcription factor-1 adenocarcinoma. After the procedure, the patient endorsed dyspnea and was advised to go to the emergency department. A chest computed tomography angiography identified a new 2.4 × 1.1 × 1.1 cm thrombus within the proximal aortic arch. No pulmonary emboli or intrapulmonary shunts were identified. A hypercoagulable workup was negative. Transthoracic echocardiogram was without left ventricular thrombus, akinesis or hypokinesis, left atrial dilation, or intracardiac shunts. A lower extremity ultrasound was negative for deep vein thrombosis. Given the procedural risk, thrombectomy was deferred. The patient was transitioned to enoxaparin, and a repeat computed tomography for resolution is in process. CONCLUSION: To our knowledge, this is the only case detailing an in situ ascending aortic thrombus in the setting of lung cancer, without structural risk factors, chemotherapy use, or other hypercoagulable comorbidities. Optimal management for an aortic thrombus and malignant disease is less clear. Clinicians should be vigilant for unusual arterial thromboses in patients with high metastatic burden.


Adenocarcinoma of Lung , Cisplatin , Lung Neoplasms , Thrombosis , Humans , Female , Middle Aged , Lung Neoplasms/drug therapy , Lung Neoplasms/pathology , Cisplatin/therapeutic use , Thrombosis/diagnostic imaging , Adenocarcinoma of Lung/drug therapy , Adenocarcinoma of Lung/secondary , Adenocarcinoma of Lung/complications , Aortic Diseases/diagnostic imaging , Anticoagulants/therapeutic use , Adenocarcinoma/drug therapy , Adenocarcinoma/complications , Enoxaparin/therapeutic use , Antineoplastic Agents/therapeutic use , Antineoplastic Agents/adverse effects , Computed Tomography Angiography , Aorta/diagnostic imaging , Aorta/pathology
2.
Pharmacoepidemiol Drug Saf ; 33(5): e5795, 2024 May.
Article En | MEDLINE | ID: mdl-38680090

PURPOSE: Guidelines recommend low-molecular-weight heparins (LMWHs) for patients with cancer-associated thrombosis. However, until recently, only dalteparin and tinzaparin were approved in the European Economic Area (EEA) for these patients. This study compares the benefit-risk profile of enoxaparin with dalteparin and tinzaparin for the extended treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrence in adult patients with active cancer. METHODS: A semi-quantitative structured benefit-risk assessment was conducted for the label-extension application of enoxaparin based on the benefit-risk action team descriptive framework: define decision context; determine key benefit and risk outcomes; identify data sources; extract data; interpret results. RESULTS: The key benefits were defined as reduced all-cause mortality and venous thromboembolism (VTE) recurrence (including symptomatic DVT, fatal PE or non-fatal PE); the key risks were major and non-major bleeding of clinical significance, and heparin-induced thrombocytopenia (HIT). Enoxaparin demonstrated comparable effects for the reduction of VTE recurrence and all-cause mortality versus other EEA-approved LMWHs (dalteparin, tinzaparin). There was no evidence of a significant difference between enoxaparin and the comparator groups with regard to incidence of major and non-major bleeding. The data on HIT were too limited to assess the difference between the two groups. CONCLUSIONS: The assessment demonstrated a favourable benefit-risk profile for enoxaparin similar to that of other EEA-approved LMWHs for the treatment of DVT and PE and the prevention of recurrence in patients with active cancer and thus supported the label-extension approval.


Dalteparin , Enoxaparin , Heparin, Low-Molecular-Weight , Neoplasms , Pulmonary Embolism , Tinzaparin , Venous Thrombosis , Humans , Enoxaparin/administration & dosage , Enoxaparin/adverse effects , Enoxaparin/therapeutic use , Pulmonary Embolism/prevention & control , Pulmonary Embolism/drug therapy , Venous Thrombosis/prevention & control , Venous Thrombosis/drug therapy , Risk Assessment , Neoplasms/drug therapy , Neoplasms/complications , Dalteparin/administration & dosage , Dalteparin/adverse effects , Dalteparin/therapeutic use , Tinzaparin/administration & dosage , Tinzaparin/therapeutic use , Heparin, Low-Molecular-Weight/administration & dosage , Heparin, Low-Molecular-Weight/adverse effects , Heparin, Low-Molecular-Weight/therapeutic use , Anticoagulants/administration & dosage , Anticoagulants/adverse effects , Anticoagulants/therapeutic use , Secondary Prevention/methods , Hemorrhage/chemically induced , Adult
3.
Pharmacotherapy ; 44(4): 343-347, 2024 Apr.
Article En | MEDLINE | ID: mdl-38634189

Warfarin is the only oral anticoagulant recommended in women who are breastfeeding. Although warfarin is a compatible and recommended agent in the postpartum period and during lactation, little is known regarding changes to warfarin dose requirements in this patient population. Here, we report the case of a 40-year-old woman who transitioned from enoxaparin monotherapy back to warfarin at 2 months postpartum, while she was breastfeeding. Despite resuming warfarin at her previously therapeutic dose, her international normalized ratio (INR) remained subtherapeutic and required multiple dose increases. She ultimately required a 100% increase in her warfarin dose postpartum, compared to pre-pregnancy, to achieve a therapeutic INR. This case suggests patients may require higher warfarin doses postpartum, compared to pre-pregnancy, especially if breastfeeding. Clinicians should closely monitor these patients and adjust warfarin doses as necessary.


Anticoagulants , Breast Feeding , International Normalized Ratio , Postpartum Period , Warfarin , Humans , Female , Adult , Warfarin/administration & dosage , Warfarin/adverse effects , Anticoagulants/administration & dosage , Anticoagulants/adverse effects , Dose-Response Relationship, Drug , Enoxaparin/administration & dosage , Enoxaparin/adverse effects , Enoxaparin/therapeutic use
4.
PLoS One ; 19(4): e0298152, 2024.
Article En | MEDLINE | ID: mdl-38626226

BACKGROUND: This study compares aspirin to enoxaparin for symptomatic VTE prophylaxis within 90 days of any type of hip or knee arthroplasty performed for any diagnosis, in patients enrolled in the CRISTAL trial. MATERIALS AND METHODS: CRISTAL was a cluster-randomised crossover, registry-nested non-inferiority trial across 31 hospitals in Australia. The primary publication was restricted to patients undergoing primary total hip or knee arthroplasty for a diagnosis of osteoarthritis. This report includes all enrolled patients undergoing hip or knee arthroplasty procedures (partial or total, primary or revision) performed for any indication. Hospitals were randomized to administer patients aspirin (100mg daily) or enoxaparin (40mg daily), for 35 days after hip arthroplasty and 14 days after knee arthroplasty. Crossover occurred after the patient enrolment target had been met for the first group. The primary outcome was symptomatic VTE within 90 days. Analyses were performed by randomization group. RESULTS: Between April 20, 2019 and December 18, 2020, 12384 patients were enrolled (7238 aspirin group and 5146 enoxaparin). Of these, 6901 (95.3%) given aspirin and 4827 (93.8%) given enoxaparin (total 11728, 94.7%) were included in the final analyses. Within 90 days, symptomatic VTE occurred in 226 (3.27%) aspirin patients and 85 (1.76%) enoxaparin patients, significant for the superiority of enoxaparin (estimated treatment difference 1.85%, 95% CI 0.59% to 3.10%, p = 0.004). Joint-related reoperation within 90 days was lower in the enoxaparin group (109/4827 (2.26%) vs 171/6896 (2.47%) with aspirin, estimated difference 0.77%; 95% CI 0.06% to 1.47%, p = 0.03). There were no significant differences in the other secondary outcomes. CONCLUSION: In patients undergoing hip or knee arthroplasty (of any type, performed for any indication) enrolled in the CRISTAL trial, aspirin compared to enoxaparin resulted in a significantly higher rate of symptomatic VTE and joint-related reoperation within 90 days. These findings extend the applicability of the CRISTAL trial results. TRIAL REGISTRATION: Anzctr.org.au, identifier: ACTRN12618001879257.


Arthroplasty, Replacement, Hip , Arthroplasty, Replacement, Knee , Arthroplasty, Replacement , Venous Thromboembolism , Humans , Enoxaparin/therapeutic use , Aspirin/therapeutic use , Venous Thromboembolism/etiology , Venous Thromboembolism/prevention & control , Venous Thromboembolism/drug therapy , Arthroplasty, Replacement, Knee/adverse effects , Arthroplasty, Replacement, Hip/adverse effects , Anticoagulants/therapeutic use
5.
J Vasc Nurs ; 42(1): 10-17, 2024 Mar.
Article En | MEDLINE | ID: mdl-38555173

Venous thromboembolism (VTE), including deep venous thrombosis (DVT) and pulmonary embolism (PE), has been an increasingly common post-surgical complication for surgical patients. In the United States, VTE has become a leading cause of preventable hospital death with more than half occurring after discharge and are directly linked to a recent (within 30 days) hospitalization or surgery [1]. In large, hospital-associated/acquired VTE (HA-VTE) are preventable through measures such as the use of risk stratification tools and chemoprophylaxis. The project institution, a community, academic, medical center, for multiple years has consistently remained a high outlier for postoperative VTE. Also, the choice of VTE chemoprophylaxis in surgical patients at the time of discharge depended on, and varied between, the individual prescribing physician. The goal was to implement and determine the efficacy of a standardized intervention tool, the Caprini risk assessment model (RAM), for reducing postoperative VTE complications and its influence on the physician's prescription of enoxaparin at discharge. Results: Risk assessment scoring pre-operatively increased from 0% baseline to 26.3% at Plan-Do-Study-Act (PDSA) cycle 1 and demonstrated a statistically significant change (p-value = 0.006). Risk assessment scoring pre-operatively was 42.9% by PDSA cycle 2 but was not statistically significantly different from PDSA cycle 1. Risk assessment scoring post-operatively (for eligible patients) remained the same throughout all three cycles at 0%. Appropriate prescription of anticoagulation declined from baseline (12.5%) to PDSA cycle 1 (0%), and improved at PDSA cycle 2 (33.3%), however no differences were significant (p-value 0.302). The National Surgical Quality Improvement Project (NSQIP) database showed a decline in VTE occurrences at the projects institution from baseline (1.02%, 6 occurrences, 2021) to PDSA cycle 2 (0.92%, 4 occurrences, 2022) when compared to the national benchmark (1.0%) for the first time since 2018. Given the significant national problem HA-VTE pose to the public, and the rise in occurrences, this quality improvement (QI) project is clinically relevant.


Enoxaparin , Venous Thromboembolism , Humans , Enoxaparin/therapeutic use , Venous Thromboembolism/prevention & control , Venous Thromboembolism/drug therapy , Venous Thromboembolism/etiology , Patient Discharge , Risk Assessment , Postoperative Complications/prevention & control , Postoperative Complications/etiology , Prescriptions , Risk Factors , Retrospective Studies , Anticoagulants/therapeutic use
6.
BMJ Case Rep ; 17(3)2024 Mar 15.
Article En | MEDLINE | ID: mdl-38490698

We describe a case of a term neonate with a swollen right arm and weakened pulses, diagnosed with arterial thromboembolism in the right axillary and brachial arteries. Treatment involved heparin, followed by enoxaparin, resulting in significant improvement. Maternal SARS-CoV-2 infection during pregnancy was considered as a potential factor, supported by the newborn's reactive COVID antibodies. The authors hypothesise a potential correlation between neonatal thrombosis and maternal SARS-CoV-2 infection during pregnancy. It is important to note that this association remains speculative and warrants further investigation for validation. The case underscores the importance of recognising and managing neonatal arterial thrombosis, especially in the context of maternal illness. We discuss the case in detail and review current knowledge on this condition.


COVID-19 , Pregnancy Complications, Infectious , Thrombosis , Pregnancy , Infant, Newborn , Female , Humans , COVID-19/complications , SARS-CoV-2 , Heparin/therapeutic use , Enoxaparin/therapeutic use , Thrombosis/drug therapy , Thrombosis/etiology
7.
Ann Afr Med ; 23(1): 46-52, 2024.
Article En | MEDLINE | ID: mdl-38358171

Introduction: Portomesenteric venous thrombosis (PMVT) may complicate sleeve gastrectomy. We believe that single dose of enoxaparin postoperatively can reduce the risk of PMVT. Objective: The objective was to study the outcomes of enoxaparin single dose compared to other perioperative prophylactic doses in preventing PMVT. Methods: Participants included 590 patients who underwent laparoscopic sleeve gastrectomy (LSG). These retrospective cohort data were collected from patient medical charts after bariatric surgery. Patients were followed up in the close postoperative period and at 1, 3, 6, 12, and 18 months. Descriptive statistical analysis was carried out. The objective was to estimate the incidence of PMVT with postoperative single 40 mg subcutaneous enoxaparin prophylactic regimen. Results: From January 2017 to December 2021, 590 patients with obesity underwent LSG. Five patients developed PMVT with an estimate incidence of 0.85%. Three patients had unexplained tachycardia and three patients had postoperative bleeding. Conclusions: Single-dose enoxaparin 40 mg is an effective thrombosis prophylaxis without increasing risk of bleeding.


Résumé Introduction: La thrombose veineuse portomésentérique (TVPM) peut compliquer la gastrectomie en manchon. Nous pensons qu'une dose unique d'énoxaparine en postopératoire peut réduire le risque de PMVT. Objectif: L'objectif était d'étudier les résultats de la dose unique d'énoxaparine par rapport à d'autres doses prophylactiques périopératoires dans la prévention de la PMVT. Méthodes: Les participants comprenaient 590 patients ayant subi une gastrectomie laparoscopique en manchon (LSG). Ces données de cohorte rétrospectives ont été collectées à partir des dossiers médicaux des patients après une chirurgie bariatrique. Les patients ont été suivis dans la période postopératoire étroite et à 1, 3, 6, 12 et 18 mois. Une analyse statistique descriptive a été réalisée. L'objectif était d'estimer l'incidence de la PMVT avec un régime prophylactique postopératoire unique d'énoxaparine sous-cutanée de 40 mg. Résultats: De janvier 2017 à décembre 2021, 590 patients obèses ont subi une LSG. Cinq patients ont développé une PMVT avec une incidence estimée à 0,85 %. Trois patients présentaient une tachycardie inexpliquée et trois patients présentaient des hémorragies postopératoires. Conclusions: Une dose unique d'énoxaparine de 40 mg est une prophylaxie efficace contre la thrombose sans augmenter le risque de saignement. Mots-clés: Énoxaparine, gastrectomie laparoscopique en manchon, thrombose veineuse portomésentérique prophylaxie, thromboembolie veineuse.


Laparoscopy , Obesity, Morbid , Venous Thrombosis , Humans , Enoxaparin/therapeutic use , Retrospective Studies , Obesity, Morbid/surgery , Laparoscopy/adverse effects , Portal Vein , Mesenteric Veins , Anticoagulants/therapeutic use , Venous Thrombosis/etiology , Venous Thrombosis/prevention & control , Gastrectomy/adverse effects , Postoperative Complications/prevention & control , Postoperative Complications/drug therapy
9.
J Thromb Thrombolysis ; 57(4): 658-667, 2024 Apr.
Article En | MEDLINE | ID: mdl-38393675

DOACs have emerged as first-line treatment in most cancer-associated thrombosis (CAT), representing a paradigm shift in its management. However, CAT management remains challenging and requires careful risk-benefit considerations. A retrospective analysis of CAT presentations to a tertiary referral centre from January 2011 to December 2020. Outcomes in CAT patients were compared to VTE patients without malignancy. Subgroup analysis was also conducted for CAT according to anticoagulation type. 514 CAT cases from 491 patients were identified from 3230 total VTE cases. CAT patients had higher rates of major VTE (PE and/or proximal DVT) compared to patients without malignancy (78.4% vs. 66.8%, p < 0.001). CAT patients also had higher rates of VTE recurrence (HR 1.66, 95%CI 1.23-2.26), major bleeding (HR 3.41, 95%CI 2.36-4.93), VTE-related mortality (HR 2.59, 95%CI 1.46-4.62) and bleeding-related mortality (HR 2.66, 95%CI 1.05-6.73). There were no significant differences in rates of VTE recurrence, major bleeding, VTE-related mortality or fatal bleeding between CAT patients treated with DOACs, enoxaparin or warfarin. In the subgroup of CAT treated with DOACs, there was no significant difference in rates of GI bleeding compared to the enoxaparin subgroup (HR 0.17, 95%CI 0.02-1.26). CAT was associated with a larger clot burden and higher rates of VTE recurrence, major bleeding and mortality compared to VTE patients without malignancy in this large real-world study. This study demonstrated no significant differences in complication rates for CAT patients treated with DOACs over enoxaparin, suggesting that DOACs can be safely used in most cases of CAT.


Neoplasms , Thrombosis , Venous Thromboembolism , Humans , Anticoagulants/therapeutic use , Venous Thromboembolism/drug therapy , Enoxaparin/therapeutic use , Retrospective Studies , Hemorrhage/chemically induced , Thrombosis/drug therapy , Treatment Outcome , Neoplasms/complications , Administration, Oral
10.
Blood Coagul Fibrinolysis ; 35(3): 101-107, 2024 Apr 01.
Article En | MEDLINE | ID: mdl-38358899

Venous thromboembolism (VTE) is a preventable cause of significant morbidity and mortality in hospitalized patients world-wide. In Australia, the low-molecular weight heparins (LMWHs) enoxaparin or dalteparin are usually used as first-line prophylaxis for VTE, though there is uncertainty whether dalteparin has the same effectiveness as enoxaparin in real-world settings. This is relevant because dalteparin is less renally cleared and may be more cost effective than enoxaparin. The aim of this study was to explore VTE event incidence in a general cohort of hospitalized adult inpatients who were prescribed enoxaparin or dalteparin for VTE prophylaxis. A retrospective observational study was conducted at a quaternary hospital in Brisbane, Australia, of patients who had experienced a hospital-acquired VTE from 1 September 2021 to 1 March 2023. Patients were identified from routinely collected data following an in-hospital VTE event, and further data was retrieved retrospectively from the integrated electronic Medical Record (ieMR). Incidence and type of VTE events, LMWH-prescribing patterns, and risk factors were assessed. The incidence of VTE events were similar across the dalteparin and enoxaparin cohorts (42.1 events/10 000 patients vs. 34.4 events/10 000 patients, respectively), although patients prescribed enoxaparin had a higher number of risk factors, particularly obesity and active cancer. Our research indicates comparable incidence of VTE in patients prescribed dalteparin compared with enoxaparin in an Australian hospital general cohort of adult inpatients. Dalteparin may be as effective as enoxaparin for VTE prophylaxis in a real-world cohort of patients, and as such dalteparin may be considered a suitable alternative to enoxaparin for VTE prophylaxis. Further research including large randomized controlled trials are required to confirm these results.


Dalteparin , Venous Thromboembolism , Adult , Humans , Dalteparin/therapeutic use , Enoxaparin/therapeutic use , Venous Thromboembolism/etiology , Venous Thromboembolism/prevention & control , Venous Thromboembolism/drug therapy , Heparin, Low-Molecular-Weight/therapeutic use , Retrospective Studies , Australia , Anticoagulants/therapeutic use
11.
Medicina (Kaunas) ; 60(1)2024 Jan 15.
Article En | MEDLINE | ID: mdl-38256416

Low-molecular-weight heparins are a class of drugs derived from the enzymatic depolymerization of unfractionated heparin that includes enoxaparin. Several studies have been performed on enoxaparin in recent years, in particular for the prevention and treatment of venous thromboembolism and for the treatment of acute coronary syndrome. Furthermore, the use of enoxaparin has been extended to other clinical situations that require antithrombotic pharmacological prevention, such as hemodialysis and recurrent abortion. In this review, we report the main clinical experiences of using enoxaparin in the prevention of VTE in nonsurgical patients.


Acute Coronary Syndrome , Enoxaparin , Female , Pregnancy , Humans , Enoxaparin/pharmacology , Enoxaparin/therapeutic use , Heparin , Heparin, Low-Molecular-Weight , Patients
12.
BMC Pharmacol Toxicol ; 25(1): 8, 2024 01 10.
Article En | MEDLINE | ID: mdl-38200581

BACKGROUND: We aimed to examine the efficiency of fixed daily dose enoxaparin (40 mg) thromboprophylaxis strategy for patients undergoing inpatient rehabilitation. METHODS: This was an observational, prospective, cohort study that included 63 hospitalized patients undergoing rehabilitative treatment following sub-acute ischemic stroke (SAIS) or spinal cord injury (SCI), with an indication for thromboprophylaxis. Anti-Xa level measured three hours post-drug administration (following three consecutive days of enoxaparin treatment or more) was utilised to assess in vivo enoxaparin activity. An anti-Xa level between 0.2-0.5 U/ml was considered evidence of effective antithrombotic activity. RESULTS: We found sub-prophylactic levels of anti-Xa (<0.2 U/ml) in 19% (12/63). Results were within the recommended prophylactic range (0.2-0.5 U/ml) in 73% (46/63) and were supra-prophylactic (>0.5 U/ml) in 7.9% (5/63) of patients. Anti-Xa levels were found to inversely correlate with patients' weight and renal function as defined by creatinine clearance (CrCl) (p<0.05). CONCLUSIONS: Our study confirmed that a one-size-fits-all approach for venous thromboembolism (VTE) prophylaxis may be inadequate for rehabilitation patient populations. The efficacy of fixed-dose enoxaparin prophylaxis is limited and may be influenced by renal function and weight. This study suggests that anti-Xa studies and prophylactic enoxaparin dose adjustments should be considered in certain patients, such as those who are underweight, overweight and or have suboptimal renal function. TRIAL REGISTRATION: No. NCT103593291, registered August 2018.


Ischemic Stroke , Venous Thromboembolism , Humans , Inpatients , Enoxaparin/therapeutic use , Anticoagulants/therapeutic use , Venous Thromboembolism/drug therapy , Venous Thromboembolism/prevention & control , Cohort Studies , Prospective Studies
13.
J Orthop Traumatol ; 25(1): 1, 2024 Jan 09.
Article En | MEDLINE | ID: mdl-38194191

BACKGROUND: Several clinical investigations have compared different pharmacologic agents for the prophylaxis of venous thromboembolism (VTE). However, no consensus has been reached. The present investigation compared enoxaparin, fondaparinux, aspirin and non-vitamin K antagonist oral anticoagulants (NOACs) commonly used as prophylaxis following total hip arthroplasty (THA). A Bayesian network meta-analysis was performed, setting as outcomes of interest the rate of deep venous thrombosis (DVT), pulmonary embolism (PE) and major and minor haemorrhages. METHODS: This study was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) extension statement for reporting systematic reviews incorporating network meta-analyses of healthcare interventions. All randomised controlled trials (RCTs) comparing two or more drugs used for the prophylaxis of VTE following THA were accessed. PubMed, Web of Science and Google Scholar databases were accessed in March 2023 with no time constraint. RESULTS: Data from 31,705 patients were extracted. Of these, 62% (19,824) were women, with age, sex ratio, and body mass index (BMI) being comparable at baseline. Apixaban 5 mg, fondaparinux, and rivaroxaban 60 mg were the most effective in reducing the rate of DVT. Dabigatran 220 mg, apixaban 5 mg, and aspirin 100 mg were the most effective in reducing the rate of PE. Apixaban 5 mg, ximelagatran 2 mg and aspirin 100 mg were associated with the lowest rate of major haemorrhages, while rivaroxaban 2.5 mg, apixaban 5 mg and enoxaparin 40 mg were associated with the lowest rate of minor haemorrhages. CONCLUSION: Administration of apixaban 5 mg demonstrated the best balance between VTE prevention and haemorrhage control following THA. Level of evidence Level I, network meta-analysis of RCTs.


Arthroplasty, Replacement, Hip , Venous Thromboembolism , Female , Humans , Male , Arthroplasty, Replacement, Hip/adverse effects , Aspirin/therapeutic use , Enoxaparin/therapeutic use , Fibrinolytic Agents/therapeutic use , Fondaparinux/therapeutic use , Hemorrhage/chemically induced , Network Meta-Analysis , Rivaroxaban/therapeutic use , Venous Thromboembolism/etiology , Venous Thromboembolism/prevention & control
14.
J Thromb Thrombolysis ; 57(3): 418-427, 2024 Mar.
Article En | MEDLINE | ID: mdl-38281232

To evaluate the safety of direct oral anticoagulants (DOACs) versus low-molecular weight heparin (LMWH) in patients with central nervous system (CNS) malignancies and secondary metastases. All adult patients with CNS malignancies and secondary metastases who were treated with a DOAC or LMWH for any indication from 2018 to 2022 were included. The primary outcome was the incidence of any intracranial hemorrhage (ICH) after anticoagulation initiation. Secondary outcomes included non-ICH bleeding events and thromboembolic events. Tolerability was assessed by any changes in anticoagulant therapy during study period. 153 patients were included; 48 patients received enoxaparin and 105 received DOACs, of which apixaban was used most commonly. The population was predominantly White (74%) and male (59%) with a median age of 65. Data was censored for immortal time bias for outcomes evaluated beyond 3 months. ICH occurred in 7.7% of the population, more frequently in the enoxaparin group (DOACs 4, 4% vs. enoxaparin 7, 16%, p = 0.037). Non-ICH bleeds were predominantly minor and more common in the DOAC group (DOACs 13, 13% vs. enoxaparin 1, 2%, p = 0.037). Thromboembolic events were not different between groups (DOACs 9. 9% vs, enoxaparin 2, 4%, p = 0.503). Anticoagulant switches occurred more in the enoxaparin group (DOACs 12, 12.4% vs. enoxaparin, 37.8%, p < 0.001), primarily due to patient or provider preference. Our data supports DOACs to be preferred over LMWH for the treatment of VTE or for stroke prevention with AF to prevent ICH in patients with brain tumors or metastases.


Brain Neoplasms , Thromboembolism , Venous Thromboembolism , Adult , Humans , Male , Anticoagulants/adverse effects , Heparin, Low-Molecular-Weight/therapeutic use , Enoxaparin/therapeutic use , Thromboembolism/prevention & control , Hemorrhage/chemically induced , Hemorrhage/drug therapy , Intracranial Hemorrhages/chemically induced , Intracranial Hemorrhages/complications , Brain Neoplasms/complications , Venous Thromboembolism/prevention & control , Administration, Oral
15.
Pharmacotherapy ; 44(3): 224-230, 2024 Mar.
Article En | MEDLINE | ID: mdl-38088033

STUDY OBJECTIVE: The objective of the study was to assess clinical outcomes (composite of any venous thromboembolism [VTE], any bleeding, and mortality) associated with anti-Xa monitoring in the 30 days following enoxaparin initiation for VTE prophylaxis. DESIGN: Retrospective cohort study. SETTING: Hospital within an academic healthcare system. PATIENTS: Propensity score-matched hospitalized adults receiving enoxaparin for VTE prophylaxis. INTERVENTION: Low-molecular-weight heparin anti-Xa monitoring. MEASUREMENTS AND MAIN RESULTS: During the 13-month study period, a total of 6611 patients received enoxaparin for VTE prophylaxis, 301 in the anti-Xa monitored group and 6310 in the unmonitored group (4.6% received monitoring). The mean age was 52.9 years and 52% of patients were male. The mean body mass index was 31 kg/m2 and the mean creatinine clearance was 109 mL/min. Twenty percent of patients had active cancer. The most common indication for enoxaparin prophylaxis was hospitalization for medical illness (52%) followed by nonorthopedic surgery (37%). The adjusted odds ratio for the primary outcome comparing monitored to unmonitored patients was 1.26 (95% confidence interval, 0.75-2.11). None of the between-group differences in the individual components of the composite outcome were statistically significant. CONCLUSIONS: Thirty-day clinical outcomes in patients receiving enoxaparin for VTE prophylaxis were not improved by anti-Xa monitoring. Our results support current evidence-based guideline recommendations against anti-Xa monitoring for patients receiving enoxaparin for VTE prophylaxis.


Enoxaparin , Venous Thromboembolism , Adult , Humans , Male , Middle Aged , Female , Enoxaparin/therapeutic use , Venous Thromboembolism/prevention & control , Venous Thromboembolism/drug therapy , Retrospective Studies , Anticoagulants/therapeutic use , Heparin, Low-Molecular-Weight
16.
Aust N Z J Obstet Gynaecol ; 64(1): 36-41, 2024 Feb.
Article En | MEDLINE | ID: mdl-37434425

BACKGROUND: Current international guidelines recommend 28 days of enoxaparin as venous thromboembolism (VTE) prophylaxis after surgery for gynaecologic cancer. Direct oral anticoagulants (DOACs) have been investigated as an alternative to enoxaparin for post-operative VTE prophylaxis. High-quality evidence to demonstrate safety and efficacy is lacking. AIMS: We aim to investigate the current practice regarding VTE prophylaxis among gynaecological oncologists in Australia and New Zealand following laparotomy for gynaecological malignancy, in particular the use of DOACs for VTE prophylaxis. MATERIALS AND METHODS: Sixty-seven practising gynaecologic oncologists (GO) were identified through Royal Australia and New Zealand College of Obstetricians and Gynaecologists database and emailed online surveys that asked about VTE prophylaxis practice and views of DOACs in this setting. Data were then collected through Survey Monkey and evaluated. RESULTS: The majority (77.1%) routinely prescribed 28 days of enoxaparin following laparotomy for gynaecological malignancies. In clinical circumstance such as laparoscopy for gynaecological malignancies and surgery for vulva malignancies, there was variation in thromboprophylaxis practices. No GO reported routine use of DOACs in any clinical circumstance. There were 56% of GOs who used a DOAC in their practice at some point. Barriers to routine use of DOACs in current practice included insufficient evidence (68%), issue with cost (40.4%) and concerns about safety (29.7%). CONCLUSIONS: Enoxaparin prescribed for 28 days remains the current clinical practice in preventing VTE following laparotomy for gynaecological malignancy. The main barrier to routine DOAC use as post-operative thromboprophylaxis is a lack of evidence which reflects the need for a larger prospective study.


Genital Neoplasms, Female , Venous Thromboembolism , Female , Humans , Anticoagulants , Venous Thromboembolism/prevention & control , Enoxaparin/therapeutic use , Genital Neoplasms, Female/drug therapy , New Zealand , Prospective Studies
17.
Thromb Haemost ; 124(4): 363-373, 2024 Apr.
Article En | MEDLINE | ID: mdl-37832588

BACKGROUND: The optimal therapy of venous thromboembolism (VTE) in cancer patients with renal insufficiency (RI) is unknown. Current guidelines recommend to use low-molecular-weight heparin over direct oral anticoagulants to treat VTE in cancer patients at high risk of bleeding. METHODS: We used the Registro Informatizado Enfermedad Tromboemb00F3lica (RIETE) registry to compare the 6-month incidence rates of (1) VTE recurrences versus major bleeding and (2) fatal pulmonary embolism (PE) versus fatal bleeding in three subgroups (those with mild, moderate, or severe RI) of cancer patients receiving enoxaparin monotherapy. RESULTS: From January 2009 through June 2022, 2,844 patients with RI received enoxaparin for ≥6 months: 1,432 (50%) had mild RI, 1,168 (41%) moderate RI, and 244 (8.6%) had severe RI. Overall, 68, 62, and 12%, respectively, received the recommended doses. Among patients with mild RI, the rates of VTE recurrences versus major bleeding (4.6 vs. 5.4%) and fatal PE versus fatal bleeding (1.3 vs. 1.2%) were similar. Among patients with moderate RI, VTE recurrences were half as common as major bleeding (3.1 vs. 6.3%), but fatal PE and fatal bleeding were close (1.8 vs. 1.2%). Among patients with severe RI, VTE recurrences were threefold less common than major bleeding (4.1 vs. 13%), but fatal PE was threefold more frequent than fatal bleeding (2.5 vs. 0.8%). During the first 10 days, fatal PE was fivefold more common than fatal bleeding (2.1 vs. 0.4%). CONCLUSION: Among cancer patients with severe RI, fatal PE was fivefold more common than fatal bleeding. The recommended doses of enoxaparin in these patients should be revisited.


Neoplasms , Pulmonary Embolism , Renal Insufficiency , Venous Thromboembolism , Humans , Venous Thromboembolism/drug therapy , Enoxaparin/therapeutic use , Neoplasms/drug therapy , Hemorrhage/drug therapy , Pulmonary Embolism/epidemiology , Registries , Anticoagulants/therapeutic use
19.
Transplant Proc ; 55(9): 2191-2196, 2023 Nov.
Article En | MEDLINE | ID: mdl-37802745

BACKGROUND: Thromboembolic complications are common post-lung transplant, leading to significant morbidity. We instituted multiple interventions because of an observed 36.8% incidence of venous thromboembolism (VTE) (Incidence rate (IR) 5.74/1000 pt days) in our recipients. METHODS: Our initiative commenced January 2015 with enoxaparin initiation within 6-8 hours of intensive care unit arrival and continuation for 4-6 weeks. We evaluated the IR of VTE in lung transplant recipients within 90 days of transplant. In 2017, the protocol was modified to extend the time to initiation of prophylaxis to within 72 hours of ICU arrival. In 2019, we further amended our intraoperative vascular access strategy. RESULTS: Eighteen of 26 lung transplant recipients (LTR) met inclusion criteria in the 2015 cohort. Six of 18 (33.3%) developed VTE, 50% of which were upper extremity (UE), line associated. Fifty two of 75 LTR were eligible for enoxaparin prophylaxis in the 2017 cohort. Fifteen of 52 subjects (28.8%) developed VTE, 77.8% of which were UE and line associated. Despite improved adherence in 2017, there was little change in VTE IR (3.90/1000 pt days compared with 3.85/1000 pt days). Twenty six of 43 LTR met protocol inclusion criteria in the 2019 cohort. Ten subjects (38.5%) developed VTE, 67% of which were UE and line associated (IR 5.18/1000 pt days). CONCLUSION: Our prospective study found that LTR remain at high risk for VTE despite aggressive prophylaxis with 4-6 weeks of enoxaparin and adjustment of vascular access approach. Alternative interventions should be investigated to minimize VTE development in this vulnerable population.


Lung Transplantation , Venous Thromboembolism , Humans , Venous Thromboembolism/diagnosis , Venous Thromboembolism/epidemiology , Venous Thromboembolism/etiology , Enoxaparin/therapeutic use , Incidence , Prospective Studies , Lung Transplantation/adverse effects , Anticoagulants/therapeutic use
20.
Int J Gynecol Cancer ; 33(12): 1875-1881, 2023 Dec 04.
Article En | MEDLINE | ID: mdl-37903564

OBJECTIVE: To determine our institutional rate of venous thromboembolism (VTE) following minimally invasive surgery for endometrial cancer and to perform a cost-effectiveness analysis of extended prophylactic anticoagulation after minimally invasive staging surgery for endometrial cancer. METHODS: All patients with newly diagnosed endometrial cancer who underwent minimally invasive staging surgery from January 1, 2017 to December 31, 2020 were identified retrospectively, and clinicopathologic and outcome data were obtained through chart review. Event probabilities and utility decrements were obtained through published clinical data and literature review. A decision model was created to compare 28 days of no post-operative pharmacologic prophylaxis, prophylactic enoxaparin, and prophylactic apixaban. Outcomes included no complications, deep vein thrombosis (DVT), pulmonary embolism, clinically relevant non-major bleeding, and major bleeding. We assumed a willingness-to-pay threshold of $100 000 per quality-adjusted life year (QALY) gained. RESULTS: Three of 844 patients (0.36%) had a VTE following minimally invasive staging surgery for endometrial cancer. In this model, no pharmacologic prophylaxis was less costly and more effective than prophylactic apixaban and prophylactic enoxaparin over all parameters examined. When all patients were assigned prophylaxis, prophylactic apixaban was both less costly and more effective than prophylactic enoxaparin. If the risk of DVT was ≥4.8%, prophylactic apixaban was favored over no pharmacologic prophylaxis. On Monte Carlo probabilistic sensitivity analysis for the base case scenario, no pharmacologic prophylaxis was favored in 41.1% of iterations at a willingness-to-pay threshold of $100 000 per QALY. CONCLUSIONS: In this cost-effectiveness model, no extended pharmacologic anticoagulation was superior to extended prophylactic enoxaparin and apixaban in clinically early-stage endometrial cancer patients undergoing minimally invasive surgery. This model supports use of prophylactic apixaban for 7 days post-operatively in select patients when the risk of DVT is 4.8% or higher.


Anticoagulants , Cost-Benefit Analysis , Endometrial Neoplasms , Hysterectomy , Venous Thromboembolism , Female , Humans , Anticoagulants/administration & dosage , Anticoagulants/economics , Anticoagulants/therapeutic use , Chemoprevention/economics , Chemoprevention/methods , Chemoprevention/statistics & numerical data , Cost-Effectiveness Analysis , Endometrial Neoplasms/pathology , Endometrial Neoplasms/surgery , Enoxaparin/administration & dosage , Enoxaparin/economics , Enoxaparin/therapeutic use , Hysterectomy/adverse effects , Hysterectomy/economics , Hysterectomy/methods , Hysterectomy/statistics & numerical data , Minimally Invasive Surgical Procedures/adverse effects , Minimally Invasive Surgical Procedures/economics , Minimally Invasive Surgical Procedures/methods , Minimally Invasive Surgical Procedures/statistics & numerical data , Neoplasm Staging , Retrospective Studies , Venous Thromboembolism/epidemiology , Venous Thromboembolism/etiology , Venous Thromboembolism/prevention & control
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