Treatment Of Venous Thromboembolism Research Articles

Efficacy and Safety of Direct Oral Anticoagulants for Acute Treatment of Venous Thromboembolism in Older Adults: A Network Meta-Analysis of Randomised Controlled Trials.

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. 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. 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. 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.

Enoxaparin treatment dosing for venous thromboembolism in pediatric patients with obesity.

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 0.5-1unit/mL in pediatric patients with obesity. 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 0.5-1unit/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. Pediatric patients with obesity (n=89) required a mean enoxaparin dose of 0.8±0.18mg/kg twice daily to attain a therapeutic anti-Xa level. Children with BMI 95th-99th percentile and weight ≤100kg 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±0.15mg/kg twice daily; p<.001) and weight greater than 100kg (0.95±0.14 vs. 0.7±0.12mg/kg twice daily; p<.001). BMI, BMI percentile, and weight showed a moderate to strong negative correlation with enoxaparin dose requirement. Pediatric patients with obesity required a lower weight-based dose of enoxaparin to achieve a therapeutic anti-Xa than the recommended starting dose of 1mg/kg twice daily for treatment of VTE. Among obesity indices, weight showed the strongest negative correlation with total daily enoxaparin requirement.

Construction of Training Curriculum System for Venous Thromboembolism (VTE) Liaison Nurses

Objective To construct a training curriculum system for venous thromboembolism (VTE) liaison nurses and provide a basis for corresponding clinical training, evaluation and certification. Methods Analyzed the training needs of VTE liaison nurses. Conducted two rounds of Delphi surveys with 27 experts from Hubei, Sichuan, Guizhou, Guangxi and Guangdong provinces in China. Determined the weights of indicators at all levels using the Analytic Hierarchy Process (AHP) and equal weighting method. Results The age of the participants ranged from 38~59 (46.63±5.343), and the years of working ranged from 12~42 (25.48±7.439). 27 and 26 valid questionnaires were collected respectively from the first and second rounds of the surveys. The effective response rates of the two-round Delphi survey were 90.0% and 96.3%, respectively, and the experts’ authoritative coefficients were 0.884 and 0.906, respectively, and Kendall’s coefficient of concordance of experts’ opinions were 0.261 and 0.276, respectively (P &amp;lt;0.01). A training system with 5 first-level indicators and 26 second-level indicators was finally formed after two rounds of Delphi surveys. Conclusions The training system for VTE liaison nurses constructed in this study is highly scientific and practical, which can provide a basis for the training assessment and ability evaluation of VTE liaison nurses, and also provide a reference for VTE prophylaxis, treatment and nursing.

Safety and Outcomes of Inferior Vena Cava Filter Placement in Oncology Patients: A Single-Centre Experience.

The risk of venous thromboembolism (VTE) in the oncology population is significantly higher than in non-cancer patients. Inferior vena cava (IVC) filters may, therefore, be an important part of VTE treatment. In this study, we address the outcomes of placing IVC filters in the oncology population. This single-centre, observational, retrospective study included 62 patients with active malignancy and acute VTE who underwent an IVC filter implantation due to contraindications to anticoagulation during the period 2012-2023. The control group consisted of 117 trauma patients. In both groups, an urgent surgical procedure requiring temporary cessation of anticoagulation was the most noted reason for IVC filter placement-76% in the oncology group vs. 100% in the non-oncology group (p < 0.001). No complications were reported during the IVC filter implantation procedures. There was no recurrence of pulmonary embolism or deep venous thrombosis in the oncology group after filter implantation. The rate of successful filter explantation, median time to retrieval, and abnormal findings during retrieval were not significantly different between both subgroups (64.3% vs. 76.5%, p = 0.334; 77 days vs. 84 days, p = 0.764; 61.5% vs. 54.2%, p = 0.672; respectively). The study showed that IVC filter placement is a safe and effective method of preventing PE in cancer patients with contraindications to anticoagulation. The complication rate following IVC filter implantation in cancer patients is low and similar to that in non-oncology patients.

D-dimer and risk of venous thromboembolism recurrence: Comparison of two studies with similar designs but different laboratory and clinical results

BackgroundD-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. MethodsBoth 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. ResultsMore 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). ConclusionThe 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.

The Role of Direct Oral Anticoagulants in the Treatment of Cancer-Associated Venous Thromboembolism: Review by Middle East and North African Experts.

Venous thromboembolism is a leading cause of morbidity and mortality in patients with active cancer who require anticoagulation treatment. Choice of anticoagulant is based on careful balancing of the risks and benefits of available classes of treatment: vitamin K antagonists, low-molecular-weight heparin (LMWH), and direct oral anticoagulants (DOACs). Results from randomized controlled trials have shown the consistent efficacy of DOACs versus LMWH in the treatment of cancer-associated venous thromboembolism (VTE). However, increased major gastrointestinal bleeding was observed for edoxaban and rivaroxaban, but not apixaban, compared with LMWH dalteparin. Most guidelines recommend DOACs for the treatment of cancer-associated VTE in patients without gastrointestinal or genitourinary cancer, and with considerations for renal impairment and drug-drug interactions. These updates represent a major paradigm shift for clinicians in the Middle East and North Africa. The decision to prescribe a DOAC for a patient with cancer is not always straightforward, particularly in challenging subgroups of patients with an increased risk of bleeding. In patients with gastrointestinal malignancies who are at high risk of major gastrointestinal bleeds, apixaban may be the preferred DOAC; however, caution should be exercised if patients have upper or unresected lower gastrointestinal tumors. In patients with gastrointestinal malignancies and upper or unresected lower gastrointestinal tumors, LMWH may be preferred. Vitamin K antagonists should be used only when DOACs and LMWH are unavailable or unsuitable. In this review, we discuss the overall evidence for DOACs in the treatment of cancer-associated VTE and provide treatment suggestions for challenging subgroups of patients with cancer associated VTE.

Current Topics from the Revised German S2k Guideline on Diagnosis and Treatment of Venous Thromboembolism.

It is an honor and a great pleasure for us to be guest editors for this special issue of Hämostaseologie - Progress in Haemostasis, which addresses important issues surrounding the complex of venous thromboembolism (VTE). In February 2023, the revised guideline on "Diagnostics and Therapy of Venous Thrombosis and Pulmonary Embolism" has been published on the website of the Association of the Scientific Medical Societies in Germany (AWMF)1. This guideline was drawn up under the leadership of the German Society of Angiology (DGA), and representatives of 17 scientific societies contributed to its content. As an S2k guideline, its recommendations are consensus based and are the result of a systematic review and evaluation of current evidence and consideration of the benefits and harms of diagnostic and therapeutic options. In this special issue, guideline authors provide a comprehensive overview of selected guideline topics which might be of clinical relevance to our readers and our community of haemostaseologists.

Trends In Percutaneous Device Use For The Treatment Of Venous Thromboembolism Over Time In The PINC AI Healthcare Database And The National Inpatient Sample

The number of different methodologies of reperfusion therapy to treat venous thromboembolism (VTE) has increased substantially. Nevertheless, investigation of data representativeness and device-level usage in administrative databases has been limited. Using the National Inpatient Sample (NIS) and the PINC AI Healthcare Database (PHD), all hospital encounters with a diagnosis code of VTE were identified between 1/1/2016 and 12/31/2020. Patient demographics and trends in treatment modalities were evaluated over time. An algorithm was developed to identify specific devices used for VTE treatment in the PHD cohort. 145,870 VTE patients treated with reperfusion therapy were identified in the NIS (Pulmonary embolism (PE): 88,725; isolated DVT (iDVT): 57,145) and 39,311 in the PHD (PE: 25,383; iDVT: 13,928). Patient demographics were qualitatively similar in the NIS and PHD. Over time, there was a significant increase in the use of mechanical thrombectomy (MT) in the PE and iDVT populations (p<0.05 in both databases) with catheter directed thrombolysis (CDT) use plateauing in PE (p=0.83 and p=0.14 in NIS and PHD respectively) and significantly decreasing for the iDVT population (p<0.05 in both databases). In the PHD cohort, specific reperfusion devices were identified in 14,105 patients (PE: 9,098; iDVT: 5,007). In conclusion, the use of MT for the treatment of VTE has increased over time, while rates of CDT therapy have remained stagnant or decreased. Further research is needed to understand the uptake of these treatment modalities as well as the unique abilities of the PHD to study specific device therapy in the VTE population.

Management of DOAC-related bleeding in cancer patients: a single center-case series.

Venous thromboembolism (VTE) and stroke carry significant mortality and morbidity in cancer patients. Direct oral anticoagulants (DOACs) have been demonstrated to be effective for the treatment of VTE and prevention of stroke in atrial fibrillation (AF). Bleeding rates are variable and are based on the cancer type and the patient's specific risk factors. There are approved specific antidotes for DOAC-associated bleeding. Other strategies are available for bleeding reversal, including the use of prothrombin complex concentrate (PCC). No randomized studies have compared head-to-head the efficacy and safety of reversal agents. We aim to examine the safety and effectiveness of hemostatic agents in cancer patients with DOAC-related major bleeding. A retrospective chart review study of patients at MD Anderson Cancer Center with DOAC-related major bleeding between 2014 and 2019. Bleeding severity and clinical hemostasis were described based on ISTH guidelines and the Sarode criteria, respectively. The rates of thrombotic complications and mortality at 30-day from the index bleeding event were described. We identified 23 patients with DOAC-related major bleeding; 14 patients received PCC and 9 patients received andexanet alfa. The most common sites of bleeding were the gastrointestinal tract and intracranial. Effective hemostasis and 30-day mortality were similar to reported results from other reports of outcomes of reversal agents for DOAC related-bleeding in non-cancer patients. One patient in each treatment group experienced a thrombotic event. Further larger scale studies are needed to confirm our findings in cancer patients.

Drug-Drug Interactions of FXI Inhibitors: Clinical Relevance.

Inhibitors of the factor FXI represent a new class of anticoagulant agents that are facing clinical approval for the treatment of acute coronary syndrome (ACS), venous thromboembolism (VTE), and stroke prevention of atrial fibrillation (AF). These new inhibitors include chemical small molecules (asundexian and milvexian), monoclonal antibodies (abelacimab, osocimab, and xisomab), and antisense oligonucleotides (IONIS-FXIRX and fesomersen), and thus, they have very peculiar and different pharmacokinetic and pharmacodynamic properties. Besides their clinical efficacy and safety, based on their pharmacological heterogeneity, the use of these drugs in patients with comorbidities may undergo drug-drug interactions (DDIs) with other concomitant therapies. Although only little clinical evidence is available, it is possible to predict clinically relevant DDI by taking into consideration their pharmacokinetic properties, such as the CYP450-dependent metabolism, the interaction with drug transporters, and/or the route of elimination. These characteristics may be useful to differentiate their use with the direct oral anticoagulant (DOAC) anti -FXa (rivaroxaban, apixaban, edoxaban) and thrombin (dabigatran), whose pharmacokinetics are strongly dependent from P-gp inhibitors/inducers. In the present review, we summarize the current clinical evidence on DDIs of new anti FXI with CYP450/P-gp inhibitors and inducers and indicate potential differences with DOAC anti FXa.

Inferior Vena Cava Filters: A Clinical Review and Future Perspectives.

Anticoagulation represents the first line treatment for venous thromboembolism (VTE). However, inferior vena cava (IVC) filter insertion can be considered as a possible therapeutic strategy when anticoagulant therapy is contraindicated, to avoid embolization from the lower limbs to pulmonary circulation. Other possible indications are debated among experts. Both permanent and retrievable caval filters are available in clinical practice. Retrievable filters can be removed when no longer necessary, as their use may be indicated only for a limited amount of time. Moreover, caval filter insertion is not devoid of possible complications, particularly in cases of permanent or long-dwelling filters. A multidisciplinary approach is recommended to review the appropriateness of caval filter use and to define the best timing for retrieval.

European expert consensus recommendations on the primary care use of direct oral anticoagulants in patients with venous thromboembolism

BackgroundDirect oral anticoagulants for the treatment of venous thromboembolism are supported by robust clinical trial evidence. Despite published guidance, general practitioners are faced with increasingly complex decisions and implementation remains sub-optimal in certain real-world scenarios.MethodsA two stage formal consensus exercise was performed to formulate consensus statements and a summary guide, facilitating optimal management of direct oral anticoagulants in venous thromboembolism patients by generalist physicians across Europe. An online questionnaire distributed to a broad panel (Phase 1), followed by a virtual panel discussion by an expert group (Phase 2) were conducted. Phase 1 statements covered nine management domains, and were developed via a literature review and expert steering committee. Participants rated statements by their level of agreement. Phase 1 responses were collated and analysed prior to discussion and iterative refinement in Phase 2.ResultsIn total 56 participants from across Europe responded to Phase 1. The majority had experience working as general practitioners. Consensus indicated that direct oral anticoagulants are the treatment of choice for managing patients with venous thromboembolism, at initiation and for extended treatment, with a review at three to six months to re-assess treatment effect and risk profile. Direct oral anticoagulant choice should be based on individual patient factors and include shared treatment choice between clinicians and patients; the only sub-group of patients requiring specific guidance are those with cancer.ConclusionResults demonstrate an appreciation of best practices, but highlight challenges in clinical practice. The patient pathway and consensus recommendations provided, aim to highlight key considerations for general practice decision making, and aid optimal venous thromboembolism treatment.

Diagnosis and treatment of venous thromboembolism during pregnancy relate to genetic polymorphism.

Previous research had shown that age, a positive family history, comorbidities, major surgical operations, gestation, and use of several medications could increase the incidence of venous thromboembolism (VTE). With the development of medical and clinical individualized treatment, many people exposed to above risk factors did not develop VTE, suggested that genetic factors are also involved in the development of VTE. In this review, we aim to summarize VTE diagnosis and treatment in pregnancy women related to gene polymorphism. A comprehensive electronic search using PubMed, MEDLINE, EMBASE and Web of Science was conducted to find relevant journal articles with key search terms including: "pregnancy OR pregnant," "venous thromboembolism OR VTE," "deep vein thrombosis OR DVT," "pulmonary embolism OR PE," and "genetic OR gene." Prominent publications from establishment of database till present were analysed to achieve a deeper understanding of VTE during pregnancy relate to genetic polymorphism, and the information was then collated to form this review. The literature review revealed that inherited thrombophilia significantly associated with the development of VTE, especially the factor V Leiden (FVL) and prothrombin gene mutation (PGM). Furthermore, the role of methylenetetrahydrofolate reductase (MTHFR) gene mutation in the development of pregnancy-related VTE remains controversial, further study is required. In the present study, Marburg I polymorphism (G511E), c.1538G>A and c.1601G>A in Factor V (FV), JAK2V617F mutation were reported as an independent risk factor for VTE, there is no sufficient evidence to confirm the gene mutation is related to VTE during pregnancy, these factors appearing as another promising potential diagnostic marker of VTE during pregnancy. Besides, the dosages of heparin in the treatment of VTE during pregnancy need be adjusted according to gene polymorphism of these population, particularly FVL or PGM carriers, and this area is not studied deeply, it is worth further study. Inherited thrombophilia significantly associated with the development of VTE, especially the FVL and PGM, however the relation between MTHFR gene mutation and pregnancy-related VTE remains controversial, further study is needed. In addition, the dosages of heparin in the treatment of VTE during pregnancy suggested to adjusted based on gene polymorphism in FVL and PGM, and establish better prediction models is a direction of future research.

Direct Oral Anticoagulants for Pulmonary Embolism.

Venous thromboembolism (VTE) is the third most common cardiovascular disease. For most patients, the standard of treatment has long consisted on low-molecular-weight heparin followed by vitamin K antagonists, but a number of clinical trials and, subsequently, post-marketing studies have shown that direct oral anticoagulants (DOACs) with or without lead-in heparin therapy are effective alternatives with fewer adverse effects. This evidence has led to important changes in the guidelines on the treatment of VTE, including pulmonary embolism (PE), with the DOACs being now recommended as the first therapeutic choice. Additional research has contributed to identifying low-risk PE patients who can benefit from outpatient management or from early discharge from the emergency department with DOAC treatment. There is evidence to support the use of DOACs in intermediate-risk PE patients as well as in high-risk patients receiving thrombolytic treatment. The use of DOACs has also been proven to be safe and effective in special populations of PE patients, such as patients with renal impairment, liver impairment, and cancer.

Role of Vena Cava Filter in the Prophylaxis and Treatment of Venous Thromboembolism in Injured Adult Patients: A Systematic Review, Meta-Analysis, and Practice Management Guideline from the Eastern Association for the Surgery of Trauma.

Injured patients are at an increased risk of developing deep vein thrombosis (DVT) and pulmonary embolism (PE). Inferior vena cava (IVC) filters have been used in injured patients to prevent venous thromboembolism (VTE), but current evidence-based guidelines are lacking. Questions regarding IVC filter use in injured patients with clearly defined Population(s), Intervention(s), Comparison(s), and appropriately selected Outcomes (PICO) were formulated. The study sought to understand the evidence behind use of ultra short term IVC filters and use of IVC filters in injured patients with and without known VTE who are unable to receive therapeutic anticoagulation and chemoprophylaxis, respectively. A literature search and review was conducted, followed by meta-analysis. The quality of evidence was assessed per Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology. There were twenty-one studies that were analyzed. Three studies were randomized controlled trials (RCTs), three were observational studies, and fifteen studies were retrospective studies. In injured patients without known acute VTE who cannot receive chemoprophylaxis, we recommend against placement of an IVC filter due to associated higher rate of mortality, DVT, PE, and length of stay. The quality of evidence was assessed to be low. In injured patients with known DVT who cannot receive chemoprophylaxis we conditionally recommend against placement of an IVC filter. The quality of evidence was assessed to be very low. No recommendations can be made with respect to placement of ultra short term IVC filters based upon available data. IVC filters should not be placed routinely for prophylaxis in injured adult patients without known VTE who cannot receive chemoprophylaxis. The taskforce conditionally recommends against the placement of IVC filter in injured adult patients with known DVT who cannot receive chemoprophylaxis. Guideline; Systematic review/meta-analysis, level IV.

Safety profile of rivaroxaban in first-time users treated for venous thromboembolism in four European countries.

The European rivaroxaban post-authorization safety study evaluated bleeding risk among patients initiated on rivaroxaban or vitamin K antagonists for the treatment and secondary prevention of venous thromboembolism in routine clinical practice. Cohorts were created using electronic healthcare databases from the UK, the Netherlands, Germany and Sweden. Patients with a first prescription of rivaroxaban or vitamin K antagonist during the period from December 2011 (in the UK, January 2012) to December 2017 (in Germany, December 2016) for venous thromboembolism indication, with no record of atrial fibrillation or recent cancer history, were observed until the occurrence of each safety outcome (hospitalization for intracranial, gastrointestinal, urogenital or other bleeding), death or study end (December 2018; in Germany, December 2017). Crude incidence rates of each outcome per 100 person-years were computed. Overall, 44 737 rivaroxaban and 45 842 vitamin K antagonist patients were enrolled, mean age, 59.9-63.8 years. Incidence rates were similar between rivaroxaban and vitamin K antagonist users with some exceptions, including higher incidence rates for gastrointestinal bleeding in rivaroxaban users than in vitamin K antagonist users. Among rivaroxaban users, mortality and bleeding risk generally increased with age, renal impairment and diabetes. This study provides further data from routine clinical practice that broadly support safety profile of rivaroxaban for VTE indication and complement findings from previous randomized clinical trials.

The incidence of major bleeding in adult patients with urogenital and gynecological cancer being treated with direct oral anticoagulants (DOACs): a systematic review.

Direct oral anticoagulants (DOACs) are the mainstay of treatment for venous thromboembolism (VTE) and non-valvular atrial fibrillation (AF), with or without an underlying cancer. Patients with cancer have a 2-3-fold increase in risk for bleeding complications compared to non-cancer patients taking anticoagulant therapy, however the incidence of bleeding for urogenital and gynecological cancers on DOACs are uncertain. To assess the bleeding risk associated with the use of DOACs in patients with urogenital and/or gynecological cancers. We conducted a systematic review of randomized controlled trials (RCTs) and prospective cohort studies to address the safety of DOACs for VTE and AF when used in patients with urogenital and/or gynecological malignancy. The primary outcomes assessed were major and clinically relevant non-major (CRNMB) bleeding, with minor bleeding considered as a secondary outcome. MEDLINE, EMBASE and COCHRANE Central Registry of Controlled Trials were searched up to and including Oct 28, 2022. The study protocol was registered in PROSPERO (CRD42022370981). Studies were independently assessed for inclusion and data extracted in duplicate. Seven studies met our inclusion criteria (Fig.1): 2 RCTs and 5 prospective cohort studies. A total of 676 patients treated with DOACs were included, 628 (92.8%) had VTE and 48 (7.1%) had AF. In patients with VTE treated with DOACs, the pooled major bleeding rate was 2.1%, 95% confidence intervals (CI) 0.9-3.3% (Fig.2). Pooled estimates could not be determined for AF patients given small event and patient numbers. Major bleeding rates in urogenital and/or gynecological cancer patients treated with DOACs are similar to that of the general cancer population.

Factor Xa inhibitors versus warfarin in severely obese patients with venous thromboembolism or atrial fibrillation

Objectives: Clinical data for the safety and efficacy of Factor Xa (FXa) inhibitors in severely obese patients is limited. Additional information is needed to assess the risks and benefits of using FXa inhibitors in this patient population. Materials and Methods: A single-center and retrospective chart review was conducted in severely obese patients (body mass index [BMI] &gt;40 kg/m2 or weight &gt;120 kg), who received rivaroxaban, apixaban or warfarin for venous thromboembolism (VTE) treatment or prevention of stroke and systemic embolism in non-valvular atrial fibrillation (AF). The primary endpoint was treatment failure, defined as recurrent VTE in VTE treatment or stroke, transient ischemic attack or systemic embolism in AF within one year of anticoagulation initiation. Secondary endpoints included a composite of major bleeding rates and clinically relevant non-major bleeding (CRNMB) rates. Results: Seventy-three patients were included in the final analysis consisting of 43 patients in the FXa inhibitor arm (apixaban [n = 33] and rivaroxaban [n = 10]) and 30 patients in the warfarin arm. The rate of treatment failure was similar between the FXa inhibitor and warfarin groups (4.7% vs. 6.7%; P = 0.814). Although not statistically significant, major bleeding and CRNMB occurred less frequently in patients receiving FXa inhibitors compared to warfarin (9.3% vs. 23.3%; P = 0.182). Subgroup analysis in patients with BMI &gt;50 kg/m2 or weight &gt;150 kg demonstrated similar efficacy and safety outcomes. The use of non-recommended dosing was more common in the apixaban group compared to the rivaroxaban group. Conclusion: FXa inhibitors (apixaban and rivaroxaban) appear to have similar efficacy and safety compared to warfarin in severely obese patients. Larger prospective studies are needed to confirm these results.

Venous thromboembolism treatment in patients with cancer: reflections on an evolving landscape

Cancer is a leading cause of morbidity and mortality worldwide. It is also one of the strongest risk factors for venous thromboembolism (VTE), reported in approximately 20% of all cases of VTE diagnosed. The thrombotic effect of cancer and its treatments, however, is highly variable among patients and changes over the course of their cancer. Anticoagulant therapy remains the cornerstone of VTE treatment, but it is associated with a substantial rate of VTE recurrence and the potential for serious bleeding. The risk of bleeding in patients with cancer is also dependent on the cancer type and its treatments, often revealing underlying tumor invasion of mucosal or parenchymal tissues, and treatment complications such as thrombocytopenia or coagulopathy. Over the past few decades, efforts to improve the efficacy and safety of anticoagulant therapy for the treatment and prevention of cancer-associated thromboembolism have resulted in changes in the standard of practice. This evolution has been made possible largely through the development of new anticoagulants. This review will reflect on the major advances in the treatment of cancer-associated thrombosis and offer insights on how to address unmet needs in this field.

Secondary Prophylaxis of Venous Thromboembolism (VTE) with Low Dose Apixaban or Rivaroxaban: Results from a Patient Population with More than 2 Years of Median Follow-up.

Direct oral anticoagulants (DOACs) are widely used for the treatment and secondary prophylaxis of venous thromboembolism (VTE). Nowadays, DOACs represent the gold standard for long-term anticoagulation, with low-intensity DOACs administration becoming increasingly used worldwide in such scenario. Albeit low-intensity apixaban and rivaroxaban are approved for clinical usage as secondary VTE prophylaxis, there are few literature data regarding their efficacy and safety with a long follow-up. The aim of our study was to evaluate the efficacy and safety of low-dose DOACs for VTE secondary prophylaxis in patients at high risk of VTE recurrence. We retrospectively evaluated patients who required long-term anticoagulant secondary prophylaxis to prevent recurrent VTE, treated with apixaban 2.5 mg BID or rivaroxaban 10 mg daily with a follow-up ≥ 12 months. The examined patients were 323. The median low-dose DOAC administration time was 25.40 months (IQR 13.93-45.90). Twelve (3.7%) VTE recurrences were observed; 21 bleeding events were registered (6.5%), including one episode of Major bleeding (MB) (0.3%), 8 Clinically relevant nonmajor bleeding (CRNMB) (2.5%) and 12 minor bleeding (3.7%). No statistically significant difference in the rate of VTE recurrence and/or bleeding events emerged between the rivaroxaban and apixaban groups. Patients included in the study for multiple episodes of VTE presented a significantly higher risk of a new VTE recurrence during low-intensity DOAC. Our data suggest that low-dose DOACs may be effective and safe in secondary VTE prophylaxis in patients at high risk of VTE recurrence; however, attention might be needed in their choice in such a scenario for patients who experienced multiple episodes of VTE.