Venous Thromboembolic Events Research Articles

The impact of preoperative venous thromboembolism on patients undergoing TURBT: Perioperative outcomes and healthcare costs from US insurance claims data

AbstractObjectivesTo assess the impact of a positive history of venous thromboembolism (VTE) on perioperative outcomes, including length of in‐hospital stay, readmission rates, 90‐day postoperative complications, and healthcare costs in bladder cancer (BCa) patients undergoing transurethral resection of bladder tumour (TURBT) in the United States.Patients and MethodsPatients aged ≥18 years with a BCa diagnosis undergoing TURBT were identified in the Merative® Marketscan® Research de‐identified databases between 2007 and 2021. Multivariable logistic regression adjusted by relevant perioperative confounders was used to investigate the association between diagnosis of VTE before TURBT and 90‐day complication rates, new postoperative VTE events, re‐hospitalization, and total hospital expenditures (2021 US dollars). Sensitivity analyses on VTE severity (pulmonary embolism [PE], deep venous thrombosis [DVT] or superficial thrombophlebitis/phlebitis [SVT]), as well as TURBT extent (minor vs. major) were additionally examined.ResultsIn total, 139 800 patients were identified, with 5.3% having preoperative VTE, including DVT (n = 3112, 42.20%), PE (n = 2046, 27.74%) and SVT (n = 2217, 30.06%). A history of preoperative VTE predicted higher rates of any complication (adjusted odds ratio [aOR] 1.28, 95% CI 1.14–1.43) and also higher rates of infectious and haemorrhagic complications. Additionally, preoperative VTE increased the risk of novel VTE events following TURBT (aOR 17.30, 95% CI 16.05–18.65), hospital length of stay (aOR 2.23, 95% CI 1.90–2.62), readmissions (aOR 1.47, 95% CI 1.39–1.56), and hospital associated costs (aOR 1.17, 95% CI 1.12–1.23). DVT and non‐minor TURBT procedures did not increase the risk of any, infectious, or haemorrhagic complications, but other associations were maintained regardless of the severity of VTE (PE, DVT, SVT) or TURBT extent (minor/major).ConclusionsA history of VTE before undergoing transurethral procedures for BCa is associated with significantly worse perioperative outcomes and higher healthcare costs. These findings may help us to counsel on the risks of the intervention and hopefully improve our ability to mitigate such risks.

Comparative evaluation of venous thromboembolic risk in urologic inpatients using different risk assessment models

Introductions: The process of determining thromboprophylaxis decisions in urologic surgery entails assessing the risk of venous thromboembolism (VTE) in comparison to the risk of bleeding. Risk assessment models (RAMs) have been created to systematically calculate an individual’s risk of VTE. In our study, we evaluated the risk of VTE in urologic inpatients using two RAMs specifically designed for urology by the European Association of Urology (EAU) and the American Urological Association (AUA), the Caprini score, and the CHA2DS2-VASc score. Methods: The study group consisted of 236 inpatients within the urology department. Data from medical records included information on various factors, such as age, gender, body mass index, personal and family history of the patients. The risk of VTE was determined using the RAMs provided by EAU and AUA, the Caprini score, and the CHA2DS2-VASc score. Results: Chemical prophylaxis was advised for 48 (35.3%) patients according to the EAU model, 47 patients (34.6%) according to the AUA model, 128 (94.1%) patients based on the Caprini score, and 80 (58.8%) patients according to the CHA2DS2-VASc score. Limitations of the study include a small sample size and lack of post-surgery venous thromboembolic events recording. Conclusions: The VTE RAMs developed by the EAU and AUA provide consistent recommendations for thromboembolism prophylaxis in urologic patients, while the Caprini model's strict adherence may lead to excessive prophylaxis recommendations. The EAU approach is user-friendly but urologists must judiciously weigh bleeding and VTE risks on an individual basis, ensuring optimal prophylaxis use.

Guideline Concordant Extended Pharmacologic Venous Thromboembolism Prophylaxis Utilization After Colorectal Cancer Resection Is Low Regardless of Patient Factors or Hospital Characteristics.

Venous thromboembolism after colorectal cancer resection is common and highly morbid. Extended pharmacologic venous thromboembolism prophylaxis after cancer surgery lowers venous thromboembolism risk and is recommended by major professional societies. Adherence is low in contemporary local and regional studies. Assess patient and hospital factors associated with receipt of prophylaxis after colorectal cancer surgery in a national data set. Retrospective cohort study. Surveillance, epidemiology, and end results Medicare dataset. Patients over age 64 undergoing resection for colorectal cancer between 2016 and 2017. Primary outcome was receipt of prophylaxis within 7 days of discharge. Patient and hospital factors associated with receiving prophylaxis were identified using multivariable logistic regression. Secondary outcomes included 30- and 90-day venous thromboembolism. Of 23,527 patients, 4.7% received prophylaxis. Utilization increased from 2016 to 2017 (3.9% vs. 5.5%; p < 0.001). Patients treated at National Cancer Institute designated hospitals received prophylaxis more frequently than teaching, non-National Cancer Institute hospitals and non-teaching, non-National Cancer Institute hospitals (10.2% vs. 5.6% vs. 1.7%; p < 0.001). Patients receiving care at larger hospitals by bed size quartile were more likely to receive prophylaxis compared to those at smaller hospitals (9.0% vs. 4.0% vs. 3.4% vs. 2.2%; p < 0.01). On multivariable regression, National Cancer Institute status, larger bed size, White race (compared to other), rectal tumor location and more recent year of treatment were independently associated with prophylaxis utilization. Venous thromboembolism events at 30- and 90-days were 1.87% and 2.63%, respectively. Prophylaxis was associated with decreased 30-day venous thromboembolism (1.26% vs. 1.9%; p = 0.1211). Retrospective, large database study. Utilization of prophylaxis after colorectal cancer surgery remains limited even in large, specialized hospitals. Further work is needed to understand this departure from guideline concordant care. See Video Abstract.

C-reactive Protein, Genetic Susceptibility, and the Long-Term Risk of Venous Thromboembolism in Patients with Past Cancer.

Several studies have indicated that C-reactive protein (CRP) level is associated with the risk of venous thromboembolism (VTE) in the general population. However, CRP appears to be unrelated to VTE events in patients newly diagnosed with cancer. As the survival time of cancer patients increases, the effect of CRP on the long-term risk of VTE may change. We aimed to investigate the association between CRP and VTE in cancer survivors and further assess the modification effect of genetic susceptibility. The Cox proportional hazards model was used to evaluate the association between CRP levels and VTE risk as well as to investigate the joint effect of CRP and genetic susceptibility. The Kaplan-Meier curve and restricted cubic spline were used to visualize the relationship between CRP and VTE. This study included 27,806 participants with cancer diagnosis at baseline in the UK Biobank. Over a follow-up period of 344,636 person-years, a total of 1,151 VTE events were recorded. Participants were divided into four groups based on CRP level quartiles. The adjusted hazard ratios (95% CIs) of Q1, Q2, Q3, and Q4 were 1.00, 1.20 (0.99-1.44), 1.25 (1.04-1.50), and 1.51 (1.25-1.82), respectively. For those with high genetic risk of VTE, high CRP had an additional increased risk for VTE. CRP can be used as a predictive biomarker for VTE risk in cancer survivors, especially in those with high genetic risk. Future research can explore whether prevention and treatment strategies for VTE can be developed based on CRP for cancer survivors.

Can we predict the risk of venous thromboembolism in patients with Cushing's syndrome: a nationwide cohort analysis.

Patients with Cushing's syndrome (CS) have an increased venous thromboembolism (VTE) risk with most studies focusing on the perioperative period. The purpose of this study was to assess the 5-year VTE risk and identify predictors of VTE at CS diagnosis. A comparative nationwide retrospective cohort study of 609 patients (mean age 48.1 ± 17.2years, 65.0% women) with CS, and 3018 age-, sex-, body mass index-, and socioeconomic status-individually matched controls. Ectopic CS and adrenal cancer were excluded. The time-to-event of pulmonary embolism (PE) or deep vein thrombosis (DVT) within 5years of CS diagnosis was examined. VTE risk was calculated with death as competing event. VTE occurred in 16 cases (2.6%), compared to 17 (0.56%) controls (hazard ratio [HR] 4.71, 95% CI, 2.38-9.33). The 5-year HRs for PE and DVT were 7.47 (95% CI, 2.66-20.98) and 3.32 (95% CI, 1.36-8.12), respectively. After excluding patients and controls with current or prior malignancy the risk for VTE was 7.57 (95% CI, 2.98-19.20). Patients with CS ≥ 60years at diagnosis (HR, 3.49; 95% CI, 1.30-9.35), with hypertension (HR, 5.53; 95% CI, 1.26-24.27), ischemic heart disease (HR, 3.60; 95% CI, 1.25-10.36), kidney disease (HR, 4.85; 95% CI, 1.39-16.90), or VTE event prior to CS diagnosis (HR, 33.65; 95% CI, 10.07-112.42) had an increased risk of VTE within five years. In this large cohort of patients with CS, the 5-year VTE risk was 5 times higher compared with matched controls. Key baseline predictors included age ≥ 60, hypertension, heart/kidney disease, and prior VTE.

Thromboembolic events associated with combined oral contraceptives: a real-world study based on the FDA adverse event reporting system (FAERS) database

ABSTRACT Background The clinical characteristics and time-to-onset of thromboembolic events (TEEs) associated with combined oral contraceptives (COCs) remain unclear, our current study was committed to providing more data for risk evaluation and management of COCs treatment. Research design and methods This pharmacovigilance study was conducted in the FAERS database. We evaluated significant pharmacovigilance signals by using disproportionality analysis. The Weibull shape parameter test was used to analyze the time-to-onset of TEEs. Results A total of 25,080 adverse events were involved in this study. Overall COCs were significantly related to venous thromboembolism (VTE) events. Levonorgestrel, desogestrel, and drospirenone containing COCs were significantly associated with arterial thromboembolism (ATE) besides norethisterone containing COCs. Drospirenone containing COCs associated with TEEs had the highest reporting frequencies (n = 22868, 91.18%). The most-mentioned PT was pulmonary embolism (n = 9244, 36.86%). The median time-to-onset of all TEEs was 264 days, the median time-to-onset of VTE was 258.0 days, shorter than ATE (344.0 days). The Weibull shape parameter test results showed that all of the disproportionality signals had early failure-type features. Conclusions This study found an increased risk of TEEs treated with COCs, particularly with drospirenone. We should pay close attention to risk monitor on the treatment of early stages.

Cancer-related thrombosis: impact of biological sex on the risk of rethrombosis and bleeding.

Patients with cancer present a higher risk of rethrombosis and bleeding secondary to anticoagulant treatment than individuals without cancer. Given the lack of specific clinical trials, the decision regarding the optimal duration of treatment must consider multiple factors, including sex. The current study used data from the international, prospective TESEO Registry that includes consecutive patients diagnosed with cancer-associated thrombosis (CAT). Between July 2018 and December 2022, 2,823 patients were included in the TESEO Registry, 1,351 (48%) of whom were female. The most common venous thromboembolic event (VTE) in both sexes was pulmonary embolism (PE), with an incidence of 58.0% among men and 54.3% in women (p=0.045). After a median follow-up of 6.9 months (IQR, 1.9-14.4), the rethrombosis rate at the end of follow up was 10.0% in males and 15.0% in females (p=0.14). The location of the primary tumor in the gastrointestinal tract was associated with a greater risk of rethrombosis, whereas sex had no significant impact. Men presented twice as many major bleeds. Additional risk factors for major bleeding included situations of risk due to tumor site or thrombocytopenia, as well as the presence of active tumor bleeding at the time of VTE diagnosis. Overall survival was higher among women. Given the higher incidence of major bleeding among men, sex should be deemed a relevant factor when deciding on the duration of anticoagulant treatment in cancer patients.

Air pollution is associated with increased risk of venous thromboembolism: the Multi-Ethnic Study of Atherosclerosis.

Air pollution exposure may induce procoagulant effects, and chronic exposure may be linked to greater risk of venous thromboembolism (VTE). We tested the hypothesis that air pollution is associated with increased VTE risk in the prospective Multi-Ethnic Study of Atherosclerosis (MESA), which has well-characterized air pollution measures and information on potential confounding factors. We included 6,651 participants recruited in 2000-2002 (baseline age range: 45-84 yrs; 53% female). Air pollution was assessed with a validated spatio-temporal model that incorporates cohort-specific monitoring. Four indices of air pollution updated each fortnight over follow-up were averaged to estimate participant-level chronic exposure: fine particulate matter ≤2.5 micrometers in aerodynamic diameter (PM2.5), oxides of nitrogen (NOx), nitrogen dioxide (NO2), and ozone (O3). Mean±SD PM2.5 was 13.5±3.0 µg/m3, NO2 17.9±8.2 ppb, NOx 36.1±19.6 ppb, and O3 22.2±3.7 ppb. Incident VTE was identified using hospitalization discharge codes through 2018. A total of 248 VTE events accrued over a median follow-up of 16.7 years. After adjustment for baseline demographics, health behaviors and body mass index, the hazard ratio (95% CI) for incident VTE associated per 3.6 µg/m3 higher PM2.5 was 1.39 (1.04-1.86); per 13.3 ppb higher NO2 concentration was 2.74 (1.57-4.77); and per 30 ppb higher NOx was 2.21 (1.42-3.44). O3 was not related. In this prospective community-based cohort with individual-level estimation of chronic air pollution exposure, higher average ambient concentrations of PM2.5, NO2 and NOX were associated with greater risk of developing VTE. Findings add to accumulating evidence of adverse health effects attributed to air pollution exposure.

Update on Cancer-Associated Venous Thromboembolism in Children.

Children with cancer have an increased risk for venous thromboembolic events (VTEs) compared to the healthy pediatric population. VTE rates in children with cancer vary among cancer types. Other VTE risk factors include central venous catheters and cancer therapies. VTE diagnosis relies on objective radiological imaging, and management to this date typically involves anticoagulant therapy. Low-molecular-weight heparins (LMWHs) are the most common choice. Evidence for primary VTE prevention is conflicting, and antithrombin replacement, LMWH, or apixaban have been studied. Recently, direct oral anticoagulants such as rivaroxaban or dabigatran were investigated for VTE treatment, showing promise in efficacy and safety. However, bleeding risks in this population need careful consideration, especially periprocedurally or with treatment-related thrombocytopenia. Prediction tools for VTE require adaptation for pediatric cancer patients. Progress in understanding and managing VTE in children with cancer is significant, with ongoing trials and real-world data contributing to improved strategies.

Upper Limb Deep Venous Thrombosis Associated With Peripherally Inserted Central Catheters in Hospitalised Surgical Patients.

Introduction Surgical inpatients frequently require peripherally inserted central catheters (PICCs) for parenteral feeding and administration of medication. PICCs may cause upper limb deep venous thrombosis (ULDVT), which impacts patient morbidity. We investigated the risk and prevention of PICC-ULDVT in hospitalised surgical inpatients. Methods We conducted a retrospective analysis of 168 consecutive surgical inpatients who received a PICC over the same four-year period. Data from 136 additional consecutive general medical inpatients with PICCs over the same period were included for comparison. We observed and compared the incidence of ULDVT confirmed on dedicated upper limb venous imaging in the cohort of surgical patients compared to a time matched cohort of medical patients. We extracted data including patient demographics, details of admission, and insertion site of the PICC from the hospital electronic notes. Results The incidence of ULDVT in surgical patients was 4.7% compared to 1.5% in medical patients despite increased age (p=0.001) and comorbidity burden (p=0.001) in the latter group. Ninety percent of surgical patients had abdominal surgery within 30 days of PICC placement. Regression multivariate analysis identified concurrent cancer (p=0.048), median Charlson Comorbidity Index (CCI) (p=0.034), admission with malignant bowel obstruction (p=0.002), and catheter insertion into the brachial vein (p=0.033) as significant risk factors for PICC-ULDVT in hospitalised surgical patients. Standard pharmacological venous thromboembolic events (VTE) prophylaxis, as per national guidelines, did not reduce the risk of PICC-ULDVT. Conclusion Our study indicates that surgical inpatients are at greater risk of developing PICC-associated upper limb deep vein thrombosis (ULDVT) compared to medical inpatients, with limited evidence supporting the effectiveness of pharmacological thromboprophylaxis in reducing this risk. PICCs should be used with caution in patients with cancer, cancer-related bowel obstruction, and surgical patients with a higher comorbidity index. PICCs inserted via the basilic vein may reduce ULDVT risk, but further studies are needed on the preferential site of insertion in surgical patients.

Gender-affirming hormone therapy in the transgender patient: influence on thrombotic risk.

Research regarding the hematologic sequelae of estrogen and testosterone therapy for transgender people is an emerging area. While estrogen therapy has been widely studied in cisgender women, studies in transgender individuals are limited, revealing variable adverse effects influenced by the dose and formulation of estrogen used. Thrombotic risk factors in transgender and gender-diverse individuals are multifactorial, involving both modifiable and nonmodifiable factors. Management of venous thromboembolism (VTE) in individuals receiving gender-affirming estrogen entails standard anticoagulation therapy alongside shared decision-making regarding hormone continuation and risk factor modification. While data and guidance from cisgender women can offer a reference for managing thrombotic risk in transgender individuals on hormone therapy, fully applying these insights can be challenging. The benefits of gender-affirming hormone therapy include significantly reducing the risk of suicide and depression, highlighting the importance of a contemplative approach to the management of hormonal therapy after a VTE event. Although limited, the available data in the literature indicate a low thrombotic risk for transgender individuals undergoing gender-affirming testosterone therapy. However, polycythemia is a common adverse effect necessitating monitoring and, occasionally, adjustments to hormonal therapy. Additionally, iron deficiency may arise due to the physiological effects of testosterone or health care providers' use of phlebotomy, an aspect that remains unstudied in this population. In conclusion, while the set of clinical data is expanding, further research remains vital to refine management strategies and improve hematologic outcomes for transgender individuals undergoing gender-affirming hormone therapy.

The rate of postoperative hematoma following risk-adapted cessation of oral anticoagulation in patients undergoing endoscopic endonasal surgery for pituitary adenomas.

This study describes the management of patients on oral anticoagulation (OAC) undergoing endoscopic endonasal transsphenoidal surgery (EETS) and analyzes the risk of postoperative hematoma and epistaxis following treatment of pituitary adenoma (PA). Patients with OAC prior to EETS for PA were analyzed in a single center retrospective case series of consecutive patients with PA, who were treated between December 2008 and July 2022. Patient data (age, sex, clinical, endocrinology, tumor histology) were entered into a SPSS® database. The rate of postoperative hemorrhage (intracranial and epistaxis) and other perioperative complications were assessed. Of 305 patients, 20 patients were on OAC prior to EETS for PA. Indications included non-valvular atrial fibrillation (AF) in 10 patients and previous venous thromboembolic event (VTE) in 8 patients, in 2 patients had overlapping indications. Twelve patients on direct oral anticoagulants (DOAC) paused medication 1-3 days (43.6 ± 23.6h) before surgery, while phenprocoumon was paused 234 ± 123.55h (min 6, max 22 days) before surgery. Baseline characteristics such as age, sex, tumor growth direction, tumor volume, and largest diameter showed no significant differences. No significant increase in postoperative hemorrhage was observed in patients with OAC compared to those without. One patient on apixaban paused 48h before surgery experienced postoperative epistaxis. Among patients without OAC, one experienced intracranial hemorrhage and seven experienced epistaxis. Patients with OAC prior to EETS for PA have no increased risk for postoperative hematoma when OAC is paused based on individual risk assessment and recent general recommendations.

Hypothermia During Microsurgical Head and Neck Reconstruction and Incidence of Venous Thromboembolism

Venous thromboembolism (VTE) is a severe complication after microsurgical free tissue transfer (FTT) to the head and neck. Hypothermia during surgery is a modifiable risk factor, and avoiding it may reduce the postoperative VTE rate. To assess the association between hypothermia (temperature <36 °C) and postoperative VTE and free flap pedicle thrombosis rates after head and neck reconstruction with FTT. This retrospective cohort study in a tertiary academic referral center used prospective and retrospective database and medical record data collected for patients who underwent head and neck reconstruction with FTT between January 1, 2012, and August 31, 2023. Temperature over time was classified as normothermia (temperature ≥36 °C), hypothermia (<36 °C) for more than 30 minutes and less than 120 minutes, and hypothermia for 120 minutes or more. Venous thromboembolism. The study outcomes were VTE events and thrombosis of the free flap pedicle that required revision surgery. Univariable and multivariable regressions were used to test the association between the outcomes and clinical factors. A total of 1078 patients (mean [SD] age, 61.3 [12.6] years; 724 males [67.2%]; mean [SD] Caprini score, 6.4 [2.1]) were included. The VTE and pedicle thrombosis rates were 3.2% (35 patients) and 2.2% (24 patients), respectively. In a multivariable model controlled for Caprini score and chemoprophylaxis, VTE was associated with hypothermia of more than 30 minutes and less than 120 minutes (odds ratio [OR], 3.82; 95% CI, 0.99-14.07) and hypothermia of 120 minutes or longer (OR, 3.55; 95% CI, 1.05-11.95). Free flap pedicle thrombosis was not associated with hypothermia (OR, 0.61; 95% CI, 0.26-1.43). These findings suggest that preventing hypothermia during microsurgical FTT to the head and neck may decrease the postoperative rate of VTE. Future studies should explore the optimal intraoperative body temperature range that may prevent the development of VTE without compromising patient safety.

Perioperative Venous Thromboembolism Chemoprophylaxis Does Not Increase Risk of Complications in Free Flap Breast Reconstruction.

Patients undergoing abdominal-based free flap breast reconstruction are at risk for perioperative venous thromboembolism (VTE), but the optimal anticoagulation protocol remains unknown. We hypothesized that a standardized chemoprophylaxis protocol would minimize VTE events without increasing hematoma, flap loss, or reoperation. A retrospective review was conducted on patients who underwent abdominal-based free flap breast reconstruction from 2010 to 2023. In 2015, we implemented an enhanced recovery after surgery (ERAS) protocol including preoperative enoxaparin. Patients with a BMI < 30 and > 30 received enoxaparin for 7 and 30 days postoperatively, respectively. 2010-2015 patients were pre-ERAS and 2015-2023 patients were the ERAS cohort. Patient demographics, comorbidities, and outcomes were analyzed. The primary outcomes were VTE, hematoma, flap loss, and reoperation. 2317 patients were included: 679 were pre-ERAS and 1638 were in the ERAS cohort. The incidence of deep vein thrombosis (0.7%) and pulmonary embolism (pre-ERAS 0.6% vs. ERAS 0.5%) was low in both cohorts with no significant differences. Hematoma (pre-ERAS 7.2% vs. ERAS 5.5%) and reoperation (pre-ERAS 7.8% vs. ERAS 9.7%) were similar, but the ERAS cohort had significantly lower flap failure (0.7% vs. 2.1%, p < 0.05). A standardized perioperative anticoagulation protocol for abdominal-based breast reconstruction maintained low VTE rates without increasing hematoma, flap failure, or reoperation.

Genomic Landscape of Thrombosis Recurrence Risk Across Venous Thromboembolism Subtypes.

Venous thromboembolism (VT) is a frequent (annual incidence of 1 to 2 per 1,000) and potentially life-threatening (case-fatality rate up to 10%) disease. VT is associated with serious short-term and long-term complications including a recurrence rate of approximately 20% within five years. Anticoagulant therapy, the mainstay of VT treatment, drastically reduces the risk of early VT recurrence, but it exposes patients to a substantial risk of bleeding. We analysed the genomic architecture of VT recurrence using data from 6,571 patients across eight cohorts, 1,816 of whom experienced recurrence, with a particular focus on the clinical manifestation of the type of first VT event. Through genome-wide association studies (GWAS), we identified three loci significantly associated (P<5×10-8) with VT recurrence in the general VT population: GPR149/MME, L3MBTL4, and THSD7B. Protein Quantitative Trait Locus and Mendelian Randomization analyses further identified elevated plasma levels of coagulation factor XI and GOLM2 as risk factors for recurrence, while decreased levels of PCSK9 and pro-IL16 were linked to reduced VT recurrence risk. Subgroup analyses revealed 18 loci associated with VT recurrence, with notable differences between pulmonary embolism (PE) and deep vein thrombosis (DVT). For example, the exonic variant SLC4A1 p.Glu40Lys was significantly associated with recurrence in PE patients (Hazard Ratio (HR)=3.23, P=9.7×10-12) but showed no effect in DVT (HR=1.00, P=0.98). These findings emphasize the role of specific genetic loci and protein pathways in influencing VT recurrence and provide valuable insights into potential therapeutic targets. Further research is needed to clarify the biological mechanisms driving these associations.

Characterization of thrombosis risk in ambulatory patients with cancer: results of the observational, prospective, multicenter CARTAGO study.

Venous thromboembolism (VTE) is one of the leading causes of death in patients with cancer. Currently, there is a need to develop an easily applicable risk model that can identify patients who will benefit from receiving primary thromboprophylaxis to reduce the incidence of VTE. This was a non-interventional, multicenter, observational, prospective study carried out in 62 Oncology and Hematology services in Spain and Portugal between January 2018 and December 2019. The main objective of the CARTAGO study was to develop a predictive model within a competitive risk framework to assess the risk of VTE in patients with cancer undergoing chemotherapy, biological, or hormonal treatment. A total of 1596 patients were analyzed. VTE events occurred in 124 (8%) during the 6-month follow-up period (42% of deep vein thrombosis [DVT], 48% of pulmonary embolism [PE], and 10% of both DVT and PE). Four variables were selected for the multivariate predictive model to determine the risk of VTE (tumor type, D-dimer, compression of a vessel by the tumor, and leukocyte count). The 4 variables were associated with an increased risk of VTE (C-statistic, 0.646 [95%CI, 0.620-0.673]). The most significant variables in the internal validation with bootstrapping were the "very high risk" tumors (hazard ratio [HR] 2.032; 95%CI, 1.287-3.211). The CARTAGO model predicts the VTE risk in patients with cancer receiving anticancer therapy in an outpatient setting. This model can easily aid in identifying ambulatory patients who would probably benefit from primary thromboprophylaxis.

Incidence, Risk Factors, and Modified Risk Assessment Model of Venous Thromboembolism in Non-Hodgkin Lymphoma Patients.

Venous thromboembolic events (VTEs) are the second-leading cause of death in cancer patients, with an incidence of 5%-17% in lymphoma patients, particularly higher in those with non-Hodgkin lymphoma (NHL). Existing risk assessment models (RAMs) like the Khorana and ThroLy scores have limitations and are inadequately validated for NHL patients. Coagulation markers such as D-dimer, thrombin-antithrombin complex (TAT), and thrombomodulin (TM) show a potential predictive value for cancer-associated VTE but lack extensive research in NHL. This study aimed to analyze characteristics and predictive risk factors for VTE in newly diagnosed NHL patients and to evaluate and improve the clinical applicability of the Khorana and ThroLy scores. Data were collected from newly diagnosed NHL patients to analyze characteristics and potential predictive risk factors for VTE. The clinical applicability of the Khorana and ThroLy scores was evaluated, and the ThroLy score was improved by adjusting the hemoglobin cutoff and combining it with D-dimer testing. Sequential testing with TM and TAT levels was also performed. VTE developed in 7.09% of NHL patients. Independent risk factors for VTE included clinical Stage III/IV, mediastinal involvement, history of VTE, D-dimer≥ 1345 μg/dL, and platelet (PLT)≥ 298 × 109, and Hb≥ 110 g/L was an independent protective factor for VTE. The ThroLy score was improved by adjusting the hemoglobin cutoff and combining it with D-dimer testing. Sequential testing of TM and TAT achieved a sensitivity of 66.7%, specificity of 100%, positive predictive value (PPV) of 100%, and negative predictive value (NPV) of 96.7%. VTE is a significant complication in NHL patients. The study highlighted independent risk factors and proposed a modified risk assessment model that effectively predicted VTE risk, potentially optimizing prevention and reducing healthcare costs.

Apixaban versus enoxaparin to prevent venous thromboembolism in post-operative patients with gynecologic cancers at an urban academic medical center

ObjectiveA recent clinical trial demonstrated that the use of apixaban was safe and equal to enoxaparin (LMWH) in post-operative gynecologic oncology patients. This study aimed to determine if these findings are applicable in a diverse patient population at a single site urban academic medical center. MethodsThis was a retrospective cohort study of patients who underwent an exploratory laparotomy for confirmed or presumed gynecologic cancer from the years 2017–2023 at a single-site urban academic medical center. Venous thromboembolism (VTE) prophylaxis with LMWH was standard practice at our institution up until January 2021 after which apixaban became standard for post-operative prophylaxis in our division. Baseline demographic and clinical characteristics of patients receiving apixaban post-operatively were compared to the population previously receiving enoxaparin. The primary outcome was a VTE event within 90days of surgery. Secondary outcomes included major and minor bleeding events. ResultsTwo hundred fifteen patients met inclusion criteria, of which 65 were discharged on enoxaparin and 150 were discharged on apixaban. Baseline characteristics in terms of age, race/ethnicity and BMI found no significant difference between the two groups. Rates of any VTE event within 90 days of surgery were similar for apixaban and LMWH (3.33 % vs. 4.61 %, p = 0.6). Secondary outcomes demonstrated that the rate of a major bleeding event in apixaban group was 1.31 % and LMWH group was 3.08 %, (p = 0.38). Minor bleeding events in the apixaban group were comparable to the LMWH group (10.60 % vs 10.16 %, p = 0.5). ConclusionsIn this real world, urban setting, for women undergoing laparotomy for gynecologic cancer, apixaban as post-operative VTE prophylaxis showed no increase in VTE events and appeared safe with no increase in bleeding events compared to LMWH. This study adds to the literature demonstrating that apixaban is safe and effective for VTE prophylaxis in our gynecologic oncology patients.

New world of big data - new challenges for evidence synthesis: Impact of data duplication on estimates generated by meta-analyses, and the development of a framework for its identification and management.

The aim of this study was to highlight the effects of entering duplicated or overlapping data from published studies using the same data registries into a meta-analysis, including its identification and management using a novel structured framework. Secondary analysis of data from a proportional meta-analysis of 30-day cumulative incidence of venous thromboembolic events (VTE) after metabolic and bariatric surgery was performed. Sensitivity analysis was conducted a) including all studies regardless of duplication (uncorrected sample) and b) comparing it to a corrected sample of studies. We developed a decision tree framework to identify duplicated data from prospective studies and data registries. We demonstrated that biasing from duplicated data, primarily from data registries, underestimated the incidence of VTE in the literature by 0.15% of the patient population (an erroneous difference equivalent to 22.06% of total VTE). This error persisted at 8.16% of total VTE when limiting to studies using a primarily laparoscopic approach. The decision tree framework used a comparison of the data source (country and hospital or registry), sampling timeframe (dates/years of included data) and inclusion characteristics (included procedures/diagnoses or inclusion criteria) to identify potentially duplicated data. Inter-rater reliability was excellent (κ=1.00, p<0.001), although only 17.86% of studies coded as containing data duplication were be verified by the authors while the remaining studies could not be verified. Lastly, we identified a strong lack of diversity in the geographical origins of the data from the included studies. We demonstrated that including duplicated data in a meta-analysis can result in substantially inaccurate pooled estimates. We outlined a comprehensive decision tree framework that future researchers can apply to assist with decision making when identifying and managing duplicated data, including that from data registries or other publicly accessible datasets.

EE241 Fondaparinux: A Cost-Saving Alternative to Low-Molecular-Weight Heparins for Venous Thromboembolic Event Prevention/Treatment and Acute Coronary Syndrome Treatment

EE241 Fondaparinux: A Cost-Saving Alternative to Low-Molecular-Weight Heparins for Venous Thromboembolic Event Prevention/Treatment and Acute Coronary Syndrome Treatment