Incidence Of Venous Thromboembolism Research Articles

Development and validation of a predictive risk tool for VTE in women with breast cancer under chemotherapy: a cohort study in China.

The incidence of venous thromboembolism (VTE) is significantly elevated in breast cancer patients, with a three-to-fourfold increase, and further escalates to sixfold in those undergoing chemotherapy. This study aims to identify the risk factors for VTE and develop a Nomogram risk prediction model distinct from the traditional Khorana score. Univariate Cox regression analysis assessed the impact of each variable on the occurrence of VTE, while stepwise multivariate Cox regression analysis identified independent predictors. Based on these results, we constructed a Nomogram model. The model's performance was validated using the C-index, receiver-operating characteristic curve (ROC), calibration curves, and decision curve analysis (DCA). Comparisons were made with the Khorana score to evaluate the practical application value. Out of the 903 patients, 108 (11.96%) developed VTE. Cox regression analysis identified that Stage, undergoing surgery, age, white blood cells (WBC), D-dimer, and carcinoembryonic antigen (CEA) were significant risk factors for VTE (P < 0.05). The Nomogram model's C-index was 0.77 (95% CI 0.72-0.83) in the training set and 0.76 (95% CI 0.69-0.84) in the validation set. The model demonstrated excellent predictive accuracy and generalizability on the receiver-operating characteristic (ROC) curves and calibration curves. Compared to the traditional Khorana score, the Nomogram model showed superior predictive accuracy and greater clinical benefit. This study established a VTE risk prediction model for breast cancer patients undergoing chemotherapy. The model is characterized by its intuitive and straightforward application, making it highly suitable for rapid VTE risk assessment in clinical practice.

Comparison of total blood loss between limited tourniquet use and conventional tourniquet use in total knee arthroplasty: a randomized controlled trial.

This study examined the differences in total blood loss, the need for blood transfusions, length of hospital stay, wound grading scores, incidence of venous thromboembolism (VTE), and reoperation rates between conventional and limited tourniquet use during unilateral primary total knee arthroplasty (TKA). This double-blind, randomized controlled trial included 90 patients undergoing unilateral primary TKA. Forty-five patients were allocated to the limited tourniquet use group (LIM-TKA), and 45 to the conventional tourniquet use group (CON-TKA). The study analyzed differences in total blood loss, the need for blood transfusions, wound grading scores, incidence of VTE, length of hospital stay, and reoperation rates. The mean total blood loss in the LIM-TKA group was 589.55 ± 238.2ml, significantly lower than the 692.31 ± 276.15ml observed in the CON-TKA group (P = 0.031). Significantly poorer wound grades were seen in the CON-TKA group compared to the LIM-TKA group, with 23 vs. 34, 15 vs. 11, 5 vs. 0, 1 vs. 0 and 1 vs. 0 patients, respectively, having grade 1, 2A, 2B, 2C and 3A wounds according to the Southampton Scoring System (P = 0.032). Patients in the LIM-TKA group also had a shorter hospital stay versus the CON-TKA group (5.6 ± 1.28 vs. 7.2 ± 4.06 days, P = 0.006). The rates of blood transfusion, VTE complications, and reoperation were similar between both groups. LIM-TKA results in significantly lower total blood loss and improved wound grading scores, as well as a decreased length of hospital stay compared to CON-TKA. LIM-TKA could be a suitable option for surgeons aiming to minimize tourniquet-related adverse outcomes while maintaining a dry bone surface during TKA cementation. This study was retrospectively registered at Thai Clinical Trials Registry (thaiclinicaltrials.org) on July 28, 2024. TCTR20240728002.

Meta-Analysis Investigating Optimal Timing of Chemoprophylaxis for Venous Thromboembolism in Operatively Managed Blunt Spinal Injuries.

Blunt spinal injuries (BSIs) are associated with substantial morbidity and mortality. Management typically involves stabilization of the spinal column and may include chemoprophylaxis for venous thromboembolism (VTE) prevention. The optimal timing of chemoprophylaxis initiation in operatively managed BSI patients remains debated. Analyze available literature on optimal chemoprophylaxis timing for the prevention of VTE in patients postinjury undergoing operative repair. Systematic review and meta-analysis. A systematic review and meta-analysis were conducted following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. PubMed and MEDLINE were searched for studies assessing chemoprophylaxis timing in adult BSI patients. Inclusion criteria focused on operatively managed BSIs and anticoagulant usage assessment. Three studies involving 4345 patients were included. Early chemoprophylaxis initiation was associated with significantly lower deep vein thrombosis (DVT) and overall VTE incidence compared with late initiation. No significant differences were found in pulmonary embolism (PE) incidence or mortality. Early anticoagulant administration after spinal fixation for BSI reduces DVT and overall VTE risk without impacting PE incidence or mortality. Further research is recommended to solidify these findings and address existing gaps in the literature. Early chemoprophylaxis initiation in operatively managed BSI patients reduces DVT and overall VTE risk without affecting PE incidence or mortality LEVEL OF EVIDENCE: 2.

The risk of venous thromboembolism in adult patients with diffuse glioma: a nationwide population-based study.

Venous thromboembolism (VTE) is a cause of increased morbidity and risk of death. Studies report VTE in up to 30% of glioma patients but the results vary. The VTE risk is relevant when evaluating prophylaxis to avoid unnecessary bleeding or overdiagnosis. This study examines the VTE incidence in patients with glioma WHO grade 2-4, and when VTE occurred, risk factors, and overall survival (OS) for patients with WHO grade 4. In total 3,630 patients with WHO grade 2 (n = 230), grade 3 (n = 317), and grade 4 (n = 3,083) gliomas from 2010 to 2018 were identified using the Danish Neuro-Oncology Registry. VTE diagnoses and time of death were obtained from Statistics Denmark. The VTE incidence was 5.2, 6.3, and 6.8% in patients with WHO grade 2, 3, and 4 gliomas, respectively. The VTE incidence rate was highest during the first 3 months after the diagnosis with 53 events. Increasing age (HR 1.03, 95%CI 1.01-1.04), male sex (HR 1.47, 95%CI 1.09-1.99), poor performance status (HR 1.57, 95%CI 1.10-2.25), and post-operative long-course radiochemotherapy (HR 2.10, 95%CI 1.19-3.72) were predictors of VTE in patients with glioma WHO grade 4. There was no difference in OS comparing patients having VTE to those without (p = 0.068). In conclusion, patients with glioma WHO grade 2-4 were at high risk of VTE, especially the first 3 months after diagnosis. Increasing age, male sex, poor performance status, and long-course radiochemotherapy were associated with increased risk of VTE in patients with glioma WHO grade 4.

OGC SO12 - Extended Venous Thromboembolism Prophylaxis in Postoperative Oesophagogastric Cancer Patients: A Completed Audit

Abstract Background Venous thromboembolism (VTE) is a life-threatening complication for cancer patients undergoing oesophagogastric surgery. The NICE recommends extending pharmacological VTE prophylaxis to 28 days for patients undergoing major abdominal cancer surgery. While the effectiveness of in-hospital VTE prophylaxis is well-documented, the optimal duration for postoperative VTE prophylaxis remains a subject of debate. This study aims to evaluate the prescribing compliance, effectiveness, and safety of extending VTE prophylaxis to 28 days following hospital discharge (HD), a policy adopted trust-wide since 2014. Method This is an 11-year retrospective study from July 2012-2022, followed by a complete audit cycle conducted between January 2023-2024. The study included all patients who underwent cardio-esophagectomy or gastrectomy for oesophagogastric cancers. Exclusion criteria comprised patients who died during the index admission, those who underwent benign oesophagogastric surgery or local excision of gastrointestinal stromal tumours (GIST), and patients with peripherally inserted central catheter (PICC) line-associated VTE. The primary outcome measured was the prescribing compliance of 28-day VTE prophylaxis post-hospital discharge. Secondary endpoints included the incidence of VTE and bleeding complications necessitating hospital readmission within 28 days of discharge. Results Our study included 582 patients, showing that post-2014, 423 out of 490 patients (86.3%) were discharged with 28-day VTE prophylaxis, compared to 13 out of 92 patients (14.1%) pre-2014, indicating a significant improvement (p&amp;lt;0.05). Only one patient (0.17%) developed VTE more than 28 days post-discharge, and no readmissions due to bleeding complications. In the subsequent audit, 63 out of 68 patients (92.6%) received the prophylaxis, further increasing prescribing compliance. Comparing the two periods, compliance improved from 86.3% to 92.6%, though not statistically significant (p=0.145). Overall, VTE incidence was minimised from 0.17% to 0%, with no readmissions due to bleeding complications. Conclusion Routine extended VTE prophylaxis for 28 days post-hospital discharge should be recommended for cancer patients undergoing oesophagogastric surgery. This practice has significantly improved prescribing compliance rates, reduced post-hospital discharge VTE incidence, and demonstrated safety, with no hospital readmissions due to bleeding complications.

Large inferior vena cava thrombosis in a 25-year-old female patient: A case report.

The incidence of venous thromboembolism is increasing, and it is more common in older than in younger patients. Inferior vena cava (IVC) thrombosis is a rare subtype of deep vein thrombosis, and it is associated with a high incidence of arterial and venous thrombosis in patients with systemic lupus erythematosus (SLE). We present the case of a 25-year-old female patient with a large IVC thrombosis caused by SLE that was intractable to thrombolytic therapy. A 25-year-old previously healthy female patient presented to the emergency department with a 5-day history of fever. Her computed tomography revealed a large thrombus with an approximate length 25 cm extending from the suprarenal IVC to the right common iliac vein and the left external and internal iliac veins. We decided to perform intravenous thrombolysis (alteplase 65 mg) because of the massive thrombus burden followed by an infusion of intravenous heparin. However, the size of the thrombus did not showed reduction 3 days after treatment. For the next step, the catheter-directed thrombolysis (CDT) was performed; however, no changes were observed. She was diagnosed with SLE, and the large IVC thrombus gradually improved after primary treatment for SLE, including immunosuppressive drugs combined with anticoagulant. We found a large IVC thrombus secondary to SLE in a young female patient. In this case, systemic thrombolysis or CDT did not improve the thrombus. The thrombus only improved after immunosuppressive treatment for SLE. Our case highlights the importance of treatment for etiologic disease in an intractable thrombosis developed by provoked cause.

Brisk walking pace offsets venous thromboembolism risk equivalent to established monogenic mutations.

Mendelian mutations in F2 and F5 genes are known risk factors for venous thromboembolism (VTE). This study aimed to explore the association between walking pace and VTE, compare its risk with Mendelian mutations, and identify if blood biomarkers mediate this effect. We followed 445,261 UK Biobank participants free of VTE at baseline. Walking pace was self-reported, and carrier status for F2 and F5 gene mutations was determined by rs1799963 and rs6025 genotypes. We used a Cox proportional hazard model to estimate walking pace's effect on VTE risk, bidirectional Mendelian randomization (MR) analysis to assess causality, and mediation analysis to explore blood biomarkers. Over a median follow-up of 12.8 years, 11,155 incident VTE cases were identified. The 10-year incidence rates for brisk and slow walking paces were 1.32% and 3.90%, respectively. For F5 carriers, the rates were 1.70% (brisk pace) and 3.62% (slow pace). Brisk walking pace reduced VTE risk in F5 carriers (2.65%) compared to non-carriers with a slow pace (3.66%). MR analysis confirmed a causal relationship from walking pace to VTE risk. Mediation analysis revealed that serum albumin and cystatin C mediated 8.7% to 11.7% of the effect of brisk walking pace on VTE risk. A slow walking pace is causally associated with increased VTE risk. A brisk walking pace mitigates VTE risk, particularly in individuals with F5 gene mutations, and this effect is partially mediated by serum albumin and cystatin C.

The Effects of Perioperative Gender-affirming Hormone Therapy on Facial Feminization Surgery Adverse Events, Facial Features Addressed, and Esthetic Satisfaction: A Multimodal Analysis.

Facial feminization surgery (FFS) treats gender dysphoria in transfeminine patients by addressing the facial bony and soft tissue components. Individuals seeking FFS may be taking gender-affirming hormone replacement therapy [gender-affirming hormone therapy (GAHT)]. This study aims to better characterize the GAHT's impact on venous thromboembolism (VTE) risk, surgical planning, and outcomes. A systematic review and meta-analysis of the literature were carried out to assess the effect of perioperative GAHT continuation on VTE. Cochrane Q and I2 statistics measured study heterogeneity with the following meta-regression exploring these results. Simultaneously, a retrospective review of the senior author's FFS cohort was conducted to investigate GAHT duration's impact on FFS revision rate, complication incidence, and facial structures operated on. Eleven articles were included: 602 patients stopped GAHT, of whom 3 VTEs were recorded (0.49%). This is compared with one episode among the 925 who continued GAHT perioperatively (0.11%). Study heterogeneity was low (0%), but limited VTE sample size precluded meta-analytic conclusions. Gender-affirming hormone therapy duration does not impact the incidence of all-cause complications (P = 0.478), wound infection (P = 0.283), hematoma (P = 0.283), or VTE (P = 1). The only procedures significantly less associated with higher GAHT were tracheal shaving (P = 0.002) and mandibuloplasty (P = 0.003). Finally, the FFS revision rate was not associated with GAHT duration (P = 0.06). There is a paucity of data to assess the safety or harm of continuing GAHT in the FFS perioperative period. Thus, a shared provider-patient decision-making process examining the risks and benefits of GAHT perioperative continuation is warranted. As patients seeking gender-affirming care are diverse, a "one-protocol-fits-all" is not appropriate.

UK Foot and Ankle Thromboembolism (UK-FATE).

Venous thromboembolism (VTE) is a potential complication of foot and ankle surgery. There is a lack of agreement on contributing risk factors and chemical prophylaxis requirements. The primary outcome of this study was to analyze the 90-day incidence of symptomatic VTE and VTE-related mortality in patients undergoing foot and ankle surgery and Achilles tendon (TA) rupture. Secondary aims were to assess the variation in the provision of chemical prophylaxis and risk factors for VTE. This was a multicentre, prospective national collaborative audit with data collection over nine months for all patients undergoing foot and ankle surgery in an operating theatre or TA rupture treatment, within participating UK hospitals. The association between VTE and thromboprophylaxis was assessed with a univariable logistic regression model. A multivariable logistic regression model was used to identify key predictors for the risk of VTE. A total of 13,569 patients were included from 68 sites. Overall, 11,363 patients were available for analysis: 44.79% were elective (n = 5,090), 42.16% were trauma excluding TA ruptures (n = 4,791), 3.50% were acute diabetic procedures (n = 398), 2.44% were TA ruptures undergoing surgery (n = 277), and 7.10% were TA ruptures treated nonoperatively (n = 807). In total, 11 chemical anticoagulants were recorded, with the most common agent being low-molecular-weight heparin (n = 6,303; 56.79%). A total of 32.71% received no chemical prophylaxis. There were 99 cases of VTE (incidence 0.87% (95% CI 0.71 to 1.06)). VTE-related mortality was 0.03% (95% CI 0.005 to 0.080). Univariable analysis showed that increased age and American Society of Anesthesiologists (ASA) grade had higher odds of VTE, as did having previous cancer, stroke, or history of VTE. On multivariable analysis, the strongest predictors for VTE were the type of foot and ankle procedure and ASA grade. The 90-day incidence of symptomatic VTE and mortality related to VTE is low in foot and ankle surgery and TA management. There was notable variability in the chemical prophylaxis used. The significant risk factors associated with 90-day symptomatic VTE were TA rupture and high ASA grade.

Rescue of COVID-19 Patient Complicated by Spontaneous Pneumothorax and Acute Pulmonary Thromboembolism

Abstract Pulmonary thromboembolism is a common cardiovascular disease, with high morbidity and mortality rates in hospitalized patients. Because of clotting disorders and hypoxemia caused by COVID-19, critically ill patients are highly susceptible to thrombotic complications. A study published in the Journal of the American Medical Association in 2022 showed that the incidence of venous thromboembolism (VTE) in critically ill COVID-19 patients was approximately 10% to 35%, whereas the incidence of VTE in autopsy cases was as high as 60% (JAMA Intern Med 182:1063-1070). Clinicians need increased awareness of VTE in COVID-19 patients, to reduce the risk of deep vein thrombosis and pulmonary thromboembolism and to be alert to life-threatening complications.

Incidence of venous thromboembolic disease and risk of bleeding in critically ill patients with hematologic malignancies: A retrospective study

ObjectiveOur objectives were to describe the use of thromboprophylaxis and the incidence of VTE/bleeding in critically ill patients with hematologic malignancies (HM). DesignRetrospective cohort study (2014–2022). SettingMedic-Surgical Intensive Care Unit (ICU) in a tertiary care academic center. PatientsAdult patients admitted to ICU with a concomitant diagnosis of a hematological malignancy. InterventionsNone. Main variables of interestWe analyzed demographic data, use of thromboprophylaxis and secondary outcomes that included incidence of VTE (venous thromboembolism), bleeding, mortality, severity scores and organ support. We applied a multivariable logistic regression model to examine the risk of thrombosis in the ICU. ResultsWe included 862 ICU admissions (813 unique patients). Thromboprophylaxis was given during 65% of admissions (LMWH 14%, UFH 8%, and SCDs 43%); in 21% it was contraindicated due to thrombocytopenia; 14% of cases lacked documentation on prophylaxis. There were 38 unique incident cases of VTE (27 DVT, 11 PE), constituting 4.4% of ICU episodes. Most of VTE cases happened in patients with various degrees of thrombocytopenia. In the multivariable analysis, SOFA score on the first ICU day was independently associated (OR 0.85, 95% CI 0.76−0.96) with the risk of VTE. Bleeding occurred in 7.2% (minor) and 14.4% (major) of episodes; most frequent sites being CNS, abdomen/GI and pulmonary. ConclusionsIn this cohort of critically ill patients with HM, there was considerable variability in the utilization of DVT prophylaxis, with predominant use of SCDs. The incidence of VTE was 4.4% and major bleeding 14%. Clinical Trial RegistrationNCT05396157. Venous Thromboembolism in Hematologic Malignancy and Hematopoietic Cell Transplant Patients: a Retrospective Study (https://clinicaltrials.gov/).

Evaluation of the Khorana score and association with venous thromboembolism incidence among patients with uterine cancer: Implications for patient care

Evaluation of the Khorana score and association with venous thromboembolism incidence among patients with uterine cancer: Implications for patient care

Venous thromboembolism incidence and risk factors in patients undergoing hematopoietic stem cell transplantation

BackgroundMalignancy is a well-known risk factor for venous thromboembolism (VTE), and the Khorana risk score is effective for screening solid tumor patients. However, there is a lack of validated screening tools and established risk factors for patients undergoing hematopoietic stem cell transplant (HCT). Current literature reports VTE incidence in HCT patients ranging from 2.5% to 8.5%. Anticoagulation is difficult to manage post-transplant given prolonged thrombocytopenia and the likelihood of bleeding. By identifying risk factors, a predictive model may be developed to prospectively test prophylaxis strategies in patients at the highest thromboembolic event (TE) risk. ObjectivesThis study evaluated the cumulative incidence of TE at 6 months following allogeneic and autologous HCTs. This study also aimed to identify risk factors for developing TE, to evaluate time from HCT to TE, and to compare one-year survival following HCT between patients experiencing TE and those who did not. Study DesignThis is a retrospective single-center study evaluating the incidence of TE events in adult subjects undergoing HCT between March 2014 and December 2019. ICD-9 and ICD-10 codes were used to determine cancer diagnosis, TE events up 180 days after HCT, and comorbidities of interest. Each subject was reviewed for data accuracy by manual retrospective chart review. The study employed statistical tests such as the cumulative incidence method with competing risks, Gray's test, and univariate and multivariate Cox proportional hazards models to analyze the time to first thromboembolic (TE) event, evaluate risk factors, and assess 1-year survival post-HCT in relation to TE events within 180 days of HCT. Variables examined included age, sex, body mass index (BMI), transplant type, hospital length of stay, history of TE prior to transplant, active infections, graft-versus-host disease (GVHD), veno-occlusive disorder (VOD), cytomegaly virus (CMV) and other factors. ResultsThe study included 636 evaluable patients; the majority were male (57.9%), white (68.7%), and underwent an autologous HCT (68.4%). Twenty-nine patients (4.6%) experienced a TE event within 180 days post-transplant. TE events were more common in the allogeneic transplant group (n=13/201, 6.5%) than the autologous transplant group (n=16/435, 3.7%) (p=0.122). The cumulative incidence of TE was higher in patients who developed an active infection than those who did not (7.6% vs 3.1%, P=.011). Hospital LOS [HR 1.03, 95% CI 1.0-1.06, p=0.036] and active infection [HR 2.34, 95% CI 1.1-4.95, p=0.027] were significantly associated with TE in the univariate analysis but were not retained in the final multivariate model. There was no difference in one-year survival among all patients who experienced a TE event and those who did not; however, in the autologous HCT subgroup, one-year survival rate was significantly lower in those with TE compared to those without TE (Figure 3c, 80.4% vs 95.3%, P=.01). Examined variables, including history of TE event and GVHD, were not associated with TE event risk. ConclusionWhile the overall incidence of TE in our study was low, many patients received pharmacologic or mechanical prophylaxis, suggesting such strategies may be effective in mitigating TE risk. Factors such as infection and hospital LOS may further increase TE risk. Providers should continuously monitor for risk factors and signs and symptoms of TE post-transplant. It is also imperative to consider chemical prophylaxis if counts are recovered while hospitalized.

Venous thromboembolism in adolescents and young adults with acute lymphoblastic leukemia treated on a pediatric-inspired regimen

Asparaginase (ASP)-containing regimens for acute lymphoblastic leukemia (ALL) are associated with venous thromboembolism (VTE). We evaluated the prevalence, risk factors, role of prophylaxis and clinical impact of VTE among adolescents and young adult (AYA) patients (15–50 years) treated on Dana-Farber Cancer Institute (DFCI) ALL protocols. The 1- and 2-year cumulative incidence of VTE were 31.9% (95% CI: 27.0%, 36.9%) and 33.5% (95% CI: 28.5%, 38.5%) respectively, with most events occurring during ASP-based consolidation phase (68.6%). VTE was more frequent in patients with overweight/obese vs. normal BMI (39.2% vs. 29.0%, p = 0.048). In a 1-year landmark analysis, the 4-year overall survival was 91.5%, without difference between patients with vs. without VTE (93.8% vs. 90.0%, p = 0.93). Relapse and non-relapse mortality rates were also similar. Among patients treated at Dana-Farber/Harvard Cancer Center, cerebral sinus vein thrombosis occurred in 3.6% of patients (8.5% of VTE events) in comparison to pulmonary embolism (32.9%) and deep vein thromboses (58.6%, 24.4% line-associated). In a Cox regression model for VTE free-time, elevated BMI was associated with shorter VTE free-time (HR 1.94 [95% CI 1.13-3.35], p = 0.018), while low molecular weight heparin (LMWH) prophylaxis as time-varying covariate was not. In conclusion, we found that VTE was frequent in AYAs treated on DFCI ALL protocols but did not impact survival outcomes. Overweight/obese BMI increased risk for VTE.

Estimated glomerular filtration rate versus creatinine clearance to determine anticoagulant dosage after lower-limb orthopedic surgery.

Anticoagulation is recommended for thromboprophylaxis after lower-limb orthopedic surgery. The suggested dosage is based on creatinine clearance (CCr) in the labels. However, most facilities only provide estimated glomerular filtration rate (eGFR) as laboratory data. Because the eGFR equation adjusts for a body surface area (BSA) of 1.73 m2, it may overestimate renal function in patients with a small BSA. This retrospective study aimed to determine whether different renal function estimation formulas affect the incidences of venous thromboembolism (VTE) and bleeding when determining anticoagulant dosages. This study included patients who underwent lower-limb orthopedic surgery and received anticoagulants (edoxaban, enoxaparin, and fondaparinux) between 2017 and 2020 at Yaizu City Hospital. Anticoagulant dosing was evaluated using CCr, eGFR, and de-indexed eGFR (without correction for BSA), and the incidences of VTE and bleeding were compared among these formulas. The median values for BSA, CCr, eGFR, and de-indexed eGFR were 1.40 m2, 56.0mL/min, 73.0mL/min/1.73m2, and 60.9mL/min, respectively. There was no significant difference in the VTE incidence among these formulas. However, when dose reduction or contraindication threshold was determined by eGFR vs. CCr, the bleeding incidence was significantly higher in the group that was overdosed by CCr (6.0% vs. 25.7%, p < 0.05). Similarly, using de-indexed eGFR vs. CCr, the bleeding incidence was significantly higher in the group that was overdosed by CCr (7.5% vs. 28.6%, p < 0.05). In orthopedic surgery, anticoagulant dosages should be based on CCr for patients with a small BSA to avoid bleeding risks.

Incidence, patient characteristics, and treatment patterns of U.S. active-duty service members diagnosed with COVID-19-associated VTE in the outpatient setting

Abstract Background Venous Thromboembolism (VTE) is a well-established complication of acute coronavirus disease 2019 (COVID-19) infection. We sought to clarify the incidence, patient characteristics, and treatment patterns of VTE within United States active-duty service members (ADSM) diagnosed with COVID-19 infection in the outpatient setting. Methods Our team conducted a multicenter retrospective review of the outpatient healthcare records for all U.S. ADSM diagnosed COVID-19-associated VTE between January 1, 2020, and April 30, 2022. The data was obtained from the COVID-19 surveillance case list maintained by the Armed Services Health Surveillance Division (ASHSD) of the U.S. Defense Health Agency (DHA). The Defense Medical Surveillance System (a database containing inpatient and outpatient electronic medical records for active-duty service members) was used to capture all appropriate medical encounters using ICD-10 coding for venous thromboembolic events within 365 days of COVID-19 diagnosis. Chart review for data adjudication was performed by the physician investigator team. Results Among 365,788 ADSM who were diagnosed with COVID-19 in the outpatient setting, a total of 159 patients were identified as having COVID-19-associated VTE. The overall incidence rate of VTE was 43.47 per 100,000 people within 365 days of diagnosis (90-day incidence rate of 32.5/100,000). The median time from COVID-19 diagnosis to VTE was 23 days (IQR 13-87). Of 159 patients, 33 (20.7%) were diagnosed with DVT, 143 (90%) with PE, and 20 (12.5%) with both PE and DVT. The median age was 30 years old (IQR 23-38). The majority of patients were male (85%). 49% were white. The most common medical comorbidity was obesity (33%), 11% had a history of active tobacco use, and 9.4% of patients had a prior VTE diagnosis. Only 34% of patients were vaccinated for COVID-19 prior to their diagnosis (35 Pfizer–BioNTech, 13 Moderna, and 4 other). 148 (93%) of patients were treated with a direct oral anticoagulant, 10 (6.2%) were treated with low molecular weight heparin, and 1 (0.8%) was treated with a vitamin K antagonist. 96 (60.3%) required hospitalization with 4 (2.5%) requiring subsequent thrombectomy. None experienced major bleeding events. Only 2 (1.3%) of the patients died within 22 days from VTE diagnosis. The remaining 98.7% were alive at 875 days (SD 230) of follow-up. Conclusion The incidence of venous thromboembolism in active-duty military patients with COVID-19 was rare, affecting mostly unvaccinated, minority men in their 30s with risk factors such as obesity, prior VTE, and prior tobacco use. Of the women with VTE, 54% were non-white minorities. While VTE diagnosis was associated with a low mortality rate, the majority of patients required hospitalization.

A novel dynamic risk score to predict venous thromboembolism (VTE) recurrences after 3 months of anticoagulation in patients with incident VTE and without active cancer

Abstract Background Predicting the risk of recurrent venous thromboembolism (rVTE) during and following anticoagulation is complex. Current models lack the ability to adapt to changing patient conditions over time and fail to account for the direct impact of anticoagulation in real-world clinical settings. Purpose To develop a dynamic risk prediction model for rVTE to help clinicians decide on the duration of anticoagulant therapy in conjunction with a model for bleeding (also submitted to the conference). Methods UK Clinical Practice Research Datalink data (2001-2020) was used to generate a retrospective cohort with first VTE who had received 3 months of anticoagulation. Patient episodes of rVTE were evaluated. Covariates were collected at baseline and subsequently as time-varying data to capture changes post-VTE. Hazards with 95% confidence intervals (CI) were estimated and covariates included in a Fine &amp; Gray model used as predictors of rVTE. An additive (logarithmic) scoring scheme was developed from subdistribution hazard ratios, discrimination (expressed by the C-statistic) estimated from 10-fold cross-validation. Results 51,465 patients with a first VTE were included; 4041 rVTE were identified in 200,698 person-years of observation. Incidence rates for rVTE were 2.01 per 100 person-years. Nineteen independent predictors of rVTE (recorded before or after the VTE diagnosis) were included in the model, 13 associated with increased risk and 6 with decreased risk, Table 1. Patients recognised as lower-risk, medium and higher-risk (10.5%, 37% and 52.5% of the population, respectively, at 90 days after first VTE, assuming no anticoagulation treatment) had an annualised rVTE incidence rate of 2.20, 3.84, and 7.44 per 100 person-years. The C-statistic for rVTE was 0.65 (95%CI, 0.64-0.66). The points scored can be added or subtracted to predict risk (Table 2). Conclusions Our dynamic risk score effectively identifies patients at risk of rVTE three months post their initial VTE diagnosis. It allows for continuous monitoring of risk, and modelling of treatment impact, providing clinicians with a pragmatic tool to help determine treatment duration, and adapt their strategies in response to evolving patient conditions.Table 1:Predictors for VTE recurrenceTable 2:VTE recurrence risk score

A novel dynamic risk score to predict Clinically Significant Bleeding (CSB) after 3 months of anticoagulation in patients with incident Venous ThromboEmbolism (VTE) and without active cancer

Abstract Background Predicting the risk of clinically significant bleeding (CSB), bleeding requiring hospitalisation or fatal bleeding, during and following anticoagulation is complex. Current models lack the ability to adapt to changing patient conditions over time and fail to account for the direct impact of anticoagulation in real-world clinical settings. Purpose To develop a dynamic risk prediction model for CSB to help clinicians decide on the duration of anticoagulant therapy in conjunction with a model for recurrences of VTE (also submitted to the conference). Methods UK Clinical Practice Research Datalink data (2001-2020) was used to generate a retrospective cohort with first VTE who had received 3 months of anticoagulation. Patient episodes of CSB and recurrent VTE were evaluated. Covariates were collected at baseline and subsequently as time-varying data to capture changes post-VTE. Hazards with 95% confidence intervals (CI) were estimated and covariates included in a Fine &amp; Gray model used as predictors of CSB. An additive (logarithmic) scoring scheme was developed from subdistribution hazard ratios, discrimination (expressed by the C-statistic) estimated from 10-fold cross-validation. Results 51,621 patients with a first VTE were included; 3307 CSB were identified in 206,292 person-years of observation. Incidence rates for CSB were 1.60 per 100 person-years. 18 independent predictors of CSB (recorded before or after the VTE diagnosis) were included in the model, Table 1. Patients recognised as lower-risk, medium and higher-risk (67.5 %, 15.9 % and 16.7 % of the population, respectively, at 90 days after first VTE, assuming no anticoagulation treatment) had an annualised incidence rate of 0.84, 2.94, and 9.45 per 100 person-years. The C-statistic for CSB was 0.78 (95%CI, 0.77-0.79). The points scored can be added to predict risk (Table 2). Conclusions Our dynamic score effectively identifies patients at risk of CSB three months post their initial VTE diagnosis. It allows for continuous monitoring of risk, and modelling of treatment impact, providing clinicians with a pragmatic tool to help determine treatment duration, and adapt their strategies in response to evolving patient conditions.Table 1:Predictors for CSBTable 2:CSB risk score

The initial high-dose versus maintenance-dose anticoagulation therapy with direct oral anticoagulants for cancer-associated venous thromboembolism: from the COMMAND VTE Registry-2

Abstract Background/Introduction Initial high-dose anticoagulation therapy with rivaroxaban and apixaban has been a standard treatment for venous thromboembolism (VTE), although there could be concerns of an increased risk of bleeding events especially among high bleeding-risk patients including those with active cancer. Purpose The present study aimed to evaluate the clinical outcome of initial high-dose anticoagulation therapy comparing to maintenance-dose anticoagulation therapy in patients with cancer-associated VTE using propensity score-matching analysis. Methods The COMMAND VTE Registry-2 is a multicenter registry enrolling 5197 consecutive acute symptomatic VTE patients among 31 centers in Japan between January 2015 and August 2020. Among 1507 patients with cancer-associated VTE, we evaluated 180-day clinical outcomes before discontinuation of anticoagulation therapy using a 1:1 propensity score-matching model with 21 risk-adjusting variables Results After the propensity score-matching, we enrolled 324 patients with initial high-dose anticoagulation therapy and 324 patients with initial maintenance dose anticoagulation therapy. Of patients with initial high-dose anticoagulation therapy, rivaroxaban and apixaban were administered in 198 and 126 patients, respectively. Of those with initial maintenance-dose anticoagulation therapy, rivaroxaban, apixaban, and edoxaban were administered in 34, 46 and 244 patients, respectively. The median durations of initial high-dose anticoagulation therapy were 18 [IQR: 15-21] days for rivaroxaban and 7 [IQR: 7-7] days for apixaban. In the current study population, the mean age was 67±12 years, 346 were women, and the mean body weight was 58±12 kg. There was no significant difference in the distribution of gastrointestinal cancer such as stomach and colorectal cancer between the 2 groups (4.6% vs. 4.9%, P=1.0, 8.3% vs. 11.4%, P=0.22). The cumulative 180-day incidence of discontinuation of anticoagulation was not significantly different between the 2 groups (27.8% vs. 30.5%, P=0.50). There were no significant differences in the cumulative 180-day incidences of recurrent VTE (3.1% vs. 1.0%, P=0.08), nor major bleeding (8.1% vs. 7.0%, P=0.66), nor all-cause death (25.1% vs. 21.6%, P=0.33) between the 2 groups. There were also no significant differences in the cumulative 180-day incidences of all clinically relevant bleeding (14.9% vs. 13.3%, P=0.72), gastrointestinal bleeding (8.4% vs. 5.4%, P=0.15), nor major gastrointestinal bleeding (5.4% vs. 2.7%, P=0.10). Conclusions There was no signal of an increased risk of recurrent VTE in the initial maintenance-dose anticoagulation therapy. Considering a numerically slightly higher incidence of gastrointestinal bleeding in the initial high-dose anticoagulation therapy for cancer-associated VTE, the initial maintenance-dose anticoagulation therapy could be a potential treatment option for selected patients including patients at a high risk of gastrointestinal bleeding.Study flow chartResults

The association between steroid use and recurrent venous thromboembolism: from the COMMAND VTE Registry-2

Abstract Background It is well known that use of oral steroids is a risk factor for development of venous thromboembolism (VTE). However, the impact of use of oral steroids on VTE recurrence has not been fully evaluated in the era of direct oral anticoagulants (DOAC), which has been a clinically relevant issue in the decision-making of anticoagulation strategies for patients who need oral steroids after VTE diagnosis. Purpose We aimed to investigate long-term clinical outcomes in VTE patients treated with oral steroids after VTE diagnosis in the DOAC era. Methods The COMMAND VTE Registry-2 is a multicenter registry enrolling 5,197 consecutive acute symptomatic VTE patients among 31 centers in Japan between January 2015 and August 2020. The current study population were divided into 2 groups according to the use of oral steroids after VTE diagnosis; the steroid group and the non-steroid group. We compared clinical characteristics, management strategies, and outcomes including recurrent VTE, major bleeding and all-cause death, between the 2 groups. Results Patients with steroids and those without accounted for 693 (13%) and 4,504 (87%), respectively. Patients with steroids more often had chronic kidney disease (29% vs. 18%, P&amp;lt;0.001), autoimmune disease (50% vs. 5.4%, P&amp;lt;0.001), thrombocytopenia (7.7% vs 4.9%, P=0.002), and anemia (64.4% vs 54.1%, P&amp;lt;0.001), whereas there was no significant difference in the mean age (68.5 vs. 67.6 years old, P=0.16), the prevalence of women (62% vs 58%, P=0.06), active cancer (30% vs. 29%, P=0.42), and history of VTE (8.4% vs 6.8%, P=0.12) between the 2 groups. The cumulative 5-year incidence of discontinuation of anticoagulation therapy were not significantly different between the 2 groups (61.5% vs. 58.5%, log-rank P=0.16). The cumulative 5-year incidences of recurrent VTE nor major bleeding were not significantly different between the 2 groups (10.4% vs. 9.4%, log-rank P=0.55; 16.9% vs. 13.3%, log-rank P=0.16, respectively). Even after adjusting confounders, the risks of recurrent VTE nor major bleeding were not significantly different (adjusted hazard ratio = 0.97, 95% confidence interval = 0.65-1.45, P = 0.89; adjusted hazard ratio = 1.12, 95% confidence interval = 0.84-1.50, P = 0.44). The cumulative 5-year incidences of all-cause death was significantly different between the 2 groups (44.2% vs. 30.2%, log-rank P&amp;lt;0.001). Even after adjusting confounders, the risk of all-cause death remained significantly different (adjusted hazard ratio = 1.82, 95% confidence interval = 1.56-2.12, P&amp;lt;0.001). Conclusions Use of oral steroids after VTE diagnosis was not significantly associated with an increased risk of VTE recurrence in the DOAC Era, which might suggest that there could be no major concerns on an increased risk of recurrent VTE with oral steroids after VTE diagnosis under appropriate anticoagulation therapy.