Prevention Of Venous Thromboembolism In Patients Research Articles

Effect of different application duration of a venous foot pump on prevention of venous thromboembolism after hip and knee arthroplasty: a multicenter prospective clinical trial

ObjectiveTo investigate the optimal duration of applying a venous foot pump (VFP) in the prevention of venous thromboembolism (VTE) following hip and knee arthroplasty.MethodsA total of 230 patients undergoing hip and knee arthroplasty between March 2021 and March 2022 in orthopaedic departments of four major teaching hospitals were prospectively enrolled. Patients were randomly divided into five groups based on the duration of the VFP application. Postoperative deep vein thromboses (DVT), including proximal, distal, and intermuscular DVT, were recorded for analysis. Postoperative blood coagulation examinations, such as D-dimer and active partial thromboplastin time (APTT), pain outcome, and degree of comfort were also collected.ResultsTwo of the 230 patients withdrew due to early discharge from the hospital, and 228 patients were included in the final analysis. The mean age was 60.38 ± 13.33 years. The baseline characteristics were comparable among the five groups. Compared with the other groups, patients treated with 6-hour VFP had the lowest incidence of DVT (8.7%, 4/46), followed by those treated with 1-hour VFP (15.2%, 7/46), 12-hour VFP (15.6%, 7/45), 18-hour VFP(17.8%, 8/45) and 20-hour VFP(21.7%, 10/46), but with no significant difference (P = 0.539). Regarding postoperative blood coagulation examinations, patients treated with 6-hour VFP had the lowest D-dimer (P = 0.658) and the highest APTT (P = 0.262) compared with the other four groups. 6-hour VFP also had the lowest pain score (P = 0.206) and the highest comfort score (P = 0.288) compared with the other four groups.ConclusionsSix hours may be the optimal duration of applying VFP for the prevention of VTE in patients undergoing hip and knee arthroplasty in terms of VTE incidence, postoperative blood coagulation examinations, pain outcomes, and comfort scores.

A Survey of Clinician Perspectives on the Management of Catheter-Related Upper Extremity Deep Vein Thrombosis in Patients with Cancer

Background: Central venous catheters (CVCs) are commonly used in cancer patients to facilitate blood draws, administration of chemotherapy or other supportive care treatment. Catheter-related upper extremity deep vein thrombosis (DVT) is a major complication of CVCs, with studies reporting a rate of symptomatic venous thromboembolism (VTE) of 7% over 3 months in patients with active cancer and a new CVC. Despite the frequent occurrence, the optimal management in patients with cancer and catheter-related upper extremity DVT is unclear, given the lack of high-quality data. Objective: We conducted a survey aiming to characterize practice patterns and perceptions of clinicians who treat patients with cancer and catheter-related upper extremity DVT. Methods: An online survey was distributed to international clinicians who manage patients with cancer and catheter-related upper extremity DVT. The survey explored the type and duration of anticoagulation, focusing on the management after the initial 3 months of anticoagulation, as well as treatment strategies upon catheter removal and interests in future clinical studies. Descriptive statistics was used to summarize survey responses. Results: The survey was generated on LimeSurvey ® in English and publicized by Twitter ® and email communications via multiple international organizations of hematologists, oncologists, and/or thrombosis specialists, including the International Society on Thrombosis and Haemostasis (ISTH), Thrombosis Canada, the Canadian Venous Thromboembolism Research Network (CanVECTOR), and more. As of July 30, 2023, 115 clinicians from 26 countries had completed the survey. The majority of the respondents specialized in thrombosis (N=72, 62.6%) and/or hematology (N=60, 52.2%), followed by internal medicine (N=38, 33.0%) and oncology (N=14, 12.2%) (multiple selection was permitted for this question). For the initial management of a patient without unresected gastrointestinal (GI) or genitourinary (GU) cancer, thrombocytopenia, or relevant drug-drug interactions, 75% of clinicians would prescribe a direct oral anticoagulant (DOAC) and 25% would give low-molecular-weight heparin (LMWH). On the other hand, in patients with unresected GI/GU cancer, the majority (N=105, 91.3%) of respondents chose to initiate LMWH. After the initial 3 months of anticoagulation, if the CVC remains in place in a patient with active cancer, the majority (N=112/114, 98.2%) of clinicians would continue anticoagulation, but with variable doses (57% and 43% chose therapeutic and prophylactic dosing, respectively). If the CVC remains in place but the cancer is in remission, fewer (70%) respondents would continue anticoagulation, and more would continue prophylactic as compared to therapeutic dosing (73% vs. 27%) in this setting. Practice variation further increases upon catheter removal, especially in the presence of active cancer (Figures 1 and 2). The majority of respondents (N=111, 96.5%) agree that there is a need for prospective studies to evaluate the management of patients with cancer and catheter-related upper extremity DVT, and over 91% (N=105) would consider enrolling their patients in a study to evaluate prophylactic dosing of anticoagulation for secondary prevention of VTE in patients with cancer and catheter-related upper extremity DVT. To help plan such a study, we evaluated respondents' perception on the maximal “tolerable” recurrent VTE rate between 3 and 6 months (as the main interest is in the management strategy after the initial 3 months), and 2% and 3% were the most common responses (41.2% and 31.6% of the respondents, respectively). Conclusions: Our survey demonstrates that current practice in managing patients with cancer and catheter-related upper extremity DVT is heterogenous, especially after the initial 3 months of anticoagulation and upon catheter removal. Well-conducted prospective studies in this population are needed, which is supported by most clinicians.

Evaluation of Clinical Risk Factors and Thrombosis-Related Biomarkers in Newly Diagnosed Patients with Multiple Myeloma at Risk for Cancer-Associated Thrombosis. the Observational Roadmat-CAT-MM Study

Background: Hypercoagulability is a common blood alteration in newly diagnosed chemotherapy naïve patients with multiple myeloma. Multiple myeloma (MM) figures among malignancies that significantly increase the risk of venous thromboembolism (VTE). The rate of VTE is higher at the time of diagnosis and during the first months following initiation of first line therapy; approximately 10% of newly diagnosed MM (NDMM) will develop a VTE. Despite adequate thromboprophylaxis as per guidelines, the risk of residual VTE is not eliminated and remains as high as 12%. The optimization of VTE prevention in patients with MM is an unmet need. The exact mechanism of the increased risk of VTE is not yet fully understood. The identification of the procoagulant potential of cancer cells, which is related principally to tissue factor (TF) expression, attracts particular interest. Aim: We conducted a longitudinal prospective observational study, to explore the relationship of MM with cellular and plasma hypercoagulability as well as tissue factor positive microparticles, aiming to identify the most relevant biomarkers, which could be used in a Risk Assessment Model (RAM) for VTE in combination with clinical risk factors. Methods: Newly diagnosed patients (182) with multiple myeloma (NDMM) were prospectively enrolled. Patients were followed up for 12 months and the primary end-point was symptomatic objectively confirmed VTE. Patients were risk stratified and received thromboprophylaxis (none, aspirin on low molecular weight heparin (LMWH) based on previously published recommendations by the IMWG and EMN. Prior to treatment initiation and thromboprophylaxis initiation baseline biomarkers were obtained: Thrombin generation (TGT) in citrated PPP was assessed with the Thrombogram-Thrombinoscope® assay using PPP-reagent® 5 pm TF by Diagnostica Stago. The levels of P-Selectin and heparanase in plasma were measured with ELISA Kit (Cusabio Biotech and R&D Systems respectively). The procoagulant phospholipids clotting time was measured with STA-Procoag-PPL®, Levels of Factor VIIa were measured by Staclot VIIa-rTF®, D-Dimers (DDi) by Liatest D-Di (Diagnostica Stago, France), and Tissue Factor activity (TFa) by specific clotting based home test. TF expression MPC-derived microparticles (MPC-dMPs) were detected using a Zymuphen MP-TF activity kit (Hyphen BioMed, Neuville sur Oise, France). These were compared against values in a population of healthy individuals (n=30). Results: The distribution of patients enrolled in the study is as follows: Median age was 67 years (36-86) and 52% of the population was male. Median time to follow up was 7 months (1-12 months). The control group (30 healthy individuals). The overall rate of symptomatic VTE during follow-up was 11.5% (n = 21 patients). Eleven out of 21 events (52%) occurred within 3 months from treatment initiation. Six of these patients did not receive any thromboprophylaxis; six patients were on aspirin at the time of the event and three were on LMWH.At inclusion, patients showed significantly increased levels of TFa, FVIIa, D-Dimers and FM, and significantly shorter Procoag-PPL® as compared to the group of healthy individuals. Levels of P-selectin and TM were significantly lower in patients as compared to healthy individuals. The levels of heparanase were not significantly different in the group of patients as compared to the healthy individuals. Overall thrombin generation was attenuated in patients compared to healthy individuals. Lag-time and ttPeak were significantly increased and Peak, MRI, and ETP were significantly lower as compared to the control group, MP-TF activity measured in NDMM significantly increased 1.46± 0.38 pg/mL compared to control subjects 0.19 ± 0.05 pg/mL (Table 1). Multivariate logistic regression analysis demonstrated that ETP, Procoag-PPL® and MP-TF were independently associated with VTE occurrence. (Table 2) Conclusion: The prospective ROADMAP-CAT-MM study demonstrates the presence of pronounced cellular hypercoagulability in newly diagnosed chemotherapy naïve patients with MM characterized by decreased Procoag-PPL® clotting time, enhanced endothelial cell activation, and exhausted thrombin generation. The Procoag-PPL clotting time and the ETP and MP-TF were found to be independently associated with the risk of VTE and can be prospectively incorporated into a RAM for VTE in MM.

Venous thromboembolism prophylaxis in shoulder surgery: a break-even cost-effectiveness study

Venous thromboembolism (VTE) is a serious complication following orthopedic shoulder surgery; however, research is limited involving the break-even cost-effectiveness of VTE prophylaxis. The purpose of this study was to determine if the cost of aspirin and enoxaparin would break even for VTE prevention in patients following shoulder surgery. A drug retail database was used to obtain the lowest price for a course of aspirin (81 mg) and enoxaparin (40 mg) to perform a break-even cost analysis. Our institutional purchasing records were then searched to estimate the cost of treating a symptomatic VTE. The TriNetX national database was then queried to establish a rate of VTE after shoulder surgery. A break-even cost analysis was performed by determining the absolute risk reduction. This value was used to calculate the number of patients who are treated to prevent a single VTE while breaking even on cost. Sensitivity analyses were performed for drugs that did not break-even at the database derived VTE rates. A full medication course of aspirin and enoxaparin were found to cost $1.18 and $125.37, respectively. The cost of treating a symptomatic VTE was determined to be $9,407.00. Data from the TriNetX database showed rates of symptomatic VTE following shoulder arthroplasty, hemiarthroplasty, and arthroscopic rotator cuff repair were 1.60%, 1.50%, and 0.68%, respectively. Aspirin broke even on cost for all procedures if the initial rate decreased by an ARR of 0.01% (NNT=7,972). Similarly, enoxaparin broke even for shoulder arthroplasty and hemiarthroplasty if the initial rate of VTE decreased by an ARR of 1.33% (NNT=75). Enoxaparin did not break-even at the initial VTE rate for arthroscopic rotator cuff repair, however sensitivity analysis found enoxaparin was if the cost could be obtained for $60.00 or less. Enoxaparin broke even if the cost of treating a symptomatic VTE was $20,000.00 or higher. The cost of a three-week course of twice daily aspirin or once daily enoxaparin breaks even for VTE prophylaxis following shoulder arthroplasty and hemiarthroplasty if they reduce the VTE rate by a calculated absolute risk reduction. Given the lower rate of VTE observed for patients undergoing arthroscopic rotator cuff repair, only the three-week course of aspirin broke even under these conditions. Once-daily enoxaparin did not break-even at current market rate. Further research is needed to help determine optimal VTE prophylaxis after shoulder surgery.

Risk Assessment Model for Postpartum Venous Thromboembolism Prevention in Patients with Systemic Lupus Erythematosus.

This article assesses the application of the Royal College of Obstetricians and Gynaecologists (RCOG) venous thromboembolism (VTE) risk model on a cohort of postpartum patients with a history of systemic lupus erythematosus (SLE). This is a secondary analysis of an ongoing patient registry of women with SLE from 2016 to 2022. There were 49 SLE patients with 55 pregnancies using the Definitions of Remission in SLE (DORIS) criteria to determine SLE disease activity. RCOG risk assessment model scoring was calculated for each patient prior to and after delivery. The primary outcome was the qualification of "active SLE" by standard rheumatologic criteria and assessment of recommendations for VTE prophylaxis based on RCOG VTE risk assessment scoring. Data were analyzed using Fisher's exact test, chi-square test, and Mann-Whitney U test with significance defined as p < 0.05. In the study cohort, 34 pregnancies (61.8%) were in DORIS remission at delivery. Twenty-one pregnancies (38.2%) were not and scored 3 points on the RCOG VTE risk model. Of these pregnancies, only 19% (n = 4) were recommended for VTE prophylaxis by the obstetrical provider despite RCOG score ≥3. Only 35.7% (n = 5) of pregnancies in DORIS remission, but with 3 points for non-SLE-related VTE risk factors (n = 14), were recommended for VTE prophylaxis. Of the 20 pregnancies in remission with an RCOG score < 3 after assessing all risk factors, 15% (n = 3) were nevertheless recommended for VTE prophylaxis. No patients had a postpartum VTE regardless of therapy. These data reveal a need to improve upon providing postpartum VTE prophylaxis to SLE patients not in remission while also recognizing a diagnosis of SLE alone should not equate with active disease. Moreover, SLE patients in remission may still warrant VTE prophylaxis if other non-SLE-related risk factors are present. · Those with SLE are at increased risk for VTE postpartum.. · VTE prophylaxis should be instituted when clinically appropriate.. · Caution should be exercised in broadly assigning disease activity for SLE diagnosis only.. · This study supports VTE prophylaxis use in postpartum patients with SLE..

Risk Assessment Model for Postpartum Venous Thromboembolism Prevention in Patients with Systemic Lupus Erythematosus

Background Patients with Systemic Lupus Erythematosus (SLE) may be at increased risk for developing a venous thromboembolism (VTE), particularly in the postpartum period. The Royal College of Obstetricians and Gynaecologists (RCOG) guideline for postpartum VTE prophylaxis is often used to triage which patients should get VTE prophylaxis. In this RCOG guideline, a score ≥ 3 drives a formal recommendation for postpartum anticoagulation. RCOG is unique in its inclusion of “active SLE” as an actionable VTE risk factor (adding 3 points). We sought to determine if a cohort of postpartum patients with a known history of SLE a) qualify as having “active” SLE by standard rheumatologic criteria b) have other risk factors for VTE c) received the recommended prophylaxis based on RCOG VTE risk assessment scoring and d) had a postpartum VTE. Objective To assess the application of the RCOG venous thromboembolism (VTE) risk model on a cohort of postpartum patients with a history of Systemic Lupus Erythematosus (SLE). Study Design This is a secondary analysis of an ongoing patient registry of women with SLE from 2016-2022. There were 49 SLE patients with 55 pregnancies using Definitions of Remission in SLE (DORIS) criteria to determine SLE disease activity. RCOG risk assessment model scoring was calculated for each patient prior to and after delivery. The primary outcome was the qualification of “active SLE” by standard rheumatologic criteria and assessment of recommendations for VTE prophylaxis based on RCOG VTE risk assessment scoring. Data were analyzed using Fisher’s Exact test, chi-square test, and Mann-Whitney U test with significance defined as p&lt;0.05. Results In the study cohort, 34 pregnancies (61.8%) were in DORIS remission at delivery. Twenty-one pregnancies (38.2%) were not and scored 3 points on the RCOG VTE risk model. Of these pregnancies, only 19% (n=4) were recommended for VTE prophylaxis by the obstetrical provider despite RCOG score ≥ 3. Only 35.7% (n=5) of pregnancies in DORIS remission, but with 3 points for non-SLE related VTE risk factors (n=14), were recommended for VTE prophylaxis. Of the 20 pregnancies in remission with an RCOG score &lt; 3 after assessing all risk factors, 15% (n=3) were nevertheless recommended for VTE prophylaxis. No patients had a postpartum VTE regardless of therapy. Conclusion These data reveal a need to improve upon providing postpartum VTE prophylaxis to SLE patients not in remission while also recognizing a diagnosis of SLE alone should not equate with active disease. Moreover, SLE patients in remission may still warrant VTE prophylaxis if other non-SLE-related risk factors are present.

Treatment and prevention of cancer-associated thrombosis in the Netherlands: A national survey

BackgroundIn the recent years, numerous studies on the optimal treatment and prevention of cancer-associated venous thromboembolism (VTE) have been published, leading to updated (inter)national guidelines. These include direct oral anticoagulants (DOACs) as the first-line treatment agent in general and the recommendation of primary thromboprophylaxis in selected ambulatory patients. ObjectivesThe objective of this study was to evaluate the clinical practice regarding treatment and prevention of VTE in patients with cancer in the Netherlands and practice variation among different specialties. MethodsAn online survey was conducted between December 2021, and June 2022, among Dutch physicians (oncologists, hematologists, vascular medicine specialists, acute internal medicine specialists, and pulmonologists) treating patients with cancer, in which we explored the treatment of choice for cancer-associated VTE, the use of VTE risk stratification tools, and primary thromboprophylaxis. ResultsA total of 222 physicians participated, of whom the majority (81%) used DOACs as a first-line agent for treating cancer-associated VTE. The treatment varied between the following specialties: hematologists and acute internal medicine specialists more often prescribed low-molecular-weight heparin than physicians of the other specialties (OR, 0.32; 95% CI, 0.13-0.80). The minimum duration of anticoagulant treatment was usually 3 to 6 months (87%), and treatment was extended when the malignancy was still active (98%). Regarding the prevention of cancer-associated VTE, no risk stratification tool was used. Three quarters of respondents never prescribed thromboprophylaxis to ambulatory patients, mostly because the thrombosis risk was not perceived high enough to justify prophylaxis. ConclusionDutch physicians largely adhere to the updated guidelines regarding the treatment of cancer-associated VTE but less to the recommendations for its prevention.

Implementation science approaches to optimizing venous thromboembolism prevention in patients with traumatic injuries: Findings from the 2022 Consensus Conference to Implement Optimal Venous Thromboembolism Prophylaxis in Trauma.

Disease burden of venous thromboembolism (VTE) without pharmacologic prophylaxis is high in trauma patients. Although VTE prophylaxis guidelines exist, studies on real-world use of VTE prophylaxis in trauma shows limited uptake of guideline recommendations. Despite existing guidelines, reports indicate that VTE prophylaxis implementation across trauma centers is lagging. Implementation barriers of VTE prophylaxis in trauma are multifactorial, and VTE prescribing practices require further optimization. Implementation science methods can help standardize and improve care; well-established approaches in medical and surgical hospitalized patients and their effects on clinical outcomes such as VTE and bleeding complications must be investigated because they apply to trauma patients. Nonadministration of VTE prophylaxis medications in hospitalized patients is associated with VTE events and remains a barrier to providing optimal defect-free care. Further investigations are required for VTE prophylaxis implementation across all trauma populations.

International consensus on prevention of venous thromboembolism in patients after orthopedic interventions

International consensus on prevention of venousthromboembolism in patients after orthopedicinterventions

Venous thromboembolism in musculoskeletal oncology surgery.

Venous thromboembolism (VTE), including both deep venous thrombosis (DVT) and pulmonary embolism (PE), is a major complication of musculoskeletal surgery in general, and the risk is heightened in musculoskeletal oncology surgery. Despite the well-known association between cancer and VTE, the mechanism promoting this pathology is not entirely well understood. It is estimated that nearly all cancer patients will experience from some form of VTE, whether or not clinically relevant, during the course of their disease. Nonetheless, numerous studies have analyzed the occurrence and prevention of VTE in patients with cardiovascular disease or suffering trauma, but very few have specifically examined the safety or efficacy of preventing VTE in cancer patients with metastatic skeletal disease. This review will examine the various types of prophylactic treatment, timing of administration, risk stratification for determining the appropriate course of anticoagulation (AC), and discuss current views on chemical prophylaxes relativity to wound complications and excessive bleeding in orthopedic oncology patients. Overall, careful choice of anticoagulant and timing of administration must be made in order to avoid bleeding complications. A risk stratification system to determine which chemical prophylaxis to administered could be beneficial in both reducing the occurrence of VTE and decreasing associated wound complications or mortality. Further study should be conducted to tailor chemical prophylaxes recommendations to this largely affected population and effectively reduce the occurrence of VTE.

Evidence-based research and prognosis of novel coagulation factor Ⅺ inhibitors in venous thromboembolism

Thrombosis is the main cause of the development and progression of venous thromboembolism(VTE). Anticoagulant therapy is the cornerstone for the prophylaxis and treatment of VTE, and it has evolved mainly through indirect thrombin inhibitors, direct thrombin inhibitors, vitamin K antagonists and new oral anticoagulants. Although safety is improving, the risk of bleeding remains a non-negligible side effect of current anticoagulation therapy, especially in patients with higher bleeding risk. Studies of the coagulation pathway have found that FXI is not involved in the initiation of hemostasis, but promotes thrombus growth and stabilization primarily through feedback activation of FⅪ by thrombin. Further studies have found that inhibition of FⅪ significantly inhibits thrombus formation and only affects hemostasis slightly. Recent studies have confirmed the efficacy and safety of FⅪ inhibitors in the prevention of VTE in patients after knee replacement. In addition, the safety of FⅪ inhibitors has been further confirmed by the studies of FⅪ inhibitors in people with higher bleeding risk. FⅪ inhibitors may be the most promising anticoagulant drugs in the next decade.

Thromboprophylaxis Reduced Venous Thromboembolism in Sickle Cell Patients with Central Venous Access Devices: A Retrospective Cohort Study.

Sickle cell disease (SCD) induces a chronic prothrombotic state. Central venous access devices (CVADs) are commonly used for chronic transfusions and iron chelation in this population. CVADs are an additional venous thromboembolism (VTE) risk factor. The role of thromboprophylaxis in this setting is uncertain. The objectives are: (1) to determine whether thromboprophylaxis reduces VTE risk in SCD patients with CVAD and (2) to explore characteristics associated with VTE risk. We identified adults with SCD and CVAD intended for chronic use (≥3 months) at two comprehensive SCD centers. Thromboprophylaxis presence; type; intensity; and patient-, catheter-, and treatment-related VTE risk factors were recorded. Among 949 patients, 49 had a CVAD (25 without and 24 with VTE prophylaxis). Thromboprophylaxis type and intensity varied widely. Patients without thromboprophylaxis had higher VTE rates (rate ratio (RR) = 4.0 (95% confidence interval: 1.2–12.6), p = 0.02). Hydroxyurea was associated with lower VTE rates (RR = 20.5 (6.4–65.3), p < 0.001). PICC lines and Vortex and Xcela Power implantable devices were associated with higher rates compared with Port-a-Cath (RR = 5.8 (1.3–25.9), p = 0.02, and RR = 58.2 (15.0–225.0), p < 0.001, respectively). Thromboprophylaxis, hydroxyurea, and CVAD subtype were independently associated with VTE. The potentially protective role of thromboprophylaxis and hydroxyurea for VTE prevention in patients with SCD and CVAD merits further exploration.

Safety of Venous Thromboembolism Prophylaxis Protocol Using a Novel Leg Exercise Apparatus in Bedridden Patients due to Spinal Diseases.

Purpose: Venous thromboembolism (VTE) is a complication in patients with a spinal disease requiring bedfast for conservative therapies. We previously developed a novel leg exercise apparatus (LEX) to encourage patients to exercise their lower extremities during bed rest. The purpose of this study was to evaluate the feasibility and safety of the LEX for the prevention of VTE in patients on bed rest due to spinal disease.Methods: Patients with spinal diseases requiring bed rest were included in the study. Exercise using the LEX was performed for ≥5 minutes. The exercises were performed three or more times per day during the bed rest period. In addition, we evaluated adverse events, such as symptomatic VTE and changes in vital signs, using venous ultrasonography, blood tests, and measurement of vital signs.Results: In total, 31 patients were enrolled (11 men, 20 women), with mean age, height, weight, and body mass index of 72.4 years, 155.2 cm, 55.0 kg, and 22.6 kg/m2, respectively. Twenty-four subjects had spinal fractures. Twenty-nine patients continued exercising until they could leave their beds. No symptomatic VTE was observed in any patient, and no other severe adverse events were observed. There were no significant changes in vital signs. The average number of exercise days with LEX and length of hospitalization were 11 and 31 days, respectively.Conclusions: This is the first study regarding mechanical thromboprophylaxis through in-bed exercise for patients with bedridden spinal disease. The LEX exercise protocol, in addition to mechanical prophylaxis with graduated compression stockings and intermittent pneumatic compression devices, for the prevention of symptomatic VTE may be feasible and safe for patients with bedridden spinal disease.

Nonvitamin K Antagonist Oral Anticoagulant in Patients With Venous Thromboembolism and Polycythemia Vera or Essential Thrombocythemia: A Cohort Study.

Thrombosis is the most common adverse event in patients with polycythemia vera (PV) and essential thrombocythemia (ET). Little is known about the use of nonvitamin K antagonist oral anticoagulants (NOACs) in patients with myeloproliferative neoplasms. We sought to evaluate the efficacy and safety of NOAC in a cohort of patients with PV and ET, who experienced venous thromboembolism (VTE). We enrolled 48 consecutive patients with PV (70.8%) and ET [median age 67.0 (interquartile range, 58.5-72.0) years], who experienced VTE. Patients received apixaban (39.6%), rivaroxaban (33.3%), or dabigatran (27.1%). During a median follow-up of 30 (interquartile range, 20.5-41.5) months, recurrent thrombotic events and bleeding were recorded. Four thrombotic events (3.3 per 100 patient-years) were reported. Three deep vein thrombosis episodes (2.5 per 100 patient-years) were experienced by 2 patients with PV, who received apixaban (5 mg bid) and dabigatran (150 mg bid), and 1 patient with ET, who received dabigatran (150 mg bid). One ischemic stroke occurred in a patient with PV on rivaroxaban (20 mg/d). There was 1 major bleeding (0.8 per 100 patient-years) in a patient with ET on dabigatran (150 mg bid) and 3 clinically relevant nonmajor bleeding (2.5 per 100 patient-years): 2 on rivaroxaban (20 mg/d) and 1 on apixaban (5 mg bid). We did not observe significant differences related to the type of NOAC. Three deaths (2.5 per 100 patient-years) unrelated to either VTE or bleeding were recorded. This study shows that NOACs may be effective and safe as secondary prevention of VTE in patients with myeloproliferative neoplasms.

Effectiveness and Safety of Rivaroxaban Versus Warfarin for Treatment of Venous Thromboembolism in Patients with Known Primary Hypercoagulable States

Background: The efficacy and safety of rivaroxaban versus enoxaparin/vitamin K antagonist (VKA) for treatment and secondary prevention of venous thromboembolism (VTE) was demonstrated in the EINSTEIN clinical trial program. As screening for primary hypercoagulable states was not required as part of the EINSTEIN trial program protocol, fewer than 500 total patients with a known primary hypercoagulable state were identified.Objective: To assess the effectiveness and safety of rivaroxaban versus warfarin for treatment and secondary prevention of VTE in patients with a known primary hypercoagulable state in a large, real-world population.Methods: US MarketScan claims data from January 2012-September 2015 were utilized. We identified adult patients with a primary International Classification of Diseases-9th Revision (ICD-9) discharge diagnosis code for deep vein thrombosis (DVT) (ICD-9=451.1, 451.2, 453.40, 453.41, 453.42, 453.8, 453.9) or pulmonary embolism (PE)(ICD-9=415.1x), diagnosed during a hospitalization or emergency department visit (the index event), with ≥180-days of continuous medical and prescription benefits prior to the index event (baseline), a documented diagnosis for a primary hypercoagulable state (ICD-9=289.81) during baseline or the index VTE encounter and newly-initiated on rivaroxaban or warfarin within 30-days of the index VTE event. Patients with a claim for an anticoagulant before the index event were excluded. Effectiveness and safety endpoints included recurrent VTE, any major bleeding (identified per the Cunningham algorithm), intracranial hemorrhage (ICH) and gastrointestinal bleeding (GIB). Patients were followed for a maximum of 12-months from the index event or until occurrence of an endpoint, switch or discontinuation (14-day permissible gap) of index oral anticoagulation or insurance disenrollment. Rivaroxaban users were 1:1 propensity-score matched to warfarin users. Balance between cohorts was evaluated by inspecting standardized differences for baseline covariates (differences >0.1 indicating imbalance). Cox regression was performed and results reported as hazard ratios (HRs) with 95% confidence intervals (CIs).Results: We matched 403 rivaroxaban and 403 warfarin users with a known primary hypercoagulable state and experiencing a VTE. Mean±standard deviation (SD) duration of patient follow-up was 0.5±3 years. All baseline covariates had a standardized difference <0.1 after matching. Mean±SD age of the population was 50±14 years; PE (with or without DVT) was present in 53% of patients, 50% of patients were female and 12% had a hospital admission within 180-days of their qualifying VTE event. Rivaroxaban use was associated with a 30% non-significant relative reduction in the hazard of recurrent VTE and a non-significant 45% relative reduction in the hazard of major bleeding as compared to warfarin (Table). Only 2 patients experienced an ICH (both warfarin users). Rivaroxaban users had a non-significant 53% relative reduction in the hazard of GIB versus warfarin.Conclusion: Our study results suggest rivaroxaban's relative effectiveness and safety versus warfarin is maintained when treating VTE patients with known primary hypercoagulable states in routine practice. These real-world study findings are consistent with that of the overall EINSTEIN clinical trial program and its subgroup analysis of patients with primary hypercoagulable states. [Display omitted] DisclosuresColeman:Boehringer Ingelheim: Consultancy, Honoraria; Janssen Pharmaceuticals: Consultancy, Honoraria, Research Funding; Bayer AG: Consultancy, Honoraria, Research Funding. Turpie:Bayer HealthCare Pharmaceuticals: Consultancy; Janssen Research and Development: Consultancy, Honoraria. Beyer-Westendorf:Pfizer: Honoraria, Research Funding; Daiichi-Sankyo: Honoraria, Research Funding; Bayer: Honoraria, Research Funding; Boehringer-Ingelheim: Honoraria, Research Funding.

The Effect of Aspirin and Enoxaparin on the Prevention of Venous Thromboembolism in Patients With Ankle Sprain and Cast Immobilization: A Randomized Clinical Trial

Background: The incidence of Venous Thromboembolism (VTE) and its prophylaxis in patients with an ankle injury and cast immobilization are controversial. Objectives: This study aimed to investigate the effect of aspirin and enoxaparin on VTE prevention in patients with an ankle sprain and cast immobilization. Methods: In a double-blind, randomized clinical trial, 90 eligible patients were divided into three groups: patients who did not receive the drugs (the control group), patients who received aspirin (325 mg/d) for 3 weeks (the ASA group), and patients who received enoxaparin (40 mg/d subcutaneously) for 3 weeks (the enoxaparin group). After 3 weeks, the plaster was opened, and the D-dimer level was measured if there was a VTE symptom during the study. Otherwise, at the end of the study, the bilateral lower-limb Complete Compression Ultrasonography (CCUS) and color Doppler ultrasound were used to image the lower limb venous system. Results: Sixty-eight patients completed the study. The mean±SD values of D-dimer in the control, ASA, and enoxaparin groups were 0.33 (0.47) μg/dL (Median=0.18 μg/dL), 0.32 (0.14) μg/dL (Median=0.3 μg/dL) and 0.32 (0.25) μg/dL (Median=0.21 μg/dL), respectively (P&gt;0.05). The positive D-dimer was seen in 2 patients (8%) of the control group, 2 patients (8.3%) of the ASA group, and 2 patients (10.5%) of the enoxaparin group (P&gt;0.05). The color Doppler ultrasound was negative in all patients. Conclusion: Because none of the 68 patients in the current study developed VTE during our 30 days follow-up period, it seems that prophylaxis treatment is unnecessary in patients with an ankle sprain and cast immobilization. Further studies on more patients with a longer period of follow-up are recommended.

Nonadministration of pharmacologic venous thromboembolism prophylaxis is less common in hospitalized patients with COVID-19.

IntroductionThe incidence of venous thromboembolism (VTE) in patients hospitalized with COVID-19 is higher than most other hospitalized patients. Nonadministration of pharmacologic VTE prophylaxis is common and is associated with VTE events. Our objective was to determine whether nonadministration of pharmacologic VTE prophylaxis is more common in patients with COVID-19 versus other hospitalized patients.Materials and methodsIn this retrospective cohort analysis of all adult patients discharged from the Johns hopkins hospital between Mar 1 and May 12, 2020, we compared demographic, clinical characteristics, VTE outcomes, prescription and administration of VTE prophylaxis between COVID-19 positive, negative, and not tested groups.ResultsPatients tested positive for COVID-19 were significantly older, and more likely to be Hispanic, have a higher median body mass index, have longer hospital length of stay, require mechanical ventilation, develop pulmonary embolism and die (all p < 0.001). COVID-19 patients were more likely to be prescribed (aOR 1.51, 95% CI 1.38–1.66) and receive all doses of prescribed pharmacologic VTE prophylaxis (aOR 1.48, 95% CI 1.36–1.62). The number of patients who missed at least one dose of VTE prophylaxis and developed VTE was similar between the three groups (p = 0.31).ConclusionsIt is unlikely that high rates of VTE in COVID-19 are due to nonadministration of doses of pharmacologic prophylaxis. Hence, we should prioritize research into alternative approaches to optimizing VTE prevention in patients with COVID-19.

PCV58 Cost Analysis of Low-Molecular-Weight Heparins for the Treatment of Venous Thromboembolism in Spain

The aim of this study was to assess the treatment cost of tinzaparin, enoxaparin (brand and biosimilar) and bemiparin for the prevention of recurrence of venous thromboembolism (VTE) in Spain. The cost analysis model was built to estimate the initial treatment (15 days) for all patients and over a 180-day period in the secondary prevention of VTE in patients with active cancer. Specific dosage was based on each Summary of Product Characteristics. We selected data of RIETE registry to calculate the weights of different doses of enoxaparin. Drug prices were ex-factory (01/2020) + VAT (4%) + Royal Decree law 08/2010. Robustness were checked by a one-way sensitivity analysis considering patient weights. Daily cost was 10.48€ for tinzaparin, 11.24€ for biosimilar enoxaparin, 11.84€ for enoxaparin and 15.21€ for bemiparin. Tinzaparin showed a cheaper initial treatment cost with reduction between 7% (biosimilar enoxaparin) and 31% (bemiparin). In the long-term, total average cost treatment was 1.577€ for tinzaparin, 2.050€ for biosimilar enoxaparin, 2.161€ for enoxaparin and 2.408 for bemiparin. Independently of patients’ weight (40kg-100kg), tinzaparin was cheaper for all patient’s initial treatment and for the secondary prevention of VTE in patients with active cancer. The range of cost-savings with tinzaparin was 12-49% vs enoxaparin, 12-40% vs biosimilar enoxaparin and 25-48% vs bemiparin. Tinzaparin is a cost-saving alternative versus the rest of low molecular weight heparins in the treatment of VTE in Spain. This savings was observed in the initial treatment of all patients with VTE as well as in the long-term treatment of cancer associated thrombosis.

Frequency of venous thromboembolism in 6513 patients with COVID-19: a retrospective study

AbstractPatients infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) appear to be at increased risk for venous thromboembolism (VTE), especially if they become critically ill with COVID-19. Some centers have reported very high rates of thrombosis despite anticoagulant prophylaxis. The electronic health record (EHR) of a New Orleans–based health system was searched for all patients with polymerase chain reaction–confirmed SARS-CoV-2 infection who were either admitted to hospital or treated and discharged from an emergency department between 1 March 2020 and 1 May 2020. From this cohort, patients with confirmed VTE (either during or after their hospital encounter) were identified by administrative query of the EHR.: Between 1 March 2020 and 1 May 2020, 6153 patients with COVID-19 were identified; 2748 of these patients were admitted, while 3405 received care exclusively through the emergency department. In total, 637 patients required mechanical ventilation and 206 required renal replacement therapy. Within the hospitalized cohort, the overall mortality rate was 24.5% and VTE occurred in 86 patients (3.1%). In the 637 patients who required mechanical ventilation at some point during their hospital stay, 45 developed VTE (7.2%). After a median follow-up of 14.6 days, VTE had been diagnosed in 3 of the 2075 admitted who were discharged alive (0.14%). Among 6153 patients with COVID-19 who were hospitalized or treated in emergency departments, we did not find evidence of unusually high VTE risk. Pending further evidence from prospective, controlled trials, our findings support a traditional approach to primary VTE prevention in patients with COVID-19.

Frequency of Venous Thromboembolism in 6513 Patients with COVID-19: A Retrospective Study

Background: Patients infected with coronavirus 2 (SARS-CoV-2) appear to be at increased risk for venous thromboembolism (VTE), especially if they become critically ill with coronavirus disease 2019 (COVID-19). Some centers have reported very high rates of thrombosis despite anticoagulant prophylaxis.Methods: The electronic health record (EHR) of a New Orleans-based health system was searched for all patients with PCR-confirmed SARS-CoV-2 infection who were either admitted to hospital or treated and discharged from an emergency department between March 1 and May 1, 2020. From this cohort, patients with confirmed VTE (either during or after their hospital encounter) were identified by administrative query of the EHR.Results: Between March 1, 2020 and May 1, 2020, 6,153 patients with COVID-19 were identified; 2,748 of these patients were admitted, while 3,405 received care exclusively through the emergency department. Data on patient outcomes were determined up until and including May 21, 2020. In total, 637 patients required mechanical ventilation and 206 required renal replacement therapy. Within the hospitalized cohort, the overall mortality rate was 24.5% and VTE occurred in 86 patients (3.1%). In the 637 patients who required mechanical ventilation at some point during their hospital stay, 45 developed VTE (7.2%). After a median follow-up of 14.6 days, VTE had been diagnosed in 3 of the 2,075 admitted who were discharged alive (0.14%).Conclusions: Among 6,153 patients with COVID-19 who were hospitalized or treated in emergency departments, we did not find evidence of unusually high VTE risk. Pending further evidence from prospective, controlled trials, our findings support a traditional approach to primary VTE prevention in patients with COVID-19.DisclosuresCrowther:Precision Biologicals: Membership on an entity's Board of Directors or advisory committees; Hemostais Reference Laboratories: Honoraria; Pfizer: Speakers Bureau; CSL Behring: Speakers Bureau; Alnylam: Divested equity in a private or publicly-traded company in the past 24 months; Servier Canada: Membership on an entity's Board of Directors or advisory committees; Diagnostica Stago: Speakers Bureau; Asahi Kasei: Membership on an entity's Board of Directors or advisory committees.