scholarly journals Design and Baseline Data for a Prospective Observational Study of Rivaroxaban in Patients with Venous Thromboembolism in Japan (XASSENT)

TH Open ◽  
2021 ◽  
Author(s):  
Ikuo Fukuda ◽  
Atsushi Hirayama ◽  
Kazuo Kawasugi ◽  
Takao Kobayashi ◽  
Hideaki Maeda ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Venous Thromboembolism ◽  
Patient Characteristics ◽  
Open Label ◽  
Phase 3 ◽  
Vein Thrombosis ◽  
Post Marketing Surveillance ◽  
Post Marketing ◽  
History Of ◽  
Deep Vein

Background The efficacy and safety of rivaroxaban have been demonstrated in phase 3 trials of patients with venous thromboembolism (VTE; pulmonary embolism [PE] and deep vein thrombosis [DVT]). Data regarding rivaroxaban treatment of VTE in routine Japanese clinical practice remain limited. Objectives XASSENT will evaluate rivaroxaban treatment of VTE in real-world Japanese clinical practice. We report the study design and baseline patient characteristics. Methods XASSENT (NCT02558465) is a an open-label, prospective observational, post-marketing surveillance cohort study in patients receiving rivaroxaban treatment for VTE. Enrolment took place between November 2015 and March 2018. XASSENT will follow patients for up to 2 years. Primary outcome variables: major bleeding and symptomatic recurrent VTE. Statistical analyses are exploratory and descriptive. Results Baseline patient characteristics at June 2020 (n=2,299) are presented (58.2% female; mean age 66.7 years; mean weight 60.9kg). The population encompasses patients with wide-ranging characteristics including older age, low weight, and renal dysfunction. Most participants (67.6%) had a history of VTE risk factors at baseline. Half of the population (50.4%) had DVT only; 41.4% had DVT with PE; 8.2% had PE only. Overall, 68.4% were inpatients and 77.1% had symptomatic VTE. Rivaroxaban was prescribed for initial treatment in 84.6% of patients and maintenance treatment in 15.4%. Most were prescribed the approved dose of rivaroxaban for initial (30mg daily; 84.4%) or maintenance (15mg daily; 81.9%) treatment of VTE in Japan. The most common reason for selecting non-recommended dose was ‘elderly’. Conclusions Results from XASSENT will complement phase 3 trial data and inform clinical practice.

scholarly journals A Case Series of Non-Hodgkin's Lymphoma Recurrence in Lower Extremities Mimicking Deep Vein Thrombosis

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 5344-5344
Author(s):  
Shelly Ann Christiansen ◽  
Philip Cohen ◽  
Catherine Broome
Keyword(s):  
Lower Extremity ◽  
Inguinal Lymph Node ◽  
Bone Biopsy ◽  
Patient Characteristics ◽  
Ct Guided ◽  
Vein Thrombosis ◽  
Pet Ct ◽  
History Of ◽  
Relapsed Disease ◽  
Deep Vein

Background: While uncommon, non-Hodgkin's Lymphoma (NHL) can relapse in extranodal sites in the lower extremities. It is well established that venous thomboembolism occurs in higher incidence in patients with underlying malignancy. We describe 3 cases of NHL in which relapsed disease was discovered after lower extremity swelling prompted evaluation for deep vein thrombosis (DVT), and revealed recurrent NHL. CASE 1: A 61 YO F with history of Stage IEA Marginal Zone Lymphoma (MZL) of the dura diagnosed in 2012 received treatment with whole-brain and local brain radiation. In 2016 she developed recurrence in cervical lymph nodes. Six months after receiving 4 cycles of bendamustine and rituximab she developed left leg pain and calf swelling. PET/CT showed a hypermetabolic lesion in left tibia. MRI confirmed large lesion in mid-shaft of tibia extending down the length of the bone. CT-guided bone biopsy confirmed MZL. CASE 2: A 67 YO F with history of triple-negative inflammatory breast cancer treated in 2000 with neoadjuvant chemotherapy and mastectomy. PET/CT in 2008 showed 2 left femoral lesions. She underwent CT-guided bone biopsy of femoral lesion which confirmed follicular lymphoma (FL). Interim PET/CT in 2010 showed decreased FDG uptake in left femur. She was followed with watchful waiting. Then in 2014 patient developed leg swelling and pain, thought to be a DVT. Duplex ultrasound of the lower extremity was negative. PET/CT showed a left inguinal mass and left calf mass. MRI confirmed large mass within the left lower leg centered on the left fibular diaphysis with a very large associated soft tissue component with extensive muscular and neurovascular involvement. Biopsy of left inguinal lymph node confirmed diffuse large B-Cell lymphoma (DLBCL). CASE 3: A 61 YO M with history Stage IV FL in 1988 and initially treated with 4 cycles of PROMACE-CytaBOM. He relapsed nodally in 1995 and was treated on the IDEC investigational protocol with rituximab which led to a complete remission. In 2001 he developed a subcutaneous nodule on his back, biopsy showed FL, grade 1. A staging CT scan of neck, chest, abdomen, and pelvis was unremarkable, but a PET scan showed left axillary disease. He was re-treated with rituximab and local radiation which led to a complete response. Patient presented in 2008 with right calf swelling. Ultrasound at that time showed no DVT but confirmed swelling and suggested right inguinal adenopathy. PET/CT showed FDG uptake in multiple areas in groin and pelvis plus extensive uptake in thickened calf muscles extending from the right knee to the toe. Biopsy of right inguinal lymph node confirmed FL. Conclusion: Among NHLs, relapse patterns can vary significantly. Timing and frequency of relapse is largely dependent on whether NHL is classified as indolent or aggressive. However, location of relapsed disease in NHL is less well established. NHL relapse can occur in a fashion mimicking DVT with lower extremity swelling. When patients with history of NHL present with lower extremity swelling, relapsed disease should be included in the differential diagnosis. Table Patient characteristics Table. Patient characteristics Disclosures Cohen: Takeda Oncology: Honoraria; Pharmacyclics: Honoraria; Seattle Genetics: Honoraria; Amgen: Honoraria. Broome:True North Therapeutics: Honoraria; Alexion Pharmaceuricals: Honoraria.

Multimodal prophylaxis in patients with a history of venous thromboembolism undergoing primary elective hip arthroplasty

2020 ◽  
Vol 102-B (7_Supple_B) ◽  
pp. 71-77
Author(s):  
Alejandro Gonzalez Della Valle ◽  
Kate A. Shanaghan ◽  
Joseph Nguyen ◽  
Jiabin Liu ◽  
Stavros Memtsoudis ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Hip Arthroplasty ◽  
Vena Cava ◽  
Haemorrhagic Stroke ◽  
International Normalized Ratio ◽  
First Year ◽  
Vein Thrombosis ◽  
History Of ◽  
One Year ◽  
Deep Vein

Aims We studied the safety and efficacy of multimodal thromboprophylaxis in patients with a history of venous thromboembolism (VTE) who undergo total hip arthroplasty (THA) within the first 120 postoperative days, and the mortality during the first year. Multimodal prophylaxis includes discontinuation of procoagulant medications, VTE risk stratification, regional anaesthesia, an intravenous bolus of unfractionated heparin prior to femoral preparation, rapid mobilization, the use of pneumatic compression devices, and chemoprophylaxis tailored to the patient’s risk of VTE. Methods Between 2004 to 2018, 257 patients with a proven history of VTE underwent 277 primary elective THA procedures by two surgeons at a single institution. The patients had a history of deep vein thrombosis (DVT) (186, 67%), pulmonary embolism (PE) (43, 15.5%), or both (48, 17.5%). Chemoprophylaxis included aspirin (38 patients), anticoagulation (215 patients), or a combination of aspirin and anticoagulation (24 patients). A total of 50 patients (18%) had a vena cava filter in situ at the time of surgery. Patients were followed for 120 days to record complications, and for one year to record mortality. Results Postoperative VTE was diagnosed in seven patients (2.5%): DVT in five, and PE with and without DVT in one patient each. After hospitalization, three patients required readmiss-ion for evacuation of a haematoma, one for wound drainage, and one for monitoring of an elevated international normalized ratio (INR). Seven patients died (2.5%). One patient died five months postoperatively of a PE during open thrombectomy. She had discontinued anticoagulation. One patient died of a haemorrhagic stroke while receiving Coumadin. PE or bleeding was not suspected in the remaining five fatalities. Conclusion Multimodal prophylaxis is safe and effective in patients with a history of VTE. Postoperative anticoagulation should be prudent as very few patients developed VTE (2.5%) or died of suspected or confirmed PE. Mortality during the first year was mostly unrelated to either VTE or bleeding. Cite this article: Bone Joint J 2020;102-B(7 Supple B):71–77.

scholarly journals The management of acute venous thromboembolism in clinical practice

2017 ◽  
Vol 117 (07) ◽  
pp. 1326-1337 ◽  
Author(s):  
Alexander T. Cohen ◽  
Anselm K. Gitt ◽  
Rupert Bauersachs ◽  
Eva-Maria Fronk ◽  
Petra Laeis ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Venous Thromboembolism ◽  
Real World ◽  
Hospital Setting ◽  
Initial Therapy ◽  
Full Spectrum ◽  
Vein Thrombosis ◽  
Using Data ◽  
Acute Venous Thromboembolism ◽  
Deep Vein

SummaryVenous thromboembolism (VTE) is a significant cause of morbidity and mortality in Europe. Data from real-world registries are necessary, as clinical trials do not represent the full spectrum of VTE patients seen in clinical practice. We aimed to document the epidemiology, management and outcomes of VTE using data from a large, observational database. PREFER in VTE was an international, non-interventional disease registry conducted between January 2013 and July 2015 in primary and secondary care across seven European countries. Consecutive patients with acute VTE were documented and followed up over 12 months. PREFER in VTE included 3,455 patients with a mean age of 60.8 ± 17.0 years. Overall, 53.0% were male. The majority of patients were assessed in the hospital setting as inpatients or outpatients (78.5%). The diagnosis was deep-vein thrombosis (DVT) in 59.5% and pulmonary embolism (PE) in 40.5%. The most common comorbidities were the various types of cardiovascular disease (excluding hypertension; 45.5%), hypertension (42.3%) and dyslipidaemia (21.1%). Following the index VTE, a large proportion of patients received initial therapy with heparin (73.2%), almost half received a vitamin K antagonist (48.7%) and nearly a quarter received a DOAC (24.5%). Almost a quarter of all presentations were for recurrent VTE, with >80% of previous episodes having occurred more than 12 months prior to baseline. In conclusion, PREFER in VTE has provided contemporary insights into VTE patients and their real-world management, including their baseline characteristics, risk factors, disease history, symptoms and signs, initial therapy and outcomes.

scholarly journals Pregnancy-Associated Venous Thromboembolism: Insights from GARFIELD-VTE

TH Open ◽  
2021 ◽  
Vol 05 (01) ◽  
pp. e24-e34
Author(s):  
Carlos Jerjes-Sánchez ◽  
David Rodriguez ◽  
Alfredo E. Farjat ◽  
Gloria Kayani ◽  
Peter MacCallum ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Vitamin K Antagonists ◽  
Childbearing Age ◽  
Diagnostic Strategies ◽  
Vein Thrombosis ◽  
All Cause Mortality ◽  
History Of ◽  
Common Risk Factors ◽  
Deep Vein ◽  
Compression Ultrasonography

Abstract Introduction The risk of venous thromboembolism (VTE) increases during pregnancy and the puerperium such that VTE is a leading cause of maternal mortality. Methods We describe the clinical characteristics, diagnostic strategies, treatment patterns, and outcomes of women with pregnancy-associated VTE (PA-VTE) enrolled in the Global Anticoagulant Registry in the FIELD (GARFIELD)-VTE. Women of childbearing age (<45 years) were stratified into those with PA-VTE (n = 183), which included pregnant patients and those within the puerperium, and those with nonpregnancy associated VTE (NPA-VTE; n = 1,187). Patients with PA-VTE were not stratified based upon the stage of pregnancy or puerperium. Results Women with PA-VTE were younger (30.5 vs. 34.8 years), less likely to have pulmonary embolism (PE) (19.7 vs. 32.3%) and more likely to have left-sided deep vein thrombosis (DVT) (73.9 vs. 54.8%) compared with those with NPA-VTE. The most common risk factors in PA-VTE patients were hospitalization (10.4%), previous surgery (10.4%), and family history of VTE (9.3%). DVT was typically diagnosed by compression ultrasonography (98.7%) and PE by chest computed tomography (75.0%). PA-VTE patients more often received parenteral (43.2 vs. 15.1%) or vitamin K antagonists (VKA) (9.3 vs. 7.6%) therapy alone. NPA-VTE patients more often received a DOAC alone (30.2 vs. 13.7%). The risk (hazard ratio [95% confidence interval]) of all-cause mortality (0.59 [0.18–1.98]), recurrent VTE (0.82 [0.34–1.94]), and major bleeding (1.13 [0.33–3.90]) were comparable between PA-VTE and NPA-VTE patients. Uterine bleeding was the most common complication in both groups. Conclusion VKAs or DOACs are widely used for treatment of PA-VTE despite limited evidence for their use in this population. Rates of clinical outcomes were comparable between groups.

Apixaban versus Dalteparin for the Treatment of Acute Venous Thromboembolism in Patients with Cancer: The Caravaggio Study

2018 ◽  
Vol 118 (09) ◽  
pp. 1668-1678 ◽  
Author(s):  
Giancarlo Agnelli ◽  
Cecilia Becattini ◽  
Rupert Bauersachs ◽  
Benjamin Brenner ◽  
Mauro Campanini ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Primary Outcome ◽  
National Guidelines ◽  
Open Label ◽  
Safety Outcome ◽  
Vein Thrombosis ◽  
Patients With Cancer ◽  
Acute Venous Thromboembolism ◽  
Deep Vein ◽  
To Receive

AbstractInternational and national guidelines recommend low-molecular-weight heparin for the treatment of venous thromboembolism (VTE) in patients with cancer. The aim of the Caravaggio study is to assess whether oral apixaban is non-inferior to subcutaneous dalteparin for the treatment of acute proximal deep vein thrombosis and/or pulmonary embolism in patients with cancer. The study is an investigator-initiated, multi-national, prospective, randomized, open-label with blind end-point evaluation (PROBE), non-inferiority clinical trial (NCT03045406). Consecutive patients are randomized to receive oral apixaban or subcutaneous dalteparin for 6 months. Apixaban is given at a dose of 10 mg twice daily for the first 7 days and then 5 mg twice daily; dalteparin is given at a dose of 200 IU/kg for the first month and then 150 IU/kg once daily. The primary outcome of the study is objectively confirmed recurrent VTE as assessed by a central independent adjudication committee unaware of study treatment allocation. The primary safety outcome is major bleeding defined according to the guidelines of the International Society of Thrombosis and Haemostasis. Assuming a 6-month incidence of the primary outcome of 7% with dalteparin and an upper limit of the two-sided 95% confidence interval of the hazard ratio below the pre-specified margin of 2.00, 1,168 patients will be randomized considering an up to 20% loss in total patient-years (β = 80%; α one-sided = 0.025). The Caravaggio study has the potential, along with other recently performed or on-going studies, to make less cumbersome the management of VTE in patients with cancer by replacing parenteral with oral anticoagulation.

Altered fibrin clot structure/function in patients with idiopathic venous thromboembolism and in their relatives

Blood ◽  
2009 ◽  
Vol 114 (19) ◽  
pp. 4272-4278 ◽  
Author(s):  
Anetta Undas ◽  
Krystyna Zawilska ◽  
Mariola Ciesla-Dul ◽  
Agata Lehmann-Kopydłowska ◽  
Agnieszka Skubiszak ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Structure Function ◽  
Ex Vivo ◽  
Fibrin Clot ◽  
Clot Lysis ◽  
Vein Thrombosis ◽  
Reactive Protein ◽  
History Of ◽  
Deep Vein ◽  
Clot Structure

Abstract We tested the hypothesis that fibrin structure/function is unfavorably altered in patients after idiopathic venous thromboembolism (VTE) and their relatives. Ex vivo plasma fibrin clot permeability, turbidimetry, and efficiency of fibrinolysis were investigated in 100 patients with first-ever VTE, including 34 with pulmonary embolism (PE), 100 first-degree relatives, and 100 asymptomatic controls with no history of thrombotic events. Known thrombophilia, cancer, trauma, and surgery were exclusion criteria. VTE patients and their relatives were characterized by lower clot permeability (P < .001), lower compaction (P < .001), higher maximum clot absorbancy (P < .001), and prolonged clot lysis time (P < .001) than controls, with more pronounced abnormalities, except maximum clot absorbance, in the patients versus relatives (all P < .01). Fibrin clots obtained for PE patients were more permeable, less compact, and were lysed more efficiently compared with deep-vein thrombosis patients (all P < .05) with no differences in their relatives. Being VTE relative, fibrinogen, and C-reactive protein were independent predictors of clot permeability and fibrinolysis time in combined analysis of controls and relatives. We conclude that altered fibrin clot features are associated with idiopathic VTE with a different profile of fibrin variables in PE. Similar features can be detected in VTE relatives. Fibrin properties might represent novel risk factors for thrombosis.

scholarly journals Symptomatic perioperative venous thromboembolism is a frequent complication in patients with a history of deep vein thrombosis

2010 ◽  
Vol 52 (3) ◽  
pp. 651-657 ◽  
Author(s):  
Timothy K. Liem ◽  
Thanh M. Huynh ◽  
Shannon E. Moseley ◽  
Renee C. Minjarez ◽  
Gregory J. Landry ◽  
...  
Keyword(s):  
Deep Vein Thrombosis ◽  
Venous Thromboembolism ◽  
Frequent Complication ◽  
Vein Thrombosis ◽  
History Of ◽  
Deep Vein

scholarly journals Presenting Characteristics, Treatment Patterns, and Outcomes among Patients with Venous Thromboembolism during Hospitalization for COVID-19

2020 ◽  
Author(s):  
Carmen Fernández-Capitán ◽  
Raquel Barba ◽  
María del Carmen Díaz-Pedroche ◽  
Patricia Sigüenza ◽  
Pablo Demelo-Rodriguez ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Major Bleeding ◽  
Optimal Strategies ◽  
Patient Characteristics ◽  
Treatment Patterns ◽  
Adverse Outcomes ◽  
Vein Thrombosis ◽  
Medical Wards ◽  
Deep Vein ◽  
Hospital Wards

AbstractVenous thromboembolism (VTE) is common in patients with coronavirus disease-2019 (COVID-19). However, limited data exist on patient characteristics, treatments, and outcomes. To describe the clinical characteristics, treatment patterns, and short-term outcomes of patients diagnosed with VTE during hospitalization for COVID-19. This is a prospective multinational study of patients with incident VTE during the course of hospitalization for COVID-19. Data were obtained from the Registro Informatizado de la Enfermedad TromboEmbólica (RIETE) registry. All-cause mortality, VTE recurrences, and major bleeding during the first 10 days were separately investigated for patients in hospital wards versus those in intensive care units (ICUs). As of May 03, 2020, a total number of 455 patients were diagnosed with VTE (83% pulmonary embolism, 17% isolated deep vein thrombosis) during their hospital stay; 71% were male, the median age was 65 (interquartile range, 55–74) years. Most patients (68%) were hospitalized in medical wards, and 145 in ICUs. Three hundred and seventeen (88%; 95% confidence interval [CI]: 84–91%) patients were receiving thromboprophylaxis at the time of VTE diagnosis. Most patients (88%) received therapeutic low-molecular-weight heparin, and 15 (3.6%) received reperfusion therapies. Among 420 patients with complete 10-day follow-up, 51 (12%; 95% CI: 9.3–15%) died, no patient recurred, and 12 (2.9%; 95% CI: 1.6–4.8%) experienced major bleeding. The 10-day mortality rate was 9.1% (95% CI: 6.1–13%) among patients in hospital wards and 19% (95% CI: 13–26%) among those in ICUs. This study provides characteristics and early outcomes of patients diagnosed with acute VTE during hospitalization for COVID-19. Additional studies are needed to identify the optimal strategies to prevent VTE and to mitigate adverse outcomes associated.

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