scholarly journals Extended Anticoagulant Treatment with Full- or Reduced-Dose Apixaban in Patients with Cancer-Associated Venous Thromboembolism: the API-CAT Study

2021 ◽  
Author(s):  
Isabelle Mahé ◽  
Giancarlo Agnelli ◽  
Cihan Ay ◽  
Aristotle Bamias ◽  
Cecilia Becattini ◽  
...  
Keyword(s):  
Dose Regimen ◽  
Double Blind ◽  
Vein Thrombosis ◽  
Reduced Dose ◽  
Venous Thromboembolic Events ◽  
Safety Endpoint ◽  
Venous Thromboembolic ◽  
Recurrent Vte ◽  
Cancer Associated Thrombosis ◽  
Active Cancer

Cancer-associated thrombosis (CAT) is associated with a high risk of recurrent venous thromboembolic events (VTE) that require extended anticoagulation in patients with active cancer, putting them at risk of bleeding.The aim of the API-CAT study (NCT03692065) is to assess whether a reduced-dose regimen of apixaban (2.5 mg twice daily [bid]) is non-inferior to a full-dose regimen of apixaban (5 mg bid) for the prevention of recurrent VTE in patients with active cancer who have completed ≥6 months of anticoagulant therapy for a documented index event of proximal deep-vein thrombosis and/or pulmonary embolism.APICAT is an international, randomized, parallel-group, double-blind, non-inferiority trial with blinded adjudication of outcome events. Consecutive patients are randomized to receive apixaban 2.5 mg or 5 mg bid for 12 months. The primary efficacy outcome is a composite of recurrent symptomatic or incidental VTE during the treatment period. The principal safety endpoint is clinically relevant bleeding, defined as a composite of major bleeding or non-major clinically relevant bleeding. Assuming a 12-month incidence of the primary outcome of 4% with apixaban and an upper limit of the 2-sided 95% confidence interval of the hazard ratio <2.0, 1722 patients will be randomized,assuming an up to 10% loss in total patient-years (β = 80%; α 1-sided = 0.025). This trialhas the potential to demonstrate that a regimen of extended treatment for patients with CAT beyond an initial 6 months, with a reduced apixaban dose,has an acceptable risk of recurrent VTE recurrence and decreases the risk of bleeding.

scholarly journals Recurrence of Upper Extremity Deep Vein Thrombosis Secondary to COVID-19

Viruses ◽  
2021 ◽  
Vol 13 (5) ◽  
pp. 878
Author(s):  
Yesha H. Parekh ◽  
Nicole J. Altomare ◽  
Erin P. McDonnell ◽  
Martin J. Blaser ◽  
Payal D. Parikh
Keyword(s):  
Deep Vein Thrombosis ◽  
Lower Extremity ◽  
Upper Extremity ◽  
Thromboembolic Events ◽  
Vein Thrombosis ◽  
Venous Thromboembolic Events ◽  
Venous Thromboembolic ◽  
Deep Vein

Infection with SARS-CoV-2 leading to COVID-19 induces hyperinflammatory and hypercoagulable states, resulting in arterial and venous thromboembolic events. Deep vein thrombosis (DVT) has been well reported in COVID-19 patients. While most DVTs occur in a lower extremity, involvement of the upper extremity is uncommon. In this report, we describe the first reported patient with an upper extremity DVT recurrence secondary to COVID-19 infection.

scholarly journals Screening for Cancer in Patients with Acute Venous Thromboembolic Disease

2021 ◽  
Vol 41 (01) ◽  
pp. 042-047
Author(s):  
Marc Blondon
Keyword(s):  
Cancer Screening ◽  
Whole Body ◽  
Care Providers ◽  
Vein Thrombosis ◽  
Risk Assessment Models ◽  
Occult Cancer ◽  
Pet Ct ◽  
Venous Thromboembolic ◽  
Deep Vein ◽  
Active Cancer

AbstractActive cancer causes approximately 25% of all acute events of venous thromboembolism (VTE). While most of the cancer diagnoses are known or clinically apparent at the time of VTE, care providers and patients may be worried about the 3 to 8% risk of occult cancer occurring in the year after VTE. Several studies have compared limited to extensive cancer screening after acute VTE, especially with the addition of abdominal computed tomography (CT) or whole-body PET-CT, with the hope to shorten the time to cancer diagnosis and lead to less advanced cancer stages. These studies have not shown improved clinical outcomes with an extensive screening, and have led to current recommendations of limited screening for cancer in patients with acute VTE, including unprovoked cases. Several risk assessment models have been developed to identify patients at greatest risk of occult cancer, however, with low discriminative performances and no current clinical usefulness. Some clinical situations may empirically deserve a more thorough cancer screening, such as unprovoked upper extremity deep vein thrombosis (DVT), bilateral leg DVT, descending leg DVT, or recurrent VTE during anticoagulation.

scholarly journals Predicting Venous Thromboembolic Events in Patients with Coronavirus Disease 2019 Requiring Hospitalization: an Observational Retrospective Study by the COVIDIC Initiative in a Swiss University Hospital

2020 ◽  
Vol 2020 ◽  
pp. 1-11 ◽  
Author(s):  
Eleftheria Kampouri ◽  
Paraskevas Filippidis ◽  
Benjamin Viala ◽  
Marie Méan ◽  
Olivier Pantet ◽  
...  
Keyword(s):  
Deep Vein Thrombosis ◽  
Retrospective Study ◽  
University Hospital ◽  
Thromboembolic Events ◽  
Vein Thrombosis ◽  
Venous Thromboembolic Events ◽  
Venous Thromboembolic ◽  
Wells Score ◽  
Deep Vein ◽  
D Dimer

Background. Coronavirus disease 2019 (COVID-19) can result in profound changes in blood coagulation. The aim of the study was to determine the incidence and predictors of venous thromboembolic events (VTE) among patients with COVID-19 requiring hospital admission. Subjects and Methods. We performed a retrospective study at the Lausanne University Hospital with patients admitted because of COVID-19 from February 28 to April 30, 2020. Results. Among 443 patients with COVID-19, VTE was diagnosed in 41 patients (9.3%; 27 pulmonary embolisms, 12 deep vein thrombosis, one pulmonary embolism and deep vein thrombosis, one portal vein thrombosis). VTE was diagnosed already upon admission in 14 (34.1%) patients and 27 (65.9%) during hospital stay (18 in ICU and nine in wards outside the ICU). Multivariate analysis revealed D-dimer value > 3,120   ng / ml ( P < 0.001 ; OR 15.8, 95% CI 4.7-52.9) and duration of 8 days or more from COVID-19 symptoms onset to presentation ( P 0.020; OR 4.8, 95% CI 1.3-18.3) to be independently associated with VTE upon admission. D-dimer value ≥ 3,000   ng / l combined with a Wells score for PE ≥ 2 was highly specific (sensitivity 57.1%, specificity 91.6%) in detecting VTE upon admission. Development of VTE during hospitalization was independently associated with D-dimer value > 5,611   ng / ml ( P < 0.001 ; OR 6.3, 95% CI 2.4-16.2) and mechanical ventilation ( P < 0.001 ; OR 5.9, 95% CI 2.3-15.1). Conclusions. VTE seems to be a common COVID-19 complication upon admission and during hospitalization, especially in ICU. The combination of Wells ≥ 2 score and D − dimer ≥ 3,000   ng / l is a good predictor of VTE at admission.

The EINSTEIN DVT Study: Does Localization of the Initial DVT Affect the Occurrence of Recurrent VTE While Patients Are on Anticoagulation?

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 207-207
Author(s):  
Martin H Prins ◽  
Paolo Prandoni ◽  
Anthonie WA Lensing ◽  
Bonno van Bellen ◽  
Akos F Pap ◽  
...  
Keyword(s):  
Board Of Directors ◽  
Research Funding ◽  
Recurrent Events ◽  
Femoral Vein ◽  
Popliteal Vein ◽  
Advisory Committees ◽  
Common Femoral Vein ◽  
Vein Thrombosis ◽  
Venous Thromboembolic Events ◽  
Recurrent Vte

Abstract Abstract 207 Background: The extent of deep vein thrombosis (DVT) is, for many physicians, an important variable that is considered in decisions on the type and duration of anticoagulant treatment. Although it has been consistently demonstrated that localization of the initial DVT is a powerful and independent predictor of recurrent venous thromboembolism (VTE) after discontinuation of anticoagulation (Baglin T et al. J Thromb Haemost 2010;8:2436–2442), it remains unknown to what extent localization of the initial DVT affects the occurrence of recurrent VTE while patients are on anticoagulation. Data from the EINSTEIN DVT study, which randomized 3,449 patients with proximal DVT, offers an opportunity to investigate this question. Aim: To investigate whether localization of the initial DVT was predictive of the rate of recurrent venous thromboembolic events in the whole cohort of patients in the EINSTEIN DVT study, in those who received rivaroxaban, or in those who received conventional anticoagulation with enoxaparin plus vitamin K antagonists (VKA) followed by VKA alone. Methods: Patients were randomized to rivaroxaban or enoxaparin plus VKA followed by VKA only for intended treatment durations of 3, 6, or 12 months. Patients were grouped into four categories according to the extent of the proximal vein thrombosis that was recorded at baseline: 1) popliteal vein alone; 2) popliteal and superficial femoral vein; 3) popliteal, superficial femoral, and common femoral vein; and 4) all combinations of DVT without popliteal vein involvement. Patients were followed for recurrent events. All baseline and recurrent events were assessed by a central independent adjudication committee that was unaware of treatment allocation. The effect of thrombus location on the incidence of recurrent VTE was assessed using a Cox proportional hazard model. Results: Recurrent VTE occurred in 21/1,040 (2.0%) patients with popliteal vein thrombosis only; in 28/1,002 (2.8%) patients with thrombosis located in the popliteal and superficial femoral vein; in 26/935 (2.8%) patients with thrombosis in the popliteal, superficial femoral, and common femoral vein (± iliac vein); and in 11/370 (3.0%) patients without popliteal vein involvement. None of these differences was statistically significant (p=0.87). The relative effect of rivaroxaban versus enoxaparin/VKA was similar in these subgroups (Table). Conclusions: At baseline, most patients in the EINSTEIN DVT study had thrombosis that involved more than one proximal vein. While patients were on treatment, the extent of the DVT at baseline was not predictive for recurrent VTE irrespective of type of treatment. Patients with extensive thrombosis (i.e. popliteal, superficial femoral, and common femoral vein involvement) had a recurrence rate below 3%, which was similar to the rate of recurrence in patients with thrombosis in only one vein at baseline. In summary, this analysis suggests that the localization and extent of the initial DVT was not predictive of the rate of recurrent venous thromboembolic events in the EINSTEIN DVT patient population while patients were on anticoagulation. Character count: 2670/3800 (spaces excluded) (2983 including table) Disclosures: Prins: Bayer HealthCare: Consultancy, Honoraria. Prandoni:GSK: Membership on an entity's Board of Directors or advisory committees. Lensing:Bayer HealthCare AG: Employment. van Bellen:Bayer: Membership on an entity's Board of Directors or advisory committees, Research Funding. Pap:Bayer HealthCare AG: Employment. Raskob:Bayer: Consultancy, Honoraria; Johnson & Johnson: Consultancy, Honoraria; BMS: Consultancy, Honoraria; Pfizer: Consultancy, Honoraria; Daiichi Sankyo: Consultancy, Honoraria; Boehringer-Ingelhiem: Consultancy, Honoraria; Takeda: Consultancy, Honoraria; GSK: Consultancy, Honoraria; Sanofi-Aventis: Consultancy, Honoraria. Büller:Sanofi-aventis: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Bayer HealthCare: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Bristol-Meyers Squibb: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Daiichi-Sankyo: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; GlaxoSmithKline: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Pfizer: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Roche: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding.

Evaluation of Rivaroxaban and Dalteparin in Cancer Associated Thrombosis

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 432-432
Author(s):  
Ateefa Chaudhury ◽  
Asha Balakrishnan ◽  
Christy Thai ◽  
Bjorn Holmstrom ◽  
Michael V. Jaglal
Keyword(s):  
Cancer Patients ◽  
Anticoagulant Therapy ◽  
Major Bleeding ◽  
Cancer Center ◽  
Minor Bleeding ◽  
Efficacy And Safety ◽  
Recurrent Vte ◽  
Chi Square Analysis ◽  
Cancer Associated Thrombosis ◽  
Active Cancer

Abstract Introduction: Venous thromboembolism (VTE) in the form of deep venous thrombosis (DVT) or pulmonary embolism (PE) is a complication of malignancy. Several studies have demonstrated the superiority of dalteparin (Fragmin®), a low molecular weight heparin (LMWH), in comparison to oral vitamin K antagonists in preventing VTE recurrence in the setting of active cancer. LMWH is the preferred treatment of cancer associated thrombosis. However, the cost of LMWH can be prohibitive and the need for daily subcutaneous injections can decrease patients' quality of life. While rivaroxaban (Xarelto®), a Factor Xa inhibitor, has been approved for the treatment and secondary prevention of DVT and PE, there is limited data regarding its use in cancer patients. The objective of our study is to determine the efficacy and safety of rivaroxaban compared to dalteparin in cancer associated thrombosis. Methods: This is a retrospective chart review of cancer patients greater than age 18 treated at H. Lee Moffitt Cancer Center between May 3, 2010 and June 30, 2015 on anticoagulation with rivaroxaban or dalteparin. Patients were excluded if the length of anticoagulant therapy was < 30 days, anticoagulant therapy was initiated > 6 months after VTE diagnosis, the indication for treatment was not DVT/PE, if patients had contraindications to either LMWH or rivaroxaban, or patients were not on treatment doses of therapy. Out of 459 patients identified, 226 patients (107 in the rivaroxaban group, and 119 in the dalteparin group) were eligible for analysis based on our exclusion criteria. Efficacy was determined by the incidence of recurrent VTE, such as recurrent DVT, new fatal or non-fatal PE within 30 days. The secondary endpoint of the study was to determine the safety of rivaroxaban compared to dalteparin in cancer patients for the treatment of VTE. Safety was determined by the incidence and severity of bleeding. Major bleeding was defined as clinically overt if it was associated with a fall in hemoglobin of 2 g/dL or more, required transfusions of ≥ 2 units of packed red blood cells, involved retroperitoneal, intracranial, or critical site bleeding, or if it contributed to death. Minor bleeding was defined as overt bleeding not meeting the criteria for major bleeding but associated with medical intervention, unscheduled contact with a physician, interruption or discontinuation of anticoagulation treatment, or associated with any other discomfort such as pain or impairment of activities of daily life. Descriptive statistical analyses were utilized. Chi square analysis and t- test were performed to compare categorical and continuous variables. All data was analyzed using SPSS version 21.0 statistical software. Results: Rivaroxaban had a similar rate of DVT and PE failure with 1 event versus 2 with dalteparin (p = 0.625). The rivaroxaban group had 0 major and 8 minor bleeds compared to 3 major and 8 minor bleeds in the dalteparin group with p values of 0.09 and 0.86 respectively. Comorbidities and risk factors for thrombosis were similar in both groups as summarized in Table 1. Table. Rivaroxaban vs. Dalteparin: No Significant Differences in the Efficacy and Safety Profile in Cancer Associated Thrombosis RivaroxabanN = 107 DalteparinN =119 P value DVT Failure within 30 days 1 (0.93%) 2 (1.68%) 0.625 PE Failure within 30 days 1 (0.93%) 1 (0.84%) 0.94 Major Bleeding 0 (0 %) 3 (2.5%) 0.09 Minor Bleeding 8 (7.5%) 8 (6.7%) 0.864 Median Age (Yrs) 61 65 0.93 MaleFemale 58 (54.2%) 49 (45.8%) 60 (50.4%) 59 (49.6%) 0.596 Active Cancer 96 (86.5%) 111 (93.2%) 0.350 Surgery within 30 Days 14 (13.1%) 13 (10.9%) 0.684 Hypertension 58 (54.2%) 61 (51.3%) 0.69 Diabetes 14 (13.1%) 14 (11.8%) 0.84 Coronary Artery Disease 6 (5.61%) 11 (9.2%) 0.326 History of Previous DVT 12 (11.2%) 5 (4.2%) 0.074 BMI >30 39 (36.4%) 48 (40.3%) 0.585 Creatinine Clearance (Cr Cl) 30 - 50 Cr Cl 50 - 70 7 (6.5%) 100 (93.3%) 7 (5.9%) 112 (94.1%) 0.837 Conclusions: Our study evaluated the safety and efficacy of rivaroxaban compared to dalteparin in patients with predominantly active cancer treated at a large comprehensive cancer center and found rivaroxaban to be comparable to dalteparin in this cohort. There were no significant differences in regards to recurrent VTE or major/minor bleeding with patients on rivaroxaban or dalteparin in our cohort of patients. Large randomized trials evaluating the efficacy and safety of rivaroxaban in the oncology population are needed to further validate our findings. Disclosures No relevant conflicts of interest to declare.

Subgroup Analysis of Patients with Cancer in Xalia - a Non-Interventional Study of Rivaroxaban in Routine Treatment of Deep Vein Thrombosis

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 1438-1438 ◽  
Author(s):  
Alexander G G Turpie ◽  
Lorenzo G Mantovani ◽  
Sylvia Haas ◽  
Reinhold Kreutz ◽  
Danja Monje ◽  
...  
Keyword(s):  
Deep Vein Thrombosis ◽  
Venous Thromboembolism ◽  
Major Bleeding ◽  
Research Funding ◽  
Incidence Rates ◽  
Vein Thrombosis ◽  
All Cause Mortality ◽  
Recurrent Vte ◽  
Deep Vein ◽  
Active Cancer

Abstract Background: XALIA is a prospective, non-interventional study of rivaroxaban in the treatment of acute deep vein thrombosis. The overall XALIA results showed that rivaroxaban was associated with similarly low rates of major bleeding and symptomatic recurrent venous thromboembolism (VTE) as standard anticoagulation. A subset of patients in XALIA had active cancer at the time of enrolment into the study. Purpose: To describe the demographics, clinical characteristics, treatment strategies and outcomes of patients in XALIA with cancer and VTE. The primary outcomes were major bleeding, recurrent VTE and all-cause mortality. Methods: Patients with deep vein thrombosis with or without concomitant pulmonary embolism aged ≥18 years who had active cancer and were scheduled to receive ≥3 months of anticoagulation with rivaroxaban or standard therapy were eligible. Therapy type, dose and duration were at the physician's discretion. For the purpose of this substudy, we defined the following treatment cohorts: rivaroxaban cohort (patients treated with rivaroxaban alone or who received heparin/fondaparinux for ≤48 hours before switching to rivaroxaban); early switchers cohort (patients treated with rivaroxaban who received heparin/fondaparinux for >48 hours-14 days and/or a vitamin K antagonist [VKA] for 1-14 days before changing to rivaroxaban); standard anticoagulation cohort (patients treated with heparin/fondaparinux and a VKA or a VKA only); and heparin/fondaparinux cohort (patients treated with heparin/fondaparinux alone). Results: Of 5136 patients in XALIA who received study medication, 587 (11.4%) had active cancer at baseline. Of these, 146 (24.9%) received rivaroxaban, 30 (5.1%) were early switchers, 167 (28.4%) received standard anticoagulation (of which 26 [4.4%] received a VKA only) and 244 (41.6%) received heparin/fondaparinux only, of whom 223 (38.0%) received low molecular weight heparin and the remainder other heparins or fondaparinux. Demographics are shown in Table 1. The most common type of active cancer at baseline in all cohorts was genitourinary, with the exception of the heparin/fondaparinux cohort where gastrointestinal cancer was the most common type (Table 2). The incidence rates for the primary outcomes for each cohort are shown in Figure 1. The rates of major bleeding were highest in the standard anticoagulation cohort (n=8 [4.8%]) and lowest in the early switchers (no major bleeding events occurred). The rates of recurrent VTE were similar in the in the rivaroxaban, early switcher and standard anticoagulation cohorts (n=5 [3.4%], n=1 [3.3%] and n=6 [3.6%], respectively) and were highest in the heparin/fondaparinux cohort (n=12 [4.9%]). All-cause mortality was highest in the heparin/fondaparinux cohort (n=61 [25.0%]) and lowest in the early switchers (no deaths occurred). Conclusions: In the real-world XALIA study, 38.0% of patients with cancer received treatment with low molecular weight heparin, which was in line with guidelines. The remaining patients received rivaroxaban, standard anticoagulation or were early switchers. For the three primary outcomes, the lowest incidence rates were observed in the early switcher cohort. The highest rates were in the standard anticoagulation cohort for major bleeding and the heparin/fondaparinux cohort for recurrent VTE and all-cause mortality; rates for all three primary outcomes were low in the rivaroxaban cohort, suggesting that rivaroxaban may be a safe and effective treatment option for patients with VTE and active cancer. Figure 1 Primary outcomes in patients with active cancer at baseline by treatment group. VTE, venous thromboembolism. Figure 1. Primary outcomes in patients with active cancer at baseline by treatment group. / VTE, venous thromboembolism. Disclosures Turpie: Janssen Research & Development, LLC: Consultancy, Honoraria; Bayer Pharma AG: Consultancy, Honoraria. Mantovani:Janssen-Cilag Ltd: Research Funding; Boehringer Ingelheim: Research Funding; Daiichi Sankyo: Consultancy; Bayer Pharma AG: Consultancy; Pfizer Inc: Research Funding. Haas:Sanofi SA: Consultancy; Pfizer Inc: Consultancy; Daiichi Sankyo: Consultancy; Bristol-Myers Squibb: Consultancy; Bayer Pharma AG: Consultancy; Aspen Pharmacare: Consultancy. Kreutz:Bayer Pharma AG: Honoraria; Servier Laboratories Ltd: Consultancy; Lundbeck Ltd: Consultancy; Daiichi Sankyo: Consultancy; Berlin-Chemie Menarini: Consultancy; Bayer Pharma AG: Consultancy; Bristol-Myers Squibb: Honoraria; Daiichi Sankyo: Honoraria. Monje:Bayer Pharma AG: Employment. Schneider:Bayer Pharma AG: Employment. van Eickels:Bayer Pharma AG: Employment. Gebel:Bayer Pharma AG: Employment. Ageno:Boehringer Ingelheim: Consultancy, Honoraria; Bristol-Myers Squibb: Consultancy, Honoraria; Bayer Pharmaceuticals: Research Funding; Daiichi Sankyo: Consultancy, Honoraria; Bayer Pharma AG: Consultancy, Honoraria.

Prevalence of recurrent thrombosis in cancer patients with isolated gonadal vein thrombosis: A retrospective study.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e19645-e19645
Author(s):  
Suebpong Tanasanvimon ◽  
Naveen Garg ◽  
Chitra Viswanathan ◽  
Milind M. Javle ◽  
Mylene Truong ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Metastatic Disease ◽  
Vena Cava ◽  
Cancer Center ◽  
Vein Thrombosis ◽  
Gonadal Vein ◽  
Radiology Reports ◽  
Recurrent Vte ◽  
Active Cancer

e19645 Background: The natural history of isolated gonadal vein thrombosis (GVT) occurring in cancer patients (pts) is not well described in the medical literature. GVT in cancer pts it is of uncertain clinical significance. Methods: Utilizing a software program allowing a searchable database of radiology reports, the computerized tomographic scan (CT) reports of pts at a single cancer center from January 1, 2004 to June 30, 2011, were searched for the term “gonadal vein thrombus”. Pts included in this analysis had a diagnosis of cancer, isolated GVT (i.e. no evidence of thrombosis at another site), and at least six months of follow-up information. Results: 162 cancer pts with GVT were identified for analysis [median age 57.8 ± 12 years, right GVT 89 pts (54.9%), left GVT 59 pts (36.4%), bilateral 14 pts (8.6%)]; the majority of the pts (96, 59.3%) had a non-gynecologic malignancy. At the time of diagnosis of GVT the majority of pts were receiving chemotherapy (84, 51.9%); 70 pts (43.2%) had surgery within the prior six months (the most common being hysterectomy, 127 pts, 78.6%). The majority of pts in this study had metastatic disease (93, 57.4%) as well as active cancer (138, 85.1%, defined as GVT occurring at the time of cancer diagnosis, disease recurrence, metastatic disease, or treatment for cancer within the prior six months); median follow-up time was 22 months. A minority of pts received anticoagulation (28pts, 17.2%). Twenty-two pts (13.6%) developed a recurrent venous thromboembolic event (VTE); these events were pulmonary embolism (12 pts, 7.4%), deep venous thrombosis (5 pts, 3.1%), inferior vena cava thrombosis (4 pts, 2.5%). Median time to development of re-thrombosis was 7 months (range 2-13.5 months). Active cancer was the only risk factor significantly associated with recurrent VTE (p = 0.047); pts with prior hysterectomy had a significantly reduced risk of recurrent VTE (p = 0.036). Conclusions: Incidental isolated GVT identified in cancer pts has a high risk of recurrent VTE (13.6%). Based upon specific pts risk factors for VTE, treatment of an incidentally detected GVT in cancer pts with anticoagulation, as per guidelines for other VTE sites, may be indicated.

A randomized, double-blind, phase II study of first-line FOLFOX plus bevacizumab with onartuzumab versus placebo in patients with metastatic colorectal cancer (mCRC).

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 663-663 ◽  
Author(s):  
Johanna C. Bendell ◽  
Howard S. Hochster ◽  
Lowell L. Hart ◽  
Irfan Firdaus ◽  
Joseph Ronald Mace ◽  
...  
Keyword(s):  
Phase Ii ◽  
Phase Ii Study ◽  
Progression Free Survival ◽  
Final Analysis ◽  
First Line ◽  
Double Blind ◽  
Venous Thromboembolic Events ◽  
Venous Thromboembolic ◽  
Grade 3 ◽  
Tumor Types

663 Background: In mCRC, MET overexpression has been associated with poor prognosis and resistance to anti-VEGF therapy. We initiated a phase II study to evaluate the combination of onartuzumab (O), a ligand-blocking monoclonal antibody directed against the MET receptor, plus bevacizumab and FOLFOX, in first-line mCRC (GO27827; NCT01418222). Methods: This double-blind, randomized, multicenter phase II study randomized patients 1:1 to receive O (10 mg/kg iv) or placebo (P), plus mFOLFOX6 and bevacizumab (5 mg/kg iv). Stratification was by prior adjuvant therapy. All treatments were given on day 1–3 of a 2-week cycle. Oxaliplatin was given for up to 8–12 cycles; all other agents were continued until progression, unacceptable toxicity or death. Primary endpoint was progression-free survival (PFS) in ITT and MET+ subgroup by immunohistochemistry (IHC). MET status was determined by central laboratory IHC evaluation, with scores of 2+ or 3+ considered MET+. Results: From September 2011 to November 2012, 194 patients were enrolled. A recommendation was made to stop O after an interim efficacy and safety analysis in September 2013, due to lack of efficacy. The final analysis (cut-off Feb 2014) found that O did not improve PFS vs. P in the ITT (HR 0.75 [0.52–1.08]; p=0.12) or MET IHC+ populations (n=79; HR 1.03 [0.56–1.89]; p=0.93), although improvement was noted in the MET IHC− population (n=108; HR 0.60 [0.37–0.97]; p=0.03). Neither overall survival (OS) nor response rate (RR) was improved with O vs. P in any of the groups (OS HR 0.96 [0.61–1.50], p=0.85 for ITT; OS HR 1.24 [0.63–2.43], p=0.54 for MET IHC+; OS HR 0.83 [0.44–1.56], p=0.56 for MET IHC−; RR 57.3% vs. 57.7% for ITT, 43.2% vs. 57.1% for MET IHC+, 66.1% vs. 60.8% for MET IHC−). More edema (65.7% vs. 12.9%) and venous thromboembolic events (30.3% vs. 16.1%) were seen with O vs. P, respectively. Grade ≥3 events were similar (86.9% vs. 84.9%) and events leading to discontinuation were increased (48.5% vs. 37.6%) with O vs. P. Conclusions: Adding onartuzumab to FOLFOX/bevacizumab did not prolong PFS in first-line unselected or MET IHC+ mCRC. A trend towards PFS benefit was seen in those with MET IHC− mCRC, contrary to prior reports in other tumor types. Clinical trial information: NCT01418222.

High incidence of in-hospital pulmonary embolism following joint arthroplasty with dalteparin prophylaxis

2010 ◽  
Vol 103 (01) ◽  
pp. 123-128 ◽  
Author(s):  
Jason Kerr ◽  
Lori-Ann Linkins
Keyword(s):  
Pulmonary Embolism ◽  
Knee Arthroplasty ◽  
Hip Arthroplasty ◽  
Tertiary Care ◽  
Signs And Symptoms ◽  
Joint Arthroplasty ◽  
Vein Thrombosis ◽  
Venous Thromboembolic Events ◽  
Venous Thromboembolic ◽  
Deep Vein

SummaryThe in-hospital incidence of pulmonary embolism (PE) in patients undergoing elective joint arthroplasty who receive a minimum of 10 days of dalteparin prophylaxis is reported to be less than 1%. Recent clinical experience raised suspicion that the incidence of PE was significantly higher at our tertiary care institution. It was the objective of this study to determine the incidence of in-hospital PE and symptomatic deep-vein thrombosis following elective joint arthroplasty in patients who received a minimum of 10 days of dalteparin prophylaxis. Consecutive charts of patients who underwent elective joint arthroplasty at our institution between January 2008 and June 2008 were reviewed. Data on risk factors for venous thromboembolism, objectively documented venous thromboembolic events, and signs and symptoms of PE were abstracted. Patients who received concomitant warfarin in the postoperative period were excluded. The study population consisted of 437 knee arthroplasty and 246 hip arthroplasty patients. The incidence of in-hospital PE following knee arthroplasty and hip arthroplasty was 4.6% and 0.4%, respectively. One out of every 10 knee patients, and one out of every 20 hip patients underwent testing for pulmonary embolism. Pulmonary embolism was diagnosed a median of 3.5 days after knee arthroplasty. The incidence of in-hospital PE in knee arthroplasty patients who received dalteparin prophylaxis was significantly higher than expected. Potential explanations for this finding include poor efficacy of dalteparin started 12–24 hours postoperatively and/or a low threshold for ordering diagnostic imaging for PE. Studies to clarify these issues are needed.

The benefit of EXtending oral antiCOAgulation treatment (EXCOA) after acute cerebral vein thrombosis (CVT): EXCOA-CVT cluster randomized trial protocol

2018 ◽  
Vol 13 (7) ◽  
pp. 771-774 ◽  
Author(s):  
Bruno Miranda ◽  
Sanjith Aaron ◽  
Antonio Arauz ◽  
Fernando Barinagarrementeria ◽  
Afshin Borhani-Haghighi ◽  
...  
Keyword(s):  
Thromboembolic Event ◽  
Cluster Randomized Trial ◽  
Venous Thromboembolic Event ◽  
Cerebral Vein ◽  
Thromboembolic Events ◽  
Cerebral Vein Thrombosis ◽  
Vein Thrombosis ◽  
Venous Thromboembolic Events ◽  
Venous Thromboembolic ◽  
Cluster Randomized

Rationale After a cerebral vein thrombosis, there is an increased risk of further venous thromboembolic events. The optimal duration of anticoagulation after cerebral vein thrombosis is unknown. Aim To compare efficacy and safety of a policy of short- (3–6 months) versus long-term (12 months) anticoagulation (any type venous thromboembolic events) after cerebral vein thrombosis for the prevention of venous thromboembolic events. Sample size estimates A sample of 1428 patients (749 per arm) allows detecting a reduction from 10 to 5% in the risk of venous thromboembolic event recurrence with 80% power at 5% significance, with 3% dropout rate. Methods and design An international multicenter, prospective cluster-randomized trial with equal allocation between both interventions (ISRCTN25644448). Each cluster is a participating center, which accepted to be randomly allocated to one of the anticoagulation policies. Eligible patients are adults with radiologically confirmed cerebral vein thrombosis within 30 days, and stable to initiate post-acute anticoagulation. Patients judged by the investigator to be an absolute indication for permanent anticoagulation are excluded. Follow-up is at 6, 12 and 24 months. Study outcomes Primary efficacy outcome is any symptomatic and confirmed fatal/nonfatal venous thromboembolic event (recurrent-cerebral vein thrombosis or non-cerebral venous thromboembolic event). Primary safety outcomes include bleeding events during treatment periods and death from any cause. Discussion This study responds to a knowledge gap in the post-acute management of cerebral vein thrombosis patients by comparing short- versus long-term anticoagulation for the prevention of venous thromboembolic event recurrence.

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