Characteristics and Management of Patients with Venous Thromboembolism: The GARFIELD-VTE Registry

Ageno, Walter; Haas, Sylvia; Weitz, Jeffrey I.; Goldhaber, S.Z.; Turpie, Alexander G. G.; Goto, Shinichi; Angchaisuksiri, Pantep; Nielsen, Joern Dalsgaard; Kayani, Gloria; Pieper, Karen S.; Schellong, Sebastian; Bounameaux, Henri; Mantovani, Lorenzo Giovanni; Prandoni, Paolo; Kakkar, Ajay K.

doi:10.2139/ssrn.3244938

Cited by 24 publications

(34 citation statements)

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“…4 The patients in the J'xactly Study had similar demographic and clinical characteristics to those in 2 previous registry studies conducted in Japan; the JAVA study 10 and the COMMAND VTE registry, 20 but the present study participants had a higher prevalence of body weight <50 kg, CrCl <50 mL/min, and active cancer than those in studies from Western countries. [27][28][29] In a pooled analysis of the global EINSTEIN-DVT and EINSTEIN-PE randomized trials, 16 only 42 patients with body weight <50 kg were included in the rivaroxaban group, and thus there are few data to support the efficacy and safety of rivaroxaban 20 mg once daily for low-weight European VTE patients. For Japanese VTE patients, the J-EINSTEIN study demonstrated the efficacy and safety of rivaroxaban treatment, and the results of this study results were consistent with those of the EINSTEIN-DVT and EINSTEIN-PE studies.…”

Section: Discussionmentioning

confidence: 99%

A Multicenter Prospective Observational Cohort Study to Investigate the Effectiveness and Safety of Rivaroxaban in Japanese Venous Thromboembolism Patients (The J’xactly Study)

Okumura

Fukuda

Nakamura³

et al. 2020

Circ J

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In a more recent epidemiologic study in Japan, the numbers of patients newly diagnosed with DVT and PE in 2011 were 24,538 and 16,096, with overall annual incidences of 19.2 and 12.6 per 100,000 population, V enous thromboembolism (VTE) is a common acute cardiovascular disease, 1 and includes deep vein thrombosis (DVT) and pulmonary embolism (PE). 2 According to a questionnaire-based Japanese epidemiologic study conducted in 2006, the annual numbers of newly

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Section: Discussionmentioning

confidence: 99%

A Multicenter Prospective Observational Cohort Study to Investigate the Effectiveness and Safety of Rivaroxaban in Japanese Venous Thromboembolism Patients (The J’xactly Study)

Okumura

Fukuda

Nakamura³

et al. 2020

Circ J

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“…16,17 Yet, their use in patients with CAT remained limited because of the lack of evidence from head-to-head comparisons with the standard of treatment, LMWH. 16 After the publication of the first randomized LMWH-controlled trials, Hokusai-VTE Cancer and SELECT-D, 2,3 international guidelines were updated, suggesting the use of DOACs also for patients with cancer-associated VTE, but with the exception of or with caution in those with gastrointestinal malignancies and, more in general, of patients at high risk for mucosal bleeding due to the higher rates of major bleedings observed in these studies. 1,[4][5][6][7] These patients represent up to one-third of all patients with solid malignancy.…”

Section: Thrombosis and Haemostasismentioning

confidence: 99%

Bleeding with Apixaban and Dalteparin in Patients with Cancer-Associated Venous Thromboembolism: Results from the Caravaggio Study

et al. 2020

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Background Direct oral anticoagulants are recommended for the treatment of cancer-associated thrombosis (CAT) as an alternative to low-molecular-weight heparin (LMWH), but an increased bleeding risk in patients with gastrointestinal cancer was reported. The Caravaggio study compared apixaban and dalteparin for the treatment of patients with CAT. Here we describe sites of bleeding, associated cancer sites, clinical presentation, and course of major bleeding in patients included in the Caravaggio study. Methods The Caravaggio study was a multinational, randomized, open-label, noninferiority study. Bleeding events and the severity of major bleedings were adjudicated by a committee unaware of treatment allocation using predefined criteria; for the purpose of this analysis, data were analyzed in the safety population. Results Major bleeding occurred in 22 of 576 patients on apixaban (3.8%) and in 23 of 579 patients on dalteparin (4.0%). The sites of major bleeding and their distribution according to the type of cancer were similar between the two treatment groups. Major bleeding occurred in nine patients with gastrointestinal cancer in each treatment group. The clinical presentation of major bleeding was severe or fatal in 6 patients on apixaban and in 5 patients on dalteparin, while the clinical course was severe in 5 patients on apixaban and in 7 patients on dalteparin. Conclusion Apixaban is a safe alternative to LMWH for the treatment in patients with CAT. No excess in gastrointestinal bleeding was observed in patients who received apixaban, including those with gastrointestinal cancer.

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“…Acute intercurrent or chronic coexisting diseases are increasingly common in patients who are diagnosed with acute venous thromboembolism (VTE), especially in the aging population. 1 These coexisting morbidities are important because they (1) increase the risk for VTE; (2) interfere with the diagnostic strategies; (3) drive the efficacy and safety of anticoagulant therapy; and (4) impact importantly on the prognosis of these patients suffering from several diseases. While this has probably been best studied for cancer-associated thrombosis, 2 also chronic obstructive pulmonary disease (COPD) and VTE have a complicated relationship.…”

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confidence: 99%

Activation of Endoplasmic Reticulum Stress and Unfolded Protein Response in Congenital Factor VII Deficiency

et al. 2018

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Congenital factor (F) VII deficiency is a bleeding disorder caused by a heterogeneous pattern of mutations in the F7 gene. Protein misfolding due to mutations is a strong candidate mechanism to produce the highly represented type I FVII deficiency forms, characterized by a concomitant deficiency of FVII antigen and activity. Misfolded proteins can accumulate within the endoplasmic reticulum (ER) causing ER stress with subsequent activation of the unfolded protein response (UPR). So far, there are limited data on this important issue in FVII deficiency. In this study, we chose as candidate FVII model mutations, the p.Q160R, p.I289del and p.A354V-p.P464Hfs, which are all associated with severe to moderate type I FVII deficiency. In vitro expression of the recombinant (r) mutants rFVII-160R, rFVII-289del or rFVII-354V-464Hfs, which are characterized by either amino acid substitution, deletion, or by an extended carboxyl terminus, demonstrated inefficient secretion of the mutant proteins, probably caused by intracellular retention and association with ER chaperones. Both ER stress and UPR were activated following expression of all FVII mutants, with the highest response for rFVII-289del and rFVII-354V-464Hfs. These data unravel new knowledge on pathogenic mechanisms leading to FVII deficiency, and support the investigation of pharmaceutical modulators of ER stress and UPR as therapeutic agents.

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Characteristics and Management of Patients with Venous Thromboembolism: The GARFIELD-VTE Registry

Cited by 24 publications

References 0 publications

A Multicenter Prospective Observational Cohort Study to Investigate the Effectiveness and Safety of Rivaroxaban in Japanese Venous Thromboembolism Patients (The J’xactly Study)

A Multicenter Prospective Observational Cohort Study to Investigate the Effectiveness and Safety of Rivaroxaban in Japanese Venous Thromboembolism Patients (The J’xactly Study)

Bleeding with Apixaban and Dalteparin in Patients with Cancer-Associated Venous Thromboembolism: Results from the Caravaggio Study

Activation of Endoplasmic Reticulum Stress and Unfolded Protein Response in Congenital Factor VII Deficiency

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