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1.
Stud Health Technol Inform ; 264: 793-797, 2019 Aug 21.
Artigo em Inglês | MEDLINE | ID: mdl-31438033

RESUMO

Potentially inappropriate prescribing of direct oral anticoagulants is frequent with the most common errors being dosage, administration, and duration of therapy. We developed RecosDoc-MTeV, a documentary-based clinical decision support system (CDSS) for the management of direct oral anticoagulant prescription to prevent and treat venous thromboembolism. Simultaneously, the network of Parisian public hospitals (AP-HP, France) developed narrative clinical practice guidelines (CPGs) and a companion smartphone application to enhance medication and patient safety related to direct oral anticoagulant prescription. To assess the effectiveness of these CDS tools, we performed a retrospective review of 274 random patients hospitalized in 2017, which were either at risk of venous thromboembolism or actually treated for the disease. Consistency between the two CDS tools was measured at 96.7%. Administered treatments were compliant in 67.2% and 72.3% of the cases, with AP-HP CPGs and RecosDoc-MTeV, respectively. These results support that implementing CDSSs for the prescription of direct oral anticoagulants may ensure safe prescribing of high-risk medications.


Assuntos
Anticoagulantes/uso terapêutico , Tromboembolia Venosa , Administração Oral , França , Humanos , Estudos Retrospectivos , Tromboembolia Venosa/tratamento farmacológico
2.
Lancet Haematol ; 6(10): e500-e509, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31420317

RESUMO

BACKGROUND: Rivaroxaban has been shown to be efficacious for treatment of venous thromboembolism in adults, and has a reduced risk of bleeding compared with standard anticoagulants. We aimed to develop paediatric rivaroxaban regimens for the treatment of venous thromboembolism in children and adolescents. METHODS: In this phase 2 programme, we did three studies to evaluate rivaroxaban treatment in children younger than 6 months, aged 6 months to 5 years, and aged 6-17 years. Our studies used a multicentre, single-arm design at 54 sites in Australia, Europe, Israel, Japan, and north America. We included children with objectively confirmed venous thromboembolism previously treated with low-molecular weight heparin, fondaparinux, or a vitamin K antagonist for at least 2 months or, in children who had catheter-related venous thromboembolism for at least 6 weeks. We administered rivaroxaban orally in a bodyweight-adjusted 20 mg-equivalent dose, based on physiologically-based pharmacokinetic modelling predictions and EINSTEIN-Jr phase 1 data in young adults, in either a once-daily (tablets; for those aged 6-17 years), twice-daily (in suspension; for those aged 6 months to 11 years), or three times-daily (in suspension; for those younger than 6 months) dosing regimen for 30 days (or 7 days for those younger than 6 months). The primary aim was to define rivaroxaban treatment regimens that match the target adult exposure range. The principal safety outcome was major bleeding and clinically relevant non-major bleeding. Analyses were per-protocol. The predefined efficacy outcomes were symptomatic recurrent venous thromboembolism, asymptomatic deterioration on repeat imaging at the end of the study treatment period. These trials are registered at ClinicalTrials.gov, numbers NCT02564718, NCT02309411, and NCT02234843. FINDINGS: Between Feb 11, 2013, and Dec 20, 2017, we enrolled 93 children (ten children younger than 6 months; 15 children aged 6 months to 1 year; 25 children aged 2-5 years; 32 children aged 6-11 years; and 11 children aged 12-17 years) into our study. 89 (96%) children completed study treatment (30 days of treatment, or 7 days in those younger than 6 months), and 93 (100%) children received at least one dose of study treatment and were evaluable for the primary endpoints. None of the children had a major bleed, and four (4%, 95% CI 1·2-10·6) of these children had a clinically relevant non-major bleed (three children aged 12-17 years with menorrhagia and one child aged 6-11 years with gingival bleeding). We found no symptomatic recurrent venous thromboembolism in any patients (0%, 0·0-3·9). 24 (32%) of 75 patients with repeat imaging had their thrombotic burden resolved, 43 (57%) patients improved, and eight (11%) patients were unchanged. No patient deteriorated. We confirmed therapeutic rivaroxaban exposures with once-daily dosing in children with bodyweights of at least 30 kg and with twice-daily dosing in children with bodyweights of at least 20 kg and less than 30 kg. Children with low bodyweights (<20 kg, particularly <12 kg) showed low exposures so, for future studies, rivaroxaban dosages were revised for these weight categories, to match the target adult exposure range. 61 (66%) of 93 children had adverse events during the study. Pyrexia was the most common adverse event (ten [11%] events), and anaemia and neutropenia or febrile neutropenia were the most frequent grade 3 or worse events (four [4%] events each). No children died or were discontinued from rivaroxaban because of adverse events. INTERPRETATION: Treatment with bodyweight-adjusted rivaroxaban appears to be safe in children. The treatment regimens that we confirmed in children with bodyweights of at least 20 kg and the revised treatment regimens that we predicted in those with bodyweights less than 20 kg will be evaluated in the EINSTEIN-Jr phase 3 trial in children with acute venous thromboembolism. FUNDING: Bayer AG, Janssen Research and Development.


Assuntos
Anticoagulantes/uso terapêutico , Rivaroxabana/uso terapêutico , Tromboembolia Venosa/tratamento farmacológico , Adolescente , Anemia/etiologia , Anticoagulantes/efeitos adversos , Anticoagulantes/farmacocinética , Peso Corporal , Criança , Pré-Escolar , Esquema de Medicação , Cálculos da Dosagem de Medicamento , Fator Xa/análise , Feminino , Meia-Vida , Hemorragia/etiologia , Humanos , Lactente , Masculino , Neutropenia/etiologia , Tempo de Protrombina , Rivaroxabana/efeitos adversos , Rivaroxabana/farmacocinética , Resultado do Tratamento , Tromboembolia Venosa/patologia
3.
Int J Gynaecol Obstet ; 147(2): 252-257, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31420876

RESUMO

OBJECTIVE: To retrospectively review the efficacy and safety of novel direct oral anticoagulants (DOACs) and compare the results with those of vitamin K antagonists (VKA) when used in clinical practice to treat venous thromboembolism (VTE) because there is insufficient evidence regarding its use in patients with gynecological cancers. METHODS: A study was conducted of patients diagnosed with gynecological cancers at Osaka University Hospital between January 2010 and December 2017. The medical records of those who suffered from deep venous thrombosis (DVT) and/or pulmonary embolism (PE) were retrospectively reviewed. RESULTS: Among the 1698 cases of gynecological cancers, 107 (6.3%) cases were diagnosed as having VTE. A total of 34 (31.8%) patients presented DVT plus PE and 73 (68.2%) patients had DVT alone. Fifty-four cases were treated with DOACs and 53 with VKA. Although 3 of the 53 patients (5.7%) in the VKA group developed recurrent VTE, only 1 (1.9%) patient in the DOAC group showed clinically relevant bleeding from a tumor penetrating the rectum. DOACs were non-inferior to VKA with respect to the composite outcome, including recurrent venous thrombosis and relevant bleeding (hazard ratio 0.31, 95% confidence interval 0.03-3.12, P=0.363). CONCLUSION: DOACs can be effectively and safely used in VTE patients with gynecological cancers.


Assuntos
Anticoagulantes/administração & dosagem , Heparina/administração & dosagem , Tromboembolia Venosa/tratamento farmacológico , Vitamina K/antagonistas & inibidores , Administração Oral , Idoso , Feminino , Neoplasias dos Genitais Femininos/epidemiologia , Humanos , Pessoa de Meia-Idade , Estudos Retrospectivos , Tromboembolia Venosa/epidemiologia
4.
Harefuah ; 158(8): 499-502, 2019 Aug.
Artigo em Hebraico | MEDLINE | ID: mdl-31407535

RESUMO

BACKGROUND: The use of direct oral anticoagulants (DOACs) provides immediate and useful anticoagulation without the need of monitoring. The recent expansion in use of DOACs might change the therapeutic approaches in venous thromboembolism (VTE). OBJECTIVES: To evaluate the treatment of VTE as well as the 90-days compliance with anticoagulants in the pre-DOACs era. METHODS: A retrospective study was conducted at Beilinson Hospital, Rabin Medical Center. Inclusion criteria entailed: patients >18 years old; new lower extremities deep vein thrombosis or pulmonary embolism, diagnosed at ER between May, 2014 and May, 2015. Patients with previous diagnosis; upper extremities or inner organs thrombosis or with missing data were excluded. Data collected included: gender and age, comorbidity with active malignancy, provoked/unprovoked events, hospitalization and length of stay, anticoagulation treatment during hospitalization and discharge, recommendations for duration of treatment or further hematologist's evaluation and 90-days compliance with anticoagulation treatment. RESULTS: The study group included 208 patients, 29% with active malignancy. All were hospitalized. In 54% of the subjects without active malignancy the event was provoked, whereas in 46% unprovoked. This detail was not discussed in any of the cases. The average length of stay tended to be longer in patients with a complete switch to warfarin than in ones on DOACs (10.3+7.5 vs. 6.4+5.2 days, p=0.09). Recommendations for the length of treatment or the need for further evaluation by a hematologist were not found in the majority. The overall 90-days compliance with anticoagulants was 47%. CONCLUSIONS: Most of the therapeutic approach errors might be resolved during the expanded use of DOACs, along with the simplicity of the recommendations at discharge. The study was supported by an educational grant from Pfizer, Inc.


Assuntos
Anticoagulantes/uso terapêutico , Tromboembolia Venosa/tratamento farmacológico , Administração Oral , Adolescente , Anticoagulantes/administração & dosagem , Humanos , Estudos Retrospectivos , Centros de Atenção Terciária
5.
Harefuah ; 158(8): 534-539, 2019 Aug.
Artigo em Hebraico | MEDLINE | ID: mdl-31407544

RESUMO

INTRODUCTION: Venous thromboembolism is a major cause of morbidity and mortality. The main initial therapy for thromboembolism is anticoagulation for a period of three months (active treatment period). The aim of treatment beyond three months is prevention of recurrence. The duration of anticoagulation is being determined by the degree of provocation leading to the thromboembolic event, but other factors like the patient's gender, oral contraceptive use, cancer etc. may influence the period of anticoagulation. The direct oral anticoagulants (DOACs) are as effective as warfarin with less major bleeding events. Despite their growing use, it is important to remember that there is still a lack of evidence about their safety and efficacy in many clinical situations. Preliminary evidence for their efficacy in venous thromboembolic diseases (VTE) in cancer patients has been published. In this article we will address these and other issues arising in treating VTE by discussing common clinical scenarios.


Assuntos
Tromboembolia Venosa/terapia , Administração Oral , Anticoagulantes/uso terapêutico , Hemorragia , Humanos , Tromboembolia Venosa/tratamento farmacológico , Varfarina
7.
Cancer Treat Res ; 179: 87-101, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31317482

RESUMO

Cancer patients have an increased risk of thrombosis. The development of cancer thrombosis is dependent on a number of factors including cancer type, stage, various biologic markers, and the use of central venous catheters. In addition, cancer treatment itself may increase thrombotic risk. Tamoxifen increases the risk of venous thromboembolism (VTE) by two- to sevenfold, while an impact on risk of arterial thrombosis is uncertain. Immunomodulatory imide drugs (IMiDs) such as thalidomide and lenalidomide increase the risk of VTE in patients with multiple myeloma (MM) by about 10-40% when given in combination with glucocorticoids or other chemotherapy agents; the risk of VTE in MM patients treated with IMiD-containing regimens necessitates that such patients receive thromboprophylaxis with aspirin, low-molecular-weight heparin, or warfarin. Among cytotoxic chemotherapy agents, cisplatin, and to a lesser extent fluorouracil, has been described in association with thrombosis. L-asparaginase in treatment of acute lymphoblastic leukemia is significantly associated with increased thrombosis particularly affecting the CNS, which may be due to acquired antithrombin deficiency; at some centers, plasma infusions or antithrombin replacement is used to mitigate this. Bevacizumab, an inhibitor of vascular endothelial growth factor, increases arterial and possibly venous thrombotic risk, although the literature is conflicting about the latter. Supportive care agents in cancer care, such as erythropoiesis-stimulating agents, granulocyte colony stimulating factor, and steroids, also have some impact on thrombosis. This review summarizes the mechanisms by which these and other therapies modulate thrombotic risks and how such risks may be managed.


Assuntos
Antineoplásicos/efeitos adversos , Neoplasias/tratamento farmacológico , Trombose/tratamento farmacológico , Anticoagulantes/uso terapêutico , Antineoplásicos/uso terapêutico , Humanos , Neoplasias/complicações , Fatores de Risco , Trombose/etiologia , Trombose/prevenção & controle , Tromboembolia Venosa/tratamento farmacológico , Tromboembolia Venosa/etiologia , Tromboembolia Venosa/prevenção & controle
8.
Cancer Treat Res ; 179: 103-115, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31317483

RESUMO

The management of cancer-associated thrombosis (CAT) is complex, and treatment strategies have been evolving over the past 15 years. It is well recognized that oral vitamin K antagonists are difficult to use in cancer patients, with higher rates of treatment failure and bleeding complications than in non-cancer patients. Low-molecular-weight-heparin (LMWH) became the widely accepted standard of care for treatment of cancer-associated thrombosis, following the CLOT study comparing dalteparin with warfarin in 2003. LMWH remains widely used for the treatment of CAT. However, in the past two years, several studies have served to validate direct oral anticoagulants as a safe and effective alternative to LMWH. Two randomized clinical trials comparing edoxaban and rivaroxaban with dalteparin, and several retrospective studies have shown the efficacy of edoxaban and rivaroxaban for the treatment of CAT. However, there is an evidence of increased bleeding with the DOACs, particularly gastrointestinal or urinary tract bleeding in patients with lesions within the gastrointestinal or urinary tracts. This chapter discusses the ongoing development of optimal treatment strategies for cancer-associated thrombosis.


Assuntos
Anticoagulantes/administração & dosagem , Inibidores do Fator Xa/administração & dosagem , Heparina de Baixo Peso Molecular/administração & dosagem , Neoplasias/complicações , Tromboembolia Venosa/tratamento farmacológico , Administração Oral , Anticoagulantes/efeitos adversos , Anticoagulantes/uso terapêutico , Inibidores do Fator Xa/efeitos adversos , Inibidores do Fator Xa/uso terapêutico , Hemorragia/induzido quimicamente , Heparina de Baixo Peso Molecular/uso terapêutico , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Estudos Retrospectivos , Tromboembolia Venosa/etiologia
9.
Cancer Treat Res ; 179: 179-189, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31317488

RESUMO

Venous thromboembolism is commonly diagnosed in patients with primary and secondary brain tumors. Anticoagulation management in the setting of brain tumors is complicated by the high background rate of spontaneous intracranial hemorrhage. Until recently, there was limited evidence to support the decision to administer therapeutic anticoagulation in the setting of brain metastases or primary brain tumors. The current evidence suggests that the safety profile of therapeutic low molecular weight heparin for the treatment of venous thromboembolism is contingent on whether the origin of brain tumor is primary (i.e., glioma) versus secondary. In patients with brain metastases, the rate of intracranial hemorrhage often exceeds 20% but is not influenced by the administration of low molecular weight heparin. In contrast, in primary brain tumors such as glioma, therapeutic anticoagulation is associated with an increased risk of intracranial hemorrhage that can negatively impact survival. This chapter reviews the underlying mechanisms contributing to thrombosis and hemorrhage in brain tumors and summarizes the current evidence and approaches in anticoagulation to treat venous thromboembolism.


Assuntos
Anticoagulantes/uso terapêutico , Neoplasias Encefálicas/complicações , Hemorragias Intracranianas/etiologia , Tromboembolia Venosa/tratamento farmacológico , Anticoagulantes/efeitos adversos , Neoplasias Encefálicas/patologia , Neoplasias Encefálicas/secundário , Humanos , Hemorragias Intracranianas/induzido quimicamente , Tromboembolia Venosa/etiologia
10.
BMJ ; 366: l4363, 2019 07 24.
Artigo em Inglês | MEDLINE | ID: mdl-31340984

RESUMO

OBJECTIVES: To determine the rate of a first recurrent venous thromboembolism (VTE) event after discontinuation of anticoagulant treatment in patients with a first episode of unprovoked VTE, and the cumulative incidence for recurrent VTE up to 10 years. DESIGN: Systematic review and meta-analysis. DATA SOURCES: Medline, Embase, and the Cochrane Central Register of Controlled Trials (from inception to 15 March 2019). STUDY SELECTION: Randomised controlled trials and prospective cohort studies reporting symptomatic recurrent VTE after discontinuation of anticoagulant treatment in patients with a first unprovoked VTE event who had completed at least three months of treatment. DATA EXTRACTION AND SYNTHESIS: Two investigators independently screened studies, extracted data, and appraised risk of bias. Data clarifications were sought from authors of eligible studies. Recurrent VTE events and person years of follow-up after discontinuation of anticoagulant treatment were used to calculate rates for individual studies, and data were pooled using random effects meta-analysis. Sex and site of initial VTE were investigated as potential sources of between study heterogeneity. RESULTS: 18 studies involving 7515 patients were included in the analysis. The pooled rate of recurrent VTE per 100 person years after discontinuation of anticoagulant treatment was 10.3 events (95% confidence interval 8.6 to 12.1) in the first year, 6.3 (5.1 to 7.7) in the second year, 3.8 events/year (95% confidence interval 3.2 to 4.5) in years 3-5, and 3.1 events/year (1.7 to 4.9) in years 6-10. The cumulative incidence for recurrent VTE was 16% (95% confidence interval 13% to 19%) at 2 years, 25% (21% to 29%) at 5 years, and 36% (28% to 45%) at 10 years. The pooled rate of recurrent VTE per 100 person years in the first year was 11.9 events (9.6 to 14.4) for men and 8.9 events (6.8 to 11.3) for women, with a cumulative incidence for recurrent VTE of 41% (28% to 56%) and 29% (20% to 38%), respectively, at 10 years. Compared to patients with isolated pulmonary embolism, the rate of recurrent VTE was higher in patients with proximal deep vein thrombosis (rate ratio 1.4, 95% confidence interval 1.1 to 1.7) and in patients with pulmonary embolism plus deep vein thrombosis (1.5, 1.1 to 1.9). In patients with distal deep vein thrombosis, the pooled rate of recurrent VTE per 100 person years was 1.9 events (95% confidence interval 0.5 to 4.3) in the first year after anticoagulation had stopped. The case fatality rate for recurrent VTE was 4% (95% confidence interval 2% to 6%). CONCLUSIONS: In patients with a first episode of unprovoked VTE who completed at least three months of anticoagulant treatment, the risk of recurrent VTE was 10% in the first year after treatment, 16% at two years, 25% at five years, and 36% at 10 years, with 4% of recurrent VTE events resulting in death. These estimates should inform clinical practice guidelines, enhance confidence in counselling patients of their prognosis, and help guide decision making about long term management of unprovoked VTE. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42017056309.


Assuntos
Anticoagulantes/uso terapêutico , Medição de Risco/métodos , Tromboembolia Venosa , Suspensão de Tratamento , Humanos , Recidiva , Tempo , Tromboembolia Venosa/tratamento farmacológico , Tromboembolia Venosa/fisiopatologia
11.
J Med Vasc ; 44(4): 266-273, 2019 Jun.
Artigo em Francês | MEDLINE | ID: mdl-31213299

RESUMO

INTRODUCTION: Venous thromboembolism (pulmonary embolism and deep-vein thrombosis) is a frequent, serious but also chronic disease. Studies reported that both general practitioners (GPs) and vascular medicine physicians (VMPs) report participating in patient education concerning venous thromboembolic disease. OBJECTIVE: To assess the role of GPs and VMPs in venous thromboembolic disease patient education, examining the patient's perspective. METHOD: Phone survey of the French patients recruited in the CACTUS trial assessing anticoagulant treatment in case of first distal deep-vein thrombosis. RESULTS: Among the 103 participating patients, 92% (n=95) reported being satisfied by information provided by the GP and VMP. Information was considered as necessary in 96% of cases (n=99). Eighty-five percent of patients (n=88) felt they did not need complementary information. The VMP would have spent more time on education as compared with the GP (an entire consultation in 93.2% vs. 38.8% of cases respectively) the information provided by the VMP being also clearer and more complete. More than 75% of patients reported that no physician warned them about risks of anticoagulants, long-term complications of venous thromboembolic disease or its prevention. CONCLUSION: In CACTUS, patients reported being satisfied by information provided by their managing physicians and information provided by the VMP was clearer and more complete. Important education messages may not have been delivered suggesting the need for a standardization of venous thromboembolic disease patient's education.


Assuntos
Anticoagulantes/uso terapêutico , Clínicos Gerais , Educação de Pacientes como Assunto/métodos , Satisfação do Paciente , Papel do Médico , Especialização , Tromboembolia Venosa/tratamento farmacológico , França , Pesquisas sobre Serviços de Saúde , Comunicação em Saúde , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Encaminhamento e Consulta , Tromboembolia Venosa/diagnóstico , Tromboembolia Venosa/fisiopatologia
12.
Biochem Med (Zagreb) ; 29(2): 020710, 2019 Jun 15.
Artigo em Inglês | MEDLINE | ID: mdl-31223264

RESUMO

Introduction: A hypercoagulable state is a predisposition for venous thromboembolism (VTE). The activated partial thromboplastin time (aPTT)-based clot waveform analysis (CWA) is a global haemostatic measure but its role in assessment of hypercoagulability and thrombotic disorders is uncertain. We aimed to study the changes of CWA parameters in acute VTE. We hypothesized that patients with acute VTE would demonstrate higher CWA values than control patients without VTE and having elevated CWA parameters is associated with acute VTE. Materials and methods: Clot waveform analysis data from patients (N = 45) with objectively proven acute VTE who had an aPTT performed prior to initiation of anticoagulation were compared with controls (N = 111). The CWA parameters measured were min1, min2, max2 and delta change. Results: While the mean aPTT between VTE patients and controls did not differ (P = 0.830), the mean CWA parameters were significantly higher among VTE patients than controls (min1, P < 0.001; min2, P = 0.001; max2, P = 0.002; delta change, P < 0.001). There were significantly more cases within the VTE group exhibiting CWA values above their reference intervals than the control group (all P < 0.001), with the odds ratios for VTE of 8.0, 5.2, 4.8 and 18.6 for min1, min2, max2 and delta change, respectively (all P < 0.001). Conclusions: Patients with acute VTE had elevated aPTT-based CWA parameters than controls. Higher CWA parameters were significantly associated with acute VTE.


Assuntos
Testes de Coagulação Sanguínea , Tempo de Tromboplastina Parcial , Tromboembolia Venosa/sangue , Doença Aguda , Adulto , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/uso terapêutico , Angiografia por Tomografia Computadorizada , Estudos Transversais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Tromboembolia Venosa/diagnóstico , Tromboembolia Venosa/tratamento farmacológico , Adulto Jovem
13.
Khirurgiia (Mosk) ; (5): 94-103, 2019.
Artigo em Russo | MEDLINE | ID: mdl-31169827

RESUMO

The review is devoted to the issue of optimal duration of anticoagulant therapy for venous thromboembolic complications (VTEC) using oral anticoagulants (OAC). These drugs are characterized by higher safety in comparison with vitamin K antagonists and make it possible to increase the duration of treatment for not only spontaneous thrombosis (with high risk of recurrence), but also thrombosis provoked by minor persistent and transient risk factors of VTEC. Efficacy and safety of prolonged treatment of VTEC using OAC was analyzed. Different classifications of primary thrombotic episode depending on risk of subsequent recurrence are presented. Moreover, scales for individual assessment of risk of recurrent thrombosis after anticoagulant therapy cancellation and risk of bleeding in case of continued treatment are given. Outcomes of long-term administration of rivaroxaban for VTEC are analyzed. It was concluded that OAC are safe for prolonged management of primary thrombotic episode. However, overall duration of treatment should be determined considering individual balance of benefits and risks.


Assuntos
Anticoagulantes/administração & dosagem , Inibidores do Fator Xa/administração & dosagem , Rivaroxabana/administração & dosagem , Tromboembolia Venosa/tratamento farmacológico , Anticoagulantes/efeitos adversos , Anticoagulantes/uso terapêutico , Esquema de Medicação , Inibidores do Fator Xa/efeitos adversos , Inibidores do Fator Xa/uso terapêutico , Hemorragia/induzido quimicamente , Humanos , Recidiva , Fatores de Risco , Rivaroxabana/efeitos adversos , Rivaroxabana/uso terapêutico , Trombose/etiologia , Fatores de Tempo , Suspensão de Tratamento
15.
Lancet Haematol ; 6(7): e359-e365, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31133411

RESUMO

BACKGROUND: Because studies of direct oral anticoagulants in patients with venous thromboembolism and non-valvular atrial fibrillation have had minimal representation of morbidly obese patients (ie, body-mass index [BMI] ≥40 kg/m2), their efficacy and safety in this population are unclear. We investigated whether apixaban and rivaroxaban are as effective and safe as warfarin in morbidly obese patients. METHODS: We did a single-centre, retrospective analysis of chart data for all adult patients aged at least 18 years at Montefiore Medical Center (Bronx, NY, USA) with a BMI of at least 40 kg/m2 who were prescribed apixaban, rivaroxaban, or warfarin for either venous thromboembolism or atrial fibrillation between March 1, 2013, and March 1, 2017. Patients who had both venous thromboembolism and atrial fibrillation were excluded, as were patients with indications other than atrial fibrillation and venous thromboembolism. Outcomes of recurrent venous thromboembolism, stroke, and bleeding were measured from the first prescription date to the earliest of a thrombotic event, medication discontinuation, death, or end of study on June 30, 2017. Analyses were stratified by anticoagulation indication and adjusted for comorbidities, CHA2DS2-VASc score, and age where appropriate. Outcome rates were compared using Pearson's χ2 or Fisher's exact test. Time-to-event analyses accounting for length of follow-up were used to compare risks of outcomes. FINDINGS: We obtained data for 795 patients: 150 prescribed apixaban, 326 rivaroxaban, and 319 warfarin. In 366 patients prescribed an anticoagulant for venous thromboembolism, the incidence of recurrent venous thromboembolism was similar between the apixaban, rivaroxaban, and warfarin cohorts (1/47 [2·1%, 95% CI 0·0-6·3], 3/152 [2·0%, 0·0-4·2], and 2/167 [1·2%, 0·0-2·9], respectively; p=0·74). Incidence of major bleeding in this patient group was also similar between the treatment cohorts (1/47 patients on apixaban [2·1%, 95% CI 0·0-6·3], 2/152 on rivaroxaban [1·3%, 0·0-3·1], and 4/167 on warfarin [2·4%, 0·1-4·7]; p=0·77). In 429 patients prescribed an anticoagulant for atrial fibrillation, incidence of stroke was similar between the treatment cohorts (1/103 patients on apixaban [1·0%, 95% CI 0·0-2·9], 4/174 on rivaroxaban [2·3%, 0·1-4·5], and 2/152 on warfarin [1·3%, 0·0-3·1], p=0·71). In this patient group, major bleeding occurred in 3/103 patients on apixaban (2·9%, 95% CI 0·0-6·2), 5/174 on rivaroxaban (2·9%, 0·4-5·4), and 12/152 on warfarin (7·9%, 3·6-12·2); p=0·063. Time-to-event analyses showed that risk of all outcomes in patients with venous thromboembolism, and stroke and composite bleeding in patients with atrial fibrillation, were similar between the anticoagulant cohorts. INTERPRETATION: Our retrospective study provides further evidence of similar efficacy and safety between the direct oral anticoagulants apixaban and rivaroxaban, and warfarin in morbidly obese patients with atrial fibrillation and venous thromboembolism. These data, if confirmed in prospective studies, might enable patients with a BMI of at least 40 kg/m2 to benefit from more convenient, and possibly safer, anticoagulants. FUNDING: None.


Assuntos
Anticoagulantes/uso terapêutico , Inibidores do Fator Xa/uso terapêutico , Obesidade Mórbida/tratamento farmacológico , Varfarina/uso terapêutico , Adulto , Idoso , Anticoagulantes/efeitos adversos , Fibrilação Atrial/complicações , Fibrilação Atrial/tratamento farmacológico , Índice de Massa Corporal , Inibidores do Fator Xa/efeitos adversos , Feminino , Hemorragia/epidemiologia , Hemorragia/etiologia , Humanos , Coeficiente Internacional Normatizado , Masculino , Pessoa de Meia-Idade , Obesidade Mórbida/patologia , Modelos de Riscos Proporcionais , Pirazóis/efeitos adversos , Pirazóis/uso terapêutico , Piridonas/efeitos adversos , Piridonas/uso terapêutico , Recidiva , Estudos Retrospectivos , Rivaroxabana/efeitos adversos , Rivaroxabana/uso terapêutico , Tromboembolia Venosa/complicações , Tromboembolia Venosa/tratamento farmacológico , Tromboembolia Venosa/epidemiologia , Varfarina/efeitos adversos
16.
Internist (Berl) ; 60(6): 644-655, 2019 Jun.
Artigo em Alemão | MEDLINE | ID: mdl-31119310

RESUMO

Virchow's triad has been known for a 100 years. The development of therapeutic possibilities during this time was enormous. Today anticoagulant therapy is much more differentiated. Four new oral substances have replaced the traditional treatment with vitamin K antagonists in angiology. A standardized dosage is available. The monitoring of the coagulation parameters is no longer necessary, but it is important to monitor renal function. Direct oral anticoagulants are approved for the treatment of venous thrombosis and pulmonary embolism, but not during pregnancy or in children. Severe bleeding complications, especially intracerebral bleeding, are less common. The incidence of venous thromboembolism is still high. Obesity and cancer are of particular importance. The "therapeutic pact" with the patient requires that physicians master the art of "talking medicine".


Assuntos
Anticoagulantes/uso terapêutico , Coagulação Sanguínea/efeitos dos fármacos , Embolia Pulmonar/tratamento farmacológico , Tromboembolia Venosa/tratamento farmacológico , Trombose Venosa/tratamento farmacológico , Anticoagulantes/administração & dosagem , Criança , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Feminino , Humanos , Testes de Função Renal , Gravidez
17.
Clin Lab ; 65(5)2019 May 01.
Artigo em Inglês | MEDLINE | ID: mdl-31115236

RESUMO

BACKGROUND: The neutrophil-lymphocyte ratio (NLR) reflects inflammatory status. An elevated NLR has been reported to be a prognostic indicator in some malignant tumors. The aim of this study was to determine whether NLR at the time of venous thromboembolism (VTE) diagnosis is a prognostic factor for the response to anticoagulation and survival in gastric cancer patients treated with anticoagulation for VTE. METHODS: We retrospectively enrolled 73 gastric cancer patients newly diagnosed with VTE, from among 597 patients pathologically confirmed for gastric cancer between January 2008 and December 2013. Univariate and multivariate analyses were performed to identify clinicopathological predictors in respect to the response to anticoagulation and overall survival. RESULTS: Compared with the low NLR group, patients with high NLR presented more frequently with advanced tumor stage (p = 0.046) and deeper tumor depth (p = 0.033). Patients with poor histology differentiation (p = 0.045), high NLR (p = 0.001), and low albumin (p = 0.016) were statistically correlated with the poor response to anticoagulation. Multivariate analysis revealed that a high level of NLR (hazard ratio, 1.56, 95% CI: 1.32 - 1.87, p = 0.032) and advance cancer stage (hazard ratio, 2.11, 95% CI: 1.29 - 3.44, p = 0.043) were independent poor prognostic factors for OS in gastric cancer patients with VTE. CONCLUSIONS: The results demonstrated that the NLR at the time of VTE diagnosis could be a useful biomarker for predicting the response to anticoagulation and survival in gastric cancer patients with VTE.


Assuntos
Biomarcadores/sangue , Linfócitos , Neutrófilos , Neoplasias Gástricas/sangue , Tromboembolia Venosa/sangue , Idoso , Anticoagulantes/uso terapêutico , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Estadiamento de Neoplasias , /métodos , /estatística & dados numéricos , Prognóstico , Modelos de Riscos Proporcionais , Estudos Retrospectivos , Neoplasias Gástricas/complicações , Tromboembolia Venosa/complicações , Tromboembolia Venosa/tratamento farmacológico
18.
Semin Thromb Hemost ; 45(4): 326-333, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31041798

RESUMO

Arterial and venous thromboses are common in glioma patients, both in the perioperative period and throughout the course of the disease. High-grade glioma patients harbor underlying hypercoagulability, which predisposes these high-risk patients with prolonged immobility and neurologic deficits to thrombotic events. Despite the high incidence and recurrent nature of these complications, there is no standardized approach to the management of glioma patients, and many challenges remain. Historically, the perceived risk of intracranial and intratumoral hemorrhage limited the use of anticoagulation, favoring nonpharmacological prophylaxis and treatment. Multiple studies have demonstrated the safety and efficacy of anticoagulation when indicated, with low molecular weight heparin as the preferred short- or long-term treatment. This review will discuss the epidemiology, risk factors, and therapeutic management of both venous and arterial thrombotic complications in glioma.


Assuntos
Glioma/epidemiologia , Trombose/epidemiologia , Tromboembolia Venosa/epidemiologia , Trombose Venosa/epidemiologia , Anticoagulantes/uso terapêutico , Comorbidade , Heparina de Baixo Peso Molecular/uso terapêutico , Humanos , Prognóstico , Fatores de Risco , Trombose/tratamento farmacológico , Tromboembolia Venosa/tratamento farmacológico , Trombose Venosa/tratamento farmacológico
19.
Semin Thromb Hemost ; 45(4): 334-341, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31041803

RESUMO

Venous thromboembolism (VTE) is a common complication in patients with primary brain tumors, with up to 20% of patients per year having a VTE event. Clinical risk factors for VTE include glioblastoma subtype, paresis, or surgery. Furthermore, specific factors playing a role in tumor biology were recently identified to predispose to prothrombotic risk. For instance, mutations in the isocitrate dehydrogenase 1 (IDH1) gene, which occurs in a subgroup of glioma, correlate with risk of VTE, with low incidence in patients with presence of an IDH1 mutation compared with those with IDH1 wild-type status. In addition, expression of the glycoprotein podoplanin on brain tumors was associated with both intratumoral thrombi and high risk of VTE. As podoplanin has the ability to activate platelets, a mechanistic role of podoplanin-mediated platelet activation in VTE development has been suggested. From a clinical point of view, the management of patients with primary brain tumors and VTE is challenging. Anticoagulation is required to treat patients; however, it is associated with increased risk of intracranial hemorrhage. This review focuses on describing the epidemiology, risk factors, and mechanisms of brain tumor-associated thrombosis and discusses clinical challenges in the prevention and treatment of VTE in patients with brain tumors.


Assuntos
Anticoagulantes/uso terapêutico , Neoplasias Encefálicas/complicações , Glioblastoma/complicações , Trombose/tratamento farmacológico , Tromboembolia Venosa/tratamento farmacológico , Neoplasias Encefálicas/genética , Neoplasias Encefálicas/metabolismo , Glioblastoma/genética , Glioblastoma/metabolismo , Humanos , Isocitrato Desidrogenase/genética , Isocitrato Desidrogenase/metabolismo , Glicoproteínas de Membrana/genética , Glicoproteínas de Membrana/metabolismo , Mutação , Ativação Plaquetária , Trombose/diagnóstico , Trombose/etiologia , Tromboembolia Venosa/diagnóstico , Tromboembolia Venosa/etiologia
20.
Anticancer Res ; 39(5): 2615-2625, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-31092460

RESUMO

BACKGROUND/AIM: This study aimed to assess whether low-molecular-weight heparin (LMWH) is effective and safe in preventing postoperative venous thromboembolism (VTE) in patients undergoing esophageal cancer surgery. PATIENTS AND METHODS: In this single-institution, prospective, randomized trial, 73 patients with esophageal cancer undergoing esophagectomy were randomly divided into the enoxaparin group (E group) and intermittent pneumatic compression group (I group). The primary endpoint was efficacy of enoxaparin, and secondary endpoints were evidence of bleeding and serum anti-Xa activity in the E group. RESULTS: The E group comprised 42 patients and the I group comprised 31 patients. Deep vein thrombosis was observed in 0 (0%) patients in the E group and 7 (22.6%) patients in the I group (p=0.002). Soluble fibrin monomer complex was significantly lower in the E versus I group on day 8 (p<0.001). D-dimer was significantly lower in the E versus I group on days 2, 8, and 15 (p=0.008, p<0.001, p<0.001, respectively). CONCLUSION: VTE was significantly reduced by using enoxaparin.


Assuntos
Enoxaparina/administração & dosagem , Neoplasias Esofágicas/complicações , Esofagectomia/efeitos adversos , Tromboembolia Venosa/tratamento farmacológico , Idoso , Neoplasias Esofágicas/patologia , Neoplasias Esofágicas/cirurgia , Feminino , Hemorragia/tratamento farmacológico , Hemorragia/etiologia , Hemorragia/patologia , Heparina de Baixo Peso Molecular , Humanos , Masculino , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Complicações Pós-Operatórias , Tromboembolia Venosa/etiologia , Trombose Venosa/diagnóstico , Trombose Venosa/patologia , Trombose Venosa/prevenção & controle
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