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1.
JAMA ; 323(2): 130-139, 2020 01 14.
Artigo em Inglês | MEDLINE | ID: mdl-31935028

RESUMO

Importance: The efficacy of factor XIa inhibition for thromboprophylaxis is unknown. Osocimab is a long-acting, fully human monoclonal antibody that inhibits factor XIa. Objective: To compare different doses of osocimab with enoxaparin and apixaban for thromboprophylaxis in patients who have undergone knee arthroplasty. Design, Setting, and Participants: Randomized, open-label, adjudicator-blinded, phase 2 noninferiority trial with observer blinding for osocimab doses, conducted at 54 hospitals in 13 countries. Adult patients undergoing unilateral knee arthroplasty were randomized from October 2017 through August 2018 and followed up until January 2019. Interventions: Single intravenous osocimab postoperative doses of 0.3 mg/kg (n = 107), 0.6 mg/kg (n = 65), 1.2 mg/kg (n = 108), or 1.8 mg/kg (n = 106); preoperative doses of 0.3 mg/kg (n = 109) or 1.8 mg/kg (n = 108); or 40 mg of subcutaneous enoxaparin once daily (n = 105) or 2.5 mg of oral apixaban twice daily (n = 105) for at least 10 days or until venography. Main Outcomes and Measures: The primary outcome was venous thromboembolism incidence between 10 and 13 days postoperatively (assessed by mandatory bilateral venography performed 10 to 13 days after surgery or confirmed symptomatic deep vein thrombosis or pulmonary embolism). A 5% noninferiority margin compared with enoxaparin was chosen. The primary safety outcome of major or clinically relevant nonmajor bleeding was assessed until 10 to 13 days postoperatively. Results: Of 813 randomized participants (mean [SD] age, 66.5 years [8.2 years]; body mass index, 32.7 [5.7]; and 74.2% women), 600 were included in the per-protocol population used for the primary analysis. The primary outcome occurred in 18 patients (23.7%) receiving 0.3 mg/kg, 8 (15.7%) receiving 0.6 mg/kg, 13 (16.5%) receiving 1.2 mg/kg, and 14 (17.9%) receiving 1.8 mg/kg of osocimab postoperatively; 23 (29.9%) receiving 0.3 mg/kg and 9 (11.3%) receiving 1.8 mg/kg of osocimab preoperatively; 20 (26.3%) receiving enoxaparin; and 12 (14.5%) receiving apixaban. Osocimab given postoperatively met criteria for noninferiority compared with enoxaparin with risk differences (1-sided 95% CIs) of 10.6% (95% CI, -1.2% to ∞) at the 0.6-mg/kg dose; 9.9% (95% CI, -0.9% to ∞) at the 1.2-mg/kg dose, and 8.4% (95% CI, -2.6 to ∞) at the 1.8-mg/kg dose. The preoperative dose of 1.8 mg/kg of osocimab met criteria for superiority compared with enoxaparin with a risk difference of 15.1%; 2-sided 90% CI, 4.9% to 25.2%). Postoperative and preoperative doses of 0.3 mg/kg of osocimab did not meet the prespecified criteria for noninferiority, with risk differences (1-sided 95% CIs) of 2.6% (95% CI, -8.9% to ∞) and -3.6% (95% CI, -15.5% to ∞), respectively. Major or clinically relevant nonmajor bleeding was observed in up to 4.7% of those receiving osocimab, 5.9% receiving enoxaparin, and 2% receiving apixaban. Conclusions and Relevance: Among patients undergoing knee arthroplasty, postoperative osocimab 0.6 mg/kg, 1.2 mg/kg, and 1.8 mg/kg met criteria for noninferiority compared with enoxaparin, and the preoperative 1.8-mg/kg dose of osocimab met criteria for superiority compared with enoxaparin for the primary outcome of incidence of venous thromboembolism at 10 to 13 days postoperatively. Further studies are needed to establish efficacy and safety of osocimab relative to standard thromboprophylaxis. Trial Registration: ClinicalTrials.gov Identifier: NCT03276143.


Assuntos
Anticoagulantes/administração & dosagem , Artroplastia do Joelho , Inibidores do Fator Xa/administração & dosagem , Hemorragia/induzido quimicamente , Complicações Pós-Operatórias/prevenção & controle , Tromboembolia Venosa/prevenção & controle , Idoso , Anticoagulantes/efeitos adversos , Relação Dose-Resposta a Droga , Enoxaparina/administração & dosagem , Enoxaparina/efeitos adversos , Inibidores do Fator Xa/efeitos adversos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Cuidados Pré-Operatórios , Embolia Pulmonar/prevenção & controle , Pirazóis/administração & dosagem , Pirazóis/efeitos adversos , Piridonas/administração & dosagem , Piridonas/efeitos adversos , Método Simples-Cego , Trombose Venosa/prevenção & controle
4.
Lancet Haematol ; 7(1): e18-e27, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31699660

RESUMO

BACKGROUND: Treatment of venous thromboembolism in children is based on data obtained in adults with little direct documentation of its efficacy and safety in children. The aim of our study was to compare the efficacy and safety of rivaroxaban versus standard anticoagulants in children with venous thromboembolism. METHODS: In a multicentre, parallel-group, open-label, randomised study, children (aged 0-17 years) attending 107 paediatric hospitals in 28 countries with documented acute venous thromboembolism who had started heparinisation were assigned (2:1) to bodyweight-adjusted rivaroxaban (tablets or suspension) in a 20-mg equivalent dose or standard anticoagulants (heparin or switched to vitamin K antagonist). Randomisation was stratified by age and venous thromboembolism site. The main treatment period was 3 months (1 month in children <2 years of age with catheter-related venous thromboembolism). The primary efficacy outcome, symptomatic recurrent venous thromboembolism (assessed by intention-to-treat), and the principal safety outcome, major or clinically relevant non-major bleeding (assessed in participants who received ≥1 dose), were centrally assessed by investigators who were unaware of treatment assignment. Repeat imaging was obtained at the end of the main treatment period and compared with baseline imaging tests. This trial is registered with ClinicalTrials.gov, number NCT02234843 and has been completed. FINDINGS: From Nov 14, 2014, to Sept 28, 2018, 500 (96%) of the 520 children screened for eligibility were enrolled. After a median follow-up of 91 days (IQR 87-95) in children who had a study treatment period of 3 months (n=463) and 31 days (IQR 29-35) in children who had a study treatment period of 1 month (n=37), symptomatic recurrent venous thromboembolism occurred in four (1%) of 335 children receiving rivaroxaban and five (3%) of 165 receiving standard anticoagulants (hazard ratio [HR] 0·40, 95% CI 0·11-1·41). Repeat imaging showed an improved effect of rivaroxaban on thrombotic burden as compared with standard anticoagulants (p=0·012). Major or clinically relevant non-major bleeding in participants who received ≥1 dose occurred in ten (3%) of 329 children (all non-major) receiving rivaroxaban and in three (2%) of 162 children (two major and one non-major) receiving standard anticoagulants (HR 1·58, 95% CI 0·51-6·27). Absolute and relative efficacy and safety estimates of rivaroxaban versus standard anticoagulation estimates were similar to those in rivaroxaban studies in adults. There were no treatment-related deaths. INTERPRETATION: In children with acute venous thromboembolism, treatment with rivaroxaban resulted in a similarly low recurrence risk and reduced thrombotic burden without increased bleeding, as compared with standard anticoagulants. FUNDING: Bayer AG and Janssen Research & Development.


Assuntos
Anticoagulantes/uso terapêutico , Rivaroxabana/uso terapêutico , Tromboembolia Venosa/tratamento farmacológico , Adolescente , Criança , Pré-Escolar , Feminino , Humanos , Lactente , Masculino , Fatores de Risco
5.
World Neurosurg ; 133: e774-e783, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31605841

RESUMO

BACKGROUND: The use of venous duplex ultrasonography (VDU) for confirmation of deep venous thrombosis in neurosurgical patients is costly and requires experienced personnel. We evaluated a protocol using D-dimer levels to screen for venous thromboembolism (VTE), defined as deep venous thrombosis and asymptomatic pulmonary embolism. METHODS: We used a retrospective bioinformatics analysis to identify neurosurgical inpatients who had undergone a protocol assessing the serum D-dimer levels and had undergone a VDU study to evaluate for the presence of VTE from March 2008 through July 2017. The clinical risk factors and D-dimer levels were evaluated for the prediction of VTE. RESULTS: In the 1918 patient encounters identified, the overall VTE detection rate was 28.7%. Using a receiver operating characteristic curve, an area under the curve of 0.58 was identified for all D-dimer values (P = 0.0001). A D-dimer level of ≥2.5 µg/mL on admission conferred a 30% greater relative risk of VTE (sensitivity, 0.43; specificity, 0.67; positive predictive value, 0.27; negative predictive value, 0.8). A D-dimer value of ≥3.5 µg/mL during hospitalization yielded a 28% greater relative risk of VTE (sensitivity, 0.73; specificity, 0.32; positive predictive value, 0.24; negative predictive value, 0.81). Multivariable logistic regression showed that age, male sex, length of stay, tumor or other neurological disease diagnosis, and D-dimer level ≥3.5 µg/mL during hospitalization were independent predictors of VTE. CONCLUSIONS: The D-dimer protocol was beneficial in identifying VTE in a heterogeneous group of neurosurgical patients by prompting VDU evaluation for patients with a D-dimer values of ≥3.5 µg/mL during hospitalization. Refinement of this screening model is necessary to improve the identification of VTE in a practical and cost-effective manner.


Assuntos
Biomarcadores/sangue , Produtos de Degradação da Fibrina e do Fibrinogênio/análise , Tromboembolia Venosa/sangue , Tromboembolia Venosa/diagnóstico , Adulto , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Sensibilidade e Especificidade , Trombose Venosa/sangue
6.
Angiology ; 71(2): 131-138, 2020 02.
Artigo em Inglês | MEDLINE | ID: mdl-31578072

RESUMO

Patients with autoimmune disorders are at an increased risk of venous thromboembolism (VTE), but this association has not been consistently evaluated. We used the RIETE (Registro Informatizado Enfermedad Trombo Embólica) database to compare the rates of VTE recurrences, major bleeding, and death during the course of anticoagulation, according to the presence or absence of autoimmune disorders. Of 71 625 patients with VTE recruited in February 2018, 1800 (2.5%) had autoimmune disorders. Median duration of anticoagulant therapy was slightly longer in patients with autoimmune disorders (median, 190 vs 182 days; P = .001). On multivariable analysis, patients with autoimmune disorders had a similar risk of VTE recurrences (hazard ratio [HR]: 0.93; 95% confidence interval [CI]: 0.68-1.27) or major bleeding (HR: 1.07; 95% CI: 0.82-1.40) and a lower risk to die (HR: 0.66; 95% CI: 0.54-0.81) than those without autoimmune disorders. Patients with giant cell arteritis had the highest rates of major bleeding (8.6 events per 100 patient-years) and the lowest rate of recurrences (zero). In other subgroups, the rates of both events were more balanced. During anticoagulation, patients with or without autoimmune disorders had similar rates of VTE recurrences or major bleeding. However, there were some differences between subgroups of patients with autoimmune disorders.


Assuntos
Doenças Autoimunes/complicações , Tromboembolia Venosa/etiologia , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/efeitos adversos , Anticoagulantes/uso terapêutico , Bases de Dados Factuais , Feminino , Hemorragia/induzido quimicamente , Humanos , Masculino , Pessoa de Meia-Idade , Recidiva , Sistema de Registros , Medição de Risco , Espanha , Tromboembolia Venosa/tratamento farmacológico , Tromboembolia Venosa/epidemiologia
7.
Urology ; 135: 44-49, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31586570

RESUMO

OBJECTIVE: To examine the use of in-hospital pharmacologic thromboprophylaxis (PTP) in patients undergoing radical cystectomy between 2004 and 2014 and to assess the risk of venous thromboembolism (VTE) across the study period. MATERIAL AND METHODS: We identified 8322 patients without contraindications to PTP undergoing radical cystectomy in the US using the Premier Healthcare Database. Nonparametric Wilcoxon type test for trend was employed to examine the trend of PTP utilization across the study period. Ensuing, we employed multivariable logistic regression and generalized linear regression models to examine the odds of receiving PTP and the risk of being diagnosed with VTE, respectively. RESULTS: Based on VTE risk-stratification, the majority of patients (87.8%) qualified as "high-risk." Across the study period the use of PTP increased (Odds ratio 1.02, 95% confidence interval (CI) 1.00-1.03, P = .044), but remained underutilized as the maximum percentage of patients receiving in-hospital PTP did not exceed 58.6%. The risk of VTE did not vary across the study period (risk ratio 0.97, 95%CI 0.92-1.02, P = .178). CONCLUSION: Utilization of PTP increased throughout the study period, while the risk of VTE did not change. Future studies are necessary to improve implementation of guideline-driven care, as PTP remained underutilized throughout the study period.


Assuntos
Anticoagulantes/administração & dosagem , Cistectomia/efeitos adversos , Fidelidade a Diretrizes/tendências , Complicações Pós-Operatórias/prevenção & controle , Tromboembolia Venosa/prevenção & controle , Adolescente , Adulto , Idoso , Feminino , Fidelidade a Diretrizes/estatística & dados numéricos , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Guias de Prática Clínica como Assunto , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Neoplasias da Bexiga Urinária/cirurgia , Tromboembolia Venosa/epidemiologia , Tromboembolia Venosa/etiologia , Adulto Jovem
8.
Rev Med Suisse ; 15(674): 2232-2235, 2019 Dec 04.
Artigo em Francês | MEDLINE | ID: mdl-31804034

RESUMO

The use of direct oral anticoagulants (DOACs) has been largely -implemented in the management of venous thromboembolic disease in non-cancer patients. In cancer-associated thrombosis, low molecular weight heparins (LMWHs) and especially dalteparin have long been the reference standard therapy. Following the publication of two randomised trials comparing edoxaban and rivaroxaban to -dalteparin, DOACs now represent an alternative with an interesting efficacy and safety profile. Moreover, they offer the comfort of an oral administration and a lower cost. In patients with gastrointestinal or genitourinary cancers however, a higher bleeding risk has been shown with DOACs. LMWHs thus remain the treatment of choice in this group of patients.


Assuntos
Anticoagulantes/administração & dosagem , Anticoagulantes/uso terapêutico , Neoplasias/complicações , Tromboembolia Venosa/complicações , Tromboembolia Venosa/tratamento farmacológico , Administração Oral , Dalteparina/administração & dosagem , Dalteparina/uso terapêutico , Heparina de Baixo Peso Molecular/administração & dosagem , Heparina de Baixo Peso Molecular/uso terapêutico , Humanos , Piridinas/administração & dosagem , Piridinas/uso terapêutico , Rivaroxabana/administração & dosagem , Rivaroxabana/uso terapêutico , Tiazóis/administração & dosagem , Tiazóis/uso terapêutico
9.
Gan To Kagaku Ryoho ; 46(12): 1883-1885, 2019 Dec.
Artigo em Japonês | MEDLINE | ID: mdl-31879408

RESUMO

A woman in her 70s developed deep vein thromboembolism(DVT)and pulmonary embolism(PE)during chemotherapy for advanced transverse colon cancer. After the first treatment with heparin and warfarin, the anticoagulant was changed to edoxaban to reduce the risk of bleeding. She continued receiving chemotherapy for 4 years. We recommend edoxaban as the first choice of anticoagulant for patients with DVT and PE requiring chemotherapy with fluoropyrimidine-based antineoplastic agents.


Assuntos
Anticoagulantes/efeitos adversos , Neoplasias do Colo , Fluoruracila/uso terapêutico , Embolia Pulmonar , Piridinas/efeitos adversos , Tiazóis/efeitos adversos , Tromboembolia , Tromboembolia Venosa , Idoso , Neoplasias do Colo/tratamento farmacológico , Humanos , Embolia Pulmonar/induzido quimicamente , Tromboembolia Venosa/induzido quimicamente
10.
Tech Vasc Interv Radiol ; 22(4): 100634, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31864529

RESUMO

Klippel-Trenaunay syndrome or KTS is a complex vascular syndrome associated with overgrowth occurring as a result of somatic mutations in the PIK3CA gene. Patients are diagnosed on the basis of physical findings, sometimes with supportive imaging, of commonly a segmental anomaly with a cutaneous port-wine stain, lymphatic and venous malformations and overgrowth. The severity of the component vascular malformations and the degree of overgrowth varies from patient to patient which demands care given by a multi-professional team with regular follow-up in a specialist clinic. Some patients may present with acute life-threatening problems, often as a result of veno-thromboembolic events (VTEs) especially following surgical and invasive radiological procedures. Awareness of such problems is vital and prophylactic measures to reduce such risks are paramount. The interventional radiologist is vital to the care team as he/she can undertake procedures including endovascular closure of significant venous anomalies which predispose to such VTEs. Although these procedures can be lengthy and complex, they can now provide a minimally invasive means to reduce the risk from life-threatening and sometimes fatal VTEs. The results however from such interventions will require long-term studies which to date are unavailable.


Assuntos
Malformações Arteriovenosas/terapia , Procedimentos Endovasculares , Síndrome de Klippel-Trenaunay-Weber/terapia , Tromboembolia Venosa/prevenção & controle , Malformações Arteriovenosas/diagnóstico , Malformações Arteriovenosas/genética , Malformações Arteriovenosas/mortalidade , Classe I de Fosfatidilinositol 3-Quinases/genética , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/mortalidade , Predisposição Genética para Doença , Hemangioma/diagnóstico , Hemangioma/genética , Hemangioma/terapia , Humanos , Síndrome de Klippel-Trenaunay-Weber/diagnóstico , Síndrome de Klippel-Trenaunay-Weber/genética , Síndrome de Klippel-Trenaunay-Weber/mortalidade , Mutação , Fenótipo , Radiografia Intervencionista , Fatores de Risco , Resultado do Tratamento , Tromboembolia Venosa/diagnóstico , Tromboembolia Venosa/genética , Tromboembolia Venosa/mortalidade
11.
Nat Genet ; 51(11): 1574-1579, 2019 11.
Artigo em Inglês | MEDLINE | ID: mdl-31676865

RESUMO

Venous thromboembolism is a significant cause of mortality1, yet its genetic determinants are incompletely defined. We performed a discovery genome-wide association study in the Million Veteran Program and UK Biobank, with testing of approximately 13 million DNA sequence variants for association with venous thromboembolism (26,066 cases and 624,053 controls) and meta-analyzed both studies, followed by independent replication with up to 17,672 venous thromboembolism cases and 167,295 controls. We identified 22 previously unknown loci, bringing the total number of venous thromboembolism-associated loci to 33, and subsequently fine-mapped these associations. We developed a genome-wide polygenic risk score for venous thromboembolism that identifies 5% of the population at an equivalent incident venous thromboembolism risk to carriers of the established factor V Leiden p.R506Q and prothrombin G20210A mutations. Our data provide mechanistic insights into the genetic epidemiology of venous thromboembolism and suggest a greater overlap among venous and arterial cardiovascular disease than previously thought.


Assuntos
Loci Gênicos , Predisposição Genética para Doença , Estudo de Associação Genômica Ampla , Inibidor 1 de Ativador de Plasminogênio/metabolismo , Doenças Vasculares/genética , Tromboembolia Venosa/genética , Idoso , Animais , Estudos de Casos e Controles , Feminino , Humanos , Masculino , Camundongos , Camundongos Endogâmicos C57BL , Pessoa de Meia-Idade , Inibidor 1 de Ativador de Plasminogênio/genética , Fatores de Risco , Reino Unido/epidemiologia , Doenças Vasculares/epidemiologia , Doenças Vasculares/patologia , Tromboembolia Venosa/epidemiologia , Tromboembolia Venosa/patologia
12.
Mayo Clin Proc ; 94(12): 2444-2454, 2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-31685262

RESUMO

OBJECTIVE: To explore the efficacy and safety of direct oral factor Xa inhibitors in the treatment of cancer-associated acute venous thromboembolism (VTE). PATIENTS AND METHODS: MEDLINE, CENTRAL (Cochrane Central Register of Controlled Trials), and Embase databases were searched for trials comparing direct oral anticoagulants (DOACs) to dalteparin for the management of cancer-associated acute VTE. Databases were searched from inception to September 19, 2018. A network meta-analysis using both frequentist and Bayesian methods was performed to analyze VTE recurrence and major and clinically relevant nonmajor bleeding. RESULTS: We identified 3 randomized controlled trials, at low risk of bias, that enrolled 1739 patients with cancer-associated VTE. Direct comparison revealed a lower rate of VTE recurrence in DOAC compared with dalteparin groups (odds ratio [OR], 0.48; 95% CI, 0.24-0.96; I2=46%). Indirect comparison suggested that apixaban had greater reduction in VTE recurrence compared with dalteparin (OR, 0.10; 95% CI, 0.01-0.82) but not rivaroxaban or edoxaban. Apixaban also had the highest probability of being ranked most effective. By direct comparisons, there was an increased likelihood of major bleeding in the DOAC group compared with dalteparin (OR, 1.70; 95% CI, 1.04-2.78). Clinically relevant nonmajor bleeding did not differ. Indirect estimates were imprecise. Subgroup analyses in gastrointestinal cancers suggested that dalteparin may have the lowest risk of bleeding, whereas estimates in urothelial cancer were imprecise. CONCLUSION: Direct oral anticoagulants appear to lower the risk of VTE recurrence compared with dalteparin while increasing major bleeding. Apixaban may be associated with the lowest risk of VTE recurrence compared with the other DOACs.


Assuntos
Inibidores do Fator Xa/uso terapêutico , Neoplasias/complicações , Tromboembolia Venosa/tratamento farmacológico , Administração Oral , Humanos , Neoplasias/terapia , Tromboembolia Venosa/etiologia
13.
Klin Lab Diagn ; 64(11): 654-658, 2019.
Artigo em Russo | MEDLINE | ID: mdl-31747492

RESUMO

The developing and the testing results of an immunochromatographic test for the D-dimer qualitative determination were presents in the article. The test was approved blood plasma samples in comparison with a quantitative enzyme-linked immunosorbent assay (ELISA). The results of assay with developed test were the same with ELISA results for 87,1% and 100% for samples with increased (more than 400 ng/ml FEU) and normal concentration of D-dimer, respectively. The immunochromatographic test for determination of D-dimer can be included in the diagnostic strategy as a cut test after the assessment of venous thromboembolism risk.


Assuntos
Produtos de Degradação da Fibrina e do Fibrinogênio/análise , Imunoensaio , Tromboembolia Venosa/diagnóstico , Ensaio de Imunoadsorção Enzimática , Humanos , Sensibilidade e Especificidade
14.
Medicine (Baltimore) ; 98(48): e18087, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31770226

RESUMO

BACKGROUND: All cancers increase developing venous thromboembolism risk, and VTE is the second-leading cause of death among cancer patients. The anticoagulant drugs are considered to be the optimal treatment for patients with cancer-associated VTE. However, there is still controversy whether rivaroxaban, a new oral anticoagulant, can lead to better outcomes globally. METHODS: We will search PubMed, Web of Science, Cochrane Central Register of Controlled Trials and China National Knowledge Infrastructure for relevant published studies before 1 September, 2019, without any language restrictions. Only published randomized controlled trials that meet the inclusion criteria will be included. Subgroup analysis of the type of cancer, the type of VTE, cancer stage, age, sex, ethnicity, history of smoking and drinking as well as the mean, dose and duration of anticoagulants will be performed. DISCUSSION: Our study aims to estimate the efficacy and safety of rivaroxaban for patients with cancer-associated VTE and to provide recommendations to key stakeholders. TRIAL REGISTRATION: PROSPERO, October 23, 2019, CRD42019143265, https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=143265.


Assuntos
Anticoagulantes/uso terapêutico , Inibidores do Fator Xa/uso terapêutico , Neoplasias/complicações , Rivaroxabana/uso terapêutico , Tromboembolia Venosa/tratamento farmacológico , Feminino , Humanos , Masculino , Metanálise como Assunto , Projetos de Pesquisa , Revisão Sistemática como Assunto , Resultado do Tratamento , Tromboembolia Venosa/etiologia
15.
Medicine (Baltimore) ; 98(48): e18204, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31770277

RESUMO

BACKGROUND: Venous thromboembolism (VTE) is a multifactorial disease in which genetic and acquired risk factors may contribute to disease pathogenesis. Several studies have demonstrated that ß-fibrinogen (FGB) polymorphisms are associated with the risk of VTE. However, the results of these studies were not totally consistent. In this paper, we performed a meta-analysis to further investigate the relationship between FGB polymorphisms and susceptibility to VTE. METHODS: To identify studies pertinent to the focused question, the following databases were systematically searched: PubMed, EMBASE, Web of Science, China National Knowledge Infrastructure, and Wanfang Data. The strength of correlations was evaluated by calculating pooled odds ratios (ORs) and 95% confidence intervals (95% CIs). Subgroup analyses stratified by ethnicity, type of disorders, and source of control were also performed. RESULTS: Overall, A total of 18 relevant case-control studies met the inclusion criteria and were incorporated in this meta-analysis, involving 3033 VTE cases and 4547 healthy controls. FGB -455G>A polymorphism and -148C>T polymorphism were not significantly associated with susceptibility to VTE in overall populations. However, results of stratified analysis demonstrated that among Caucasian population, the -455G>A mutation was negatively associated with the risk of VTE under all genetic comparison models (A:G OR = 0.80 95% CI = 0.70-0.91; GA + AA:GG OR = 0.80 95% CI = 0.68-0.93; GA:GG OR = 0.84 95% CI = 0.71-0.98; AA:GG + GA OR = 0.61 95% CI = 0.43-0.87; AA:GG OR = 0.57 95% CI = 0.40-0.82), which indicates FGB -455G>A polymorphism may be a protective factor for VTE. There was no correlation between -148C>T polymorphism and susceptibility to VTE in all subgroup analyses. CONCLUSION: FGB -455G>A polymorphism was associated with a decreased risk of VTE among the Caucasian population.


Assuntos
Fibrinogênio/genética , Tromboembolia Venosa , Grupo com Ancestrais do Continente Europeu , Humanos , Mutação , Polimorfismo de Nucleotídeo Único , Fatores de Proteção , Tromboembolia Venosa/etnologia , Tromboembolia Venosa/genética
16.
Rev Med Suisse ; 15(668): 1934-1939, 2019 Oct 23.
Artigo em Francês | MEDLINE | ID: mdl-31643154

RESUMO

Venous thromboembolic events (VTE), defined by deep vein thrombosis or pulmonary embolism, are potentially serious complications after gynecologic surgery. Without thromboprophylaxis, they are common and can lead to significant morbidity and mortality. Conversely, poorly adapted prophylaxis can be hazardous. Risk factors related to the patients and to the types of surgery have been identified and can be used to adapt the prophylaxis. Several recommendations have been proposed; however, no clear consensus exists. This article reviews the pathophysiology and specific risk factors of post-gynecologic surgical VTE and provides comprehensive and practical recommendations for perioperative thromboprophylaxis in gynecology, based on various international recommendations.


Assuntos
Procedimentos Cirúrgicos em Ginecologia/efeitos adversos , Assistência Perioperatória/métodos , Embolia Pulmonar/prevenção & controle , Tromboembolia Venosa/prevenção & controle , Trombose Venosa/prevenção & controle , Anticoagulantes/farmacologia , Anticoagulantes/uso terapêutico , Feminino , Humanos , Fatores de Risco
17.
Gan To Kagaku Ryoho ; 46(10): 1531-1535, 2019 Oct.
Artigo em Japonês | MEDLINE | ID: mdl-31631134

RESUMO

We investigated the incidence of thromboembolism in patients receiving combination chemotherapy with bevacizumab (BV)for colorectal cancer and examined its association with clinical factors. Between July 2007 and April 2014, 250 patients with colorectal cancer received combination chemotherapy with BV. Thromboembolism occurred in 24 cases(9.6%). Five predictive risk factors(platelet count B350,000/µL, hemoglobin <10 g/dL, leukocyte count>11,000/mL, body mass index B25.3 kg/m2, and D-dimer B1.44 µg/mL)were set based on a previous report, and the corresponding number of risk factors for thromboembolism and incidence of thromboembolism were examined. The results of multivariate analysis showed that the occurrence of 3 or more risk factors conferred a significant risk for the incidence of thromboembolism. Due to the increased risk of developing thromboembolism in such patients, special attention during management is required.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Neoplasias Colorretais , Tromboembolia , Tromboembolia Venosa , Bevacizumab , Neoplasias Colorretais/tratamento farmacológico , Quimioterapia Combinada , Humanos , Fatores de Risco
19.
Dis Colon Rectum ; 62(11): 1371-1380, 2019 11.
Artigo em Inglês | MEDLINE | ID: mdl-31596763

RESUMO

BACKGROUND: Patients with Crohn's disease are at increased risk of postoperative venous thromboembolism. Historically, extended outpatient prophylaxis has not met conventional measures of societal cost-benefit advantage. However, extended prophylaxis for patients with Crohn's disease may be more cost-effective because of the patients' high thrombotic risk and long life expectancy. OBJECTIVE: This study aimed to assess the cost-effectiveness of extended prophylaxis in patients with Crohn's disease after abdominal surgery. DESIGN: A decision tree model was used to assess the incremental cost-effectiveness and cost per case averted with extended-duration venous thromboembolism prophylaxis following abdominal surgery. SETTING: The risk of a postdischarge thrombotic event, age at surgery, type of thrombotic event, prophylaxis risk reduction, bleeding complications, and mortality were estimated by using existing published sources. PATIENTS: Studied were patients with Crohn's disease versus routine care. INTERVENTION: We constructed a decision analysis to compare costs and outcomes in patients with Crohn's disease postoperatively with and without extended prophylaxis over a lifetime horizon. MAIN OUTCOME MEASURES: Productivity costs ($) and benefits (quality-adjusted life-year) were used to reflect a societal perspective and were time discounted at 3%. Multivariable probabilistic sensitivity analysis accounted for uncertainty in probabilities, costs, and utility weights. RESULTS: With the use of reference parameters, the individual expected societal total cost of care was $399.83 without and $1387.95 with prophylaxis. Preventing a single mortality with prophylaxis would cost $43.00 million (number needed to treat: 39,839 individuals). The incremental cost was $1.90 million per quality-adjusted life-year. Adjusting across a range of scenarios upheld these conclusions 88% of the time. With further sensitivity testing, subpopulations with postdischarge thrombosis rates greater than 4.9% favors postoperative extended-duration venous thromboembolism prophylaxis. LIMITATIONS: Further investigation is needed to determine if specific high-risk individuals can be preemptively identified in the Crohn's surgical population for targeted prophylaxis. CONCLUSION: Extended prophylaxis in patients with Crohn's disease postoperatively is not cost-effective when the cumulative incidence of posthospital thrombosis remains less than 4.9%. These findings are driven by the low absolute risk of thrombosis in this population and the considerable cost of universal treatment. See Video Abstract at http://links.lww.com/DCR/A998. LIMITACIONES DE COSTO-BENEFICIO DE LA PROFILAXIS AMBULATORIA PROLONGADA DEL TROMBOEMBOLISMO VENOSO DESPUÉS DE CIRUGÍA EN CASOS DE ENFERMEDAD DE CROHN:: Los pacientes con enfermedad de Crohn tienen un mayor riesgo de tromboembolismo venoso postoperatorio. Históricamente, la profilaxis ambulatoria prolongada no ha cumplido con las medidas convencionales de ventajas en costo-beneficio para la sociedad. Sin embargo, la profilaxis prolongada en los pacientes con Crohn puede ser más rentable debido al alto riesgo trombótico y a una larga esperanza de vida en estos pacientes.Evaluar la rentabilidad de la profilaxis prolongada en pacientes postoperados de un Crohn.Se utilizó un modelo de árbol de decisión para evaluar el incremento de rentabilidad y el costo por cada caso evitado con la profilaxis prolongada de tromboembolismo venoso después de cirugía abdominal.Se calcularon utilizando fuentes publicadas el riesgo de evento trombótico posterior al alta, la edad del paciente al momento de la cirugía, el tipo de evento trombótico, la reducción del riesgo de profilaxis, las complicaciones hemorrágicas y la mortalidad.Se estudiaron los pacientes de atención rutinaria versus aquellos portadores de Crohn.Construimos un arbol de análisis decisional para comparar costos y resultados de pacientes portadores de Crohn, con y sin profilaxis prolongada en el postoperatorio en un horizonte de por vida.Los costos de productividad ($) y los beneficios (año de vida ajustado por calidad) se utilizaron para reflejar la perspectiva social y se descontaron en el tiempo de un 3%. El análisis de sensibilidad probabilística multivariable dió cuenta de la incertidumbre en las probabilidades, costos y peso de utilidades.Usando parámetros de referencia, el costo total social esperado de la atención individual fue de $ 399.83 sin y $ 1,387.95 con profilaxis. La prevención del deceso de un paciente con profilaxis costaría $ 43.00 millones (valor requerido para tratar: 39,839 individuos). El costo incrementado fue de $ 1.90 millones por año de vida ajustado por la calidad. El ajuste a través de una gama de escenarios confirmó estas conclusiones el 88% del tiempo. Con pruebas de sensibilidad adicionales, las subpoblaciones con tasas de trombosis posteriores al alta fueron superiores al 4,9% y favorecían la profilaxis prolongada del tromboembolismo venoso en el postoperatorio.Se necesita más investigación para determinar si se puede identificar de manera preventiva los individuos específicos de alto riesgo en la población quirúrgica de Crohn en casos de profilaxis dirigida.La profilaxis prolongada en pacientes postoperados de un Crohn no es rentable cuando la incidencia acumulada de trombosis posthospitalaria sigue siendo inferior al 4,9%. Estos hallazgos son impulsados por el bajo riesgo absoluto de trombosis en esta población y el costo considerable del tratamiento universal. Vea el resumen del video en http://links.lww.com/DCR/A998.


Assuntos
Quimioprevenção , Colectomia/efeitos adversos , Doença de Crohn/cirurgia , Complicações Pós-Operatórias , Tromboembolia Venosa , Quimioprevenção/economia , Quimioprevenção/métodos , Colectomia/métodos , Análise Custo-Benefício , Técnicas de Apoio para a Decisão , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Pacientes Ambulatoriais/estatística & dados numéricos , Complicações Pós-Operatórias/mortalidade , Complicações Pós-Operatórias/prevenção & controle , Risco Ajustado , Prevenção Secundária/economia , Prevenção Secundária/métodos , Estados Unidos , Tromboembolia Venosa/etiologia , Tromboembolia Venosa/mortalidade , Tromboembolia Venosa/prevenção & controle
20.
Expert Opin Drug Saf ; 18(12): 1119-1125, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31580164

RESUMO

Introduction: The non-vitamin K antagonist oral anticoagulants (NOACs) are changing the landscape for stroke prevention in atrial fibrillation (AF) and prevention or treatment of venous thromboembolism (VTE). In patients with AF and concomitant acute coronary syndrome (ACS), the treatment regimen of combined NOACs and P2Y12 inhibitors is gaining popularity.Areas covered: We conducted a review of safety evaluation and effectiveness of apixaban for AF and ACS treatment, both alone and in combination with different antiplatelet treatment regimens. The aim was to provide an overview of apixaban including mechanism of action, indications, adverse events and tolerability.Expert opinion: Apixaban is recommended as a safe, well tolerated and effective oral anticoagulant for reducing the risk of ischemic events among AF patients. It is of value in prevention and treatment of VTE and pulmonary embolism. Comparing to VKA, apixaban was superior in preventing stroke or systemic embolism with lower major bleeding events among AF patients. When combined with dual antiplatelet therapy apixaban may cause dose-related increase in bleeding which reduces the benefit of this treatment regimen among ACS patients but without AF. In those with ACS and concomitant AF, the combination of apixaban with P2Y12 inhibitor appears to be safe and effective.


Assuntos
Inibidores do Fator Xa/administração & dosagem , Antagonistas do Receptor Purinérgico P2Y/administração & dosagem , Pirazóis/administração & dosagem , Piridonas/administração & dosagem , Síndrome Coronariana Aguda/tratamento farmacológico , Fibrilação Atrial/complicações , Fibrilação Atrial/tratamento farmacológico , Quimioterapia Combinada , Inibidores do Fator Xa/efeitos adversos , Humanos , Intervenção Coronária Percutânea/métodos , Antagonistas do Receptor Purinérgico P2Y/efeitos adversos , Pirazóis/efeitos adversos , Piridonas/efeitos adversos , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle , Tromboembolia Venosa/etiologia , Tromboembolia Venosa/prevenção & controle
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