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1.
Am Heart J ; 216: 136-142, 2019 10.
Artigo em Inglês | MEDLINE | ID: mdl-31434031

RESUMO

BACKGROUND: Although the high-risk acute pulmonary embolism (PE) population has been described, little is known about the contemporary inpatient experience and practice patterns of the PE population as a whole. METHODS: All patients with a diagnosis of acute PE from January 1, 2016, to June 30, 2017 within our academic, multihospital health system were retrospectively identified using International Classification of Diseases, 10th Revision, codes, and data were manually abstracted by 2 clinical investigators. Descriptive analyses were performed according to clinical risk stratification categories from the European Society of Cardiology. RESULTS: Of 829 total patients, 372 (44.8%) patients had intermediate or high-risk PE. Mean age was 62.1 years old, and 42.1% of patients had a history of malignancy. One hundred fifty-three (18.5%) patients had an acute PE during a hospitalization for another indication. A total of 6.0% underwent invasive PE therapies, 26.1% required intensive care unit admission, and 9.0% experienced in-hospital death or hospice discharge. In a subgroup description, patients who developed acute PE during a hospitalization for another indication had a higher incidence of incomplete risk stratification and a higher mortality (9.8%) than the primary cohort. Mortality was attributed to PE in 48.4% of cases. CONCLUSIONS: This contemporary description of acute PE managed at a single large, multihospital academic health system highlights substantial health care utilization and high mortality despite the available of advanced therapeutics. Additional work is needed to standardize care for the heterogeneous PE population to ensure appropriate allocation of resources and improved outcomes for all PE patients.


Assuntos
Pacientes Internados , Embolia Pulmonar/mortalidade , Embolia Pulmonar/terapia , Doença Aguda , Idoso , Feminino , Hospitalização/estatística & dados numéricos , Humanos , Classificação Internacional de Doenças , Masculino , Pessoa de Meia-Idade , Embolia Pulmonar/diagnóstico , Embolia Pulmonar/epidemiologia , Estudos Retrospectivos , Risco , Distribuição por Sexo , Avaliação de Sintomas , Terapia Trombolítica/métodos
2.
Am J Med ; 132(12): 1450-1457.e1, 2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-31247183

RESUMO

BACKGROUND: Few studies describe both inpatient and outpatient treatment and outcomes of patients with acute venous thromboembolism in the United States. METHODS: A multi-institutional cohort of patients diagnosed with confirmed pulmonary embolism or deep venous thrombosis during the years 2004 through 2010 was established from 4 large, US-based integrated health care delivery systems. Computerized databases were accessed and medical records reviewed to collect information on patient demographics, clinical risk factors, initial antithrombotic treatment, and vital status. Multivariable Cox regression models were used to estimate the risk of death at 90 days. RESULTS: The cohort comprised 5497 adults with acute venous thromboembolism. Pulmonary embolism was predominantly managed in the hospital setting (95.0%), while 54.5% of patients with lower extremity thrombosis were treated as outpatients. Anticoagulant treatment differed according to thromboembolism type: 2688 patients (92.8%) with pulmonary embolism and 1625 patients (86.9%) with lower extremity thrombosis were discharged on anticoagulants, compared with 286 patients (80.1%) with upper extremity thrombosis and 69 (54.8%) patients with other thrombosis. While 4.5% of patients died during the index episode, 15.4% died within 90 days. Pulmonary embolism was associated with a higher 90-day death risk than lower extremity thrombosis (adjusted hazard ratio 1.23; 95% confidence interval, 1.04-1.47), as was not being discharged on anticoagulants (adjusted hazard ratio 5.56; 95% confidence interval, 4.76-6.67). CONCLUSIONS: In this multicenter, community-based study of patients with acute venous thromboembolism, anticoagulant treatment and outcomes varied by thromboembolism type. Although case fatality during the acute episode was relatively low, 15.4% of people with thromboembolism died within 90 days of the index diagnosis.


Assuntos
Anticoagulantes/uso terapêutico , Embolia Pulmonar/tratamento farmacológico , Embolia Pulmonar/mortalidade , Trombose Venosa/tratamento farmacológico , Trombose Venosa/mortalidade , Doença Aguda , Adulto , Idoso , Estudos de Coortes , Bases de Dados Factuais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Prognóstico , Modelos de Riscos Proporcionais , Embolia Pulmonar/diagnóstico por imagem , Estudos Retrospectivos , Medição de Risco , Índice de Gravidade de Doença , Análise de Sobrevida , Resultado do Tratamento , Trombose Venosa/diagnóstico por imagem
3.
Cochrane Database Syst Rev ; 3: CD010019, 2019 03 06.
Artigo em Inglês | MEDLINE | ID: mdl-30839095

RESUMO

BACKGROUND: Pulmonary embolism (PE) is a common life-threatening cardiovascular condition, with an incidence of 23 to 69 new cases per 100,000 people each year. For selected low-risk patients with acute PE, outpatient treatment might provide several advantages over traditional inpatient treatment, such as reduction of hospitalisations, substantial cost savings, and improvements in health-related quality of life. This is an update of the review first published in 2014. OBJECTIVES: To compare the efficacy and safety of outpatient versus inpatient treatment in low-risk patients with acute PE for the outcomes of all-cause and PE-related mortality; bleeding; adverse events such as haemodynamic instability; recurrence of PE; and patients' satisfaction. SEARCH METHODS: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL and AMED databases, and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers, to 26 March 2018. We also undertook reference checking to identify additional studies. SELECTION CRITERIA: We included randomised controlled trials of outpatient versus inpatient treatment of adults (aged 18 years and over) diagnosed with low-risk acute PE. DATA COLLECTION AND ANALYSIS: Two review authors selected relevant trials, assessed methodological quality, and extracted and analysed data. We calculated effect estimates using risk ratio (RR) with 95% confidence intervals (CIs), or mean differences (MDs) with 95% CIs. We used standardised mean differences (SMDs) to combine trials that measured the same outcome but used different methods. We assessed the quality of the evidence using GRADE criteria. MAIN RESULTS: One new study was identified for this 2018 update, bringing the total number of included studies to two and the total number of participants to 451. Both trials discharged patients randomised to the outpatient group within 36 hours of initial triage and both followed participants for 90 days. One study compared the same treatment regimens in both outpatient and inpatient groups, and the other study used different treatment regimes. There was no clear difference in treatment effect for the outcomes of short-term mortality (30 days) (RR 0.33, 95% CI 0.01 to 7.98, P = 0.49; low-quality evidence), long-term mortality (90 days) (RR 0.98, 95% CI 0.06 to 15.58, P = 0.99, low-quality evidence), major bleeding at 14 days (RR 4.91, 95% CI 0.24 to 101.57, P = 0.30; low-quality evidence) and at 90 days (RR 6.88, 95% CI 0.36 to 132.14, P = 0.20; low-quality evidence), minor bleeding (RR 1.08, 95% CI 0.07 to 16.79; P = 0.96, low-quality evidence), recurrent PE within 90 days (RR 2.95, 95% CI 0.12 to 71.85, P = 0.51, low-quality evidence), and participant satisfaction (RR 0.97, 95% CI 0.90 to 1.04, P = 0.39; moderate-quality evidence). We downgraded the quality of the evidence because the CIs were wide and included treatment effects in both directions, the sample sizes and numbers of events were small, and because the effect of missing data and the absence of publication bias could not be verified. PE-related mortality, and adverse effects such as haemodynamic instability and compliance, were not assessed by the included studies. AUTHORS' CONCLUSIONS: Currently, only low-quality evidence is available from two published randomised controlled trials on outpatient versus inpatient treatment in low-risk patients with acute PE. The studies did not provide evidence of any clear difference between the interventions in overall mortality, bleeding and recurrence of PE.


Assuntos
Assistência Ambulatorial , Enoxaparina/uso terapêutico , Hospitalização , Embolia Pulmonar/terapia , Doença Aguda , Adulto , Anticoagulantes/efeitos adversos , Anticoagulantes/uso terapêutico , Intervalos de Confiança , Enoxaparina/efeitos adversos , Hemorragia/epidemiologia , Humanos , Embolia Pulmonar/mortalidade , Pirazóis/uso terapêutico , Piridonas/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto , Rivaroxabana/efeitos adversos , Rivaroxabana/uso terapêutico
4.
Korean J Intern Med ; 34(5): 1125-1135, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-29788694

RESUMO

BACKGROUND/AIMS: Limited data are available regarding the efficacy of rivaroxaban for the treatment of cancer-associated venous thromboembolism (VTE). The aim of this study was to evaluate the effectiveness and safety of rivaroxaban for the treatment of VTE in active cancer patients. METHODS: In this prospective, multicenter, open-label trial (NCT01989845), we enrolled patients with active cancer and objectively diagnosed lower-extremity deep vein thrombosis, pulmonary embolism (PE), or both from November 2013 to June 2016. Active cancer was defined as a histologically confirmed malignancy, which was diagnosed or treated within the previous 6 months, or as a recurrent/ metastatic cancer. Patients received oral rivaroxaban 15 mg twice daily for first 3 weeks, followed by 20 mg once daily for 6 months. The primary outcome was the symptomatic recurrent VTE and the secondary outcomes included any recurrent VTE, major or clinically relevant non-major (CRNM) bleeding events, and overall mortality. All study outcomes were validated by blinded central adjudication. RESULTS: Of 124 patients enrolled, 110 (88.7%) had solid cancer, 93 (75.0%) had metastatic disease, and 110 (88.7%) were receiving chemotherapy or radiotherapy. During the 6-month study period, seven patients experienced symptomatic recurrent VTE (cumulative incidence, 5.9%), and two patients experienced incidental recurrent PE (cumulative incidence of any recurrent VTE, 7.6%). Major bleeding events occurred in six patients (cumulative incidence, 5.3%) and CRNM bleeding events in 11 patients (cumulative incidence, 10.2%). Twenty-eight patients (overall mortality, 24.0%) died. CONCLUSION: Rivaroxaban is effective and safe for the treatment of VTE in patients with active cancer.


Assuntos
Coagulação Sanguínea/efeitos dos fármacos , Inibidores do Fator Xa/administração & dosagem , Neoplasias/epidemiologia , Embolia Pulmonar/tratamento farmacológico , Rivaroxabana/administração & dosagem , Tromboembolia Venosa/tratamento farmacológico , Trombose Venosa/tratamento farmacológico , Doença Aguda , Adulto , Idoso , Idoso de 80 Anos ou mais , Esquema de Medicação , Inibidores do Fator Xa/efeitos adversos , Feminino , Hemorragia , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Neoplasias/diagnóstico , Neoplasias/mortalidade , Estudos Prospectivos , Embolia Pulmonar/sangue , Embolia Pulmonar/diagnóstico , Embolia Pulmonar/mortalidade , Recidiva , República da Coreia/epidemiologia , Fatores de Risco , Rivaroxabana/efeitos adversos , Fatores de Tempo , Resultado do Tratamento , Tromboembolia Venosa/sangue , Tromboembolia Venosa/diagnóstico , Tromboembolia Venosa/mortalidade , Trombose Venosa/sangue , Trombose Venosa/diagnóstico , Trombose Venosa/mortalidade
5.
Cardiol J ; 26(6): 623-632, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31970735

RESUMO

Pulmonary Embolism Response Team (PERT) is a multidisciplinary team established to stratify risk and choose optimal treatment in patients with acute pulmonary embolism (PE). Established for the first time at Massachusetts General Hospital in 2013, PERT is based on a concept combining a Rapid Response Team and a Heart Team. The growing role of PERTs in making individual therapeutic decisions is identified, especially in hemodynamically unstable patients with contraindications to thrombolysis or with co-morbidities, as well as in patients with intermediate-high risk in whom a therapeutic decision may be difficult. The purpose of this document is to define the standards of PERT under Polish conditions, based on the experience of teams already operating in Poland, which formed an agreement called the Polish PERT Initiative. The goals of Polish PERT Initiative are: improving the treatment of patients with PE at local, regional and national levels, gathering, assessing and sharing data on the effectiveness of PE treatment (including various types of catheter-directed therapy), education on optimal treatment of PE, creating expert documents and supporting scientific research, as well as cooperation with other communities and scientific societies.


Assuntos
Serviços Centralizados no Hospital/organização & administração , Prestação Integrada de Cuidados de Saúde/organização & administração , Equipe de Respostas Rápidas de Hospitais/organização & administração , Embolia Pulmonar/terapia , Regionalização da Saúde/normas , Tomada de Decisão Clínica , Consenso , Comportamento Cooperativo , Técnicas de Apoio para a Decisão , Humanos , Comunicação Interdisciplinar , Polônia , Embolia Pulmonar/diagnóstico , Embolia Pulmonar/mortalidade , Medição de Risco , Fatores de Risco , Resultado do Tratamento
6.
Circ J ; 82(8): 2063-2070, 2018 07 25.
Artigo em Inglês | MEDLINE | ID: mdl-29952347

RESUMO

BACKGROUND: Numerous studies have reported the association of cardiovascular risk factors with pulmonary embolism (PE), but the association of dietary factors, especially fish intake, with the risk of PE has not been fully established.Methods and Results:Using a prospective design, we studied the risk of PE mortality in relation to fish intake in 90,791 community-dwelling men and women in Japan aged 40-79 years. The hazard ratios (HRs) and 95% confidence intervals (CIs) for PE death were estimated using the Cox proportional hazards model. Compared with participants in the lowest fresh fish intake group (<1 time/month), the HRs (95% CIs) for PE death for those in the other intake groups were 0.35 (0.08-1.59) for 1-2 times/month, 0.19 (0.05-0.69) for 1-2 times/week, 0.20 (0.06-0.74) for 3-4 times/week, and 0.18 (0.05-0.66) for fish intake every day. In addition to these findings, compared with the participants in the lowest 10% of ω3 polyunsaturated fatty acid intake, those in the other groups had a 60-76% lower risk of PE death. CONCLUSIONS: Fresh fish intake, even 1-2 times/week, is associated with a lower risk of death from PE among Japanese men and women.


Assuntos
Dieta , Embolia Pulmonar/prevenção & controle , Alimentos Marinhos , Adulto , Idoso , Animais , Estudos de Coortes , Ingestão de Alimentos/fisiologia , Ácidos Graxos Ômega-3/uso terapêutico , Feminino , Peixes , Humanos , Japão , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Embolia Pulmonar/epidemiologia , Embolia Pulmonar/mortalidade , Fatores de Risco , Inquéritos e Questionários , Análise de Sobrevida
8.
J Am Coll Cardiol ; 67(16): 1941-55, 2016 Apr 26.
Artigo em Inglês | MEDLINE | ID: mdl-27102510

RESUMO

Venous thromboembolism (VTE) is a common disease associated with high risk for recurrences, death, and late sequelae, accounting for substantial health care costs. Anticoagulant agents are the mainstay of treatment for deep vein thrombosis and pulmonary embolism. The recent availability of oral anticoagulant agents that can be administered in fixed doses, without laboratory monitoring and dose adjustment, is a landmark change in the treatment of VTE. In Phase III trials, rivaroxaban, apixaban, edoxaban (antifactor Xa agents), and dabigatran (an antithrombin agent) were noninferior and probably safer than conventional anticoagulation therapy (low-molecular-weight heparin followed by vitamin K antagonists). These favorable results were confirmed in specific patient subgroups, such as the elderly and fragile. However, some patients, such as those with cancer or with intermediate- to high-risk pulmonary embolism, were underrepresented in the Phase III trials. Further clinical research is required before new oral anticoagulant agents can be considered standard of care for the full spectrum of patients with VTE.


Assuntos
Anticoagulantes/farmacologia , Heparina de Baixo Peso Molecular/administração & dosagem , Tromboembolia Venosa/tratamento farmacológico , Tromboembolia Venosa/mortalidade , Administração Oral , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/administração & dosagem , Ensaios Clínicos Fase III como Assunto , Dabigatrana/administração & dosagem , Relação Dose-Resposta a Droga , Esquema de Medicação , Quimioterapia Combinada , Feminino , Humanos , Infusões Intravenosas , Masculino , Pessoa de Meia-Idade , Flebografia/métodos , Prognóstico , Embolia Pulmonar/diagnóstico por imagem , Embolia Pulmonar/tratamento farmacológico , Embolia Pulmonar/mortalidade , Piridinas/administração & dosagem , Ensaios Clínicos Controlados Aleatórios como Assunto , Rivaroxabana/administração & dosagem , Índice de Gravidade de Doença , Análise de Sobrevida , Tiazóis/administração & dosagem , Resultado do Tratamento , Tromboembolia Venosa/diagnóstico por imagem
9.
Eur Respir Rev ; 24(137): 484-97, 2015 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-26324810

RESUMO

Pulmonary embolism (PE) is a serious and costly disease for patients and healthcare systems. Guidelines emphasise the importance of differentiating between patients who are at high risk of mortality (those with shock and/or hypotension), who may be candidates for thrombolytic therapy or surgery, and those with less severe presentations. Recent clinical studies and guidelines have focused particularly on risk stratification of intermediate-risk patients. Although the use of thrombolysis has been investigated in these patients, anticoagulation remains the standard treatment approach. Individual risk stratification directs initial treatment. Rates of recurrence differ between subgroups of patients with PE; therefore, a review of provoking factors, along with the risks of morbidity and bleeding, guides the duration of ongoing anticoagulation. The direct oral anticoagulants have shown similar efficacy and, in some cases, reduced major bleeding compared with standard approaches for acute treatment. They also offer the potential to reduce the burden on patients and outpatient services in the post-hospital phase. Rivaroxaban, dabigatran and apixaban have been shown to reduce the risk of recurrent venous thromboembolism versus placebo, when given for >12 months. Patients receiving direct oral anticoagulants do not require regular coagulation monitoring, but follow-up, ideally in a specialist PE clinic in consultation with primary care providers, is recommended.


Assuntos
Anticoagulantes/administração & dosagem , Coagulação Sanguínea/efeitos dos fármacos , Embolia Pulmonar/tratamento farmacológico , Administração Oral , Anticoagulantes/efeitos adversos , Testes de Coagulação Sanguínea , Procedimentos Clínicos , Árvores de Decisões , Monitoramento de Medicamentos/métodos , Hemorragia/induzido quimicamente , Humanos , Valor Preditivo dos Testes , Embolia Pulmonar/sangue , Embolia Pulmonar/diagnóstico , Embolia Pulmonar/mortalidade , Medição de Risco , Fatores de Risco , Resultado do Tratamento
10.
Thromb Haemost ; 114(4): 778-92, 2015 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-26272227

RESUMO

The relative efficacy and safety of dabigatran etexilate and warfarin have been evaluated in two head-to-head, phase III, treatment of acute venous thromboembolism (VTE) trials, and one extended prophylaxis trial, in patients with high risk of recurrent VTE. Dabigatran etexilate demonstrated similar efficacy to warfarin, and was associated with a reduced risk of major or clinically relevant bleeds. Based on results of these trials, and real-life disease prognosis following discontinuation of anticoagulation treatment, we evaluated the cost-utility of dabigatran etexilate compared with warfarin in six months anticoagulation, and in extended, up to 24 months anticoagulation, in patients with acute VTE, acute deep-vein thrombosis (DVT) or acute, symptomatic, pulmonary embolism (PE). Costs were analysed from the perspective of the National Health Services (NHS) and Public Social Services (PSS) in England and Wales. Outcomes were quantified in quality-adjusted life years (QALY). The estimated incremental, lifetime cost/QALY gain following acute, symptomatic VTE (DVT or PE) was £1,252/QALY when dabigatran etexilate or warfarin were administered for up to six months treatment. In treatment of acute, symptomatic PE and in DVT respective ratios were £1,767/QALY and £1,075/QALY. In extended, up to 24 months anticoagulation, dabigatran etexilate projected costs/QALY of £8,242/QALY, when compared with warfarin. Results obtained herein were robust across a number of sensitivity analyses and suggest dabigatran etexilate to be a cost-effective alternative to current standard of care when evaluated in six months treatment and in extended anticoagulation following acute VTE (DVT and/or PE).


Assuntos
Anticoagulantes/economia , Anticoagulantes/uso terapêutico , Dabigatrana/economia , Dabigatrana/uso terapêutico , Custos de Medicamentos , Embolia Pulmonar/tratamento farmacológico , Embolia Pulmonar/economia , Tromboembolia Venosa/tratamento farmacológico , Tromboembolia Venosa/economia , Trombose Venosa/tratamento farmacológico , Trombose Venosa/economia , Varfarina/economia , Varfarina/uso terapêutico , Doença Aguda , Anticoagulantes/efeitos adversos , Análise Custo-Benefício , Dabigatrana/efeitos adversos , Esquema de Medicação , Hemorragia/induzido quimicamente , Hemorragia/economia , Humanos , Estimativa de Kaplan-Meier , Modelos Econômicos , Embolia Pulmonar/diagnóstico , Embolia Pulmonar/mortalidade , Anos de Vida Ajustados por Qualidade de Vida , Medicina Estatal/economia , Fatores de Tempo , Resultado do Tratamento , Reino Unido , Tromboembolia Venosa/diagnóstico , Tromboembolia Venosa/mortalidade , Trombose Venosa/diagnóstico , Trombose Venosa/mortalidade , Varfarina/efeitos adversos
11.
Acad Emerg Med ; 22(3): 299-307, 2015 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-25716463

RESUMO

OBJECTIVES: The objective was to assess adverse outcomes in relation to the simplified Pulmonary Embolism Severity Index (PESI) score in patients treated with rivaroxaban or standard therapy in the phase III EINSTEIN PE study and to evaluate the utility of the simplified PESI score to identify low-risk pulmonary embolism (PE) patients. METHODS: A post hoc analysis of EINSTEIN PE data was performed to assess the efficacy and safety of rivaroxaban in patients with a range of simplified PESI scores. Recurrent venous thromboembolism, fatal PE, all-cause mortality, and major bleeding were stratified by simplified PESI scores of 0, 1, or ≥2 and according to treatment period at 7, 14, 30, and 90 days and at the end of the full intended treatment period. RESULTS: Simplified PESI scores could be calculated in 4,831 of the 4,832 randomized patients; of those, 53.6, 36.7, and 9.7% had PESI scores of 0, 1, and ≥2, respectively. Among patients with simplified PESI scores of 0 or 1, fatal PE, all-cause mortality, and other adverse outcomes were uncommon within the first 7, 14, and 30 days. Patients with simplified PESI scores of ≥2 had more frequent adverse outcomes. Major bleeding was lower in the rivaroxaban group, particularly in those with simplified PESI scores of 1 or ≥2. CONCLUSIONS: The findings support using risk stratification with the simplified PESI score to identify low-risk patients with PE.


Assuntos
Anticoagulantes/uso terapêutico , Inibidores do Fator Xa/uso terapêutico , Morfolinas/uso terapêutico , Embolia Pulmonar/tratamento farmacológico , Índice de Gravidade de Doença , Tiofenos/uso terapêutico , Adulto , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/administração & dosagem , Anticoagulantes/efeitos adversos , Comorbidade , Serviço Hospitalar de Emergência , Inibidores do Fator Xa/administração & dosagem , Inibidores do Fator Xa/efeitos adversos , Feminino , Hemorragia/etiologia , Humanos , Masculino , Pessoa de Meia-Idade , Morfolinas/administração & dosagem , Morfolinas/efeitos adversos , Valor Preditivo dos Testes , Prognóstico , Embolia Pulmonar/mortalidade , Risco , Rivaroxabana , Tiofenos/administração & dosagem , Tiofenos/efeitos adversos
12.
J Thromb Thrombolysis ; 39(2): 155-65, 2015 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-24989022

RESUMO

Four target-specific oral anticoagulants (TSOA's) have been compared to a vitamin K antagonist for the treatment of acute venous thromboembolism (VTE): dabigatran (D), rivaroxaban (R), apixaban (A) and edoxaban (E). We performed an indirect comparison of the TSOA's, based on the six phase III trials identified (RE-COVER I, RE-COVER II, EINSTEIN-DVT, EINSTEIN-PE, AMPLIFY and Hokusai-VTE). There was no statistically significant difference in risk of recurrent VTE or all-cause mortality between the TSOA's. For major bleeding, the RR of an event was 0.42 (95% CI 0.21-0.87, p = 0.02) for A versus D, compared with 0.57 (95% CI 0.29-1.15, p = 0.12) for A versus R, 0.37 (95% CI 0.19-0.73, p < 0.001) for A versus E, 0.74 (95% CI 0.42-1.30, p = 0.30) for R versus D, 0.64 (95% CI 0.38-1.08, p = 0.10) for R versus E and 1.15 (95% CI 0.66-2.00, p = 0.62) for E versus D. For the composite endpoint of major or clinically relevant nonmajor bleeding, the RR was 0.71 (95% CI 0.53-0.96, p = 0.02) for A versus D, 0.47 (95% CI 0.37-0.61, p < 0.001) for A versus R, 0.54 (95% CI 0.42-0.70, p < 0.001) for A versus E, 1.50 (95% CI 1.17-1.92, p = 0.001) for R versus D, 1.15 (95% CI 0.95-1.39, p = 0.16) for R versus E and 1.31 (95% CI 1.02-1.68, p = 0.04) for E versus D. Overall, apixaban appears to be associated with a lower risk of bleeding than the other TSOA's. This analysis may be helpful to the clinician in trying to balance risk versus benefit in selecting a new anticoagulant. A dedicated randomized trial directly comparing the new agents would be required to confirm these results.


Assuntos
Dabigatrana , Hemorragia/induzido quimicamente , Embolia Pulmonar , Pirazóis , Piridinas , Piridonas , Rivaroxabana , Tiazóis , Trombose Venosa , Doença Aguda , Adulto , Idoso , Anticoagulantes/administração & dosagem , Anticoagulantes/efeitos adversos , Ensaios Clínicos Fase III como Assunto , Dabigatrana/administração & dosagem , Dabigatrana/efeitos adversos , Feminino , Hemorragia/prevenção & controle , Humanos , Masculino , Pessoa de Meia-Idade , Avaliação de Resultados em Cuidados de Saúde , Embolia Pulmonar/diagnóstico , Embolia Pulmonar/tratamento farmacológico , Embolia Pulmonar/mortalidade , Pirazóis/administração & dosagem , Pirazóis/efeitos adversos , Piridinas/administração & dosagem , Piridinas/efeitos adversos , Piridonas/administração & dosagem , Piridonas/efeitos adversos , Recidiva , Medição de Risco , Rivaroxabana/administração & dosagem , Rivaroxabana/efeitos adversos , Análise de Sobrevida , Tiazóis/administração & dosagem , Tiazóis/efeitos adversos , Trombose Venosa/diagnóstico , Trombose Venosa/tratamento farmacológico , Trombose Venosa/mortalidade
13.
Clin Orthop Relat Res ; 471(5): 1576-81, 2013 May.
Artigo em Inglês | MEDLINE | ID: mdl-23392993

RESUMO

BACKGROUND: Prior research about symptomatic venous thromboembolism (VTE) after shoulder arthroplasty has not determined whether procedure type (hemiarthroplasty, total shoulder arthroplasty, or reverse shoulder arthroplasty) or surgical indication (traumatic or elective) represent risk factors for VTE after shoulder replacement. QUESTIONS/PURPOSES: We therefore asked whether the risk of symptomatic VTE events and mortality within 90 days of shoulder arthroplasty was influenced by (1) procedure type, and (2) surgical indication (traumatic or elective). METHODS: We performed a retrospective database review of symptomatic VTE events and mortality within 90 days of shoulder arthroplasty in a large (30-hospital) integrated healthcare system over a 5-year period, from January 2005 to December 2009. We compared the likelihood of VTE and death in patients undergoing reverse shoulder arthroplasties (RSAs), total shoulder arthroplasties (TSAs), and hemiarthroplasties (HAs), and we compared the likelihood of VTE and death in patients who underwent elective shoulder arthroplasties with those who underwent shoulder arthroplasty in the setting of acute trauma. RESULTS: In the 2574 eligible shoulder arthroplasties identified during the study period, VTE developed in 1.01% of patients (deep vein thrombosis 0.51% and pulmonary embolism 0.54%). With the numbers available, no differences were observed in rates of VTE or mortality by procedure type. A trend toward increased VTE occurred more frequently in patients having surgery for traumatic indications than after elective surgery (1.71% versus 0.80%; p = 0.055). A higher likelihood of 90-day mortality was observed in trauma patients compared with elective (odds ratio = 7.4; 95% CI, 2.4-25.2). CONCLUSIONS: VTE occurred infrequently in this study sample. These data support future risk and benefit assessment of routine pharmacologic VTE prophylaxis in the perioperative treatment of patients undergoing shoulder arthroplasty, especially in all RSA and traumatic HA subsets, where the risk of VTE may be higher.


Assuntos
Artroplastia de Substituição/efeitos adversos , Artroplastia de Substituição/instrumentação , Prótese Articular , Embolia Pulmonar/epidemiologia , Articulação do Ombro/cirurgia , Tromboembolia Venosa/epidemiologia , Trombose Venosa/epidemiologia , Idoso , Artroplastia de Substituição/mortalidade , California/epidemiologia , Distribuição de Qui-Quadrado , Procedimentos Cirúrgicos Eletivos , Emergências , Feminino , Humanos , Incidência , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Razão de Chances , Desenho de Prótese , Embolia Pulmonar/diagnóstico , Embolia Pulmonar/mortalidade , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Lesões do Ombro , Fatores de Tempo , Resultado do Tratamento , Tromboembolia Venosa/diagnóstico , Tromboembolia Venosa/mortalidade , Trombose Venosa/diagnóstico , Trombose Venosa/mortalidade
14.
Nutrition ; 28(9): 937-41, 2012 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-22465906

RESUMO

OBJECTIVE: Argan oil has been shown to inhibit in vitro and ex vivo platelet aggregation without extending bleeding time. In this report, we examined in vivo the antithrombotic activity of argan oil in an experimental thrombosis model in mice: acute pulmonary thromboembolism and in vitro its effect in a coagulation assay. METHODS: Acute pulmonary thromboembolism was induced, after argan oil treatment, by an intravenous injection of a collagen and epinephrine mixture. The paralyzed and dead mice in each group were numbered and the percentage of protection against acute pulmonary thromboembolism was calculated. The histologic study was conducted in lung tissue to estimate the percentage of opened and occluded vessels by platelet thrombi. The coagulation assay was monitored in platelet-poor plasma from normal rats by measuring the clotting parameters (activated partial thromboplastin time, prothrombin time, and thrombin time) in the presence and absence of argan oil. RESULTS: Argan oil (1 mL/100 g/day), administered orally, showed an antithrombotic activity preventing the paralysis or death (50%) induced by the collagen-epinephrine intravenous injection. This observation was confirmed by the lung histologic examination, in which the density of occluded blood vessels was significantly decreased (62.16 ± 3.95%). However, the argan oil remained inactive for the coagulation parameters of activated partial thromboplastin time, prothrombin time, and thrombin time at variance with heparin, an anticoagulant reference drug. The antithrombotic activity of argan oil seemed unrelated to the anticoagulant activity. CONCLUSION: We suggest that argan oil might be an interesting natural dietary source for the nutritional prevention of hemostasis and cardiovascular disorders. Clinical trials would be necessary and relevant to confirm this hypothesis.


Assuntos
Coagulação Sanguínea/efeitos dos fármacos , Pulmão/efeitos dos fármacos , Fitoterapia , Óleos de Plantas/uso terapêutico , Inibidores da Agregação Plaquetária/uso terapêutico , Embolia Pulmonar/tratamento farmacológico , Sapotaceae/química , Administração Oral , Animais , Testes de Coagulação Sanguínea , Vasos Sanguíneos/efeitos dos fármacos , Colágeno , Modelos Animais de Doenças , Epinefrina , Fibrinolíticos/farmacologia , Fibrinolíticos/uso terapêutico , Heparina/farmacologia , Pulmão/patologia , Masculino , Camundongos , Paralisia/etiologia , Paralisia/prevenção & controle , Óleos de Plantas/farmacologia , Inibidores da Agregação Plaquetária/farmacologia , Embolia Pulmonar/induzido quimicamente , Embolia Pulmonar/mortalidade , Ratos , Ratos Wistar
15.
N Engl J Med ; 366(14): 1287-97, 2012 04 05.
Artigo em Inglês | MEDLINE | ID: mdl-22449293

RESUMO

BACKGROUND: A fixed-dose regimen of rivaroxaban, an oral factor Xa inhibitor, has been shown to be as effective as standard anticoagulant therapy for the treatment of deep-vein thrombosis, without the need for laboratory monitoring. This approach may also simplify the treatment of pulmonary embolism. METHODS: In a randomized, open-label, event-driven, noninferiority trial involving 4832 patients who had acute symptomatic pulmonary embolism with or without deep-vein thrombosis, we compared rivaroxaban (15 mg twice daily for 3 weeks, followed by 20 mg once daily) with standard therapy with enoxaparin followed by an adjusted-dose vitamin K antagonist for 3, 6, or 12 months. The primary efficacy outcome was symptomatic recurrent venous thromboembolism. The principal safety outcome was major or clinically relevant nonmajor bleeding. RESULTS: Rivaroxaban was noninferior to standard therapy (noninferiority margin, 2.0; P=0.003) for the primary efficacy outcome, with 50 events in the rivaroxaban group (2.1%) versus 44 events in the standard-therapy group (1.8%) (hazard ratio, 1.12; 95% confidence interval [CI], 0.75 to 1.68). The principal safety outcome occurred in 10.3% of patients in the rivaroxaban group and 11.4% of those in the standard-therapy group (hazard ratio, 0.90; 95% CI, 0.76 to 1.07; P=0.23). Major bleeding was observed in 26 patients (1.1%) in the rivaroxaban group and 52 patients (2.2%) in the standard-therapy group (hazard ratio, 0.49; 95% CI, 0.31 to 0.79; P=0.003). Rates of other adverse events were similar in the two groups. CONCLUSIONS: A fixed-dose regimen of rivaroxaban alone was noninferior to standard therapy for the initial and long-term treatment of pulmonary embolism and had a potentially improved benefit-risk profile. (Funded by Bayer HealthCare and Janssen Pharmaceuticals; EINSTEIN-PE ClinicalTrials.gov number, NCT00439777.).


Assuntos
Anticoagulantes/uso terapêutico , Morfolinas/uso terapêutico , Embolia Pulmonar/tratamento farmacológico , Tiofenos/uso terapêutico , Administração Oral , Idoso , Anticoagulantes/efeitos adversos , Quimioterapia Combinada , Enoxaparina/efeitos adversos , Enoxaparina/uso terapêutico , Feminino , Seguimentos , Hemorragia/induzido quimicamente , Humanos , Coeficiente Internacional Normatizado , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Morfolinas/efeitos adversos , Embolia Pulmonar/mortalidade , Recidiva , Rivaroxabana , Tiofenos/efeitos adversos , Resultado do Tratamento , Vitamina K/antagonistas & inibidores
16.
Vasc Health Risk Manag ; 7: 153-8, 2011.
Artigo em Inglês | MEDLINE | ID: mdl-21468175

RESUMO

BACKGROUND AND OBJECTIVES: Cancer patients undergo routine imaging studies much more than others. The widespread use of the recently introduced multi-detector CT scanners has resulted in an increasing number of incidentally diagnosed pulmonary embolism (PE) in asymptomatic cancer patients. The significance and clinical outcome of such incidental PE is described. METHODS: Both radiology department and hospital databases were searched for all cancer patients with a diagnosis of incidental PE. CT scans were performed using a 64-slice scanner with a 5.0 mm slice thickness. RESULTS: During the study period, 34 patients with incidental PE were identified. The mean age (±SD) was 57.7 (±12.4) years. All patients had active cancer, gastric, lung, colorectal, and lymphomas being the most frequent. Most patients had advanced-stage disease at the time of PE diagnosis; 26 (77%) patients had stage IV, whereas only 3 patients had stages I or II disease. Twenty-seven (79%) patients had their PE while undergoing active treatment with chemotherapy (68%) or radiotherapy (12%); none, however, were on hormonal therapy. Most (74%) patients had their PE diagnosed without history of recent hospital admission. Except for 5 (15%), all other patients were anticoagulated. With follow-up, 2 patients developed recurrent PE, 2 others had clinical and echocardiographic evidence of pulmonary hypertension, and 9 (26%) died suddenly within 30 days of the diagnosis of incidental PE; 2 of these where among the 5 patients who were not anticoagulated. CONCLUSION: Incidental PE in cancer patients is increasingly encountered. Similar to symptomatic PE, many were diagnosed in patients with advanced stage disease and while undergoing active anti-cancer therapy. A significant percentage of patients had recurrent emboli, pulmonary hypertension, and sudden death.


Assuntos
Achados Incidentais , Neoplasias/diagnóstico por imagem , Embolia Pulmonar/diagnóstico por imagem , Tomografia Computadorizada por Raios X , Adulto , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/uso terapêutico , Humanos , Jordânia , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Neoplasias/mortalidade , Neoplasias/patologia , Neoplasias/terapia , Valor Preditivo dos Testes , Embolia Pulmonar/tratamento farmacológico , Embolia Pulmonar/mortalidade , Recidiva , Estudos Retrospectivos , Fatores de Tempo , Resultado do Tratamento
17.
Interact Cardiovasc Thorac Surg ; 11(3): 265-70, 2010 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-20547704

RESUMO

Acute massive or submassive pulmonary embolism (PE) requires prompt diagnosis, risk-stratification and aggressive treatment. Mortality rates can rise up to 70% within the first hour of presentation and are strongly correlated with the degree of right ventricular (RV) dysfunction, cardiac arrest, and consequential congestive heart failure. While anticoagulation is universally employed, there are inadequate data to establish definitive guidelines for the management of massive PE despite the availability of multiple treatment modalities. Medical thrombolytic therapy has not been shown to significantly reduce mortality in patients with massive PE but is still widely employed, whereas surgical and catheter embolectomy are only reserved as last resort treatments for critically ill patients with hemodynamic instability, or for those who are either not candidates for or have failed thrombolysis. Following an extensive review of medical literature, we outline the treatment options for this clinical scenario while focusing on the role of surgical embolectomy. Although traditionally reserved as rescue therapy for cases of failed thrombolysis, surgical embolectomy is a safe procedure with low mortality when performed early and in a selected group of patients. Sufficient evidence exists to extend the criteria for surgical embolectomy from strictly rescue therapy to include hemodynamically stable patients with RV dysfunction. Multidisciplinary approach to this condition coupled with a meticulous surgical technique has significantly lowered the mortality associated with this surgical procedure over the last 10 years.


Assuntos
Embolectomia , Embolia Pulmonar/cirurgia , Doença Aguda , Algoritmos , Anticoagulantes/uso terapêutico , Procedimentos Clínicos , Embolectomia/efeitos adversos , Embolectomia/mortalidade , Hemodinâmica , Humanos , Embolia Pulmonar/diagnóstico , Embolia Pulmonar/tratamento farmacológico , Embolia Pulmonar/mortalidade , Embolia Pulmonar/fisiopatologia , Terapia Trombolítica , Resultado do Tratamento
18.
Med. clín (Ed. impr.) ; 133(14): 547-551, oct. 2009. tab
Artigo em Espanhol | IBECS | ID: ibc-76091

RESUMO

La trombosis venosa profunda (TVP) y su principal complicación, la embolia pulmonar (EP), afectan a miles de personas anualmente en el mundo. El diagnóstico es, en ocasiones, difícil, porque los signos y síntomas no siempre son evidentes. ¿Por qué la TVP/EP sigue siendo un problema sociosanitario si hay estrategias profilácticas eficaces? La respuesta puede estar en la infrautilización de las guías clínicas por el médico y en la escasa adherencia al tratamiento por los pacientes. Se precisan, por tanto, medidas urgentes que faciliten el conocimiento del problema por el público general, sistemas de alerta hospitalarios, implementación de las guías clínicas existentes e investigación traslacional para aplicar los conocimientos adquiridos al ámbito clínico. El papel de instituciones públicas y privadas y de los Gobiernos será, asimismo, clave para reducir la incidencia de TVP/EP, una de las principales causas de mortalidad en España (AU)


Thousands of individuals suffer from deep vein thrombosis (DVT) all over the world, and many will die from its main complication, pulmonary embolism (PE). An important problem is that the diagnose is easy to overlook because the signs and symptoms are often difficult to recognize. Why do DVT and PE remain such a serious problem, particularly given the availability of effective strategies for preventing and treating them? The answer lays primarily in the failure to consistently use evidence-based interventions in high-risk individuals and in the lack of adherence to the different prophylactic interventions. In order to impact the incidence and burden of DVT/PE and increase public awareness, implementation of electronic alerts and evidence-based approaches, and scientific translational research are required. The commitment of all levels of governments as well as public and private institutions will be crucial to reduce the incidence of DVT, a leading cause of death (AU)


Assuntos
Humanos , Masculino , Feminino , Trombose Venosa/complicações , Embolia Pulmonar/diagnóstico , Trombose Venosa/diagnóstico , Trombose Venosa/tratamento farmacológico , Diagnóstico Clínico , Guias como Assunto , Espanha/epidemiologia , Trombose Venosa/mortalidade , Embolia Pulmonar/mortalidade
19.
Semin Thromb Hemost ; 35(1): 34-41, 2009 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-19308891

RESUMO

The treatment of choice for acute venous thromboembolism is anticoagulant therapy with fast-acting drugs (unfractionated or low-molecular-weight heparin or fondaparinux) aimed at preventing thrombus extension, followed by extended prophylaxis with vitamin K antagonists aimed at preventing recurrence. Experience accumulated over the years has demonstrated that strict laboratory monitoring is required for unfractionated heparin and vitamin K antagonists, making use of these drugs problematic for patients and physicians and prompting researchers to develop new anticoagulants equally effective but without the requirement for laboratory monitoring. The results of clinical trials to date, albeit limited, suggest that these new drugs will probably keep their promise. However, the definitive answer will come subsequent to these clinical trials, when clinicians will start to use these drugs to treat patients in the real world. It is likely that some sort of laboratory monitoring will be required at least for selected categories of patients. Accordingly, clinical laboratories should still be prepared to monitor patients, although the numbers may hopefully decrease sharply in the next decade or so.


Assuntos
Anticoagulantes/uso terapêutico , Coagulação Sanguínea/fisiologia , Coeficiente Internacional Normatizado , Tromboembolia Venosa/tratamento farmacológico , Ensaios Clínicos como Assunto , Fondaparinux , Heparina/uso terapêutico , Heparina de Baixo Peso Molecular/uso terapêutico , Humanos , Incidência , Monitorização Fisiológica/métodos , Morfolinas/uso terapêutico , Polissacarídeos/uso terapêutico , Tempo de Protrombina , Embolia Pulmonar/sangue , Embolia Pulmonar/tratamento farmacológico , Embolia Pulmonar/epidemiologia , Embolia Pulmonar/mortalidade , Pirazóis/uso terapêutico , Piridonas/uso terapêutico , Rivaroxabana , Tiofenos/uso terapêutico , Tromboembolia Venosa/sangue , Tromboembolia Venosa/epidemiologia , Tromboembolia Venosa/mortalidade , Trombose Venosa/sangue , Trombose Venosa/tratamento farmacológico , Trombose Venosa/epidemiologia , Trombose Venosa/mortalidade , Vitamina K/antagonistas & inibidores
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