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1.
Monaldi Arch Chest Dis ; 90(1)2020 Mar 20.
Artigo em Inglês | MEDLINE | ID: mdl-32204583

RESUMO

We present the case of a 80-year-old man with atrial fibrillation, morbid obesity (weight 123 kg, height 167 cm, BMI 44.1), high clearance of creatinine and pharmacological polytherapy, in which the serial determinations of edoxaban plasma levels help us to choose the appropriate dose.

2.
Chest ; 2020 Jan 29.
Artigo em Inglês | MEDLINE | ID: mdl-32004553

RESUMO

BACKGROUND: The influence of morbid obesity on mortality in patients receiving anticoagulant therapy for VTE has not been consistently evaluated. METHODS: Data from the RIETE (Registro Informatizado Enfermedad TromboEmbólica) registry were used to compare the mortality risk during anticoagulation in patients with VTE and morbid obesity (BMI ≥ 40 kg/m2) vs those with normal weight (BMI, 18.5-24.9 kg/m2). Patients with or without active cancer were analyzed separately. RESULTS: By September 2018, there were 4,443 patients with VTE and morbid obesity and 12,047 with normal weight in RIETE. Of these, 245 (5.5%) and 1,397 (11.6%), respectively, had cancer. Median duration of anticoagulant therapy was longer in the morbidly obese patients, with cancer (185 vs 114 days) or without cancer (203 vs 177 days). Among cancer patients, 44 (18.0%) morbidly obese and 1,377 (32.8%) patients with normal weight died during anticoagulation. Among those without cancer, 44 (3.1%) morbidly obese died and 601 (5.6%) with normal weight died. On bivariate analysis, morbid obesity was associated with a lower mortality rate, both in patients with cancer (hazard ratio, 0.34; 95% CI, 0.25-0.45) and in those without cancer (hazard ratio, 0.43; 95% CI, 0.32-0.58). Multivariable analysis confirmed a lower hazard of death in morbidly obese patients with cancer (hazard ratio, 0.68; 95% CI, 0.50-0.94) and without cancer (hazard ratio, 0.67; 95% CI, 0.49-0.96). The risk for VTE recurrences or major bleeding did not differ in patients with or without morbid obesity. CONCLUSIONS: In patients with VTE, the risk for death during anticoagulation was about one-third lower in morbidly obese patients than in those with normal weight, independently of the presence of cancer.

3.
Int J Cardiol ; 305: 115-119, 2020 Apr 15.
Artigo em Inglês | MEDLINE | ID: mdl-31954590

RESUMO

BACKGROUND: Limited data exist about the clinical presentation and outcomes of patients with inferior vena cava agenesis (IVCA) who develop deep vein thrombosis (DVT). METHODS: We used the RIETE (Registro Informatizado Enfermedad Trombo Embólica) registry to compare clinical characteristics and outcomes of patients with lower limb DVT, according to the presence or absence of IVCA. Major outcomes included recurrent DVT, major bleeding and post-thrombotic syndrome (PTS). RESULTS: Among 50,744 patients with lower-limb DVT recruited in October 2018, 31 (0.06%) had IVCA. On multivariable analysis, patients aged < 30 years (odds ratio [OR]: 17.9; 95%CI: 7.05-45.3), with unprovoked DVT (OR: 2.49; 95%CI: 1.17-5.29), proximal (OR: 2.81; 95%CI: 1.05-7.53) or bilateral DVT (OR: 11.5; 95%CI: 4.75-27.8) were at increased risk to have IVCA. Patients with DVT and IVCA had lower odds to present with coexisting PE (OR: 0.22; 95%CI: 0.07-0.73). During the first year of follow-up, the rates of DVT recurrences (hazard ratio [HR]: 1.30; 95%CI: 0.07-6.43), pulmonary embolism (HR: 2.30; 95%CI: 0.11-11.4) or major bleeding (HR: 1.32; 95%CI: 0.07-6.50) were not significantly different with those with versus those without IVCA. One year after the index DVT, IVCA patients had a higher rate of skin induration (OR: 3.70; 95%CI: 1.30-9.52), collateral vein circulation (OR: 3.57; 95%CI: 1.42-8.79) or venous ulcer (OR: 5.87; 95%CI: 1.36-1.87) in the lower limb than those without IVCA. CONCLUSIONS: Certain clinical features such as unprovoked and bilateral proximal DVT in young patients should raise the suspicion for IVCA. Patients with IVCA had higher odds for symptoms of post-thrombotic syndrome.

4.
TH Open ; 3(1): e67-e76, 2019 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31249985

RESUMO

Background The efficacy and safety of the direct oral anticoagulants (DOACs) in fragile patients (age ≥ 75 years and/or creatinine clearance levels ≤ 50 mL/min and/or body weight ≤ 50kg) with venous thromboembolism (VTE) has not been evaluated. Methods We used the RIETE database to compare the rates of the composite of VTE recurrences or major bleeding during anticoagulation in fragile patients with VTE, according to the use of DOACs or standard anticoagulant therapy. Results From January 2013 to April 2018, 24,701 patients were recruited. Of these, 10,054 (41%) were fragile. Initially, 473 fragile patients (4.7%) received DOACs and 8,577 (85%) low-molecular-weight heparin (LMWH). For long-term therapy, 1,298 patients (13%) received DOACs and 5,038 (50%) vitamin K antagonists (VKAs). Overall, 95 patients developed VTE recurrences and 262 had major bleeding. Patients initially receiving DOACs had a lower rate of the composite outcome (hazard ratio [HR]: 0.32; 95% confidence interval [CI]: 0.08-0.88) than those on LMWH. Patients receiving DOACs for long-term therapy had a nonsignificantly lower rate of the composite outcome (HR: 0.70; 95% CI: 0.46-1.03) than those on VKAs. On multivariable analysis, patients initially receiving DOACs had a nonsignificantly lower risk for the composite outcome (HR: 0.36; 95% CI: 0.11-1.15) than those on LMWH, while those receiving DOACs for long-term therapy had a significantly lower risk (HR: 0.61; 95% CI: 0.41-0.92) than those on VKAs. Conclusions Our data suggest that the use of DOACs may be more effective and safe than standard therapy in fragile patients with VTE, a subgroup of patients where the risk for bleeding is particularly high.

6.
Thromb Res ; 164: 69-74, 2018 04.
Artigo em Inglês | MEDLINE | ID: mdl-29499439

RESUMO

INTRODUCTION: Current guidelines recommend the use of anticoagulant therapy in patients with symptomatic splanchnic vein thrombosis (SVT) and suggest no routine anticoagulation in those with incidental SVT. METHODS: We used the RIETE (Registro Informatizado Enfermedad Trombo Embólica) registry to assess the rate and severity of symptomatic venous thromboembolism (VTE) recurrences and major bleeding events appearing during the course of anticoagulation in patients with symptomatic or incidental SVT. RESULTS: In March 2017, 521 patients with SVT were recruited. Of them, 212 (41%) presented with symptomatic SVT and 309 had incidental SVT. Most (93%) patients received anticoagulant therapy (median, 147 days). During the course of anticoagulation, 20 patients developed symptomatic VTE recurrences (none died) and 26 had major bleeding (fatal bleeding, 5). On multivariable analysis, patients with incidental SVT had a non-significantly higher risk for symptomatic VTE recurrences (adjusted hazard ratio [HR]: 2.04; 95%CI: 0.71-5.88) and a similar risk for major bleeding (HR: 1.12; 95%CI: 0.47-2.63) than those with symptomatic SVT. Active cancer was associated with at increased risk for VTE recurrences (HR: 3.06; 95%CI: 1.14-8.17) and anaemia (HR: 4.11; 95%CI: 1.45-11.6) or abnormal prothrombin time (HR: 4.10; 95%CI: 1.68-10.1) were associated with at increased risk for major bleeding. CONCLUSIONS: The rates of recurrent SVT and major bleeding were similar between patients with incidental or symptomatic SVT. Because the severity of bleeding complications during anticoagulation may outweigh the severity of VTE recurrences in both groups, further studies should identify those SVT patients who benefit from anticoagulant therapy.


Assuntos
Anticoagulantes/uso terapêutico , Hemorragia/etiologia , Circulação Esplâncnica/fisiologia , Trombose Venosa/tratamento farmacológico , Anticoagulantes/farmacologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Recidiva , Resultado do Tratamento
7.
Clin Pharmacol Ther ; 103(4): 684-691, 2018 04.
Artigo em Inglês | MEDLINE | ID: mdl-28675460

RESUMO

We assessed the real-life use of direct oral anticoagulants (DOACs) in patients with venous thromboembolism (VTE) and exclusion criteria for randomized trials. From 2013 to 2016, 3,578 of 18,853 patients (19%) had exclusion criteria. Irrespective of which anticoagulant was chosen, they had more VTE recurrences (hazard ratio (HR): 3.10; 95% confidence interval (CI): 2.47-3.88), major bleeds (HR: 4.10; 95% CI: 3.38-4.96), and deaths (HR: 9.47; 95% CI: 8.46-10.6) than those without exclusion criteria. During initial therapy, no patient with exclusion criteria on DOACs (n = 115) recurred, but those on rivaroxaban bled less often (adjusted HR: 0.18; 95% CI: 0.04-0.79) than those on unfractionated heparin (n = 224) and similar to those (n = 3,172) on low-molecular-weight (LMWH) heparin. For long-term therapy, patients on rivaroxaban (n = 151) had nonsignificantly fewer VTE recurrences (adjusted HR: 0.74; 95% CI: 0.08-1.32) and major bleeds (adjusted HR: 0.41; 95% CI: 0.15-1.15) than those on LMWH (n = 2,071). The efficacy and safety of DOACs were similar to standard therapy.


Assuntos
Hemorragia/diagnóstico , Seleção de Pacientes , Rivaroxabana , Tromboembolia Venosa/tratamento farmacológico , Idoso , Anticoagulantes/administração & dosagem , Anticoagulantes/efeitos adversos , Anticoagulantes/classificação , Inibidores do Fator Xa/administração & dosagem , Inibidores do Fator Xa/efeitos adversos , Inibidores do Fator Xa/farmacocinética , Feminino , Hemorragia/induzido quimicamente , Heparina/administração & dosagem , Heparina/efeitos adversos , Heparina de Baixo Peso Molecular/administração & dosagem , Heparina de Baixo Peso Molecular/efeitos adversos , Humanos , Efeitos Adversos de Longa Duração/induzido quimicamente , Efeitos Adversos de Longa Duração/diagnóstico , Masculino , Pessoa de Meia-Idade , Ensaios Clínicos Controlados Aleatórios como Assunto , Recidiva , Rivaroxabana/administração & dosagem , Rivaroxabana/efeitos adversos , Rivaroxabana/farmacocinética , Resultado do Tratamento , Tromboembolia Venosa/mortalidade
8.
Thromb Haemost ; 117(2): 382-389, 2017 01 26.
Artigo em Inglês | MEDLINE | ID: mdl-27786333

RESUMO

In patients with venous thromboembolism (VTE), the influence on outcome of using direct oral anticoagulants (DOACs) at non-recommended doses or regimens (once vs twice daily) has not been investigated yet. We used the RIETE (Registro Informatizado Enfermedad TromboEmbólica) registry to compare the outcomes in patients with VTE receiving DOACs according to the recommendations of the product label versus in those receiving non-recommended doses and/or regimens. The major outcomes were the rate of VTE recurrences, major bleeding and death during the course of therapy. As of March 2016, 1635 VTE patients had received DOACs for initial therapy and 1725 for long-term therapy. For initial therapy, 287 of 1591 patients (18 %) on rivaroxaban and 22 of 44 (50 %) on apixaban did not receive the recommended therapy. For long-term therapy, 217 of 1611 patients (14 %) on rivaroxaban, 29 of 81 (36 %) on apixaban and 15 of 33 (46 %) on dabigatran did not receive the recommended therapy. During the course of therapy with DOACs, eight patients developed VTE recurrences, 14 had major bleeding and 13 died. Patients receiving DOACs at non-recommended doses and/or regimens experienced a higher rate of VTE recurrences (adjusted HR: 10.5; 95 %CI: 1.28-85.9) and a similar rate of major bleeding (adjusted HR: 1.04; 95 %CI: 0.36-3.03) or death (adjusted HR: 1.41; 95 %CI: 0.46-4.29) than those receiving the recommended doses and regimens. In our cohort, a non-negligible proportion of VTE patients received non-recommended doses and/or regimens of DOACs. This use may be associated with worse outcomes.


Assuntos
Anticoagulantes/administração & dosagem , Coagulação Sanguínea/efeitos dos fármacos , Embolia Pulmonar/tratamento farmacológico , Tromboembolia Venosa/tratamento farmacológico , Trombose Venosa/tratamento farmacológico , Administração Oral , Adulto , Idoso , Anticoagulantes/efeitos adversos , Esquema de Medicação , Cálculos da Dosagem de Medicamento , Feminino , Fidelidade a Diretrizes , Hemorragia/induzido quimicamente , Humanos , Masculino , Pessoa de Meia-Idade , Guias de Prática Clínica como Assunto , Padrões de Prática Médica , Embolia Pulmonar/sangue , Embolia Pulmonar/diagnóstico por imagem , Embolia Pulmonar/mortalidade , Recidiva , Sistema de Registros , Estudos Retrospectivos , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Tromboembolia Venosa/sangue , Tromboembolia Venosa/diagnóstico por imagem , Tromboembolia Venosa/mortalidade , Trombose Venosa/sangue , Trombose Venosa/diagnóstico por imagem , Trombose Venosa/mortalidade
9.
Res Pract Thromb Haemost ; 1(2): 172-179, 2017 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-30046687

RESUMO

Background: Subgroup analyses from randomized trials suggested favorable results for the direct oral anticoagulants in fragile patients with venous thromboembolism (VTE). The frequency and natural history of fragile patients with VTE have not been studied yet. Objectives: To compare the clinical characteristics, treatment and outcomes during the first 3 months of anticoagulation in fragile vs non-fragile patients with VTE. Methods: Retrospective study using consecutive patients enrolled in the RIETE (Registro Informatizado Enfermedad TromboEmbolica) registry. Fragile patients were defined as those having age ≥75 years, creatinine clearance (CrCl) levels ≤50 mL/min, and/or body weight ≤50 kg. Results: From January 2013 to October 2016, 15 079 patients were recruited. Of these, 6260 (42%) were fragile: 37% were aged ≥75 years, 20% had CrCl levels ≤50 mL/min, and 3.6% weighed ≤50 kg. During the first 3 months of anticoagulant therapy, fragile patients had a lower risk of VTE recurrences (0.78% vs 1.4%; adjusted odds ratio [OR]: 0.52; 95% confidence intervals [CI]: 0.37-0.74) and a higher risk of major bleeding (2.6% vs 1.4%; adjusted OR: 1.41; 95% CI: 1.10-1.80), gastrointestinal bleeding (0.86% vs 0.35%; adjusted OR: 1.84; 95% CI: 1.16-2.92), haematoma (0.51% vs 0.07%; adjusted OR: 5.05; 95% CI: 2.05-12.4), all-cause death (9.2% vs 3.5%; adjusted OR: 2.02; 95% CI: 1.75-2.33), or fatal PE (0.85% vs 0.35%; adjusted OR: 1.77; 95% CI: 1.10-2.85) than the non-fragile. Conclusions: In real life, 42% of VTE patients were fragile. During anticoagulation, they had fewer VTE recurrences and more major bleeding events than the non-fragile.

10.
J Thromb Thrombolysis ; 41(3): 404-12, 2016 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-26121973

RESUMO

Several risk assessment models include infection and immobility among the items to be considered for venous thromboembolism (VTE) prevention. However, information on patients with infection leading to immobility and developing VTE are limited, as well as on the role of specific types of infection. Data were collected from the worldwide RIETE registry, including patients with symptomatic objectively confirmed VTE, and followed-up for at least 3 months. The overall population of RIETE at June 2013 (n = 47,390) was considered. Acute infection leading to immobility was reported in 3.9 % of non-surgical patients. Compared with patients immobilized due to dementia, patients with infection had a shorter duration of immobilization prior to VTE (less than 4 weeks in 94.2 vs. 25.9 % of cases; p < 0.001). During the 3-month follow-up, VTE patients with infection versus those with dementia had a lower rate of fatal bleeding (0.5 vs. 1.1 %; p < 0.05) or fatal PE (1.7 vs. 3.5 %; p < 0.01). Patients with respiratory tract infections had more likely PE as initial VTE presentation than other types of infection (62.3 vs. 37.7 %; p < 0.001). Significantly more patients with pneumonia than those with other respiratory infections had received VTE prophylaxis (50.2 vs. 30.6 %; p < 0.001). Following VTE, patients with sepsis showed a significantly higher risk of fatal bleeding. Based on our real-world data, infection seems to contribute to the pathogenesis of VTE by accelerating the effects of immobility. Its role as VTE risk factor probably deserves further attention and specific assessment in order to optimize VTE prophylaxis and treatment.


Assuntos
Hipocinesia , Sistema de Registros , Infecções Respiratórias , Tromboembolia Venosa , Idoso , Idoso de 80 Anos ou mais , Feminino , Seguimentos , Humanos , Hipocinesia/sangue , Hipocinesia/complicações , Hipocinesia/epidemiologia , Masculino , Pessoa de Meia-Idade , Infecções Respiratórias/sangue , Infecções Respiratórias/epidemiologia , Infecções Respiratórias/etiologia , Tromboembolia Venosa/sangue , Tromboembolia Venosa/epidemiologia , Tromboembolia Venosa/etiologia
11.
Medicine (Baltimore) ; 94(47): e1915, 2015 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-26632687

RESUMO

The outcome of patients with acute venous thromboembolism (VTE) and abnormal platelet count (PlC) at baseline has not been consistently studied. In real-world clinical practice, a number of patients with abnormal PlC receive vitamin K antagonists (VKAs) to treat acute VTE despite their higher risk of bleeding.We used the Registro Informatizado de Enfermedad TromboEmbólica registry database to compare the rate of major bleeding in patients receiving VKA for long-term therapy of acute VTE according to PlC levels at baseline. Patients were categorized as having very low (<100,000/µL), low (100,000-150,000/µL), normal (150,000-300,000/µL), high (300,000-450,000/µL), or very high (>450,000/µL) PlC at baseline.Of 55,369 patients recruited as of January 2015, 37,000 (67%) received long-term therapy with VKA. Of these, 611 patients (1.6%) had very low PlC, 4006 (10.8%) had low PlC, 25,598 (69%) had normal PlC, 5801 (15.6%) had high PlC, and 984 (2.6%) had very high PlC at baseline. During the course of VKA therapy (mean, 192 days), there were no differences in the duration or intensity (as measured by international normalized ratio levels) of treatment between subgroups. The rate of major bleeding was 3.6%, 2.1%, 1.9%, 2.1%, and 3.7%, respectively, and the rate of fatal bleeding was 0.98%, 0.17%, 0.29%, 0.34%, and 0.50%, respectively. Patients with very low or very high PlC levels were more likely to have severe comorbidities.We found a nonlinear "U-shaped" relationship between PlC at baseline and major bleeding during therapy with VKA for VTE. Consistent alteration of PlC values at baseline suggested a greater frailty.


Assuntos
Anticoagulantes/efeitos adversos , Fibrinolíticos/efeitos adversos , Hemorragia/induzido quimicamente , Contagem de Plaquetas , Tromboembolia Venosa/tratamento farmacológico , Idoso , Anticoagulantes/uso terapêutico , Feminino , Fibrinolíticos/uso terapêutico , Seguimentos , Hemorragia/epidemiologia , Humanos , Coeficiente Internacional Normatizado , Masculino , Pessoa de Meia-Idade , Sistema de Registros , Resultado do Tratamento , Vitamina K
12.
Presse Med ; 44(12 Pt 2): e377-83, 2015 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-26547675

RESUMO

Real-life data is important in understanding the needs of patients in routine clinical practice, particularly owing to the fact that almost a quarter of patients with venous thromoboembolism (VTE) have at least one exclusion criterion preventing their recruitment into randomized clinical trials. The Registro Informatizado de Enfermedad Trombo Embólica (RIETE) registry is an ongoing, international, multicentre, prospective registry of consecutive patients presenting with acute VTE. In this chapter, we summarized some of the most relevant data concerning the epidemiology of VTE in the RIETE registry.


Assuntos
Embolia Pulmonar/epidemiologia , Sistema de Registros , Europa (Continente)/epidemiologia , Humanos , Cooperação Internacional , Estudos Multicêntricos como Assunto , Seleção de Pacientes , Estudos Prospectivos , Ensaios Clínicos Controlados Aleatórios como Assunto , Fatores de Risco , Tromboembolia Venosa/epidemiologia
13.
Ann Med ; 47(7): 546-54, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-26422329

RESUMO

BACKGROUND: Current guidelines recommend initial treatment with anticoagulants at home in patients with acute deep vein thrombosis (DVT) and in patients with low-risk pulmonary embolism (PE) with adequate home circumstances. However, most of the patients with acute venous thromboembolism (VTE) are currently hospitalized regardless of their risk of short-term complications. AIM OF THE STUDY: To assess the proportion of outpatients with acute VTE initially treated in hospitals, to assess the mean duration of hospitalization, and to identify predictors for in-hospital or home treatment. METHODS: Data of Italian patients enrolled in the RIETE registry from January 2006 to December 2013 were included. RESULTS: Altogether 766 PE and 1,452 isolated DVT were included. Among PE patients, mean PESI score was 84 points (SD 35), and 56% of patients had a low-risk PESI score (<85). In all, 53.7% of DVT and 17.0% of PE were entirely treated at home, and 38.2% of DVT patients and 19.9% of PE patients were hospitalized for ≤5 days. On multivariate analysis, low PESI score was not independently associated with the hospitalization of PE patients. CONCLUSIONS: One in every two patients with DVT and five in every six with PE are still hospitalized.


Assuntos
Anticoagulantes/uso terapêutico , Hospitalização/estatística & dados numéricos , Embolia Pulmonar/tratamento farmacológico , Trombose Venosa/tratamento farmacológico , Doença Aguda , Adulto , Idoso , Anticoagulantes/administração & dosagem , Feminino , Humanos , Itália , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Pacientes Ambulatoriais , Guias de Prática Clínica como Assunto , Sistema de Registros
14.
Ann Am Thorac Soc ; 12(8): 1122-9, 2015 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-26114586

RESUMO

RATIONALE: Patients with acute symptomatic pulmonary embolism (PE) deemed to be at low risk for early complications might be candidates for partial or complete outpatient treatment. OBJECTIVES: To develop and validate a clinical prediction rule that accurately identifies patients with PE and low risk of short-term complications and to compare its prognostic ability with two previously validated models (i.e., the Pulmonary Embolism Severity Index [PESI] and the Simplified PESI [sPESI]) METHODS: Multivariable logistic regression of a large international cohort of patients with PE prospectively enrolled in the RIETE (Registro Informatizado de la Enfermedad TromboEmbólica) registry. MEASUREMENTS AND MAIN RESULTS: All-cause mortality, recurrent PE, and major bleeding up to 10 days after PE diagnosis were determined. Of 18,707 eligible patients with acute symptomatic PE, 46 (0.25%) developed recurrent PE, 203 (1.09%) bled, and 471 (2.51%) died. Predictors included in the final model were chronic heart failure, recent immobilization, recent major bleeding, cancer, hypotension, tachycardia, hypoxemia, renal insufficiency, and abnormal platelet count. The area under receiver-operating characteristic curve was 0.77 (95% confidence interval [CI], 0.75-0.78) for the RIETE score, 0.72 (95% CI, 0.70-0.73) for PESI (P < 0.05), and 0.71 (95% CI, 0.69-0.73) for sPESI (P < 0.05). Our RIETE score outperformed the prognostic value of PESI in terms of net reclassification improvement (P < 0.001), integrated discrimination improvement (P < 0.001), and sPESI (net reclassification improvement, P < 0.001; integrated discrimination improvement, P < 0.001). CONCLUSIONS: We built a new score, based on widely available variables, that can be used to identify patients with PE at low risk of short-term complications, assisting in triage and potentially shortening duration of hospital stay.


Assuntos
Anticoagulantes/uso terapêutico , Pacientes Ambulatoriais/estatística & dados numéricos , Embolia Pulmonar/diagnóstico , Embolia Pulmonar/mortalidade , Embolia Pulmonar/terapia , Índice de Gravidade de Doença , Idoso , Idoso de 80 Anos ou mais , Assistência Ambulatorial , Técnicas de Apoio para a Decisão , Feminino , Hemorragia , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Prognóstico , Estudos Prospectivos , Curva ROC , Sistema de Registros , Medição de Risco
15.
Thromb Res ; 135(4): 666-72, 2015 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-25708926

RESUMO

INTRODUCTION: Venous thromboembolism (VTE) carries a considerable risk of recurrence and anticoagulants should be administered for a minimum of three months. Since little is known about real life management of VTE, we aimed to describe current practice in the secondary prevention of VTE. MATERIALS AND METHODS: Using the database of an international, prospective registry on patients treated for VTE, RIETE, information was collected on risk factors for VTE and bleeding, anticoagulant treatment, and clinical outcomes during follow up. Multivariate analysis using logistic regression was performed to identify predictors of treatment duration. RESULTS: Of 6944 patients with a first episode of VTE 41.1% had unprovoked VTE, 31.8% had transient risk factors, 27.1% had cancer. After the exclusion of patients who died during the first year of observation, the rate of patients treated for >12 months was 55.1%, 41.9%, and 43.2%, respectively (p<0.001). Pulmonary embolism at presentation, recurrence while on treatment, chronic heart failure and age >65 years were independently associated with treatment for >12 months. Body weight <75 kg, anemia, cancer, and the presence of transient risk factors were associated with treatment for 12 months or less. Major bleeding occurred more frequently than recurrent VTE in patients with VTE secondary to transient risk factors and cancer; fatal bleeding was more frequent than fatal recurrent PE in all subgroups. CONCLUSIONS: We observed heterogeneous duration of anticoagulant treatment for the secondary prevention of VTE. A substantial proportion of patients, in particular those with VTE secondary to transient risk factors, may be exposed to a possibly unnecessary risk of bleeding.


Assuntos
Anticoagulantes/uso terapêutico , Tromboembolia Venosa/tratamento farmacológico , Idoso , Anticoagulantes/administração & dosagem , Feminino , Humanos , Masculino , Fatores de Risco , Tromboembolia Venosa/patologia
16.
Thromb Res ; 135(2): 311-7, 2015 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-25543161

RESUMO

BACKGROUND: Even in the absence of evidence on its long-term efficacy and safety, a number of patients with venous thromboembolism (VTE) receive long-term therapy with fondaparinux alone in everyday practice. METHODS: We used the Registro Informatizado de Enfermedad Tromboembólica (RIETE) registry to compare the rate of VTE recurrences and major bleeding at 10 and 90 days in patients with and without cancer. For long-term therapy, fondaparinux was compared with vitamin K antagonists (VKA) in patients without cancer and with low-molecular-weight heparin (LMWH) in those with cancer. RESULTS: Of 47,378 patients recruited, 46,513 were initially treated with heparin, 865 with fondaparinux. Then, 263 patients (78 with cancer) were treated for at least 3 months with fondaparinux. After propensity-score matching, there were no differences between patients receiving initial therapy with heparin or fondaparinux. Among patients with cancer, there were no differences between fondaparinux and LMWH. Among patients without cancer, the long-term use of fondaparinux was associated with an increased risk of major bleeding (3.24 % vs. 0.95 %, p<0.05). CONCLUSIONS: An unexpected high rate of major bleeding was observed in non-cancer patients treated with long-term fondaparinux. Our small sample does not allow to derive relevant conclusions on the use of fondaparinux in cancer patients.


Assuntos
Anticoagulantes/uso terapêutico , Polissacarídeos/uso terapêutico , Tromboembolia Venosa/tratamento farmacológico , Anticoagulantes/administração & dosagem , Feminino , Fondaparinux , Humanos , Masculino , Pessoa de Meia-Idade , Polissacarídeos/administração & dosagem , Resultado do Tratamento
17.
Rambam Maimonides Med J ; 5(4): e0037, 2014 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-25386353

RESUMO

The Registro Informatizado de Enfermedad TromboEmbólica (RIETE Registry) is an ongoing, international, prospective registry of consecutive patients with acute venous thromboembolism (VTE) designed to gather and analyze data on treatment patterns and outcomes in patients with acute VTE. It started in Spain in 2001, and 6 years later the database was translated into English with the aim to expand the Registry to other countries. In contrast to randomized controlled trials, there is no imposed experimental intervention: the management is determined solely by physicians. Thus, it provides data on patients with VTE in a real-world situation with an unselected patient population. Data from RIETE are hypothesis-generating and provide feedback from real-world clinical situations. So far, we learned about the natural history of VTE in patients with relative or absolute contraindications to anticoagulant therapy. We also learned interesting aspects on the natural history of VTE, and we built a number of prognostic scores to identify VTE patients at low, moderate, or high risk for adverse outcome.

18.
Medicine (Baltimore) ; 93(17): 309-17, 2014 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-25398066

RESUMO

In patients with venous thromboembolism (VTE), the outcome during the course of anticoagulant therapy may differ according to the patient's sex. We used the RIETE (Registro Informatizado Enfermedad TromboEmbólica) database to compare the rate of VTE recurrences, major bleeding, and mortality due to these events according to sex.As of August 2013, 47,499 patients were enrolled in RIETE, of whom 24,280 (51%) were women. Women were older, more likely presented with pulmonary embolism (PE), and were more likely to have recent immobilization but less likely to have cancer than men. During the course of anticoagulation (mean duration: 253 d), 659 patients developed recurrent deep vein thrombosis (DVT), 576 recurrent PE, 1368 bled, and 4506 died. Compared with men, women had a lower rate of DVT recurrences (hazard ratio [HR]: 0.78; 95% confidence interval [CI]: 0.67-0.91), a similar rate of PE recurrences (HR: 0.98; 95% CI: 0.83-1.15), a higher rate of major bleeding (HR: 1.21; 95% CI: 1.09-1.35), and higher mortality due to PE (HR: 1.24; 95% CI: 1.04-1.47). On multivariable analysis, any influence of sex on the risk for recurrent DVT (HR: 0.88; 95% CI: 0.75-1.03), major bleeding (HR: 1.10; 95% CI: 0.98-1.24), or fatal PE (HR: 1.01; 95% CI: 0.84-1.22) was no longer statistically significant.In conclusion, women had fewer DVT recurrences and more bleeds than men during the course of anticoagulation. These differences were not due to sex, but very likely to other patient characteristics more common in female patients and differences in treatment choice.


Assuntos
Anticoagulantes/uso terapêutico , Tromboembolia Venosa/tratamento farmacológico , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Hemorragia/induzido quimicamente , Hemorragia/mortalidade , Humanos , Masculino , Pessoa de Meia-Idade , Embolia Pulmonar/mortalidade , Recidiva , Fatores Sexuais , Tromboembolia Venosa/mortalidade
19.
J Clin Oncol ; 32(32): 3607-12, 2014 Nov 10.
Artigo em Inglês | MEDLINE | ID: mdl-25267738

RESUMO

PURPOSE: We evaluated the role of residual vein thrombosis (RVT) to assess the optimal duration of anticoagulants in patients with cancer who have deep vein thrombosis (DVT) of the lower limbs. PATIENTS AND METHODS: Patients with active cancer and a first episode of DVT treated with low molecular weight heparin (LMWH) for 6 months were eligible. Patients were managed according to RVT findings: those with RVT were randomly assigned to continue LMWH for an additional 6 months (group A1) or to discontinue it (group A2), and patients without RVT stopped LMWH (group B). The primary end point was recurrent venous thromboembolism (VTE) during the 1 year after disconinuation of LMWH, and the secondary end point was major bleeding. Analyses are from the time of random assignment. RESULTS: Between October 2005 and April 2010, 347 patients were enrolled. RVT was detected in 242 patients (69.7%); recurrence occurred in 22 of the 119 patients in group A1compared with 27 of 123 patients in group A2. The adjusted hazard ratio (HR) for group A2 versus A1 was 1.37 (95% CI, 0.7 to 2.5; P = .311). Three of the 105 patients in group B developed recurrent VTE; adjusted HR for group A1 versus B was 6.0 (95% CI, 1.7 to 21.2; P = .005). Three major bleeding events occurred in group A1, and two events each occurred in groups A2 and B. The HR for major bleeding in group A1 versus group A2 was 3.78 (95% CI, 0.77 to 18.58; P = .102). Overall, 42 patients (12.1%) died during follow-up as a result of cancer progression. CONCLUSION: In patients with cancer with a first DVT, treated for 6 months with LMWH, absence of RVT identifies a population at low risk for recurrent thrombotic events. Continuation of LMWH in patients with RVT up to 1 year did not reduce recurrent VTE.


Assuntos
Heparina de Baixo Peso Molecular/uso terapêutico , Neoplasias/complicações , Tromboembolia Venosa/tratamento farmacológico , Trombose Venosa/tratamento farmacológico , Idoso , Anticoagulantes/uso terapêutico , Progressão da Doença , Feminino , Seguimentos , Humanos , Extremidade Inferior/irrigação sanguínea , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Recidiva , Fatores de Risco , Taxa de Sobrevida , Fatores de Tempo , Resultado do Tratamento , Tromboembolia Venosa/complicações , Tromboembolia Venosa/mortalidade , Trombose Venosa/complicações
20.
Thromb Haemost ; 110(5): 1025-34, 2013 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-23925476

RESUMO

The relationship between platelet count and outcome in patients with acute venous thromboembolism (VTE) has not been consistently explored. RIETE is an ongoing registry of consecutive patients with acute VTE. We categorised patients as having very low- (<80,000/µl), low- (80,000/µl to 150,000/µl), normal- (150,000/µl to 300,000/µl), high- (300,000/µl to 450,000/µl), or very high (>450,000/µl) platelet count at baseline, and compared their three-month outcome. As of October 2012, 43,078 patients had been enrolled in RIETE: 21,319 presenting with pulmonary embolism and 21,759 with deep-vein thrombosis. In all, 502 patients (1.2%) had very low-; 5,472 (13%) low-; 28,386 (66%) normal-; 7,157 (17%) high-; and 1,561 (3.6%) very high platelet count. During the three-month study period, the recurrence rate was: 2.8%, 2.2%, 1.8%, 2.1% and 2.2%, respectively; the rate of major bleeding: 5.8%, 2.6%, 1.7%, 2.3% and 4.6%, respectively; the rate of fatal bleeding: 2.0%, 0.9%, 0.3%, 0.5% and 1.2%, respectively; and the mortality rate: 29%, 11%, 6.5%, 8.8% and 14%, respectively. On multivariate analysis, patients with very low-, low-, high- or very high platelet count had an increased risk for major bleeding (odds ratio [OR]: 2.70, 95% confidence interval [CI]: 1.85-3.95; 1.43 [1.18-1.72]; 1.23 [1.03-1.47]; and 2.13 [1.65-2.75]) and fatal bleeding (OR: 3.70 [1.92-7.16], 2.10 [1.48-2.97], 1.29 [0.88-1.90] and 2.49 [1.49-4.15]) compared with those with normal count. In conclusion, we found a U-shaped relationship between platelet count and the three-month rate of major bleeding and fatal bleeding in patients with VTE.


Assuntos
Plaquetas/patologia , Trombocitopenia/epidemiologia , Trombocitose/epidemiologia , Tromboembolia Venosa/sangue , Tromboembolia Venosa/epidemiologia , Doença Aguda , Idoso , Idoso de 80 Anos ou mais , Contagem de Células , Feminino , Hemorragia , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Mortalidade , Sistema de Registros , Risco , Resultado do Tratamento , Tromboembolia Venosa/mortalidade
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