Rationale and design for the study Apixaban versus ClopidoGRel on a background of aspirin in patient undergoing InfraPoPliteal angioplasty for critical limb ischemia: AGRIPPA trial.

BACKGROUND: New antithrombotic strategies that reduce primary thrombosis and restenosis might improve vascular outcomes in patients with peripheral artery disease (PAD) undergoing arterial angioplasty. The study objective is to evaluate the potential benefit of apixaban plus aspirin compared with standard of care dual antiplatelet therapy (DAPT) in reducing thrombotic restenosis and artery re-occlusion in patients undergoing endovascular infrapopliteal revascularization. STUDY DESIGN: This multicenter, parallel-group, prospective, randomized, open-label, blinded-endpoint adjudication, proof-of-concept, exploratory trial aims to randomize 200 patients 72 hours after successful infrapopliteal angioplasty for critical limb ischemia (CLI). Patients will be randomly assigned in a 1:1 ratio to receive oral apixaban (2.5 mg twice daily) plus aspirin (100 mg once daily) for 12 months or clopidogrel (75 mg daily) for at least 3 months on a background of aspirin (100 mg once daily) for 12 months. The primary endpoint is the composite of target lesion revascularization (TLR), major amputation, or restenosis/occlusion (RAS) in addition to major adverse cardiovascular events - MACE (myocardial infarction, stroke or cardiovascular death) at 12 months. The primary safety endpoint is the composite of major bleeding or clinically relevant non-major bleeding at 12 months. SUMMARY: This study will evaluate the efficacy and safety of apixaban 2.5 mg twice daily plus aspirin compared with DAPT (clopidogrel plus aspirin) in patients with CLI undergoing endovascular infrapopliteal revascularization and might prove the concept of an alternative antithrombotic regimen for these patients to be tested in a future large randomized clinical trial.

Benefits and risks of extended treatment of venous thromboembolism with rivaroxaban or with aspirin.

BACKGROUND: Full- or lower-dose anticoagulant therapy or aspirin can be used for extended therapy in patients with venous thromboembolism (VTE), but information on their relative benefit-risk profiles is limited. METHODS: Data from the EINSTEIN-CHOICE trial were used to compare the benefit-risk profiles of extended treatment with rivaroxaban (20 or 10 mg once daily) and aspirin (100 mg once daily) in VTE patients who had completed 6 to 12 months of anticoagulation therapy. One-year cumulative incidences of recurrent VTE and major bleeding were estimated and benefits and risks were calculated by determining the between group differences in a hypothetical population of 10,000 VTE patients treated for 1 year. FINDINGS: A total of 1107 patients were treated with 20 mg of rivaroxaban, 1127 with 10 mg of rivaroxaban, and 1131 with aspirin. The cumulative incidences of recurrent VTE in the rivaroxaban 20-mg, rivaroxaban 10-mg and aspirin groups were 1.9%, 1.6%, and 5.0%, respectively, whereas the cumulative incidences of major bleeding were 0.7%, 0.4% and 0.5%, respectively. The incidences of the combined outcome of recurrent VTE and major bleeding were 2.8% and 3.4% lower in the rivaroxaban 20-mg and 10-mg groups than in the aspirin group. For 10,000 patients treated for 1 year, there would be 284 (95% confidence interval [CI] 106 to 462) and 339 (95% CI 165 to 512) fewer events with rivaroxaban 20 mg or 10 mg than with aspirin. INTERPRETATION: Compared with aspirin, extended anticoagulation with once daily rivaroxaban reduces recurrent VTE with a favourable benefit-risk profile. FUNDING: Bayer AG.

Risk of recurrent venous thromboembolism according to baseline risk factor profiles.

The optimal duration of anticoagulation for venous thromboembolism (VTE) is uncertain. In this prespecified analysis, we used data from 2 randomized trials, which compared once-daily rivaroxaban (20 mg or 10 mg) with aspirin (100 mg) or placebo for extended VTE treatment to estimate the risk of recurrence according to baseline risk factor profiles. Index VTE events were centrally classified as unprovoked, or provoked by major transient or persistent, or minor transient or persistent risk factors, and rates of recurrence at 1 year were calculated. A total of 2832 patients received rivaroxaban; 1131 received aspirin, and 590 received placebo. With unprovoked VTE, rates of recurrence in the 1173 patients given rivaroxaban, the 468 given aspirin, and the 243 given placebo were 2.0%, 5.9%, and 10.0%, respectively. There were no recurrences in patients with VTE provoked by major transient risk factors. With VTE provoked by minor persistent risk factors, recurrence rates in the 1184 patients given rivaroxaban, the 466 given aspirin, and the 248 given placebo were 2.4%, 4.5%, and 10.7%, respectively. For patients with minor transient risk factors, recurrence rates were 0.4% in the 268 patients given rivaroxaban, 4.2% in the 121 given aspirin, and 7.1% in the 56 given placebo. Recurrence rates in patients with VTE provoked by minor persistent or minor transient risk factors were not significantly lower than that with unprovoked VTE (hazard ratio [HR], 0.81; 95% confidence interval [CI], 0.56-1.16; and HR, 0.68; 95% CI, 0.32-1.30, respectively). Therefore, such patients may also benefit from extended anticoagulation therapy.

A incidência regional do tromboembolismo venoso no Brasil / Regional incidence of venous thromboembolism in Brazil

Contexto: Vários estudos realizados em climas temperados sugerem que há uma variação na incidência de tromboembolismo venoso (TEV) de acordo com as estações climáticas. Entretanto, nenhum estudo foi feito comparando áreas de clima semiárido com áreas de clima temperado. Objetivos: Analisar se existe correlação entre a incidência do TEV em áreas de clima semiárido e de clima temperado no Brasil. Métodos: Foi feito um levantamento de dados retrospectivos de pacientes com diagnóstico de TEV no Sistema Único de Saúde de janeiro de 2011 a dezembro de 2014 provenientes dos seguintes estados com clima semiáridos: Alagoas, Ceará, Maranhão, Paraíba, Pernambuco, Piauí e Rio Grande do Norte, localizados na Região Nordeste do Brasil; e dos seguintes estados com clima temperado: Paraná, Santa Catarina e Rio Grande do Sul, localizados na Região Sul do Brasil. Os dados de variação climática foram obtidos do Instituto Nacional de Meteorologia e os dados populacionais do Instituto Brasileiro de Geografia e Estatística. Resultados: Houve correlação significativa na incidência de casos de TEV em regiões de temperaturas mais baixas (p < 0,001). A Região Sul apresentou temperaturas significativamente menores que as da Região Nordeste (p < 0,001) e apresentou número significativamente maior de casos de TEV do que a Região Nordeste (p < 0,001). Conclusão: Há mais casos de TEV em regiões de clima temperado, onde as temperaturas são mais baixas. No entanto, pouco ainda é conhecido na literatura sobre a flutuação sazonal e a incidência de TEV. Sendo assim, mais estudos são necessários nessa área

Background: Several studies conducted in areas with temperate climates have suggested that the incidence of venous thromboembolism (VTE) varies depending on seasonal climatic fluctuations. However, no studies have been conducted comparing areas with semi-arid climate with areas with temperate climates. Objectives: To analyze whether there is a correlation between the incidence of VTE in areas with semi-arid climates and areas with temperate climates in Brazil. Methods: Retrospective data were acquired for patients diagnosed with VTE from January 2011 to December 2014 from the Brazilian National Health Service for the following Brazilian states that have semi-arid climates: Alagoas, Ceará, Maranhão, Paraíba, Pernambuco, Piauí, and Rio Grande do Norte (all located in the Northeast Region of Brazil); and the following states with temperate climates: Paraná, Santa Catarina, and Rio Grande do Sul (all located in the South Region of Brazil). Data on climatic variation were obtained from the National Meteorological Institute and population data were obtained from the Brazilian Institute of Geography and Statistics. Results: There was a significant correlation in the incidence of VTE cases in areas with lower temperatures (p < 0.001). The South Region exhibited significantly lower temperatures than the Northeast Region (p < 0.001) and had a significantly higher number of cases of VTE than the Northeast Region (p < 0.001). Conclusions: There are more cases of VTE in areas with temperate climates, where temperatures are lower. However, there is still little information in the literature on seasonal fluctuations and incidence of VTE. More studies of this subject are needed

Prevalência de tromboembolismo pulmonar incidental em pacientes oncológicos: análise retrospectiva em grande centro / Prevalência de tromboembolismo pulmonar incidental em pacientes oncológicos: análise retrospectiva em grande centro

Contexto: Devido à maior aplicação de exames de imagem rotineiros, especialmente nos pacientes com neoplasia para controle da doença, vem aumentando o diagnóstico de tromboembolismo pulmonar (TEP) incidental, importante fator de morbimortalidade associado. Objetivo: Identificar os casos de TEP incidental em pacientes oncológicos submetidos a tomografia computadorizada (TC) de tórax, correlacionando aspectos clínicos e fatores de risco associados. Métodos: Estudo retrospectivo de todos os episódios de TEP ocorridos de janeiro de 2013 a junho de 2016, com seleção dos pacientes oncológicos e divisão deles em dois grupos: com suspeita clínica e sem suspeita clínica (incidentais) de embolia pulmonar. Resultados: Foram avaliados 468 pacientes com TEP no período citado. Destes, 23,1% eram oncológicos, entre os quais 44,4% apresentaram achado incidental de embolia pulmonar na TC de tórax. Não houve diferença estatística entre os grupos para sexo, idade e tabagismo. Quanto à procedência, 58,3% dos pacientes sem suspeita clínica eram de origem ambulatorial e 41,7% com suspeita de TEP vinham do pronto-socorro (p < 0,001). As neoplasias mais prevalentes foram de pulmão (17,6%), intestino (15,7%) e mama (13,0%). Aqueles com achado incidental apresentaram significativamente mais metástases, sem diferença entre os grupos para realização de quimioterapia, radioterapia ou cirurgia recente. Quanto aos sintomas apresentados, 41,9% daqueles sem suspeita clínica tinham queixas sugestivas de TEP quando realizaram o exame. Conclusão: TEP incidental é frequente em pacientes oncológicos, especialmente naqueles provenientes de seguimento ambulatorial e em estágios avançados da doença. Sintomas sugestivos de TEP estavam presentes em pacientes sem suspeita clínica ao realizarem a TC de tórax

Background: Increased use of routine imaging exams has led to higher rates of incidental diagnosis of pulmonary thromboembolism (PTE), especially for management of disease in cancer patients, among whom it is an important factor in associated morbidity and mortality. Objective: To identify cases of incidental PTE in cancer patients examined with computed tomography (CT) of the thorax, correlating clinical features and associated risk factors. Methods: This is a retrospective study of all episodes of PTE diagnosed between January 2013 and June 2016, selecting cases involving cancer patients and dividing them into two subsets: those with clinical suspicion and those without clinical suspicion of pulmonary embolism (incidental cases). Results: At total of 468 patients had PTE during the period investigated and 23.1% of them were cancer patients, 44.4% of whom exhibited pulmonary embolism as an incidental finding of a chest CT. There was no statistical difference between the two subsets in terms of sex, age, or smoking. In terms of patients' admission status, 58.3% of the patients without clinical suspicion were outpatients and 41.7% of those with suspicion of PTE were admitted via the emergency room (p < 0.001). The most common cancer sites were lung (17.6%), intestine (15.7%), and breast (13.0%). Patients whose PTE were diagnosed incidentally exhibited a significantly greater rate of metastases, while there were no differences between the groups in terms of chemotherapy, radiotherapy, or recent surgery. Analysis of symptoms revealed that 41.9% of patients without clinical suspicion had complaints suggestive of PTE when they underwent the CT examination. Conclusions: Incidental PTE is common among cancer patients, especially those in outpatients follow-up and in advanced stages of the disease. Patients without clinical suspicion also had symptoms suggestive of PTE when they presented for chest CT

Rivaroxaban or Aspirin for Extended Treatment of Venous Thromboembolism.

BACKGROUND: Although many patients with venous thromboembolism require extended treatment, it is uncertain whether it is better to use full- or lower-intensity anticoagulation therapy or aspirin. METHODS: In this randomized, double-blind, phase 3 study, we assigned 3396 patients with venous thromboembolism to receive either once-daily rivaroxaban (at doses of 20 mg or 10 mg) or 100 mg of aspirin. All the study patients had completed 6 to 12 months of anticoagulation therapy and were in equipoise regarding the need for continued anticoagulation. Study drugs were administered for up to 12 months. The primary efficacy outcome was symptomatic recurrent fatal or nonfatal venous thromboembolism, and the principal safety outcome was major bleeding. RESULTS: A total of 3365 patients were included in the intention-to-treat analyses (median treatment duration, 351 days). The primary efficacy outcome occurred in 17 of 1107 patients (1.5%) receiving 20 mg of rivaroxaban and in 13 of 1127 patients (1.2%) receiving 10 mg of rivaroxaban, as compared with 50 of 1131 patients (4.4%) receiving aspirin (hazard ratio for 20 mg of rivaroxaban vs. aspirin, 0.34; 95% confidence interval [CI], 0.20 to 0.59; hazard ratio for 10 mg of rivaroxaban vs. aspirin, 0.26; 95% CI, 0.14 to 0.47; P<0.001 for both comparisons). Rates of major bleeding were 0.5% in the group receiving 20 mg of rivaroxaban, 0.4% in the group receiving 10 mg of rivaroxaban, and 0.3% in the aspirin group; the rates of clinically relevant nonmajor bleeding were 2.7%, 2.0%, and 1.8%, respectively. The incidence of adverse events was similar in all three groups. CONCLUSIONS: Among patients with venous thromboembolism in equipoise for continued anticoagulation, the risk of a recurrent event was significantly lower with rivaroxaban at either a treatment dose (20 mg) or a prophylactic dose (10 mg) than with aspirin, without a significant increase in bleeding rates. (Funded by Bayer Pharmaceuticals; EINSTEIN CHOICE ClinicalTrials.gov number, NCT02064439 .).

Clinical efficacy and safety of a new 1000-mg suspension versus twice-daily 500-mg tablets of MPFF in patients with symptomatic chronic venous disorders: a randomized controlled trial.

BACKGROUND: Chronic venous disorders (CVD) is estimated to affect 30% to 50% of women and 10% to 30% of men. The most widely prescribed treatment for CVD worldwide is micronized purified flavonoid fraction 500 mg (MPFF). The aim of this clinical trial was to develop a new once daily 1000-mg oral suspension of MPFF. METHODS: In an international, randomized, double-blind, parallel-group study, symptomatic individuals classified CEAP C0s to C4s were randomized in either treatment arm and treated for 8 weeks. Lower limb symptoms (discomfort, pain and heaviness) were assessed using Visual Analog Scales (VAS), and quality of life (QoL) was measured with the CIVIQ-20 Questionnaire. RESULTS: A total of 1139 patients were included in the study. Both MPFF treatment regimens were well tolerated and associated with a significant reduction in lower limb symptoms. A non-inferiority of MPFF 1000-mg oral suspension once daily compared to MPFF 500-mg tablet twice daily (P<0.0001) was found for lower limb discomfort (-3.33 cm for MPFF 1000 mg and -3.37 cm for MPFF 500 mg), leg pain (-3.27 cm for MPFF 1000 mg and -3.31 cm for MPFF 500 mg) and leg heaviness (-3.41 cm for MPFF 1000 mg and -3.46 cm for MPFF 500 mg). The patients' QoL was improved by about 20 points on the CIVIQ scale in both groups (19.33 points for MPFF 1000 mg and 20.28 points for MPFF 500 mg). CONCLUSIONS: MPFF 1000-mg oral suspension and MPFF 500-mg tablets treatments were associated with similar reductions in lower limb symptoms and QoL improvement. The new once daily MPFF1000-mg oral suspension has a similar safety profile to two tablets of MPFF 500 mg, with the advantage of one daily intake, potentially associated with improved patient adherence and easier CVD management.

Complicações cardíacas em cirurgia vascular / Cardiac complications in vascular surgery

CONTEXTO: Aproximadamente 60% dos pacientes portadores de doença arterial oclusiva crônica periférica têm doença coronariana grave, sendo que a principal causa de morte no pós-operatório de cirurgia vascular de grande porte é o infarto agudo do miocárdio. OBJETIVOS: Determinar a prevalência da doença coronariana em pacientes submetidos a cirurgia vascular eletiva de grande porte e sua relação com as complicações cardiológicas pós-operatórias. MÉTODOS: Foram analisados 200 pacientes submetidos a cirurgia vascular arterial eletiva: doença obstrutiva carotídea, aortoilíaca e femoropoplítea distal e doença aneurismática de aorta abdominal e de artérias ilíacas. Os pacientes constituíram três grupos: grupo I, sem doença coronariana; grupo II, com doença coronariana assintomática; e grupo III, com doença coronariana sintomática. As complicações cardiológicas consideradas foram infarto agudo do miocárdio fatal e não fatal, insuficiência cardíaca congestiva, choque cardiogênico, fibrilação atrial aguda e outras arritmias. RESULTADOS: Complicações cardíacas ocorreram em 11 pacientes (5,5%): três infartos agudos do miocárdio não fatais (1,5%) sempre em pacientes do grupo III. A complicação cardíaca mais frequente foi arritmia (exceto fibrilação atrial) ocorrida em cinco (2,5%) pacientes, sendo três do grupo II. A mortalidade precoce foi de nove pacientes (4,5%). Apenas uma morte foi decorrente de problema cardíaco: choque cardiogênico em paciente do grupo III. CONCLUSÕES: A doença coronariana não foi preditora de óbito nos pacientes submetidos a cirurgia vascular periférica de grande porte. A sobrevida dos pacientes com ou sem doença coronariana não mostrou diferenças estatísticas.

BACKGROUND: Approximately 60% of patients with chronic occlusive peripheral arterial disease have severe coronary disease and the principal cause of death during the postoperative period after major vascular surgery is acute myocardial infarction. OBJECTIVES: To determine the prevalence of coronary disease among patients scheduled for elective major vascular surgery and its relationship with postoperative cardiological complications. METHODS: A total of 200 patients who underwent elective vascular arterial surgery for obstructive carotid disease, aortoiliac and distal femoropopliteal disease and aneurysmal disease of the abdominal aorta and iliac arteries were analyzed. These patients were allocated to three groups: group I, free from coronary disease; group II, asymptomatic coronary disease; and group III, symptomatic coronary disease. The cardiological complications analyzed were fatal and nonfatal acute myocardial infarction, congestive heart failure, cardiogenic shock, acute atrial fibrillation and other arrhythmias. RESULTS: Cardiac complications occurred in 11 patients (5.5%): three nonfatal acute myocardial infarctions (1.5%), all in patients from group III. The most common cardiac complication was arrhythmia (excluding atrial fibrillation) in five (2.5%) patients, three from group II. Early mortality was nine patients (4.5%). Just one death was caused by a cardiac problem: cardiogenic shock in a patient from group III. CONCLUSIONS: Coronary disease was not predictive of death among patients who underwent major peripheral vascular surgery. There were no statistical differences in survival between patients with or without coronary disease.

Recurrent venous thromboembolism and abnormal uterine bleeding with anticoagulant and hormone therapy use.

Women receiving vitamin K antagonists (VKAs) require adequate contraception because of the potential for fetal complications. It is unknown whether the use of hormonal therapy, especially those containing estrogens, is associated with recurrent venous thromboembolism (VTE) during anticoagulation. Despite the absence of data, World Health Organization guidelines state that use of estrogen-containing contraceptives confers an "unacceptable health risk" during established anticoagulation for VTE. We compared the incidences of recurrent VTE and abnormal uterine bleeding with and without concomitant hormonal therapy in women aged <60 years who were receiving anticoagulation with rivaroxaban or enoxaparin/VKA for confirmed VTE. Incidence densities in percentage per year were computed for the on and off estrogen-containing or progestin-only therapy periods. Cox regression models were fitted, with hormonal therapy (on vs off) as a time-dependent variable to derive the hazard ratio (HR) for the effects on recurrent VTE and abnormal uterine bleeding. In total, 1888 women were included. VTE incidence densities on and off hormonal therapy were 3.7%/year and 4.7%/year (adjusted HR, 0.56; 95% confidence interval [CI], 0.23-1.39), respectively, and were 3.7%/year and 3.8%/year, respectively, for estrogen-containing and progestin-only therapy. The adjusted HR for all abnormal uterine bleeding (on vs off hormonal therapy) was 1.02 (95% CI, 0.66-1.57). Abnormal uterine bleeding occurred more frequently with rivaroxaban than with enoxaparin/VKA (HR, 2.13; 95% CI, 1.57-2.89). Hormonal therapy was not associated with an increased risk of recurrent VTE in women receiving therapeutic anticoagulation. The observed increased risk of abnormal uterine bleeding with rivaroxaban needs further exploration.

Endovascular treatment of popliteal artery aneurysm. Early and midterm results.

OBJECTIVE: to evaluate the efficacy of endovascular repair of popliteal artery aneurysms on maintaining patency of the stent in the short and medium term. METHODS: this was a retrospective, descriptive and analytical study, conducted at the Integrated Vascular Surgery Service at the Hospital da Beneficência Portuguesa de São Paulo. We followed-up 15 patients with popliteal aneurysm, totaling 18 limbs, treated with stent from May 2008 to December 2012. RESULTS: the mean follow-up was 14.8 months. During this period, 61.1% of the stents were patent. The average aneurysm diameter was 2.5 cm, ranging from 1.1 to 4.5 cm. The average length was 5 cm, ranging from 1.5 to 10 cm. In eight cases (47.1%), the lesion crossed the joint line, and in four of these occlusion of the prosthesis occurred. In 66.7% of cases, treatment was elective and only 33.3% were symptomatic patients treated on an emergency basis. The stents used were Viabahn (Gore) in 12 cases (66.7%), Fluency (Bard) in three cases (16.7%), Multilayer (Cardiatis) in two cases (11.1%) and Hemobahn (Gore) in one case (5.6%). In three cases, there was early occlusion (16.6%). During follow-up, 88.2% of patients maintained antiplatelet therapy. There was no leakage at ultrasound (endoleak). No fracture was observed in the stents. CONCLUSION: the results of this study are similar to other published series. Probably, with the development of new devices that support the mechanical characteristics found on the thighs, there will be improved performance and prognosis of endovascular restoration.

Two doses of rivaroxaban versus aspirin for prevention of recurrent venous thromboembolism. Rationale for and design of the EINSTEIN CHOICE study.

Patients with unprovoked venous thromboembolism (VTE) are at high risk for recurrence. Although rivaroxaban is effective for extended VTE treatment at a dose of 20 mg once daily, use of the 10 mg dose may further improve its benefit-to-risk ratio. Low-dose aspirin also reduces rates of recurrent VTE, but has not been compared with anticoagulant therapy. The EINSTEIN CHOICE study is a multicentre, randomised, double-blind, active-controlled, event-driven study comparing the efficacy and safety of two once daily doses of rivaroxaban (20 and 10 mg) with aspirin (100 mg daily) for the prevention of recurrent VTE in patients who completed 6-12 months of anticoagulant therapy for their index acute VTE event. All treatments will be given for 12 months. The primary efficacy objective is to determine whether both doses of rivaroxaban are superior to aspirin for the prevention of symptomatic recurrent VTE, while the principal safety outcome is the incidence of major bleeding. The trial is anticipated to enrol 2,850 patients from 230 sites in 31 countries over a period of 27 months. In conclusion, the EINSTEIN CHOICE study will provide new insights into the optimal antithrombotic strategy for extended VTE treatment by comparing two doses of rivaroxaban with aspirin (clinicaltrials.gov NCT02064439).

Tomographic anatomy of the vena cava and renal veins: features relevant to vena cava filter placement / Anatomia tomográfica da veia cava e das veias renais: aspectos relevantes para implante de filtro de veia cava

There is a growing demand for invasive procedures involving the inferior vena cava, in particular for placement of vena cava filters. It is not always easy to identify the more distal renal vein with cavography, for safe release of filters. OBJECTIVES: To determine parameters for the relationships between the renal veins and the infrarenal vena cava and their corresponding vertebral bodies, their relationships with biotype and the occurrence of anatomic variations, the relationships between vertebral bodies and the bifurcation of the common iliac veins and the distance from this bifurcation to the outflow of the more distal renal vein, with reference to placement of vena cava filters. METHODS: A total of 150 abdominal computed tomography scans conducted from October to November 2011 were analyzed and classified according to the biotype exhibited (using Charpy's angle). Scans were performed at MEDIMAGEM and analyzed at the Integrated Vascular Surgery Service, both part of Hospital da Beneficência Portuguesa in São Paulo, Brazil. RESULTS: In 127 of the 150 scans analyzed (84.66%), the more distal renal vein emerged between the first lumbar intervertebral space (L1-L2) and the body of L2, irrespective of patient biotype. Just 23 patients (15.33%) exhibited a more distal renal vein with outflow below the body of L2, i.e. in the projection of the space between L2 and L3. CONCLUSIONS: The radiological correlation between the confluence of the more distal renal vein and vertebral bodies exhibits little variation, irrespective of the biotype of the patient...

Há uma demanda crescente por procedimentos invasivos que abordam a veia cava inferior, especialmente o implante de filtros de veia cava. A identificação da veia renal mais caudal para a liberação segura do filtro nem sempre é fácil durante a cavografia. OBJETIVOS: Estabelecer parâmetros da relação das veias renais e da cava infrarrenal com o corpo vertebral correspondente, sua relação com a biotipologia, presença de variações anatômicas, relação dos corpos vertebrais com a bifurcação das veias ilíacas comuns para a veia cava e distância desta bifurcação até a desembocadura da veia renal mais caudal, visando à implantação de filtro de veia cava. MÉTODOS: Foram analisadas 150 tomografias computadorizadas de abdome no período entre outubro e novembro de 2011, tendo sido agrupadas de acordo com o biotipo apresentado (ângulo de Charpy). As tomografias forem realizadas na MEDIMAGEM e analisadas no Serviço de Cirurgia Vascular Integrada, ambas da Beneficência Portuguesa de São Paulo. RESULTADOS: Dos 150 exames analisados, 127 (84,66%) apresentaram a emergência da veia renal mais caudal desde a projeção do primeiro espaço intervertebral lombar (L1-L2) até o corpo de L2, independentemente do biotipo do paciente. Somente 23 pacientes (15,33%) apresentaram a desembocadura da veia renal mais caudal abaixo do corpo de L2, ou seja, na projeção do espaço entre L2 e L3. CONCLUSÕES: A correlação radiológica da confluência da veia renal mais distal em relação aos corpos vertebrais apresenta pouca variação, independentemente do biotipo do paciente...

Endovascular treatment of popliteal artery aneurysm. early and midterm results / Tratamento endovascular de aneurisma de artéria poplítea: resultados em curto e médio prazo

OBJECTIVE: To evaluate the efficacy of endovascular repair of popliteal artery aneurysms on maintaining patency of the stent in the short and medium term. METHODS: this was a retrospective, descriptive and analytical study, conducted at the Integrated Vascular Surgery Service at the Hospital da Beneficência Portuguesa de São Paulo. We followed-up 15 patients with popliteal aneurysm, totaling 18 limbs, treated with stent from May 2008 to December 2012. RESULTS: the mean follow-up was 14.8 months. During this period, 61.1% of the stents were patent. The average aneurysm diameter was 2.5cm, ranging from 1.1 to 4.5cm. The average length was 5cm, ranging from 1.5 to 10 cm. In eight cases (47.1%), the lesion crossed the joint line, and in four of these occlusion of the prosthesis occurred. In 66.7% of cases, treatment was elective and only 33.3% were symptomatic patients treated on an emergency basis. The stents used were Viabahn (Gore) in 12 cases (66.7%), Fluency (Bard) in three cases (16.7%), Multilayer (Cardiatis) in two cases (11.1%) and Hemobahn (Gore) in one case (5.6%). In three cases, there was early occlusion (16.6%). During follow-up, 88.2% of patients maintained antiplatelet therapy. There was no leakage at ultrasound (endoleak). No fracture was observed in the stents. CONCLUSION: the results of this study are similar to other published series. Probably, with the development of new devices that support the mechanical characteristics found on the thighs, there will be improved performance and prognosis of endovascular restoration.

OBJETIVO: Avaliar a eficácia da correção endovascular do aneurisma de artéria poplítea quanto à manutenção da perviedade da endoprótese, em curto e médio prazo. MÉTODOS: trata-se de estudo retrospectivo, descritivo e analítico, realizado no Serviço de Cirurgia Vascular Integrada do Hospital Beneficência Portuguesa de São Paulo. Foram acompanhados 15 pacientes com aneurisma de poplítea totalizando 18 membros tratados com endoprótese, no período de maio de 2008 a dezembro 2012. RESULTADOS: o tempo médio de seguimento foi 14,8 meses. Nesse período, 61,1% das endopróteses estavam pérvias. A média de diâmetro dos aneurismas foi 2,5cm, variando de 1,1 a 4,5cm. A extensão média encontrada foi 5cm, variando de 1,5 a 10cm. Em oito casos (47,1%), a lesão cruzava a linha articular e, em quatro destes, ocorreu oclusão da prótese. Em 66,7% dos casos, o tratamento foi eletivo e apenas 33,3% eram pacientes sintomáticos, tratados em caráter de urgência. As endopróteses usadas foram a Viabahn (Gore) em 12 casos (66,7%), Fluency (Bard) em três casos (16,7%), Multilayer (Cardiatis) em dois casos (11,1%) e Hemobahn (Gore) em apenas um caso (5,6%). Em três casos, ocorreu oclusão precoce (16,6%). Durante o seguimento, 88,2% dos pacientes mantiveram a antiagregação plaquetária. No seguimento ultrassonográfico não foi observado nenhum vazamento (endoleak). Não foi verificada nenhuma fratura nos Stents. CONCLUSÃO: Os resultados obtidos nesse estudo são semelhantes aos de outras séries publicadas. Provavelmente com o desenvolvimento de novos dispositivos que suportem as particularidades mecânicas encontradas na região poplítea, haverá como melhorar o desempenho e prognóstico da restauração endovascular.

Comparison between the conventional method and a portable device for determination of INR / Determinação do INR: comparação entre método convencional e dispositivo portátil

CONTEXT: Anticoagulation with warfarin is considered the appropriate treatment for venous thromboembolism and other thrombotic pathologies. Regular INR control is required for dosage adjustment and therapeutic control. Use of portable monitoring systems optimizes management of these patients. OBJECTIVE: To compare INR measurements taken using the portable Coaguchek XS system in capillary blood with the standard laboratory method using venous blood. METHOD: Fifty-two samples each of venous and capillary blood were collected from nineteen patients on warfarin, who had been admitted to the Hospital da Beneficência Portuguesa de São Paulo, and analyzed using the conventional method and the Coaguchek XS system, respectively. RESULTS: Spearman's correlation coefficient ® for the overall performance of the two methods was 0.978 (p<0.0001; 95%CI 0.961-0.988). The Kappa measure of agreement for all patients was 76.8% (p<0.001; IC: 95% 0.975-0.561). Mean INR according to the Coaguchek XS system underestimated the values provided by the conventional method by -0.01 INR points, with a standard error of 0.342. Results for INR values greater than 3.5 were satisfactory with a correlation coefficient of 0.71, but without statistical significance (p>0.714). CONCLUSIONS: The Coaguchek XS system can be used to monitor prothrombin time in patients on oral anticoagulants, provided INR values greater than 3.5 are confirmed using the conventional laboratory method...

CONTEXTO: Anticoagulação por varfarina (warfarin) é considerada tratamento adequado para tromboembolismo venoso e outras patologias trombóticas. Deve ser realizada a mensuração do Índice Internacional Normalizado (INR) para ajuste de dosagem de medicamento para manutenção dos pacientes na faixa terapêutica. O uso de dispositivos portáteis otimiza o controle desses pacientes. OBJETIVO: Comparar as medidas do INR realizadas pelo sistema portátil Coaguchek XS, em sangue capilar, com o método laboratorial padrão em sangue venoso. MÉTODO: Dezenove pacientes em uso de varfarina, internados no Hospital da Beneficência Portuguesa de São Paulo, foram submetidos à coleta de 52 amostras analisadas pelo método convencional e coleta de sangue capilar para medida com o sistema Coaguchek XS. RESULTADOS: O coeficiente de correlação (r) de Spearman por meio da comparação de desempenho global entre os dois métodos foi de 0,978 (p<0,0001; IC: 95% 0,961-0,988). O percentual de concordância Kappa para todas as faixas foi de 76,8% (p<0,001; IC: 95% 0,975-0,561). O INR médio do sistema Coaguchek XS subestimou os valores obtidos em -0,01 pontos de INR, quando comparado ao método convencional, com erro padrão de 0,342. Valores acima de 3,5 mostraram resultados satisfatórios com coeficiente de correlação de 0,71, mas sem significância estatística (p>0,714). CONCLUSÕES: O sistema Coaguchek XS pode ser utilizado na monitorização do tempo de protrombina em pacientes com uso de anticoagulantes orais, desde que valores de INR acima de 3,5 sejam confirmados por meio de medidas realizadas em laboratório convencional...

Reduction in the length of stay with rivaroxaban as a single-drug regimen for the treatment of deep vein thrombosis and pulmonary embolism.

OBJECTIVE: The phase III EINSTEIN DVT and EINSTEIN PE trials demonstrated the potential of oral rivaroxaban for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE). The length of initial hospitalization in patients presenting with either symptomatic DVT or PE was assessed using hospitalization records from these trials. METHODS: Analyses were carried out in the intention-to-treat population, using non-parametric and parametric statistical methods. RESULTS: Overall, 52% (1781/3434) of EINSTEIN DVT patients and 90% (4328/4821) of EINSTEIN PE patients were admitted to hospital. The proportion of hospitalized patients with a length of stay of five or fewer days receiving rivaroxaban was 54% compared with 31% for enoxaparin/vitamin K antagonist (VKA) in patients with DVT. For patients with PE, the corresponding values were 45% and 33%. Stays of 6-10 days were observed in 29% of rivaroxaban-treated patients compared with 45% of enoxaparin/VKA-treated patients for DVT. For patients with PE, these values were 39% and 46% in the rivaroxaban and enoxaparin/VKA groups, respectively. Overall, length of stay was significantly shorter in the rivaroxaban group, compared with the enoxaparin/VKA group across all analyses performed (p < 0.0001). Across regions, the observed admission rates and length of stay duration varied greatly: Asia had the longest overall hospitalization rates, whereas the lowest rates were reported in North America, Australia and New Zealand. Nevertheless, a consistent trend was observed: length of hospital stay in patients with DVT or PE receiving rivaroxaban was shorter than, or at least similar to, patients receiving enoxaparin/VKA. CONCLUSION: A single-drug regimen with rivaroxaban may reduce the burden on healthcare systems and patients, and provides effective and well tolerated treatment. The studies shared an open-label design that allowed comparison of initial hospitalization, but limitations include the well monitored clinical trial setting in which decisions on admission and discharge could vary from real-world management.

Oral rivaroxaban versus standard therapy for the treatment of symptomatic venous thromboembolism: a pooled analysis of the EINSTEIN-DVT and PE randomized studies.

BACKGROUND: Standard treatment for venous thromboembolism (VTE) consists of a heparin combined with vitamin K antagonists. Direct oral anticoagulants have been investigated for acute and extended treatment of symptomatic VTE; their use could avoid parenteral treatment and/or laboratory monitoring of anticoagulant effects. METHODS: A prespecified pooled analysis of the EINSTEIN-DVT and EINSTEIN-PE studies compared the efficacy and safety of rivaroxaban (15 mg twice-daily for 21 days, followed by 20 mg once-daily) with standard-therapy (enoxaparin 1.0 mg/kg twice-daily and warfarin or acenocoumarol). Patients were treated for 3, 6, or 12 months and followed for suspected recurrent VTE and bleeding. The prespecified noninferiority margin was 1.75. RESULTS: A total of 8282 patients were enrolled; 4151 received rivaroxaban and 4131 received standard-therapy. The primary efficacy outcome occurred in 86 (2.1%) rivaroxaban-treated patients compared with 95 (2.3%) standard-therapy-treated patients (hazard ratio, 0.89; 95% confidence interval [CI], 0.66-1.19; pnoninferiority < 0.001). Major bleeding was observed in 40 (1.0%) and 72 (1.7%) patients in the rivaroxaban and standard-therapy groups, respectively (hazard ratio, 0.54; 95% CI, 0.37-0.79; p = 0.002). In key subgroups, including fragile patients, cancer patients, patients presenting with large clots, and those with a history of recurrent VTE, the efficacy and safety of rivaroxaban were similar compared with standard-therapy. CONCLUSION: The single-drug approach with rivaroxaban resulted in similar efficacy to standard-therapy and was associated with a significantly lower rate of major bleeding. Efficacy and safety results were consistent among key patient subgroups. TRIAL REGISTRATION EINSTEIN-PE: ClinicalTrials.gov, NCT00439777; EINSTEIN-DVT: ClinicalTrials.gov, NCT00440193.