Background Patients hospitalised with COVID-19 are at risk for thrombotic events after discharge; the role of extended thromboprophylaxis in this population is unknown. Methods In this open-label, multicentre, randomised trial conducted at 14 centres in Brazil, patients hospitalised with COVID-19 at increased risk for venous thromboembolism (International Medical Prevention Registry on Venous Thromboembolism [IMPROVE] venous thromboembolism [VTE] score of ≥4 or 2–3 with a D-dimer >500 ng/mL) were randomly assigned (1:1) to receive, at hospital discharge, rivaroxaban 10 mg/day or no anticoagulation for 35 days. The primary efficacy outcome in an intention-to-treat analysis was a composite of symptomatic or fatal venous thromboembolism, asymptomatic venous thromboembolism on bilateral lower-limb venous ultrasound and CT pulmonary angiogram, symptomatic arterial thromboembolism, and cardiovascular death at day 35. Adjudication was blinded. The primary safety outcome was major bleeding. The primary and safety analyses were carried out in the intention-to-treat population. This trial is registered at ClinicalTrials.gov , NCT04662684 . Findings From Oct 8, 2020, to June 29, 2021, 997 patients were screened. Of these patients, 677 did not meet eligibility criteria; the remaining 320 patients were enrolled and randomly assigned to receive rivaroxaban (n=160 [50%]) or no anticoagulation (n=160 [50%]). All patients received thromboprophylaxis with standard doses of heparin during hospitalisation. 165 (52%) patients were in the intensive care unit while hospitalised. 197 (62%) patients had an IMPROVE score of 2–3 and elevated D-dimer levels and 121 (38%) had a score of 4 or more. Two patients (one in each group) were lost to follow-up due to withdrawal of consent and not included in the intention-to-treat primary analysis. The primary efficacy outcome occurred in five (3%) of 159 patients assigned to rivaroxaban and 15 (9%) of 159 patients assigned to no anticoagulation (relative risk 0·33, 95% CI 0·12–0·90; p=0·0293). No major bleeding occurred in either study group. Allergic reactions occurred in two (1%) patients in the rivaroxaban group. Interpretation In patients at high risk discharged after hospitalisation due to COVID-19, thromboprophylaxis with rivaroxaban 10 mg/day for 35 days improved clinical outcomes compared with no extended thromboprophylaxis. Funding Bayer.
Background The devastating Coronavirus disease (COVID-19) pandemic is associated with a high prothrombotic state. It is unclear if the coagulation abnormalities occur because of the direct effect of SARS-CoV-2 or indirectly by the cytokine storm and endothelial damage or by a combination of mechanisms. There is a clear indication of in-hospital pharmacological thromboprophylaxis for every patient with COVID-19 after bleed risk assessment. However, there is much debate regarding the best dosage regimen, and there is no consensus on the role of extended thromboprophylaxis. Design This study aims to evaluate the safety and efficacy of rivaroxaban 10 mg once daily for 35±4 days versus no intervention after hospital discharge in COVID-19 patients who were at increased risk for VTE and have received standard parenteral VTE prophylaxis during hospitalization. The composite efficacy endpoint is a combination of symptomatic VTE, VTE-related death, VTE detected by bilateral lower limbs venous duplex scan and computed tomography pulmonary angiogram on day 35±4 post-hospital discharge and symptomatic arterial thromboembolism (myocardial infarction [MI], non-hemorrhagic stroke, major adverse limb events [MALE] and cardiovascular [CV] death) up to day 35±4 post-hospital discharge. The key safety outcome is the incidence of major bleeding according to ISTH criteria. Summary The MICHELLE trial is expected to provide high-quality evidence around the role of extended thromboprophylaxis in COVID-19 and will help guide medical decisions in clinical practice.
Objective To identify current strategies and recommendations for venous thromboembolism prophylaxis associated with the pregnancy-puerperal cycle, a condition of high morbidity and mortality among women. Methods The literature search was performed between May and October 2019, using the PubMed database, including papers published in Portuguese, English and Spanish. The terms thromboembolism (Mesh) AND pregnancy (Mesh) OR postpartum (Mesh) were used as descriptors, including randomized controlled trials, meta-analyses, systematic reviews and guidelines published from 2009 to 2019, presenting strategies for prevention of thromboembolism during pregnancy and the postpartum. Results Eight articles met the inclusion criteria. Many studies evaluated were excluded because they did not address prevention strategies. We compiled the recommendations from the American Society of Hematologists, the American College of Obstetricians and Gynecologists, the Royal College of Obstetricians and Gynecologists, the Society of Obstetricians and Gynaecologists of Canada, the American College of Chest Physicians and the Royal Australian and New Zealand College of Obstetricians and Gynaecologists. Conclusion: There are some gaps in the research, and clinical studies with appropriate methodology are needed to support decisions made regarding the risk of thromboembolism in the perigestational period. Thus, the attention of the professionals involved in the care of pregnant and postpartum women is crucial, as it is a condition associated with high morbidity and mortality.
Resumo A isquemia aguda de extremidades é um evento raro na população pediátrica, com incidência estimada em 26 a cada 100.000 internações, sendo a maioria associada a trauma ou iatrogenia. O tratamento ideal para esses quadros não está bem estabelecido pela literatura, havendo a tendência ao tratamento não invasivo. Relatamos o caso de uma lactente que apresentou isquemia dos quatro membros secundária a complicações hemodinâmicas após realização de cirurgia cardíaca complexa, apresentando preservação tecidual expressiva com o tratamento conservador.
A utilização de anticoagulantes orais diretos (DOACs), tais como dabigatrana, rivaroxabana, apixabana e edoxabana, está hoje entre as mais novas terapias para o tratamento de trombose venosa profunda. Os DOACs apresentam várias vantagens sobre drogas convencionais, como varfarina, heparinas e antagonistas da vitamina K, como início rápido de ação, farmacocinética previsível, administração simples, ausência de necessidade de monitorização laboratorial, além de fácil manuseio. Com a ampliação do seu uso, tornou-se evidente que os DOACs, além de mais fáceis de manejar, são mais seguros que a terapia convencional. Entretanto, alguns fatores devem ser levados em consideração antes da escolha da terapia com DOACs, como pacientes oncológios, gestantes e lactantes e pacientes obesos; além de sangramento maior e menor, duração do tratamento e dose-resposta. Dessa forma, para o manejo seguro de DOACs em determinadas condições, mais estudos precisam ser realizados a fim de maior segurança e eficácia parao paciente.
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