Rivaroxaban versus no anticoagulation for post-discharge thromboprophylaxis after hospitalisation for COVID-19 (MICHELLE): an open-label, multicentre, randomised, controlled trial.

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.

Conservative treatment of acute limb ischemia in a child - case report.

Acute limb ischemia is a rare event in the pediatric population, with an estimated incidence of 26 per 100,000 admissions, the majority of which are associated with trauma or iatrogeny. The ideal treatment for these cases is not well-established in the literature, although there is a tendency to choose noninvasive treatment. We report the case of an infant who suffered ischemia to all four limbs secondary to hemodynamic complications after complex heart surgery and in whom significant tissue preservation was achieved with conservative treatment.

Medically Ill hospitalized Patients for COVID-19 THrombosis Extended ProphyLaxis with rivaroxaban ThErapy: Rationale and Design of the MICHELLE Trial.

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 posthospital discharge and symptomatic arterial thromboembolism (myocardial infarction, nonhemorrhagic stroke, major adverse limb events, and cardiovascular death) up to day 35 ± 4 posthospital 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.1.

Thromboprophylaxis during the Pregnancy-Puerperal Cycle - Literature Review.

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.

OBJETIVO: Identificar as estratégias e recomendações atuais para profilaxia de tromboembolismo venoso associado ao ciclo gravídico-puerperal, condição de alta morbimortalidade entre mulheres. MéTODOS: A busca na literatura ocorreu entre maio e outubro de 2019, com pesquisa na base de dados do PubMed, contemplando trabalhos publicados nos idiomas português, inglês e espanhol. Os termos thromboembolism (Mesh) AND pregnancy (Mesh) OR postpartum (Mesh) foram utilizados como descritores, incluindo ensaios clínicos randomizados, metanálises, revisões sistemáticas e diretrizes publicadas entre 2009 a 20019, apresentando estratégias de prevenção de tromboembolismo venoso durante a gravidez e o pós-parto. RESULTADOS: Oito artigos abordando estratégias de tromboprofilaxia primária e secundária durante a gestação, parto e puerpério foram selecionados para a presente revisão sistemática. Muitos estudos avaliados foram excluídos por não abordarem estratégias de prevenção. Foram compiladas as recomendações das seguintes sociedades: American Society of Hematologists, American College of Obstetricians and Gynecologists, Royal College of Obstetricians and Gynecologists, Society of Obstetricians and Gynaecologists of Canada, American College of Chest Physicians e Royal Australian and New Zealand College of Obstetricians and Gynaecologists. CONCLUSãO: Até o presente momento, há algumas lacunas e estudos clínicos com metodologia adequada se fazem necessários para respaldar a tomada de decisão frente ao risco de tromboembolismo venoso no período perigestacional. Torna-se fundamental a atenção dos profissionais envolvidos no atendimento às gestantes e puérperas, pois trata-se de uma condição associada a alta morbimortalidade.

Tratamento conservador de isquemia aguda de extremidades em lactente - relato de caso / Conservative treatment of acute limb ischemia in a child - case report

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.

Abstract Acute limb ischemia is a rare event in the pediatric population, with an estimated incidence of 26 per 100,000 admissions, the majority of which are associated with trauma or iatrogeny. The ideal treatment for these cases is not well-established in the literature, although there is a tendency to choose noninvasive treatment. We report the case of an infant who suffered ischemia to all four limbs secondary to hemodynamic complications after complex heart surgery and in whom significant tissue preservation was achieved with conservative treatment.

Thromboprophylaxis during the pregnancy-puerperal cycle - literature review / Tromboprofilaxia no ciclo gravídico-puerperal - revisão da literatura

Abstract 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 Objetivo Identificar as estratégias e recomendações atuais para profilaxia de tromboembolismo venoso associado ao ciclo gravídico-puerperal, condição de alta morbimortalidade entre mulheres. Métodos A busca na literatura ocorreu entre maio e outubro de 2019, com pesquisa na base de dados do PubMed, contemplando trabalhos publicados nos idiomas português, inglês e espanhol. Os termos thromboembolism (Mesh) AND pregnancy (Mesh) OR postpartum (Mesh) foram utilizados como descritores, incluindo ensaios clínicos randomizados, metanálises, revisões sistemáticas e diretrizes publicadas entre 2009 a 20019, apresentando estratégias de prevenção de tromboembolismo venoso durante a gravidez e o pós-parto. Resultados Oito artigos abordando estratégias de tromboprofilaxia primária e secundária durante a gestação, parto e puerpério foram selecionados para a presente revisão sistemática. Muitos estudos avaliados foram excluídos por não abordarem estratégias de prevenção. Foram compiladas as recomendações das seguintes sociedades: American Society of Hematologists, American College of Obstetricians and Gynecologists, Royal College of Obstetricians and Gynecologists, Society of Obstetricians and Gynaecologists of Canada, American College of Chest Physicians e Royal Australian and New Zealand College of Obstetricians and Gynaecologists. Conclusão Até o presente momento, há algumas lacunas e estudos clínicos com metodologia adequada se fazem necessários para respaldar a tomada de decisão frente ao risco de tromboembolismo venoso no período perigestacional. Torna-se fundamental a atenção dos profissionais envolvidos no atendimento às gestantes e puérperas, pois trata-se de uma condição associada a alta morbimortalidade.