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Made available in DSpace on 2022-04-29T08:46:13Z (GMT). No. of bitstreams: 0 Previous issue date: 2022-01-01 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. Science Valley Research Institute Hospital e Maternidade Christóvão da Gama Grupo Leforte Santo André Unidade de Medicina Interdisciplinar em Cardiologia Instituto do Coração Hospital das Clínicas HCFMUSP Faculdade de Medicina Universidade de São Paulo Zucker School of Medicine at Hofstra/Northwell and the Feinstein Institutes for Medical Research Department of Obstetrics and Gynecology I M Sechenov First Moscow State Medical University Universidade Estadual Paulista Hospital das Clínicas de Ribeirão Preto São Paulo University Medical School Ribeirão Preto Hospital do Rocio, Campo Largo Instituto Couto Maia Salvador Hospital Municipal de Barueri São Paulo State Public Women's Health Reference Center Hospital Israelita Albert Einstein Instituto do Coração Hospital das Clínicas HCFMUSP Faculdade de Medicina Universidade de São Paulo Institute of Teaching and Research Hapvida Hospital Nossa Senhora das Graças Department of Statistics Institute of Mathematics and Statistics University of São Paulo Northshore University Health System Hemostasis and Thrombosis Research Laboratories at Loyola University Medical Center Duke Clinical Research Institute Duke University School of Medicine Universidade Estadual Paulista

CONTEXT: Diagnosis and treatment of cystic neoplasms of the pancreas increased significantly in the last decades. There are only a few Brazilian publications on these tumors. The majority of them are limited to reports of one or few cases. OBJECTIVE: To present our experience with 27 patients with cystic neoplasms of the pancreas. METHODS: Demographic data, clinical manifestations, diagnostic exams, surgical procedures, postoperative complications, and follow-up data of 27 patients with cystic neoplasms of the pancreas were analyzed, according to the histological type of the tumor. RESULTS: There were 10 (37%) serous cystic tumors, 10 (37%) mucinous cystic tumors, 4 (15%) intraductal papillary mucinous tumors, and 3 (11%) solid pseudopapillary tumors or Frantz tumor. All serous cystic tumors, 6 (60%) mucinous tumors, 2 (50%) intraductal papillary mucinous tumors, and 2 (67%) solid pseudopapillary tumors were benign. The age of the patients varied from 31 to 82 years and all tumors were more common in female. Two patients had been treated previously as a pseudocyst. Surgical procedures depended on the location and extension of the tumor. Two patients underwent only laparotomy with tumor biopsy, one cholecystectomy with Roux-en-Y hepaticojejunostomy for jaundice treatment, 6 pancreatoduodenectomy, and 18 partial pancreatectomy. The most common postoperative complication was pancreatic fistula (n = 5; 19%). One patient died of necrotic pancreatitis. Of the 10 patients with serous cystic tumor, only 1 had tumor recurrence at the section border. The three patients with mucinous cystoadenocarcinoma in which was not possible to resect the tumor, died 6 to 24 months after laparotomy. The six patients with benign mucinous tumors did not have tumor recurrence. CONCLUSIONS: The most common cystic neoplasms of the pancreas are serous and mucinous cysts. These tumors are more frequent in female. Although almost all serous cysts are benign, 40% of mucinous cysts are malign. Misdiagnosis may delay appropriate treatment and increase mortality. RACIONAL: O diagnóstico e tratamento das neoplasias císticas do pâncreas aumentaram significativamente nas últimas décadas. Existem poucas publicações brasileiras sobre estes tumores, sendo que a maioria é limitada à descrição de um ou poucos casos. OBJETIVO: Apresentar a experiência com 27 pacientes com neoplasia cística do pâncreas. MÉTODOS: Os dados demográficos, quadro clínico, exames complementares, procedimento cirúrgico com as suas complicações e a evolução pós-operatória de 27 pacientes com neoplasia cística do pâncreas foram analisados, conforme o tipo histológico do tumor. RESULTADOS: O exame anatomopatológico evidenciou 10 (37%) casos de tumor seroso, 10 (37%) de tumor mucinoso, 4 (15%) de neoplasia intraductal papilar mucinosa e 3 (11%) de neoplasia sólida pseudopapilar ou tumor de Frantz. Todos os tumores serosos, seis (60%) mucinosos, dois (50%) tumores intraductais papilares mucinosos e dois (67%) tumores sólidos pseudopapilares eram benignos. A idade dos pacientes variou amplamente de 31 a 82 anos e o sexo feminino predominou em todos os tipos de tumores. Dois pacientes tinham sido tratados previamente como pseudocisto de pâncreas. As operações realizadas dependiam da localização e extensão do tumor. Dois pacientes foram submetidos somente a laparotomia com biopsia do tumor, 1 a colecistectomia e hepaticojejunostomia em Y-de-Roux para aliviar a icterícia, sem ressecção da neoplasia, 6 a pancreatoduodenectomia e 18 a pancreatectomia parcial. A complicação pós-operatória mais comum foi fístula pancreática (n = 5; 19%). Um paciente morreu no pós-operatório imediato por pancreatite necrótica. Dos 10 pacientes com cistoadenoma seroso, apenas 1 apresentou recidiva próxima à borda de secção do tumor. Os três pacientes com cistoadenocarcinomas mucinosos em que não foi realizada a ressecção do tumor foram a óbito de 6 a 24 meses após a operação. Os seis pacientes com tumores mucinosos benignos não apresentaram recidiva. CONCLUSÕES: As neoplasias císticas pancreáticas mais comuns são os cistos serosos e os mucinosos. Estes tumores ocorrem predominantemente no sexo feminino. Apesar de quase todos os tumores serosos serem benignos, uma percentagem elevada (40%) de tumores mucinosos é maligna. O não reconhecimento desses tumores pode retardar o tratamento adequado e ser associado à elevada mortalidade.