RESUMEN
Background Venous thromboembolism (VTE) in hospitalized medically ill patients is a significant cause of morbidity and mortality. Guidelines suggest that VTE and bleeding risk assessment models (RAMs) should be integrated into the clinical decision-making process on thromboprophylaxis. However, poor evidence is available comparing the use of a RAM versus clinical judgement in evaluating VTE and bleeding occurrence. Methods Reducing Important Clinical Outcomes in hospitalized medical ill patients (RICO) is a multicenter, cluster-randomized, controlled clinical trial (ClinicalTrials.gov Identifier: NCT04267718). Acutely ill patients hospitalized in Internal Medicine wards are randomized to the use of RAMs-namely the Padua Prediction Score and the International Medical Prevention Registry on Venous Thromboembolism Bleeding Score-or to clinical judgement. The primary study outcome is a composite of symptomatic objectively confirmed VTE and major bleeding at 90-day follow-up. Secondary endpoints include the evaluation of clinical outcomes at hospital discharge and the assessment of VTE prophylaxis prescription during the study period. In order to demonstrate a 50% reduction in the primary outcome in the experimental group and assuming an incidence of the primary outcome of 3.5% in the control group at 90-day; 2,844 patients across 32 centers will be included in the study. Discussion The RICO trial is a randomized study of clinical management assessing the role of RAMs in hospitalized medical ill patients with the aim of reducing VTE and bleeding occurrence. The study has the potential to improve clinical practice since VTE still represents an important cause of morbidity and mortality in this setting.
RESUMEN
BACKGROUND: Venous thromboembolism is a frequent complication of COVID-19 infection. Less than 50% of pulmonary embolism (PE) is associated with the evidence of deep venous thrombosis (DVT) of the lower extremities. DVT may also occur in the venous system of the upper limbs especially if provoking conditions are present such as continuous positive airway pressure (CPAP). The aim of this study was to evaluate the incidence of UEDVT in patients affected by moderate-severe COVID-19 infection and to identify potential associated risk factors for its occurrence. METHODS: We performed a retrospective analysis of all patients affected by moderate-severe COVID-19 infection admitted to our unit. In accordance with the local protocol, all patients had undergone a systematic screening for the diagnosis of UEDVT, by vein compression ultrasonography (CUS). All the patients were receiving pharmacological thromboprophylaxis according to international guidelines recommendations. Univariate and multivariate analyses were used to identify risk factors associated with UEDVT. RESULTS: 257 patients were included in the study, 28 patients were affected by UEDVT with an incidence of 10.9% (95% CI, 7.1-14.7). At univariate analysis UEDVT appeared to be significantly associated (p< 0.05) with pneumonia, ARDS, PaO2/FiO2, D-dimer value higher than the age adjusted cut off value and need for CPAP ventilation. Multivariate analysis showed a significant association between UEDVT and the need for CPAP ventilation (OR 5.95; 95% IC 1.33-26.58). Increased mortality was found in patients affected by UEDVT compared to those who were not (OR 3.71; 95% CI, 1.41-9.78). CONCLUSIONS: UEDVT can occur in COVID-19 patients despite adequate prophylaxis especially in patients undergoing helmet CPAP ventilation. Further studies are needed to identify the correct strategy to prevent DVT in these patients.
Asunto(s)
COVID-19/patología , Trombosis Venosa Profunda de la Extremidad Superior/epidemiología , Anciano , Anciano de 80 o más Años , COVID-19/complicaciones , COVID-19/mortalidad , COVID-19/virología , Comorbilidad , Femenino , Productos de Degradación de Fibrina-Fibrinógeno/análisis , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Análisis Multivariante , Oportunidad Relativa , Consumo de Oxígeno , Respiración Artificial/estadística & datos numéricos , Estudios Retrospectivos , Factores de Riesgo , SARS-CoV-2/aislamiento & purificación , Índice de Severidad de la Enfermedad , Trombosis Venosa Profunda de la Extremidad Superior/diagnóstico , Trombosis Venosa Profunda de la Extremidad Superior/etiologíaRESUMEN
BACKGROUND: Inflammatory markers are significantly associated with cardiovascular disease. The ratio between neutrophils and lymphocytes (NLR) is a potential new biomarker, which can single out individuals at risk for future cardiovascular events. Among total white blood cell count (WBC) and its subtypes, NLR seems to have the greatest predictive value for death and major adverse cardiovascular events (MACE) in patients with acute coronary syndrome (ACS). We conducted a meta-analysis of the literature to assess the relation between NLR and cardiovascular outcomes in STEMI/NSTEMI patients. METHODS: MEDLINE and EMBASE databases were searched. Two reviewers selected studies and extracted data. Pooled results were reported as odds ratios (ORs) and were presented with the corresponding 95% confidence intervals (CI). RESULTS: Twenty-three studies for a total of >16,000 patients were included. Compared to those with low NLR, high NLR on-admission was associated with a higher overall mortality both in patients with STEMI (OR: 4.60, 95% CI: 2.84-7.45; Pâ¯<â¯0.00001) and in patients with NSTEMI (OR: 6.41, 95% CI: 2.65-15.50; Pâ¯<â¯0.00001). An increased MACE risk was found in STEMI patients with high NLR (OR: 3.71, 95% CI: 2.67-5.17; Pâ¯<â¯0.00001). Post-PCI mortality risk was significantly increased in patients with high NLR (OR: 3.76, 95% CI: 2.64-5.34; Pâ¯<â¯0.00001). CONCLUSIONS: In this large meta-analysis on prognostic significance of NLR in ACS we found that on-admission high NLR in patients with STEMI/NSTEMI appeared to affect clinically important outcomes including both in-hospital and long-term mortality and MACE.