Telemonitoring of patients with COPD combined with home hospitalization may allow for a reduction in healthcare costs, although its usefulness in preventing exacerbations is still unclear.
Thrombotic and thromboembolic phenomena are one of the leading complications and causes of poor outcomes in COVID-19 patients admitted to hospital [1]. In the pathophysiology of pulmonary and endothelial damage due to SARS-CoV-2 infection, an inflammatory and prothrombotic state with microvascular thrombosis has been described [2]. Therefore, early initiation of therapeutic low molecular weight heparin (LMWH) doses could be more effective than prophylactic doses not only in preventing thrombotic/thromboembolic complications (due to its anticoagulant effect), but also in improving overall outcomes (due to its anti-inflammatory properties) in patients admitted to hospital with non-severe COVID-19 pneumonia.We conducted the BEMICOVID-19 study, a single-blind, randomized (1:1 ratio), controlled trial (NCT04420299) evaluating the efficacy and safety of therapeutic (115 IU/Kg once daily) vs. prophylactic (3.500 IU once daily) subcutaneous bemiparin for a 10-day period (after this 10day phase, thromboprophylaxis management was left at investigators' choice) in patients requiring hospital admission due to non-severe COVID-19 pneumonia (defined as CURB65≤2 points without criteria for intensive care unit [ICU] admission nor mechanical ventilation requirement) with baseline D-dimer above the upper limit of normal reference range (> 500 ng/mL), at two University Hospitals (HM-Monteprincipe/HM-Puerta-Sur) in Madrid Metropolitan Area, from August-2020 to June-2021 (the trial was prematurely stopped based on slow recruitment rate due to vaccination campaign). The primary efficacy outcome was a composite of death, ICU admission, need of mechanical ventilation support, and venous (VTE)/arterial (ATE) thromboembolism within 28±2 days of enrollment. Safety outcomes were major bleeding and non-major clinically relevant bleeding. The study involved three mandatory visits (baseline/start of treatment, 10day/end of treatment, and 28-day follow-up), including computed tomography (CT) pulmonary angiography at inclusion and at day 10±1. A full list of participating centers, investigators, statistical-analysis, and eligibility-criteria are provided in Supplementary material.Seventy-six patients (mean [SD] age: 60.6 [11.5] years; men: 60 [76.9%]) were randomized to standard thromboprophylaxis (n = 38) and therapeutic dose bemiparin (n = 38). Baseline characteristics and COVID-19 therapy are shown in Table 1a. All patients completed the follow-up period. Table 1b shows the outcomes. The primary efficacy outcome (death, ICU admission, mechanical ventilation support and VTE/ATE) was registered in 7 (18.4%) patients treated with therapeuticdose of bemiparin and in 6 (15.8%) patients receiving prophylacticdose. The relative risk (RR) was 1.17 (95%CI:0.43-3.15), the odds ratio (OR) was 1.20 (95%CI:0.38-3.83), and the absolute risk difference was 2.6% (95%CI:− 14.3-19.6;p = 0.761). Neither major bleeding event nor serious adverse event (unrelated with COVID-19 evolution) were reported in any arm of treatment. Although reductions of D-dimer levels ...
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