IMPORTANCEAcutely ill inpatients with COVID-19 typically receive antithrombotic therapy, although the risks and benefits of this intervention among outpatients with COVID-19 have not been established. OBJECTIVE To assess whether anticoagulant or antiplatelet therapy can safely reduce major adverse cardiopulmonary outcomes among symptomatic but clinically stable outpatients with COVID-19. DESIGN, SETTING, AND PARTICIPANTSThe ACTIV-4B Outpatient Thrombosis Prevention Trial was designed as a minimal-contact, adaptive, randomized, double-blind, placebo-controlled trial to compare anticoagulant and antiplatelet therapy among 7000 symptomatic but clinically stable outpatients with COVID-19. The trial was conducted at 52 US sites between September 2020 and June 2021; final follow-up was August 5, 2021. Prior to initiating treatment, participants were required to have platelet count greater than 100 000/mm 3 and estimated glomerular filtration rate greater than 30 mL/min/1.73 m 2 .INTERVENTIONS Random allocation in a 1:1:1:1 ratio to aspirin (81 mg orally once daily; n = 164), prophylactic-dose apixaban (2.5 mg orally twice daily; n = 165), therapeutic-dose apixaban (5 mg orally twice daily; n = 164), or placebo (n = 164) for 45 days. MAIN OUTCOMES AND MEASURESThe primary end point was a composite of all-cause mortality, symptomatic venous or arterial thromboembolism, myocardial infarction, stroke, or hospitalization for cardiovascular or pulmonary cause. The primary analyses for efficacy and bleeding events were limited to participants who took at least 1 dose of trial medication. RESULTSOn June 18, 2021, the trial data and safety monitoring board recommended early terminationbecauseoflowerthananticipatedeventrates;atthattime,657symptomaticoutpatients with COVID-19 had been randomized (median age, 54 years [IQR,[46][47][48][49][50][51][52][53][54][55][56][57][58][59]; 59% women). The median times from diagnosis to randomization and from randomization to initiation of study treatment were 7 days and 3 days, respectively. Twenty-two randomized participants (3.3%) were hospitalized for COVID-19 prior to initiating treatment. Among the 558 patients who initiated treatment, the adjudicated primary composite end point occurred in 1 patient (0.7%) in the aspirin group, 1 patient (0.7%) in the 2.5-mg apixaban group, 2 patients (1.4%) in the 5-mg apixaban group, and 1 patient (0.7%) in the placebo group. The risk differences compared with placebo for the primary end point were 0.0% (95% CI not calculable) in the aspirin group, 0.7% (95% CI, -2.1% to 4.1%) in the 2.5-mg apixaban group, and 1.4% (95% CI, -1.5% to 5.0%) in the 5-mg apixaban group. Risk differences compared with placebo for bleeding events were 2.0% (95% CI, -2.7% to 6.8%), 4.5% (95% CI, -0.7% to 10.2%), and 6.9% (95% CI, 1.4% to 12.9%) among participants who initiated therapy in the aspirin, prophylactic apixaban, and therapeutic apixaban groups, respectively, although none were major. Findings inclusive of all randomized patients were similar.CONCLUSIONS AND RELEV...
Background Pain is one of the most common complaints that patients present to the emergency department for; emergency medicine providers are tasked with providing appropriate pain relief while simultaneously limiting the risk of personal and societal harm that may result from opioid misuse. The Lakeland Regional Medical Center developed a medical management program that identified frequent emergency department visitors with a chief complaint of pain. Individualized care plans were developed for these patients. A retrospective review was then conducted to assess the efficacy of these care plans in reducing the number of emergency department visits for pain-related complaints by the patients entered into the medical management program. Results There were 294 patients; 65% were male, and the median age was 41 (interquartile range: 33 to 51). A total of 80% percent of the patients were white, and the payors were as follows: 53% were self-pay, 42% were government programs, and 5% had private insurance. The three most common chronic pain complaints were 39% abdominal pain, 24% back/neck pain, and 23% headache/migraine (patients could have more than one area of pain). A total of 60% of the patients had a primary care provider, and another 18% had a pain management provider in addition to primary care. Post plan admissions were significantly reduced to a median of 1 (IQR 0 to 3) with the Wilcoxon signed-rank test’s p-value of less than 0.001. Conclusion The authors describe their experience with a quality improvement initiative that identifies frequent emergency department visitors with a chief complaint of pain and provides individualized care plans to these patients. The goals of the program are to improve patient’s quality and consistency of care, through interventions that eliminate the prescribing of opioids while providing non-opioid alternatives.
Background Recombinant, monoclonal antibody therapies have been utilized under emergency use authorization (EUA) for the prevention of clinical decompensation in high-risk COVID-19 positive patients for up to 10 days from symptom onset. The purpose of this study was to determine the impact of the timing of the monoclonal antibody, bamlanivimab, on clinical outcomes in high-risk COVID-19 positive patients. Methods This was an IRB-approved, retrospective evaluation of adult patients who received bamlanivimab per EUA criteria in the emergency department (ED). Patients were dichotomized into two groups– 3 days of symptoms or less ( early ) versus 4 to 10 days ( late ). The primary outcome was hospitalization for COVID-related illness at 28 days (or treatment failure). Secondary outcomes were COVID-related ED visits at 28 days, hospital and intensive care unit (ICU) length of stay (LOS), and in-hospital mortality at 28 days. Results A total of 839 patients were included in the analysis. There was no difference observed in COVID-related hospitalization rates within 28 days between the early and late bamlanivimab administration groups (7.5% vs. 8.2%, p = 0.71). There was no difference in COVID-related ED visits within 28 days with 13% of patients returning to the ED. Conclusions In conclusion, there were no differences in the rates of hospitalization at 28 days when bamlanivimab was administered in the first 3 days of illness versus days 4 to 10. Future prospective studies are warranted to expand upon the characteristics of patients that may or may not benefit from monoclonal antibody therapy.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.