Treatment guidelines and U.S. Food and Drug Administration emergency use authorizations (EUAs) of monoclonal antibodies (mAbs) for treatment of high-risk outpatients with mild to moderate COVID-19 changed frequently as different SARS-CoV-2 variants emerged. To evaluate whether early outpatient treatment with mAbs, overall and by mAb product, presumed SARS-CoV-2 variant, and immunocompromised status, is associated with reduced risk for hospitalization or death at 28 days. Hypothetical pragmatic randomized trial from observational data comparing mAb-treated patients with a propensity score–matched, nontreated control group. Large U.S. health care system. High-risk outpatients eligible for mAb treatment under any EUA with a positive SARS-CoV-2 test result from 8 December 2020 to 31 August 2022. Single-dose intravenous mAb treatment with bamlanivimab, bamlanivimab–etesevimab, sotrovimab, bebtelovimab, or intravenous or subcutaneous casirivimab–imdevimab administered within 2 days of a positive SARS-CoV-2 test result. The primary outcome was hospitalization or death at 28 days among treated patients versus a nontreated control group (no treatment or treatment ≥3 days after SARS-CoV-2 test date). The risk for hospitalization or death at 28 days was 4.6% in 2571 treated patients and 7.6% in 5135 nontreated control patients (risk ratio [RR], 0.61 [95% CI, 0.50 to 0.74]). In sensitivity analyses, the corresponding RRs for 1- and 3-day treatment grace periods were 0.59 and 0.49, respectively. In subgroup analyses, those receiving mAbs when the Alpha and Delta variants were presumed to be predominant had estimated RRs of 0.55 and 0.53, respectively, compared with 0.71 for the Omicron variant period. Relative risk estimates for individual mAb products all suggested lower risk for hospitalization or death. Among immunocompromised patients, the RR was 0.45 (CI, 0.28 to 0.71). Observational study design, SARS-CoV-2 variant presumed by date rather than genotyping, no data on symptom severity, and partial data on vaccination status. Early mAb treatment among outpatients with COVID-19 is associated with lower risk for hospitalization or death for various mAb products and SARS-CoV-2 variants. None.
Atrial fibrillation (AF) is a common cardiovascular complication affecting patients with cancer, but management strategies are not well established. The purpose of this retrospective cohort study was to evaluate cross-sectional patterns of anticoagulation (AC) use in patients with cancer with AF or atrial flutter (AFL) on the basis of their risk for stroke and bleeding. Patients with cancer and electrocardiograms showing AF or AFL performed at Moffitt Cancer Center in either the inpatient or outpatient setting were included in this retrospective analysis. We described percentages of AC prescription by stroke and bleeding risk, as determined by individual CHA2DS2-VASc and HAS-BLED scores, respectively. Multivariable logistic regression evaluated clinical variables independently associated with anticoagulant prescription. The prevalence of electrocardiography-documented AF or AFL was 4.8% (n = 472). The mean CHA2DS2-VASc score was 2.8 ± 1.4. Among patients with CHA2DS2-VASc scores ≥2 and HAS-BLED scores <3, 44.3% did not receive AC, and of these, only 18.3% had platelet values <50,000/μl. In multivariable analysis, older age, hypertension, prior stroke, and history of venous thromboembolism were each directly associated with AC use, while current chemotherapy use, prior bleeding, renal disease, and thrombocytopenia were each inversely associated with AC use. Nearly one-half of patients with cancer, the majority with normal platelet counts, had an elevated risk for stroke but did not receive AC. In addition to known predictors, current chemotherapy use was independently associated with a lower odds of AC use. This study highlights the need to improve the application of AF treatment algorithms to cancer populations.