Meridian Clinical Research

The following relationships exist related to this presentation: B.A.S. reports salary support from the NIH/NHLBI (#R56HL168264, #R21HL172288, #1R01HL177105), and research support from Abbott, Boston Scientific, Biosense-Webster, Sanofi, and AltaThera; and consulting to Sanofi, Bayer, Boston Scientific, Element Science, Milestone, and AltaThera.

The 2023 ESC guidelines changed previously recommended a strategy of early treatment in patients with STEMI. Pre-treatment with a P2Y12 receptor inhibitor may be considered in patients undergoing a primary PCI strategy (Class IIb, Level of evidence B). However, the available scientific evidence justifies a personalized approach differentiating the indications for pre-treatment with oral P2Y12 receptor inhibitors depending on the concomitant administration of opioids. In our opinion, in patients undergoing primary PCI not treated with opioids, pre-treatment with an oral P2Y12 receptor inhibitor should be applied, while in patients undergoing primary PCI treated with opioids, pre-treatment with an oral P2Y12 receptor inhibitor should be considered.

Background: COVID-19 is a multiorgan disease characterized by a prothrombotic state and increased risk of venous thromboembolism (VTE), especially in hospitalized patients. Although prior studies have attempted to identify predictors of VTE, restricted sample size and use of administrative claims data have limited such analyses. We conducted a multivariable analysis to identify predictors of VTE in hospitalized patients with COVID-19 in a multicenter patient-level registry. Methods: We utilized data from the CORONA-VTE Network, a US multicenter registry of 10,420 adult (≥18 years) patients with PCR-confirmed COVID-19 of whom 3,844 were hospitalized. The primary outcome was time-to-first-event for a composite of adjudicated pulmonary embolism and deep vein thrombosis (e.g. lower extremity, mesenteric, gonadal vein, etc.) during 90-day follow-up. The candidate variables were selected by a priori clinical consensus. The variables with ≥20% missing data were excluded, whereas those with missing data <20% were estimated using multiple imputation. Selected variables included prophylactic anticoagulation during hospitalization, corticosteroid therapy, female sex, baseline prescriptions of anticoagulants and statins, use of hormone replacement therapy, history of peripheral artery disease, prior VTE, and known thrombophilia. Subsequently, we conducted cox proportional hazard regression adjusted for the selected variables for each imputed dataset and pooled the estimated HRs for reporting (p<0.05 for significance). Results: The overall rate of VTE was 5.39%. The covariates associated with increased risk of VTE were history of VTE (HR: 1.71; 95% CI: 1.11-2.63), corticosteroid therapy (HR: 1.76; 95% CI: 1.32-2.33) and known thrombophilia (HR: 3.56; 95% CI: 1.54-8.21). The covariates associated with decreased risk of VTE were anticoagulation at baseline (HR: 0.42; 95% CI: 0.26-0.69), antecedent use of statins (HR: 0.67; 95% CI: 0.50-0.90), and prophylactic anticoagulation during hospitalization (HR: 0.52; 95% CI: 0.38-0.71). Conclusions: While prior VTE, corticosteroid therapy, and known thrombophilia were associated with increased risk of VTE, prescriptions of anticoagulation and statins were associated with a decreased risk.

Abstract Vaccination with two injections of mRNA-1273 (100-μg) was shown to be safe and efficacious at preventing coronavirus disease 2019 (COVID-19) in the Coronavirus Efficacy (COVE) trial at completion of the blinded part of the study. We present the final report of the longer-term safety and efficacy data of the primary vaccination series plus a 50-μg booster dose administered in Fall 2021. The booster safety profile was consistent with that of the primary series. Incidences of COVID-19 and severe COVID-19 were higher during the Omicron BA.1 than Delta variant waves and boosting versus non-boosting was associated with significant reductions for both. In an exploratory Cox regression model adjusted for time-varying covariates, a longer interval between primary vaccination and boosting was associated with a significantly lower incidence of COVID-19 during the Omicron BA.1 wave. Boosting elicited greater immune responses against ancestral SARS-CoV-2 than the primary series, irrespective of prior SARS-CoV-2 infection. ClinicalTrials.gov: NCT04470427