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Given the paucity of comparative efficacy data and the difference in cost between andexanet-alfa and prothrombin complex concentrates (PCC), debates continue regarding optimal cost-effective therapy for patients who present with major bleeding associated with oral factor Xa inhibitors. Available literature comparing the cost-effectiveness of the reversal agents is limited, and the large difference in price between therapy options has led many health systems to exclude andexanet-alfa from their formularies. To evaluate the clinical outcomes and cost of PCC compared to andexanet-alfa for patients with factor Xa inhibitor associated bleeds. We performed a quasi-experimental, single health system study of patients treated with PCC or andexanet-alfa from March 2014 to April 2021. Deterioration-free discharge, thrombotic events, length of stay, discharge disposition, and cost were reported. 170 patients were included in the PCC group and 170 patients were included in the andexanet-alfa group. Deterioration-free discharge was achieved in 66.5% of PCC-treated patients compared to 69.4% in the andexanet alfa-treated patients. 31.8% of PCC-treated patients were discharged home compared to 30.6% in the andexanet alfa-treated patients. The cost per deterioration-free discharge was $20,773.62 versus $5230.32 in the andexanet alfa and 4 F-PCC group, respectively. Among patients that experienced a bleed while taking a factor Xa inhibitor, there was no difference in clinical outcomes for patients treated with andexanet-alfa compared to PCC. Although there was no difference in the clinical outcomes, there was a significant difference in cost with andexanet-alfa costing approximately four times as much as PCC per deterioration-free discharge. [ABSTRACT FROM AUTHOR]

Objectives: The Centers for Medicare and Medicaid Services Severe Sepsis and Septic Shock Management Bundle (SEP‐1) assesses antibiotic administration, lactate measurement, and blood culture collection within 3 h of severe sepsis onset. The impact of the SEP‐1 3‐hour bundle among patients with severe sepsis is not extensively described. This investigation aimed to describe the impact of 3‐hour bundle compliance on 28‐day in‐hospital mortality in patients with severe sepsis. Study Design: This was a retrospective, propensity adjusted, nested case‐control study assessing the impact of compliance with a 3‐hour sepsis bundle among patients with severe sepsis. Setting: This study was conducted at a large, academic, tertiary care medical center in Detroit, Michigan from July 1, 2017 to December 31, 2019. Patients: Cases were defined as those suffering 28‐day in‐hospital mortality. Controls were defined as those surviving at or discharged by 28 days. Patients were separated based on 3‐hour bundle compliance or noncompliance. Nested and overall cohorts were assessed. Severe sepsis time zero was manually validated. Patients with shock, requiring vasopressors within 8 h of time zero, or those not meeting SEP‐1 inclusion criteria were excluded. Intervention: The primary outcome was the propensity adjusted odds of 28‐day in‐hospital mortality among 3‐hour bundle compliant versus noncompliant patients. Secondary outcomes included mortality for individual bundle element compliance, progression to septic shock, and predictors of mortality according to logistic regression. Results: A total of 325 compliant and 325 noncompliant patients were included. The median Sequential Organ Failure Assessment (SOFA) score was three in each group. There was no difference in propensity adjusted odds of mortality among those compliant versus noncompliant with the 3‐hour bundle (odds‐ratio [OR] 1.039; 95% CI: 0.721–1.497; p = 0.838) or with individual bundle elements. SOFA score and female sex were predictors of mortality. Conclusions: Three‐hour bundle compliance did not impact 28‐day in‐hospital mortality in patients with severe sepsis. Further research is needed to understand the impact of 3‐hour bundle compliance on mortality in severe sepsis. [ABSTRACT FROM AUTHOR]