Experience from clinical practice may differ from randomized trials both in patient (pt) selection and outcomes. Xigris Evaluation in the United States (XEUS) is a prospective observational study of drotrecogin alfa (activated) (DrotAA) use in clinical practice. This report compares patients treated in clinical practice (XEUS) with those enrolled in a randomized clinical trial (PROWESS).
Between April 2003 and March 2004, data were prospectively collected from a convenience sample of patients receiving DrotAA at 61 acute care hospitals in the United States. Collected data included demographics, organ dysfunction, organ support, and outcomes. Pts were followed until hospital discharge or up to 28 inpatient days whichever came first (HD-28). Since DrotAA is indicated for reduction in mortality in adult severe sepsis (SS) patients at high risk of death, the XEUS population was compared to PROWESS patients at high risk of death (APACHE II ≥ 25) who received placebo (HRP) and those who received DrotAA (HRX).
484 records were available for review. The mean APACHE II score was 28.4; however, since only 36.2% of XEUS patients had these scores recorded, no analyses using APACHE scores were performed. XEUS pts were younger, had more baseline (BL) multiorgan failure (> 1 organ dysfunction), and more vasopressor use compared to HRP and HRX (Table). The HD-28 mortality was 36.8% for XEUS, 41.9% for HRP, and 29.5% for HRX.
XEUS pts appeared to be younger, but were more severely ill (number of dysfunctional organs and vasopressor use) than HRP and HRX. The higher mortality rate in XEUS compared to HRX may reflect more advanced SS in XEUS.
SS is a progressive disease with mortality closely related to the number of dysfunctional organs. The greater frequency of vasopressor use and multiorgan failure in the XEUS population suggests either more rapid disease progression or later patient identification than was seen in PROWESS.
S. Jay, None.