There was no systematic schedule for INR monitoring after the administration of reversal agents, and repeat doses of coagulation factors were administered at the treating provider’s discretion based on the follow-up INR after the first dose. There was no systematic screening for TGF-beta Smad signaling thromboembolic events; patients were assessed for any potential thromboembolic complications as was deemed clinically appropriate. Data were

compared between the two groups to determine if differences were statistically significant for the above-mentioned demographic, coagulation, and outcome parameters, with the primary efficacy end-point being achievement of goal INR less than or equal to 1.5, and the primary safety end-point being number of thromboembolic events. Statistical tests utilized include the Wilcoxon Rank Sum test to compare continuous data, reported as median [IQR], and

Chi Square Captisol or Fisher exact test for categorical data, reported as n, %. A p value less than or equal to 0.05 was considered statistically significant. Results Based on inclusion and exclusion criteria, 74 PCC3 patients and 32 LDrFVIIa patients were included in the final analysis (Figure 1). There were no significant differences between the groups with regards to age, gender, or indication for anticoagulation with warfarin (Table 1). There Trk receptor inhibitor & ALK inhibitor was also no difference in the indication for emergent reversal (Table 2), except for more patients who presented with subdural hematoma received LDrFVIIa. The groups were similar with regards to the percentage of patients receiving vitamin K (77.0% PCC3 vs. 68.8% LDrFVIIa, p = 0.37) or FFP (66.2% PCC3 vs. 65.6% LDrFVIIa p = 0.95), and the number FFP units administered (2[0-4] PCC3 vs. 2[0-4] LDrFVIIa, p = 0.75) (Table 3). The initial dose of PCC3 was 1540[1429-1978] units or 19.9 [18.6-20.8] units/kg, and

the dose of LDrFVIIa was 1000[1000-1000] mcg or 11.5 [10.1-15.0] mcg/kg. Table 4 details the INR response comparing the two coagulation factors. Baseline INRs were equivalent for the two groups prior to the first dose of either PCC3 or LDrFVIIa (3.1[2.3-4.1] PCC3 vs. 2.8[2.2-3.6] LDrFVIIa, p = 0.52). After DNA ligase one dose of coagulation factor, 71.9% of patients in the LDrFVIIa group achieved goal INR of 1.5 or less compared to 33.8% in the PCC3 group (p = 0.001). The time between pre and post coagulation factor INRs was similar (3:53[2:32-7:17]) in PCC3 group and 4:30[2:21-6:25] in LDrFVIIa group, p = 0.78). The percent change in INR was higher after administration of LDrFVIIa compared to PCC3 (54.1% [47.3%-62.7%] for the LDrFVIIa group vs. 38.8% [30.7%-56.0%] for the PCC3 group, p = 0.002). Table 1 Baseline demographic characteristics of the study patients Characteristics PCC3 (n = 74) LD rFVIIa (n = 32) p Demographics       Age (years)* 73 [62.3-81.0] 67 [59.5-79.3] 0.32 M:F 43:31 22:10 0.