1. Ignoring instead of chasing after coagulation factor VII during warfarin management: an interrupted time series study.
- Author
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Oskarsdottir AR, Gudmundsdottir BR, Jensdottir HM, Flygenring B, Palsson R, and Onundarson PT
- Subjects
- Aged, Aged, 80 and over, Anticoagulants adverse effects, Anticoagulants pharmacology, Atrial Fibrillation complications, Comorbidity, Female, Follow-Up Studies, Humans, Iceland epidemiology, International Normalized Ratio, Interrupted Time Series Analysis, Maintenance Chemotherapy, Male, Prothrombin Time, Risk, Thromboembolism epidemiology, Thrombophilia blood, Thrombophilia epidemiology, Warfarin adverse effects, Warfarin pharmacology, Anticoagulants therapeutic use, Drug Monitoring methods, Factor VII analysis, Factor X analysis, Hemorrhage chemically induced, Prothrombin analysis, Thromboembolism prevention & control, Thrombophilia drug therapy, Warfarin therapeutic use
- Abstract
During warfarin management, variability in prothrombin time-based international normalized ratio (PT-INR) is caused, in part, by clinically inconsequential fluctuations in factor VII (FVII). The new factor II and X (Fiix)-prothrombin time (Fiix-PT) and Fiix-normalized ratio (Fiix-NR), unlike PT-INR, are only affected by reduced FII and FX. We assessed the incidence of thromboembolism (TE) and major bleeding (MB) in all 2667 patients on maintenance-phase warfarin managed at our anticoagulation management service during 30 months; 12 months prior to and 18 months after replacing PT-INR monitoring with Fiix-NR monitoring. Months 13 to 18 were predefined as transitional months. Using 2-segmented regression, a breakpoint in the monthly incidence of TE became evident 6 months after test replacement, that was followed by a 56% reduction in incidence (from 2.82% to 1.23% per patient-year; P = .019). Three-segmented regression did not find any significant trend in TE incidence (slope, +0.03) prior to test replacement; however, during months 13 to 18 and 19 to 30, the incidence of TE decreased gradually (slope, -0.12; R2 = 0.20; P = .007). The incidence of MB (2.79% per patient-year) did not differ. Incidence comparison during the 12-month Fiix and PT periods confirmed a statistically significant reduction (55-62%) in TE. Fiix monitoring reduced testing, dose adjustments, and normalized ratio variability and prolonged testing intervals and time in range. We conclude that ignoring FVII during Fiix-NR monitoring in real-world practice stabilizes the anticoagulant effect of warfarin and associates with a major reduction in TEs without increasing bleeding., (© 2021 by The American Society of Hematology.)
- Published
- 2021
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