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Ignoring instead of chasing after coagulation factor VII during warfarin management: an interrupted time series study.
- Source :
-
Blood [Blood] 2021 May 20; Vol. 137 (20), pp. 2745-2755. - Publication Year :
- 2021
-
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.<br /> (© 2021 by The American Society of Hematology.)
- 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
Subjects
Details
- Language :
- English
- ISSN :
- 1528-0020
- Volume :
- 137
- Issue :
- 20
- Database :
- MEDLINE
- Journal :
- Blood
- Publication Type :
- Academic Journal
- Accession number :
- 33512454
- Full Text :
- https://doi.org/10.1182/blood.2020008698