Thrombosis research · 2025
Bluetooth enabled point-of-care INR device validation for warfarin management.
СтатьяМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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McBane Robert D, Lutz Jennifer, O'Connor Carlee, Kramer Anna, Luker Michael, Hodge David, Thomas Colleen S, Hellweg Harold J
Аннотация
OBJECTIVE: Systems employing point-of-care (POC) INR monitoring with patient self-testing require test accuracy, data integrity, patient compliance, and prompt two-way communication for high quality warfarin management. With a goal of validating a POC Bluetooth capable device for prompt INR transfer to electronic medical record, two POC INR devices were compared against an internal plasma INR reference.
METHODS: A multicenter study (February 14, 2023 - August 29, 2023) comparing concordance of two commercially available POC devices, Vantus and CoaguChek XS (Pro and Plus), against a plasma INR reference, was pursued among warfarin treated patients. Appropriateness of dosing decisions were assessed for each device.
RESULTS: Across three Mayo Clinic sites, 151 warfarin treated patients agreed to participate. Atrial fibrillation (41.7 %), venous thromboembolism (33.1 %) and heart valve prosthesis (19.9 %) were common indications with target INR range 2.0-3.0 in 89 %. For the CoaguChek devices, 86.1 % of values fell within 0.4 INR units compared with plasma INR referent (CoaguChek - plasma INR correlation R2 = 0.95). For the Vantus device, 88.7 % of values fell within 0.4 INR units of plasma INR values (Vantus - plasma INR correlation R2 = 0.96). Mean (± standard deviation) deviation from plasma INR was 0.2 ± 0.3 for CoaguChek compared to 0.1 ± 0.2 for Vantus (p < 0.001). Using the plasma INR as the gold standard for dosing recommendations, appropriate dosing recommendations were similar between devices: CoaguChek 83.4 % vs Vantus 82.7 %.
CONCLUSIONS: Compared to a plasma referent, INR values obtained from the CoaguChek and Vantus devices exhibited strong correlation with plasma INR values without systemic bias.
METHODS: A multicenter study (February 14, 2023 - August 29, 2023) comparing concordance of two commercially available POC devices, Vantus and CoaguChek XS (Pro and Plus), against a plasma INR reference, was pursued among warfarin treated patients. Appropriateness of dosing decisions were assessed for each device.
RESULTS: Across three Mayo Clinic sites, 151 warfarin treated patients agreed to participate. Atrial fibrillation (41.7 %), venous thromboembolism (33.1 %) and heart valve prosthesis (19.9 %) were common indications with target INR range 2.0-3.0 in 89 %. For the CoaguChek devices, 86.1 % of values fell within 0.4 INR units compared with plasma INR referent (CoaguChek - plasma INR correlation R2 = 0.95). For the Vantus device, 88.7 % of values fell within 0.4 INR units of plasma INR values (Vantus - plasma INR correlation R2 = 0.96). Mean (± standard deviation) deviation from plasma INR was 0.2 ± 0.3 for CoaguChek compared to 0.1 ± 0.2 for Vantus (p < 0.001). Using the plasma INR as the gold standard for dosing recommendations, appropriate dosing recommendations were similar between devices: CoaguChek 83.4 % vs Vantus 82.7 %.
CONCLUSIONS: Compared to a plasma referent, INR values obtained from the CoaguChek and Vantus devices exhibited strong correlation with plasma INR values without systemic bias.