New Real-World Evidence Demonstrates Long-Term Performance of Forsante Warfarin Advisor
Forsante has completed a long-term real-world evaluation of Warfarin Advisor, a CE-marked Class IIb medical device that supports anticoagulation management through guideline-based dosing recommendations and care automation.
The study analysed routine clinical use between 2016 and 2026. Among 1,348 active patients in March 2026, median Time in Therapeutic Range (TTR), a key measure of anticoagulation quality, reached 83%, compared with 70% in March 2016. The analysis also showed that warfarin doses aligned with Warfarin Advisor recommendations were strongly associated with achieving target INR levels at follow-up.
Importantly, treatment quality remained consistently high throughout the observation period. During 12 calendar years of deployment, representing 82,709 patient-years of routine use, no serious device-attributable safety incidents, regulatory incident reports, or CAPA cases were identified.
These findings provide long-term real-world evidence that guideline-based warfarin dosing and care automation can support sustained high-quality anticoagulation control in everyday clinical practice. They also demonstrate the feasibility of workflow-integrated execution of guideline-driven clinical processes at scale.
While prospective studies are needed to confirm causal effects on clinical outcomes, the results highlight the potential of clinical execution technologies to improve quality, consistency, and efficiency in chronic disease management.
Read more at medRxiv: Twelve-Year Real-World Evaluation of a Regulated Guideline-Based Warfarin Dosing and Care Automation System
