Abstract
Objective: To summarize the key intervention characteristics and evaluate the effectiveness
and safety of digital therapeutics (DTx) in patients receiving oral anticoagulation, with
effectiveness evaluated using time in therapeutic range (TTR), thromboembolic events (TEE),
and mortality, and safety evaluated based on bleeding events.
Patients and Methods: We searched PubMed, Embase, Web of Science, and the Cochrane
Library from inception to June 20, 2025, and identified ten randomized controlled trials
involving 7,237 patients. The criteria required studies to assess software-based DTx
supporting anticoagulation management and report effectiveness or safety outcomes. Study
quality was evaluated using the Grading of Recommendations, Assessment, Development,
and Evaluation (GRADE) framework, and random-effects models were applied.
Results: DTx interventions were associated with a lower incidence of major bleeding than
usual care; no clear differences in TTR, TEE, or mortality. Evidence quality ranged from very
low to high. Secondary analyses showed more INR testing with DTx; rehospitalization rates
did not differ significantly between groups. Sensitivity analysis changed TTR effect after
excluding a study with enhanced control, but other outcomes remained unchanged.
Conclusion: DTx interventions for anticoagulation management improve safety outcomes,
particularly reducing major bleeding, and with greater monitoring intensity. Larger, long-term
trials are needed to confirm the clinical benefits and evaluate cost-effectiveness.
Trial Registration: PROSPERO (CRD420251107441)
and safety of digital therapeutics (DTx) in patients receiving oral anticoagulation, with
effectiveness evaluated using time in therapeutic range (TTR), thromboembolic events (TEE),
and mortality, and safety evaluated based on bleeding events.
Patients and Methods: We searched PubMed, Embase, Web of Science, and the Cochrane
Library from inception to June 20, 2025, and identified ten randomized controlled trials
involving 7,237 patients. The criteria required studies to assess software-based DTx
supporting anticoagulation management and report effectiveness or safety outcomes. Study
quality was evaluated using the Grading of Recommendations, Assessment, Development,
and Evaluation (GRADE) framework, and random-effects models were applied.
Results: DTx interventions were associated with a lower incidence of major bleeding than
usual care; no clear differences in TTR, TEE, or mortality. Evidence quality ranged from very
low to high. Secondary analyses showed more INR testing with DTx; rehospitalization rates
did not differ significantly between groups. Sensitivity analysis changed TTR effect after
excluding a study with enhanced control, but other outcomes remained unchanged.
Conclusion: DTx interventions for anticoagulation management improve safety outcomes,
particularly reducing major bleeding, and with greater monitoring intensity. Larger, long-term
trials are needed to confirm the clinical benefits and evaluate cost-effectiveness.
Trial Registration: PROSPERO (CRD420251107441)
| Original language | English |
|---|---|
| Article number | 100336 |
| Journal | Mayo Clinic Proceedings: Digital Health |
| DOIs | |
| Publication status | Published - 20 Jan 2026 |