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, 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 10 randomized controlled trials involving 7237 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 framework, and random-effects models were applied. RESULTS: Digital therapeutics interventions were associated with a lower incidence of major bleeding than usual care: no clear differences in TTR, thromboembolic events, or mortality. Evidence quality ranged from very low to high. Secondary analyses showed more international normalized ratio testing with DTx; rehospitalization rates did not differ significantly between the groups. Sensitivity analysis changed TTR effect after excluding a study with enhanced control, but other outcomes remained unchanged. CONCLUSION: Digital therapeutics 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 Identifier: CRD420251107441.