# The Effectiveness of Digital Therapeutics Intervention in Oral Anticoagulation Management: A Systematic Review and Meta-analysis

## TL;DR

Digital therapeutics for anticoagulation management reduce major bleeding but don't improve other outcomes like clot prevention or survival.

## Contribution

This study is the first systematic review and meta-analysis evaluating the effectiveness and safety of digital therapeutics in anticoagulation management.

## Key findings

- Digital therapeutics interventions were associated with a lower incidence of major bleeding compared to usual care.
- There were no significant differences in time in therapeutic range, thromboembolic events, or mortality between groups.
- Digital therapeutics increased international normalized ratio testing frequency but did not reduce rehospitalization rates.

## Abstract

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.

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.

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.

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.

PROSPERO Identifier: CRD420251107441.