Are digital therapeutics effective in oral anticoagulation management?

Introduction: Oral anticoagulation self-management is often challenging. Digital therapeutics (DTx) refers to evidence-based, digital health interventions that could support management of long-term anticoagulants. This review investigates the effects of DTx intervention in anticoagulation management compared to usual care through a meta-analysis. Methods: We searched four databases for randomized controlled trials (RCTs) from inception to June 20, 2025. Time in therapeutic range (TTR), major bleeding, thromboembolic events (TEE), mortality, rehospitalization, frequency of testing were assessed. Results were pooled using random effect models. Results: In total, 11 RCTs are included (n=7277 patients) and classified as moderate risk of bias by the Cochrane tool. DTx significantly improved TTR (95% CI 3.51-17.51, P=0.003; I2=93%) and frequency of testing (95%CI 2.57-6.94, P<0.001; I2=90%), and resulted in lower incidence of major bleeding (RR 0.47, 95% CI 0.29-0.76, P=0.002; I2=12%). Thromboembolic events and rehospitalization were reduced in DTx group, but the results were not statistically significant. Subgroup analysis revealed that mobile app-based DTx reduced mortality risk (RR 0.31, 95% CI 0.17–0.56; P= 0.0001), whereas web based DTx showed no benefit. Conclusion: DTx can be potentially useful for improving TTR and anticoagulation management process. While DTx showed insignificant impact on TEE and rehospitalization, this likely stems from TEE’s low incidence and rehospitalization's multifactorial factors beyond anticoagulation management. More large-size long-term trials are needed to validate the DTx integrated care strategy in the comprehensive management of chronic diseases, and further exploration of cost-effectiveness and optimal intervention modalities is warranted.