e-Health-based management of patients receiving oral anticoagulation therapy: results from the observational thrombEVAL study

J. H. Prochaska, S. Goebel, K. Keller, M. Coldewey, A. Ullmann, H. Lamparter, A. Schulz, H. Schinzel, C. Bickel, M. Lauterbach, M. Michal, R. Hardt, H. Binder, C. Espinola-Klein, K. J. Lackner, H. Ten Cate, T. Muenzel, P. S. Wild*

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review


Background: Management of oral anticoagulation (OAC) therapy is essential to minimize adverse events in patients receiving vitamin K-antagonists (VKAs). Data on the effect of e-health-based anticoagulation management systems on the clinical outcome of OAC patients are limited. Objectives: To compare the clinical outcome of OAC patients managed by an e-health-based coagulation service (CS) with that of patients receiving regular medical care (RMC). Methods: The prospective multicenter cohort study thrombEVAL (NCT01809015) comprised 1558 individuals receiving RMC and 760 individuals managed by a CS. Independent study monitoring and adjudication of endpoints by an independent review panel were implemented. Results: The primary study endpoint (composite of thromboembolism, clinically relevant bleeding and death) occurred in 15.7 per 100 patient-years (py) with RMC and in 7.0 per 100 py with the CS (rate ratio [RR], 2.3; 95% confidence interval [CI], 1.7-3.1). Rates for major and clinically relevant bleeding were higher with RMC than with the CS: 6.8 vs. 2.6 and 10.1 vs. 3.6 per 100 py, respectively. Thromboembolic events showed an RR of 1.5 (95% CI, 0.8-2.6) comparing RMC with the CS. Hospitalization (RR, 2.6; 95% CI, 2.3-3.0) and all-cause mortality (RR, 4.6; 95% CI, 2.8-7.7) were markedly more frequent with RMC. In Cox regression analysis with adjustment for age, sex, cardiovascular risk factors, comorbidities, treatment characteristics and sociodemographic status, hazard ratios (HR) for the primary endpoint (HR, 2.2; 95% CI, 1.5-3.4), clinically relevant bleeding (HR, 3.1; 95% CI, 1.7-5.5), hospitalization (HR, 2.2; 95% CI, 1.8-2.8) and all-cause mortality (HR, 5.6; 95% CI, 2.9-11.0) favored CS treatment. Conclusions: In this study, e-health-based management of OAC therapy was associated with a lower frequency of OAC-specific and non-specific adverse events.

Original languageEnglish
Pages (from-to)1375-1385
Number of pages11
JournalJournal of Thrombosis and Haemostasis
Issue number7
Publication statusPublished - Jul 2017


  • anticoagulants
  • delivery of healthcare
  • epidemiology
  • patient outcome assessment
  • telemedicine

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