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

Essentials e‐Health based health care by an expert centre may advance management of oral anticoagulation. Outcome of patients was compared between an e‐health based coagulation service and regular care. Patients in the coagulation service cohort experienced a significantly better clinical outcome. L...

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Bibliographic Details
Published in:Journal of thrombosis and haemostasis 2017-07, Vol.15 (7), p.1375-1385
Main Authors: Prochaska, J. H., Göbel, S., Keller, K., Coldewey, M., Ullmann, A., Lamparter, H., Schulz, A., Schinzel, H., Bickel, C., Lauterbach, M., Michal, M., Hardt, R., Binder, H., Espinola‐Klein, C., Lackner, K. J., ten Cate, H., Münzel, T., Wild, P. S.
Format: Article
Language:English
Subjects:
Administration, Oral
Age
Aged
Aged, 80 and over
Antagonists
anticoagulants
Anticoagulants - administration & dosage
Bleeding
Blood Coagulation - drug effects
Cardiovascular diseases
Clinical outcomes
Coagulation
Comorbidity
Death
delivery of healthcare
epidemiology
Female
Follow-Up Studies
Germany
Health risk assessment
Hemorrhage
Hospitalization
Humans
International Normalized Ratio
Male
Middle Aged
Mortality
patient outcome assessment
Patient Safety
Proportional Hazards Models
Prospective Studies
Risk Factors
Telemedicine
Thromboembolism
Thromboembolism - drug therapy
Treatment Outcome
Vitamin K
Vitamin K - antagonists & inhibitors
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Summary:Essentials e‐Health based health care by an expert centre may advance management of oral anticoagulation. Outcome of patients was compared between an e‐health based coagulation service and regular care. Patients in the coagulation service cohort experienced a significantly better clinical outcome. Lower risk for adverse events was related to anticoagulation‐specific and non‐specific outcome. Summary 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.
ISSN:1538-7933
1538-7836
1538-7836
DOI:10.1111/jth.13727