Premium
e‐Health‐based management of patients receiving oral anticoagulation therapy: results from the observational thromb EVAL study
Author(s) -
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.,
EspinolaKlein C.,
Lackner K. J.,
ten Cate H.,
Münzel T.,
Wild P. S.
Publication year - 2017
Publication title -
journal of thrombosis and haemostasis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.947
H-Index - 178
eISSN - 1538-7836
pISSN - 1538-7933
DOI - 10.1111/jth.13727
Subject(s) - medicine , confidence interval , observational study , cohort study , managed care , adverse effect , prospective cohort study , clinical endpoint , cohort , relative risk , emergency medicine , pediatrics , intensive care medicine , health care , clinical trial , economics , economic growth
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 ( VKA s). 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 thromb EVAL ( NCT 01809015) 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.