TY - JOUR
T1 - e-Health-based management of patients receiving oral anticoagulation therapy
T2 - results from the observational thrombEVAL study
AU - Prochaska, J. H.
AU - Goebel, S.
AU - Keller, K.
AU - Coldewey, M.
AU - Ullmann, A.
AU - Lamparter, H.
AU - Schulz, A.
AU - Schinzel, H.
AU - Bickel, C.
AU - Lauterbach, M.
AU - Michal, M.
AU - Hardt, R.
AU - Binder, H.
AU - Espinola-Klein, C.
AU - Lackner, K. J.
AU - Ten Cate, H.
AU - Muenzel, T.
AU - Wild, P. S.
PY - 2017/7
Y1 - 2017/7
N2 - 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.
AB - 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.
KW - anticoagulants
KW - delivery of healthcare
KW - epidemiology
KW - patient outcome assessment
KW - telemedicine
KW - NONVALVULAR ATRIAL-FIBRILLATION
KW - USUAL MEDICAL-CARE
KW - STROKE PREVENTION
KW - WARFARIN
KW - DABIGATRAN
KW - OUTCOMES
KW - QUALITY
KW - SERVICE
KW - METAANALYSIS
KW - RIVAROXABAN
U2 - 10.1111/jth.13727
DO - 10.1111/jth.13727
M3 - Article
C2 - 28457013
SN - 1538-7933
VL - 15
SP - 1375
EP - 1385
JO - Journal of Thrombosis and Haemostasis
JF - Journal of Thrombosis and Haemostasis
IS - 7
ER -