J H Prochaska1,2,3,4, S Göbel1,3,4, K Keller2,3, M Coldewey1,2,3, A Ullmann2,5, H Lamparter2,6, A Schulz1,3, H Schinzel2, C Bickel7, M Lauterbach8, M Michal3,9, R Hardt10, H Binder3,11, C Espinola-Klein1,3, K J Lackner3,4,12, H Ten Cate2,13, T Münzel1,2,3,4, P S Wild2,3,4,6. 1. Center for Cardiology - Cardiology I, University Medical Center Mainz, Johannes Gutenberg University, Mainz, Germany. 2. Center for Thrombosis and Hemostasis, University Medical Center Mainz, Johannes Gutenberg University, Mainz, Germany. 3. Center for Translational Vascular Biology (CTVB), University Medical Center Mainz, Johannes Gutenberg University, Mainz, Germany. 4. German Center for Cardiovascular Research (DZHK), Partner Site Rhein-Main, Mainz, Germany. 5. Chrestos Concept GmbH, Ratingen, Germany. 6. Preventive Cardiology and Preventive Medicine, Center for Cardiology, University Medical Center Mainz, Johannes Gutenberg University, Mainz, Germany. 7. Department of Medicine I, Federal Armed Forces Central Hospital, Koblenz, Germany. 8. Department of Medicine 3, Barmherzige Brüder Hospital, Trier, Germany. 9. Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Mainz, Johannes Gutenberg University, Mainz, Germany. 10. Center for General Medicine and Geriatrics, University Medical Center Mainz, Johannes Gutenberg University, Mainz, Germany. 11. Institute for Medical Biostatistics, Epidemiology and Informatics, University Medical Center Mainz, Johannes Gutenberg University, Mainz, Germany. 12. Institute of Clinical Chemistry and Laboratory Medicine, University Medical Center Mainz, Johannes Gutenberg University, Mainz, Germany. 13. Thrombosis Expertise Center Maastricht, Cardiovascular Research Institute Maastricht and Maastricht University Medical Center, Maastricht, the Netherlands.
Abstract
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.
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 OACpatients are limited. Objectives To compare the clinical outcome of OACpatients 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.
Authors: Jürgen H Prochaska; Sebastian Göbel; Markus Nagler; Torben Knöpfler; Lisa Eggebrecht; Heidrun Lamparter; Marina Panova-Noeva; Karsten Keller; Meike Coldewey; Christoph Bickel; Michael Lauterbach; Roland Hardt; Christine Espinola-Klein; Hugo Ten Cate; Thomas Rostock; Thomas Münzel; Philipp S Wild Journal: Clin Res Cardiol Date: 2018-06-09 Impact factor: 5.460
Authors: Lisa Eggebrecht; Paul Ludolph; Jürgen H Prochaska; Philipp S Wild; Sebastian Göbel; Marina Panova-Noeva; Natalie Arnold; Markus Nagler; Christoph Bickel; Michael Lauterbach; Roland Hardt; Hugo Ten Cate; Karl J Lackner; Christine Espinola-Klein; Thomas Münzel Journal: Sci Rep Date: 2021-01-28 Impact factor: 4.379