Evaluation of Oral Anticoagulation With Vitamin K Antagonists - The thrombEVAL Study Programme

Conditions

Anticoagulant Antagonists, Vitamin K and Other Coagulants Causing Adverse Effects in Therapeutic Use, Atrial Fibrillation, Venous Thromboembolism

Keywords

Oral Anticoagulation, Regular Medical Care, Coagulation Service, Vitamin-K Antagonists, Quality of therapy, Atrial fibrillation, Venous thromboembolism, Bypass surgery, Prosthetic heart valve

Brief summary

Since decades, oral anticoagulation (OAC) with vitamin K antagonists (VKA) is an established therapy for both prevention and treatment of thromboembolism in daily clinical routine. Increasing life-expectancy, the demographic change and novel oral anticoagulants lead to an increasing complexity of medical therapy. However, data on quality and management of VKA therapy with phenprocoumon in current medical care are limited. Our aim was to investigate the quality of OAC with VKA in current health care and to evaluate the potential for improvements. The investigator-initiated thrombEVAL study program comprises two cohorts of patients treated with vitamin K antagonists for oral anticoagulation therapy in real-life settings: a multicentre cohort of patients in regular medical care and a multi-local, single centre cohort of patients in a telemedicine-based coagulation service. The study program is expected to enrol a total number of approximately 2,000 to 2,500 patients. Both cohorts build on a detailed clinical assessment of participants and anticoagulation therapy at study enrolment. Subsequently active and passive follow-up investigations are carried out to document and validate complications of the treatment. Primary short-term outcome is the distribution of time in therapeutic range; the primary long-term outcome comprises the composite of stroke, systemic embolism, myocardial infarction, major and clinically-relevant bleeding and death.

Karsten Keller, Jürgen H. Prochaska, Meike Coldewey, Sebastian Göbel, Volker H. Schmitt et al. (12 authors)

Life2022-05-145 citations

10.3390/life12050734

Cost saving analysis of specialized, eHealth-based management of patients receiving oral anticoagulation therapy: Results from the thrombEVAL study.

Eggebrecht L, Ludolph P, Göbel S, Panova-Noeva M, Arnold N, Nagler M, Bickel C, Lauterbach M, Hardt R, Cate HT, Lackner KJ, Espinola-Klein C, Münzel T, Prochaska JH, Wild PS.

2021-01-284 citations

10.1038/s41598-021-82076-9

Telemedicine-Based Specialized Care Improves the Outcome of Anticoagulated Individuals with Venous Thromboembolism—Results from the thrombEVAL Study

Karsten Keller, Sebastian Göbel, Vincent ten Cate, Marina Panova‐Noeva, Lisa Eggebrecht et al. (16 authors)

Journal of Clinical Medicine2020-10-138 citations

10.3390/jcm9103281

Specialized Management of Oral Anticoagulation Therapy Improves Outcome in Patients with Chronic Renal Insufficiency

Michael Lauterbach, Eduard Uhrich, Lisa Eggebrecht, Sebastian Göbel, Marina Panova‐Noeva et al. (12 authors)

Journal of Clinical Medicine2020-02-282 citations

10.3390/jcm9030645

The relevance of depressive symptoms for the outcome of patients receiving vitamin K antagonists: results from the thrombEVAL cohort study

Matthias Michal, Lisa Eggebrecht, Sebastian Göbel, Marina Panova‐Noeva, Markus Nagler et al. (13 authors)

European Heart Journal - Cardiovascular Pharmacotherapy2020-01-064 citations

10.1093/ehjcvp/pvz085

Subtherapeutic Anticoagulation Control under Treatment with Vitamin K-Antagonists—Data from a Specialized Coagulation Service

Jürgen H. Prochaska, Christoph Hausner, Markus Nagler, Sebastian Göbel, Lisa Eggebrecht et al. (15 authors)

Thrombosis and Haemostasis2019-06-1011 citations

10.1055/s-0039-1692175

Management of Oral Anti-Coagulation in Patients with Heart Failure—Insights from the ThrombEVAL Study

Sebastian Göbel, Jürgen H. Prochaska, Lisa Eggebrecht, Ronja Schmitz, Claus Jünger et al. (19 authors)

Thrombosis and Haemostasis2018-10-241 citations

10.1055/s-0038-1673380

Sustained atrial fibrillation increases the risk of anticoagulation-related bleeding in heart failure.

Prochaska JH, Göbel S, Nagler M, Knöpfler T, Eggebrecht L, Lamparter H, Panova-Noeva M, Keller K, Coldewey M, Bickel C, Lauterbach M, Hardt R, Espinola-Klein C, Ten Cate H, Rostock T, Münzel T, Wild PS.

2018-06-096 citations

10.1007/s00392-018-1293-4

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

Prochaska JH, 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 KJ, Ten Cate H, Münzel T, Wild PS.

2017-06-068 citations

10.1111/jth.13727

History of deep vein thrombosis is a discriminator for concomitant atrial fibrillation in pulmonary embolism.

Keller K, Prochaska JH, Coldewey M, Gobel S, Ullmann A, Jünger C, Lamparter H, Ariza L, Bickel C, Lauterbach M, Konstantinides S, Rostock T, Münzel T, Wild PS.

2015-09-0328 citations

10.1016/j.thromres.2015.08.024

Quality of oral anticoagulation with phenprocoumon in regular medical care and its potential for improvement in a telemedicine-based coagulation service--results from the prospective, multi-center, observational cohort study thrombEVAL.

Prochaska JH, Göbel S, Keller K, Coldewey M, Ullmann A, Lamparter H, Jünger C, Al-Bayati Z, Baer C, Walter U, Bickel C, ten Cate H, Münzel T, Wild PS.

2015-01-2334 citations

10.1186/s12916-015-0268-9

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

1. Age ≥ 18 years of age at study inclusion 2. Written informed consent by patient or legal guardian, if appointed 3. Cohort A: Pretreatment with oral anticoagulation therapy with vitamin K antagonists (VKA) for at least 4 months in regular medical care including patients with self-management of oral anticoagulation therapy 4. Cohort B: Indication for oral anticoagulation therapy with VKA for at least 3 months (both drug-naive and -experienced patients) at enrolment including patients with self-management of oral anticoagulation therapy.

Exclusion criteria

1. Contraindication to VKA treatment, e.g. pregnancy or known hypersensitivity 2. Participation in other clinical trial

Design outcomes

Primary

Measure	Time frame	Description
Hospitalisation	Assessment at year 1 and 2 after study enrolment	Any Hospitalisation
Time in therapeutic range	Assessment during Year 1 after study enrolment	Time in therapeutic range for the International Normalized Ratio as measured by linear interpolation method
Net clinical benefit	Assessment at year 1 and 2	Composite of stroke, systemic embolism, pulmonary embolism, myocardial infarction, major and clinically relevant, non-major bleeding and death

Countries

Germany

Outcome results