Universität zu Köln

Hohmann, Christopher, Lutz, Magnus, Vignali, Sheila, Borchert, Kathrin, Seidel, Karolin, Braun, Sebastian, Baldus, Stephan and Naebauer, Michael (2022). Clinical outcomes in patients receiving edoxaban or phenprocoumon for prevention of stroke in atrial fibrillation: a German real-world cohort study. Thromb. J., 20 (1). LONDON: BMC. ISSN 1477-9560

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Abstract

Background Appropriate and timely anticoagulant therapy with vitamin K antagonists (VKAs) or non-vitamin K oral antagonists (NOACs) is essential for stroke prevention in non-valvular atrial fibrillation (NVAF). Comparative data regarding effectiveness and safety for edoxaban vs phenprocoumon, the predominant VKA in Germany, are scarce. Objectives The study evaluates effectiveness and safety of edoxaban vs phenprocoumon in NVAF patients in a German real-world setting. Methods German statutory health insurance claims data of the Institute for Applied Health Research Berlin (InGef) Research Database from 2014 until 2019 were analyzed. In NVAF patients, new users of edoxaban and phenprocoumon were compared to assess effectiveness (stroke/systemic embolism (SE)) and safety (bleeding) during therapy. Hazard ratios (HR) were estimated through multiple outcome-specific cox proportional hazard models adjusting for baseline characteristics. Outcomes of geriatric patients were analyzed in subgroup analyses. Results Between 2015 and 2018, 7,975 and 13,319 NVAF patients newly initiated treatment with edoxaban or phenprocoumon. After adjusting for baseline confounders, the risk of stroke/SE (HR: 0.85, 95% CI: 0.70-1.02) was numerically but not significantly lower, while the risk of major bleeding (HR: 0.69, 95% CI: 0.58-0.81) was significantly lower for edoxaban. In the geriatric subgroups, homogenous results compared to the main analysis were obtained. Conclusion The results of this real-world analysis indicated better effectiveness and safety outcomes in patients with NVAF initiating edoxaban treatment compared to phenprocoumon. The findings confirm that the beneficial effects observed in the pivotal ENGAGE AF-TMI 48 trial can also be achieved in real-world use of edoxaban.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Hohmann, Christopher UNSPECIFIED UNSPECIFIED UNSPECIFIED Lutz, Magnus UNSPECIFIED UNSPECIFIED UNSPECIFIED Vignali, Sheila UNSPECIFIED UNSPECIFIED UNSPECIFIED Borchert, Kathrin UNSPECIFIED UNSPECIFIED UNSPECIFIED Seidel, Karolin UNSPECIFIED UNSPECIFIED UNSPECIFIED Braun, Sebastian UNSPECIFIED UNSPECIFIED UNSPECIFIED Baldus, Stephan UNSPECIFIED UNSPECIFIED UNSPECIFIED Naebauer, Michael UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-678350
DOI:	10.1186/s12959-022-00395-x
Journal or Publication Title:	Thromb. J.
Volume:	20
Number:	1
Date:	2022
Publisher:	BMC
Place of Publication:	LONDON
ISSN:	1477-9560
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language ORAL ANTICOAGULANTS; RISK-FACTOR; WARFARIN; SAFETY; PREVALENCE; ICD-9-CM Multiple languages Hematology; Peripheral Vascular Disease Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/67835