{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,9,11]],"date-time":"2025-09-11T19:23:06Z","timestamp":1757618586923,"version":"3.44.0"},"reference-count":15,"publisher":"Springer Science and Business Media LLC","issue":"9","license":[{"start":{"date-parts":[[2025,7,12]],"date-time":"2025-07-12T00:00:00Z","timestamp":1752278400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2025,7,12]],"date-time":"2025-07-12T00:00:00Z","timestamp":1752278400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Eur J Clin Pharmacol"],"published-print":{"date-parts":[[2025,9]]},"abstract":"<jats:title>Abstract<\/jats:title>\n          <jats:sec>\n            <jats:title>Purpose<\/jats:title>\n            <jats:p>Atrial fibrillation (AF) is common in the elderly population and is associated with a high risk of thromboembolic events. Although non-vitamin K oral anticoagulants (NOACs) are the preferred drugs in antithrombotic therapy for AF, Vitamin K Anticoagulant drug (VKA) treatment is still used in a considerable proportion of patients with AF. Moreover, recent findings revealed that switching VKA to NOAC is associated with more bleeding complications in frail older patients with AF. Standard of care (SOC) monitoring of VKA treatment consists of venous blood sampling and back office dosage advice with a chain of processes and involvement of several health care professionals. We have designed a new procedure for monitoring (Near Patient Therapeutic Monitoring \/ NPTM) in order to improve the quality and safety of VKA treatment. NPTM consists of INR measurement with a point-of-care (POC) device in the home setting of a patient, performed by one professional and with an instant dosage advice.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Methods<\/jats:title>\n            <jats:p>This is a cluster-randomised, parallel group, open label study to compare SOC with NPTM of VKA treatment in patients in a home setting. The follow-up period was one year. The primary outcome was time in therapeutic range (TTR), and secondary outcomes were adverse events (deaths, bleeding and thromboembolic events).<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Results<\/jats:title>\n            <jats:p>555 Patients were included in the study. After randomisation, 271 patients received SOC and 284 patients received NPTM. The TTR did not differ significantly: 63.71% versus 62.47% (<jats:italic>p<\/jats:italic>\u2009&gt;\u20090.05) for SOC and NPTM, respectively. Significant differences were found for all-cause death (SOC <jats:italic>n<\/jats:italic>\u2009=\u200934 versus NPTM <jats:italic>n<\/jats:italic>\u2009=\u200916, <jats:italic>p<\/jats:italic>\u2009&lt;\u20090.05, OR 0.47, 95% CI: 0.25\u20130.87), total number of minor bleedings (79 events in SOC vs 52 in NPTM, <jats:italic>p<\/jats:italic>\u2009&lt;\u20090.05, OR 64 (95%CI: 0,37\u20130,81) and all non-major bleedings (100 events in SOC vs 67 in NPTM, <jats:italic>p<\/jats:italic>\u2009&lt;\u20090.05, OR 0.62 (95% CI: 043\u20130.90).<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Conclusions<\/jats:title>\n            <jats:p>NPTM of VKA treatment in AF-patients does not result in an improved TTR when compared to SOC. All-cause death, total number of minor bleedings and all non-major bleedings may be reduced in NPTM, although the study was not powered for these secondary outcomes.<\/jats:p>\n            <jats:p>Future studies are needed to determine the cost-effectiveness of NTPM versus SOC.<\/jats:p>\n          <\/jats:sec>","DOI":"10.1007\/s00228-025-03878-8","type":"journal-article","created":{"date-parts":[[2025,7,12]],"date-time":"2025-07-12T01:04:00Z","timestamp":1752282240000},"page":"1365-1371","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Optimization of vitamin K antagonist treatment: Near patient monitoring versus standard of care a parallel group clinical trial in older patients with atrial fibrillation"],"prefix":"10.1007","volume":"81","author":[{"ORCID":"https:\/\/orcid.org\/0009-0004-9293-9441","authenticated-orcid":false,"given":"Margriet","family":"van Elp","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6533-5416","authenticated-orcid":false,"given":"Maarten","family":"Beinema","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7547-1662","authenticated-orcid":false,"given":"Jacobus R. B. J.","family":"Brouwers","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Esther","family":"van \u2019t Riet","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sjef","family":"van de Leur","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ildiko","family":"Schreiber","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2788-9578","authenticated-orcid":false,"given":"Frank G. A.","family":"Jansman","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2025,7,12]]},"reference":[{"issue":"12","key":"3878_CR1","doi-asserted-by":"publisher","first-page":"857","DOI":"10.7326\/0003-4819-146-12-200706190-00007","volume":"146","author":"RG Hart","year":"2007","unstructured":"Hart RG, Pearce LA, Aguilar MI (2007) Meta-analysis: antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation. Ann Intern Med 146(12):857\u2013867. https:\/\/doi.org\/10.7326\/0003-4819-146-12-200706190-00007","journal-title":"Ann Intern Med"},{"issue":"9921","key":"3878_CR2","doi-asserted-by":"publisher","first-page":"955","DOI":"10.1016\/S0140-6736(13)62343-0","volume":"383","author":"CT Ruff","year":"2014","unstructured":"Ruff CT, Giugliano RP, Braunwald E, Hoffman EB, Deenadayalu N, Ezekowitz MD, Camm AJ, Weitz JI, Lewis BS, Parkhomenko A, Yamashita T, Antman EM (2014) Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: a meta-analysis of randomised trials. Lancet 383(9921):955\u2013962. https:\/\/doi.org\/10.1016\/S0140-6736(13)62343-0","journal-title":"Lancet"},{"key":"3878_CR3","doi-asserted-by":"publisher","unstructured":"Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomstr\u00f6m-Lundqvist C, et al.; ESC Scientific Document Group. (2021) 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Eur Heart J 42(5):373\u2013498. https:\/\/doi.org\/10.1093\/eurheartj\/ehaa612","DOI":"10.1093\/eurheartj\/ehaa612"},{"issue":"1","key":"3878_CR4","doi-asserted-by":"publisher","first-page":"e1","DOI":"10.1161\/CIR.0000000000001193","volume":"149","author":"JA Joglar","year":"2024","unstructured":"Joglar JA, Chung MK, Armbruster AL, Benjamin EJ, Chyou JY, Cronin EM et al (2024) 2023 ACC\/AHA\/ACCP\/HRS guideline for the diagnosis and management of atrial fibrillation: A report of the American college of cardiology\/American heart association joint committee on clinical practice guidelines. Circulation 149(1):e1\u2013e156. https:\/\/doi.org\/10.1161\/CIR.0000000000001193","journal-title":"Circulation"},{"issue":"10","key":"3878_CR5","doi-asserted-by":"publisher","first-page":"1612","DOI":"10.1093\/europace\/euab065","volume":"23","author":"J Steffel","year":"2021","unstructured":"Steffel J, Collins R, Antz M, Cornu P, Desteghe L, Haeusler KG et al (2021) 2021 European heart rhythm association practical guide on the use of non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation. Europace 23(10):1612\u20131676. https:\/\/doi.org\/10.1093\/europace\/euab065","journal-title":"Europace"},{"issue":"4","key":"3878_CR6","doi-asserted-by":"publisher","first-page":"279","DOI":"10.1161\/CIRCULATIONAHA.123.066485","volume":"149","author":"LPT Joosten","year":"2024","unstructured":"Joosten LPT, van Doorn S, van de Ven PM, K\u00f6hlen BTG, Nierman MC, Koek HL et al (2024Jan 23) Safety of switching from a vitamin K antagonist to a non-vitamin K antagonist oral anticoagulant in frail older patients with atrial fibrillation: Results of the FRAIL-AF randomized controlled trial. Circulation 149(4):279\u2013289. https:\/\/doi.org\/10.1161\/CIRCULATIONAHA.123.066485","journal-title":"Circulation"},{"issue":"2","key":"3878_CR7","doi-asserted-by":"publisher","first-page":"101483","DOI":"10.1016\/j.cpcardiol.2022.101483","volume":"48","author":"S Biswas","year":"2023","unstructured":"Biswas S, Bahar Y, Bahar AR, Safiriyu I, Mathai SV, Hajra A et al (2023) Present knowledge on direct oral anticoagulant and novel oral anti coagulants and their specific antidotes: A comprehensive review article. Curr Probl Cardiol 48(2):101483. https:\/\/doi.org\/10.1016\/j.cpcardiol.2022.101483","journal-title":"Curr Probl Cardiol"},{"issue":"3","key":"3878_CR8","doi-asserted-by":"publisher","first-page":"236","DOI":"10.1055\/s-0038-1651587","volume":"69","author":"FR Rosendaal","year":"1993","unstructured":"Rosendaal FR, Cannegieter SC, van der Meer FJ, Briet E (1993) A method to determine the optimal intensity of oral anticoagulant therapy. Thromb Haemost 69(3):236\u2013239","journal-title":"Thromb Haemost"},{"issue":"15","key":"3878_CR9","doi-asserted-by":"publisher","first-page":"1909","DOI":"10.1093\/eurheartj\/ehr116","volume":"32","author":"RMF van Schie","year":"2011","unstructured":"van Schie RMF, Wessels JAM, le Cessie S, de Boer A, Schalekamp T, van der Meer FJM et al (2011) Loading and maintenance dose algorithms for phenprocoumon and acenocoumarol using patient characteristics and pharmacogenetic data. Eur Heart J 32(15):1909\u20131917. https:\/\/doi.org\/10.1093\/eurheartj\/ehr116","journal-title":"Eur Heart J"},{"issue":"1","key":"3878_CR10","doi-asserted-by":"publisher","first-page":"166","DOI":"10.1186\/s12872-020-01448-7","volume":"20","author":"M Corrochano","year":"2020","unstructured":"Corrochano M, Jimenez B, Millon J, Gich I, Rambla M, Gil E et al (2020) Patient self-management of oral anticoagulation with vitamin K antagonists in everyday practice: clinical outcomes in a single centre cohort after long-term follow-up. BMC Cardiovasc Disord 20(1):166\u2013167. https:\/\/doi.org\/10.1186\/s12872-020-01448-7","journal-title":"BMC Cardiovasc Disord"},{"issue":"3","key":"3878_CR11","doi-asserted-by":"publisher","first-page":"479","DOI":"10.1111\/jth.13240","volume":"14","author":"MJ Beinema","year":"2016","unstructured":"Beinema MJ, van der Meer FJ, Brouwers JR, Rosendaal FR (2016) Optimization of vitamin K antagonist drug dose finding by replacement of the international normalized ratio by a bidirectional factor: validation of a new algorithm. J Thromb Haemost 14(3):479\u2013484. https:\/\/doi.org\/10.1111\/jth.13240","journal-title":"J Thromb Haemost"},{"key":"3878_CR12","doi-asserted-by":"publisher","unstructured":"Schulman S, Kearon C; Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. (2005) Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost 3(4):692\u20134. https:\/\/doi.org\/10.1111\/j.1538-7836.2005.01204.x","DOI":"10.1111\/j.1538-7836.2005.01204.x"},{"key":"3878_CR13","doi-asserted-by":"publisher","unstructured":"Kaatz S, Ahmad D, Spyropoulos AC, Schulman S; Subcommittee on Control of Anticoagulation. (2015) Definition of clinically relevant non-major bleeding in studies of anticoagulants in atrial fibrillation and venous thromboembolic disease in non-surgical patients: communication from the SSC of the ISTH. J Thromb Haemost. 13(11):2119\u201326. https:\/\/doi.org\/10.1111\/jth.13140.","DOI":"10.1111\/jth.13140"},{"key":"3878_CR14","doi-asserted-by":"publisher","unstructured":"van den Dries CJ, van Doorn S, Rutten FH, Oudega R, van de Leur, Sjef J C M, Elvan A, et al. (2020) Integrated management of atrial fibrillation in primary care: results of the ALL-IN cluster randomized trial. Eur Heart J 41(30):2836\u20132844. https:\/\/doi.org\/10.1093\/eurheartj\/ehaa055.","DOI":"10.1093\/eurheartj\/ehaa055"},{"key":"3878_CR15","doi-asserted-by":"publisher","unstructured":"Hendriks JM, de Wit R, Crijns HJ, Vrijhoef HJ, Prins MH, Pisters R, et al. (2012) Nurse-led care vs. usual care for patients with atrial fibrillation: results of a randomized trial of integrated chronic care vs. routine clinical care in ambulatory patients with atrial fibrillation. Eur Heart J. 33(21):2692\u20139. https:\/\/doi.org\/10.1093\/eurheartj\/ehs071.","DOI":"10.1093\/eurheartj\/ehs071"}],"container-title":["European Journal of Clinical Pharmacology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s00228-025-03878-8.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s00228-025-03878-8\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s00228-025-03878-8.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,9,7]],"date-time":"2025-09-07T06:03:57Z","timestamp":1757225037000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s00228-025-03878-8"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,7,12]]},"references-count":15,"journal-issue":{"issue":"9","published-print":{"date-parts":[[2025,9]]}},"alternative-id":["3878"],"URL":"https:\/\/doi.org\/10.1007\/s00228-025-03878-8","relation":{},"ISSN":["0031-6970","1432-1041"],"issn-type":[{"type":"print","value":"0031-6970"},{"type":"electronic","value":"1432-1041"}],"subject":[],"published":{"date-parts":[[2025,7,12]]},"assertion":[{"value":"28 August 2024","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"4 July 2025","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"12 July 2025","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Approved by the independent Institutional Review Board Isala Hospital at Zwolle (The Netherlands) and complies with the Dutch Medical Ethical Trial Guidelines.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Approval Committee or the Internal Review Board (IRB) in the Ethics Approval declaration in the manuscript"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Human ethics and consent to participate"}},{"value":"Every participant provided their informed consent.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"The authors declare no conflicts of interest.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}]}}