{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T17:39:08Z","timestamp":1791567548031,"version":"4.3.4"},"reference-count":29,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"4","license":[{"start":{"date-parts":[[2023,1,24]],"date-time":"2023-01-24T00:00:00Z","timestamp":1674518400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"name":"BMS and Pfizer","award":["N\/A"],"award-info":[{"award-number":["N\/A"]}]}],"content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["Circulation"],"published-print":{"date-parts":[[2023,1,24]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Non\u2013vitamin K oral anticoagulants have become the standard therapy for preventing stroke and ischemic thromboembolism in most patients with atrial fibrillation (AF). The effectiveness and safety of non\u2013vitamin K oral anticoagulants in patients on hemodialysis is not well known.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>From June 2017 through May 2022, AXADIA\u2013AFNET 8 (Compare Apixaban and Vitamin K Antagonists in Patients With Atrial Fibrillation and End-Stage Kidney Disease), an investigator-initiated PROBE (prospective randomized open blinded end point) outcome assessment trial, randomized patients with AF on chronic hemodialysis to either apixaban (2.5 mg BID) or the vitamin K antagonist (VKA) phenprocoumon (international normalized ratio, 2.0 to 3.0). The composite primary safety outcome was defined by a first event of major bleeding, clinically relevant nonmajor bleeding, or all-cause death. The primary efficacy outcome was a composite of ischemic stroke, all-cause death, myocardial infarction, and deep vein thrombosis or pulmonary embolism. Our hypothesis was that apixaban is noninferior to VKA.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>\n                      Thirty-nine sites randomized 97 patients (30% women; mean age 75 years; mean CHA\n                      <jats:sub>2<\/jats:sub>\n                      DS\n                      <jats:sub>2<\/jats:sub>\n                      -VASc [congestive heart failure, hypertension, age \u226575 years, diabetes, stroke or transient ischemic attack, vascular disease, age 65 to 74 years, female sex] score, 4.5; baseline characteristics balanced between groups): 48 to apixaban and 49 to VKA. The median follow-up time was 429 days (range, 37 to 1370) versus 506 days (range, 101 to 1379), respectively. Adherence to apixaban was &gt;80% in 44 of 48 patients; the median time in therapeutic range on VKA was 50.7%. Composite primary safety outcome events occurred in 22 patients (45.8%) on apixaban and in 25 patients (51.0%) on VKA (hazard ratio, 0.93 [95% CI, 0.53\u20131.65];\n                      <jats:italic>P<\/jats:italic>\n                      <jats:sub>noninferiority<\/jats:sub>\n                      =0.157). Composite primary efficacy outcome events occurred in 10 patients (20.8%) on apixaban and in 15 patients (30.6%) on VKA (\n                      <jats:italic>P<\/jats:italic>\n                      =0.51; log rank). There were no significant differences regarding individual outcomes (all-cause mortality, 18.8% versus 24.5%; major bleeding, 10.4% versus 12.2%; and myocardial infarction, 4.2% versus 6.1%, respectively).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>In this randomized trial comparing apixaban and VKA in patients with AF on hemodialysis with long follow-up, no differences were observed in safety or efficacy outcomes. Even on oral anticoagulation, patients with AF on hemodialysis remain at high risk of cardiovascular events. Larger randomized trials are needed to determine the optimal anticoagulation regimen for patients with AF on hemodialysis.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Registration:<\/jats:title>\n                    <jats:p>\n                      URL:\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.clinicaltrials.gov\">https:\/\/www.clinicaltrials.gov<\/jats:ext-link>\n                      ; Unique identifier: NCT02933697.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1161\/circulationaha.122.062779","type":"journal-article","created":{"date-parts":[[2022,11,6]],"date-time":"2022-11-06T18:20:07Z","timestamp":1667758807000},"page":"296-309","update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":185,"title":["A Randomized Controlled Trial Comparing Apixaban With the Vitamin K Antagonist Phenprocoumon in Patients on Chronic Hemodialysis: The AXADIA-AFNET 8 Study"],"prefix":"10.1161","volume":"147","clinical-trial-number":[{"clinical-trial-number":"nct02933697","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Holger","family":"Reinecke","sequence":"first","affiliation":[{"name":"Klinik f\u00fcr Kardiologie I: Koronare Herzkrankheit, Herzinsuffizienz und Angiologie (H.R., C.E., G.B.), Universitaetsklinikum Muenster, Germany."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christiane","family":"Engelbertz","sequence":"additional","affiliation":[{"name":"Klinik f\u00fcr Kardiologie I: Koronare Herzkrankheit, Herzinsuffizienz und Angiologie (H.R., C.E., G.B.), Universitaetsklinikum Muenster, Germany."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rupert","family":"Bauersachs","sequence":"additional","affiliation":[{"name":"CCB-Cardioangiologic Center Bethanien, Frankfurt, Germany (R.B.)."},{"name":"Center of Thrombosis and Hemostasis, University of Mainz, Germany (R.B.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"G\u00fcnter","family":"Breithardt","sequence":"additional","affiliation":[{"name":"Klinik f\u00fcr Kardiologie I: Koronare Herzkrankheit, Herzinsuffizienz und Angiologie (H.R., C.E., G.B.), Universitaetsklinikum Muenster, Germany."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hans-Herbert","family":"Echterhoff","sequence":"additional","affiliation":[{"name":"Dialysezentrum Bielefeld, Germany (H.-H.E.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joachim","family":"Ger\u00df","sequence":"additional","affiliation":[{"name":"Institut f\u00fcr Biometrie und Klinische Forschung, Westfaelische Wilhelms-Universitaet, Muenster, Germany (J.G., D.G.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karl Georg","family":"Haeusler","sequence":"additional","affiliation":[{"name":"Department of Neurology, Universit\u00e4tsklinikum W\u00fcrzburg, Germany (K.G.H.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bernd","family":"Hewing","sequence":"additional","affiliation":[{"name":"Klinik f\u00fcr Kardiologie III: Angeborene Herzfehler (EMAH) und Klappenerkrankungen (B.H.), Universitaetsklinikum Muenster, Germany."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joachim","family":"Hoyer","sequence":"additional","affiliation":[{"name":"Klinik f\u00fcr Innere Medizin und Nephrologie, Philipps-Universitaet Marburg, Germany (J.H.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sabine","family":"Juergensmeyer","sequence":"additional","affiliation":[{"name":"Kompetenznetz Vorhofflimmern eV, AFNET, Muenster, Germany (S.J., P.K.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Klingenheben","sequence":"additional","affiliation":[{"name":"Praxis f\u00fcr Kardiologie, Bonn, Germany (T.K.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Guido","family":"Knapp","sequence":"additional","affiliation":[{"name":"Fakultaet Statistik, Technische Universitaet Dortmund, Germany (G.K.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lars","family":"Christian Rump","sequence":"additional","affiliation":[{"name":"Department of Nephrology, Medical Faculty, University Hospital Duesseldorf, Heinrich-Heine-University Duesseldorf, Germany (L.C.R.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hans","family":"Schmidt-Guertler","sequence":"additional","affiliation":[{"name":"Zentrum f\u00fcr Nieren-, Hochdruck und Stoffwechselerkrankungen, Hannover, Germany (H.S.-G.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christoph","family":"Wanner","sequence":"additional","affiliation":[{"name":"Department Klinische Forschung &amp; Epidemiologie, Deutsches Zentrums f\u00fcr Herzinsuffizienz and Division of Nephrology, University Hospital, W\u00fcrzburg, Germany (C.W.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paulus","family":"Kirchhof","sequence":"additional","affiliation":[{"name":"Kompetenznetz Vorhofflimmern eV, AFNET, Muenster, Germany (S.J., P.K.)."},{"name":"Department of Cardiology, University Heart and Vascular Center Hamburg, University Medical Center Hamburg-Eppendorf, Germany (P.K.)."},{"name":"German Center for Cardiovascular Research (DZHK), Partner Site Hamburg\/Kiel\/L\u00fcbeck, Germany (P.K.)."},{"name":"Institute of Cardiovascular Sciences, University of Birmingham, UK (P.K.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dennis","family":"Goerlich","sequence":"additional","affiliation":[{"name":"Institut f\u00fcr Biometrie und Klinische Forschung, Westfaelische Wilhelms-Universitaet, Muenster, Germany (J.G., D.G.)."}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehaa612"},{"key":"e_1_3_3_3_2","doi-asserted-by":"publisher","DOI":"10.1093\/europace\/euab065"},{"key":"e_1_3_3_4_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1300615"},{"key":"e_1_3_3_5_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2209051"},{"key":"e_1_3_3_6_2","doi-asserted-by":"publisher","DOI":"10.1681\/ASN.2007111207"},{"key":"e_1_3_3_7_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1105594"},{"key":"e_1_3_3_8_2","doi-asserted-by":"publisher","DOI":"10.1161\/hc1102.100075"},{"key":"e_1_3_3_9_2","doi-asserted-by":"publisher","DOI":"10.1378\/chest.09-0730"},{"key":"e_1_3_3_10_2","doi-asserted-by":"publisher","DOI":"10.2215\/CJN.04550511"},{"key":"e_1_3_3_11_2","doi-asserted-by":"publisher","DOI":"10.1152\/ajprenal.00278.2020"},{"key":"e_1_3_3_12_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMra1505292"},{"key":"e_1_3_3_13_2","doi-asserted-by":"publisher","DOI":"10.1161\/circulationaha.112.099606"},{"key":"e_1_3_3_14_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.112.123992"},{"key":"e_1_3_3_15_2","doi-asserted-by":"publisher","DOI":"10.1111\/ejh.13599"},{"key":"e_1_3_3_16_2","doi-asserted-by":"publisher","DOI":"10.1002\/rth2.12083"},{"key":"e_1_3_3_17_2","doi-asserted-by":"publisher","DOI":"10.1177\/1060028017694654"},{"key":"e_1_3_3_18_2","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2018-022690"},{"key":"e_1_3_3_19_2","doi-asserted-by":"publisher","DOI":"10.1136\/jnnp.54.12.1044"},{"key":"e_1_3_3_20_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1538-7836.2005.01204.x"},{"key":"e_1_3_3_21_2","doi-asserted-by":"publisher","DOI":"10.1093\/biomet\/68.1.316"},{"key":"e_1_3_3_22_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.118.035418"},{"key":"e_1_3_3_23_2","doi-asserted-by":"publisher","DOI":"10.1055\/s-0038-1651587"},{"key":"e_1_3_3_24_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.121.054990"},{"key":"e_1_3_3_25_2","doi-asserted-by":"publisher","DOI":"10.1681\/ASN.2020111566"},{"key":"e_1_3_3_26_2","doi-asserted-by":"publisher","DOI":"10.2215\/cjn.11650919"},{"key":"e_1_3_3_27_2","doi-asserted-by":"publisher","DOI":"10.1007\/s10557-020-07108-4"},{"key":"e_1_3_3_28_2","doi-asserted-by":"publisher","DOI":"10.1053\/j.ajkd.2022.03.007"},{"key":"e_1_3_3_29_2","doi-asserted-by":"publisher","DOI":"10.3389\/fcvm.2022.847286"},{"key":"e_1_3_3_30_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2019.10.059"}],"container-title":["Circulation"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.ahajournals.org\/doi\/full\/10.1161\/CIRCULATIONAHA.122.062779","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,5,13]],"date-time":"2024-05-13T04:18:48Z","timestamp":1715573928000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.ahajournals.org\/doi\/10.1161\/CIRCULATIONAHA.122.062779"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,1,24]]},"references-count":29,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2023,1,24]]}},"alternative-id":["10.1161\/CIRCULATIONAHA.122.062779"],"URL":"https:\/\/doi.org\/10.1161\/circulationaha.122.062779","relation":{},"ISSN":["0009-7322","1524-4539"],"issn-type":[{"value":"0009-7322","type":"print"},{"value":"1524-4539","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,1,24]]},"assertion":[{"value":"2022-10-06","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-11-02","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-11-06","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}