{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,24]],"date-time":"2026-10-24T14:38:35Z","timestamp":1792852715924,"version":"4.5.0"},"reference-count":15,"publisher":"American Medical Association (AMA)","issue":"11","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Cardiol"],"published-print":{"date-parts":[[2025,11,1]]},"abstract":"<jats:sec id=\"ab-hbr250016-4\">\n                    <jats:title>Importance<\/jats:title>\n                    <jats:p>Chronic kidney disease is common in patients with atrial fibrillation (AF) and is associated with higher rates of bleeding with anticoagulation. In the AZALEA-TIMI 71 randomized clinical trial, abelacimab, a novel factor XI inhibitor, reduced rates of major or clinically relevant nonmajor (CRNM) bleeding compared with rivaroxaban in patients with AF.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"ab-hbr250016-5\">\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To examine the safety of abelacimab vs rivaroxaban across a range of kidney function.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"ab-hbr250016-6\">\n                    <jats:title>Design, Setting, and Participants<\/jats:title>\n                    <jats:p>The AZALEA-TIMI 71 study randomized patients with AF to 1 of 2 abelacimab doses (150 mg or 90 mg monthly) or to rivaroxaban, with stratification by creatinine clearance (CrCl). Patients with CrCl less than 15 mL\/min or receiving dialysis were excluded. This secondary analysis of AZALEA-TIMI 71 examines outcomes by randomized treatment and CrCl at randomization.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"ab-hbr250016-7\">\n                    <jats:title>Intervention<\/jats:title>\n                    <jats:p>Patients randomized to rivaroxaban with a CrCl greater than 50 mL\/min received rivaroxaban, 20 mg, daily, and those with a CrCl of 50 mL\/min or less received rivaroxaban, 15 mg, daily. Patients randomized to abelacimab received the assigned dose irrespective of CrCl.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"ab-hbr250016-8\">\n                    <jats:title>Main Outcomes and Measure<\/jats:title>\n                    <jats:p>The primary outcome was major bleeding or CRNM bleeding.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"ab-hbr250016-9\">\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Among 1284 patients, median (IQR) age was 74 (69-78) years and 572 patients (44.5%) were female. Median (IQR) CrCl was 71 (54-90) mL\/min, with 264 patients (20.6%) having a CrCl of 50 mL\/min or less. In the rivaroxaban group, patients with CrCl of 50 mL\/min or less experienced higher rates of major or CRNM bleeding compared with those with CrCl greater than 50 mL\/min despite dose reduction (incidence rates, 13.6 vs 7.0 per 100 person-years). Abelacimab reduced major or CRNM bleeding vs rivaroxaban irrespective of CrCl (CrCl \u226450 mL\/min: hazard ratio [HR], 0.26; 95% CI, 0.12-0.54; &amp;amp;gt;50 mL\/min: HR, 0.40; 95% CI, 0.26-0.62;\n                      <jats:italic>P<\/jats:italic>\n                      value for interaction\u2009=\u2009.33), with absolute risk reductions of 10.1 vs 4.2 per 100 person-years in those with CrCl of 50 mL\/min or less vs greater than 50 mL\/min, respectively (\n                      <jats:italic>P<\/jats:italic>\n                      value for interaction\u2009=\u2009.09). This risk reduction was consistent for major bleeding alone and for a broader composite inclusive of major, CRNM, and minor bleeding. Results were similar when comparing the individual abelacimab doses to rivaroxaban.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"ab-hbr250016-10\">\n                    <jats:title>Conclusions and Relevance<\/jats:title>\n                    <jats:p>In this secondary analysis of the AZALEA-TIMI 71 randomized clinical trial, abelacimab consistently reduced the risk of bleeding relative to rivaroxaban irrespective of kidney function. These findings suggest that abelacimab may offer a particularly favorable safety profile among those with chronic kidney disease; however, larger studies are necessary to characterize the efficacy of abelacimab for stroke prevention in AF.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1001\/jamacardio.2025.3393","type":"journal-article","created":{"date-parts":[[2025,9,1]],"date-time":"2025-09-01T13:30:18Z","timestamp":1756733418000},"page":"1214","source":"Crossref","is-referenced-by-count":7,"title":["Safety of Factor XI Inhibition With Abelacimab in Atrial Fibrillation by Kidney Function"],"prefix":"10.1001","volume":"10","author":[{"given":"Siddharth M.","family":"Patel","sequence":"first","affiliation":[{"name":"TIMI Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women\u2019s Hospital and Harvard Medical School, Boston, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert 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Department of Medicine, Brigham and Women\u2019s Hospital and Harvard Medical School, Boston, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bruce","family":"Hug","sequence":"additional","affiliation":[{"name":"Anthos Therapeutics Inc, Cambridge, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sanobar","family":"Parkar","sequence":"additional","affiliation":[{"name":"Anthos Therapeutics Inc, Cambridge, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shih-Ann","family":"Chen","sequence":"additional","affiliation":[{"name":"Heart Rhythm Center, Taipei Veterans General Hospital, Taipei, Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shaun G.","family":"Goodman","sequence":"additional","affiliation":[{"name":"Division of Cardiology, Department of Medicine, St Michael\u2019s Hospital, Unity Health Toronto, University of Toronto, Toronto, Ontario, Canada"},{"name":"Canadian VIGOUR Centre, University of Alberta, Edmonton, Alberta, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Boyoung","family":"Joung","sequence":"additional","affiliation":[{"name":"Division of Cardiology, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert G.","family":"Kiss","sequence":"additional","affiliation":[{"name":"Heart and Vascular Center, Department of Cardiology, Central Hospital of Northern Pest-Military Hospital, Semmelweis University, Budapest, Hungary"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wojciech","family":"Wojakowski","sequence":"additional","affiliation":[{"name":"Division of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeffrey I.","family":"Weitz","sequence":"additional","affiliation":[{"name":"Thrombosis and 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