{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T16:51:49Z","timestamp":1791910309040,"version":"4.3.4"},"reference-count":27,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2026,1,1]],"date-time":"2026-01-01T00:00:00Z","timestamp":1767225600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,1,1]],"date-time":"2026-01-01T00:00:00Z","timestamp":1767225600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Clin Appl Thromb Hemost"],"published-print":{"date-parts":[[2026,1]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Thromboembolic events remain a major cause of morbidity and mortality in cardiovascular diseases. Asundexian, an oral factor XIa inhibitor, has been proposed to reduce thrombosis while minimizing bleeding risk. The recent OCEANIC-STROKE trial provided substantial new evidence. We conducted an updated systematic review and meta-analysis incorporating this large trial.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>PubMed, Scopus, embase and CENTRAL were searched through April 2026. Five RCTs (n=31,301) comparing asundexian 50 mg daily with placebo or apixaban in patients with AF, acute myocardial infarction or stroke were included. Outcomes included all-cause mortality, ischemic stroke, stroke or systemic embolism, ISTH-defined major bleeding, other bleeding events, adverse events (AEs) and serious AEs. Risk ratios (RRs) with 95% confidence intervals (CIs) were pooled using a random-effects model.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Five RCTs involving 31,301 participants were included. Asundexian did not significantly affect all-cause mortality (RR 0.98, 95% CI 0.85\u20131.14), ischemic stroke (RR 1.33, 95% CI 0.66\u20132.66) or stroke\/systemic embolism (RR 1.20, 95% CI 0.28\u20135.12). No significant differences were observed in major bleeding, clinically relevant non-major bleeding, minor bleeding, hemorrhagic stroke, adverse events or serious adverse events. Sensitivity analyses reduced heterogeneity and suggested a lower risk of stroke\/systemic embolism (RR 0.74, 95% CI 0.65\u20130.84), while other findings remained unchanged.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Asundexian demonstrated a favorable safety profile but did not significantly reduce mortality or ischemic stroke. Sensitivity analyses suggest a potential benefit in reducing stroke or systemic embolism without increasing bleeding risk. Further trials are needed to identify patient populations most likely to benefit.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/10760296261496962","type":"journal-article","created":{"date-parts":[[2026,10,11]],"date-time":"2026-10-11T15:19:00Z","timestamp":1791731940000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["Safety and Efficacy of Asundexian in Cardiovascular Diseases, Updated Systemic Review and Meta Analysis"],"prefix":"10.1177","volume":"32","author":[{"given":"Erum","family":"Siddiqui","sequence":"first","affiliation":[{"name":"Jinnah Sindh Medical University"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0004-6266-0992","authenticated-orcid":false,"given":"Noor","family":"Ahmad","sequence":"additional","affiliation":[{"name":"Punjab Medical College"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-5976-0921","authenticated-orcid":false,"given":"Simrn","family":"Majid","sequence":"additional","affiliation":[{"name":"Punjab Medical College"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maryam","family":"Ayesha","sequence":"additional","affiliation":[{"name":"Liaquat University of Medical and Health Sciences"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marium","family":"Khan","sequence":"additional","affiliation":[{"name":"Karachi Medical and Dental College"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arshia Arif","family":"Janjua","sequence":"additional","affiliation":[{"name":"Shaheed Mohtarma Benazir Bhutto Medical College"},{"name":"Lyari (SMBBMCL-DUHS)"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shamyl","family":"Zehra","sequence":"additional","affiliation":[{"name":"Jinnah Sindh Medical University"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniyal","family":"Rashid","sequence":"additional","affiliation":[{"name":"Jinnah Sindh Medical University"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sajida","family":"Batool","sequence":"additional","affiliation":[{"name":"Karachi Medical and Dental College"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hajra","family":"Fatima","sequence":"additional","affiliation":[{"name":"Fatima Memorial College of Medicine and Dentistry"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roheen","family":"Raza","sequence":"additional","affiliation":[{"name":"Dow University of Health Sciences"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ayesha","family":"Masood","sequence":"additional","affiliation":[{"name":"Nishtar Medical University and Hospital"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Misheezable","family":"Ishaq","sequence":"additional","affiliation":[{"name":"Karachi Medical and Dental College"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-4228-6476","authenticated-orcid":false,"given":"Muhammad Saad","family":"Khan","sequence":"additional","affiliation":[{"name":"Jinnah Sindh Medical University"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0004-5360-6249","authenticated-orcid":false,"given":"Syed Hassan","family":"Ali","sequence":"additional","affiliation":[{"name":"Liaquat University of Medical and Health Sciences"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0000-3283-1982","authenticated-orcid":false,"given":"Aminath","family":"Waafira","sequence":"additional","affiliation":[{"name":"The Maldives National University"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2026,10,11]]},"reference":[{"key":"e_1_3_5_2_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2020.11.010"},{"key":"e_1_3_5_3_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(13)62343-0"},{"key":"e_1_3_5_4_2","first-page":"19","article-title":"Factors XI and XII as targets for new anticoagulants","volume":"4","author":"Weitz JI","year":"2017","unstructured":"Weitz JI, Fredenburgh JC. Factors XI and XII as targets for new anticoagulants. Front Med (Lausanne). 2017;4:19.","journal-title":"Front Med (Lausanne)"},{"key":"e_1_3_5_5_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2105872"},{"key":"e_1_3_5_6_2","doi-asserted-by":"publisher","DOI":"10.1111\/jth.15700"},{"issue":"12","key":"e_1_3_5_7_2","first-page":"1681","article-title":"Pharmacokinetics and pharmacodynamics of asundexian","volume":"61","author":"Heitmeier S","year":"2022","unstructured":"Heitmeier S, Visser M, Tersteegen A, et al. Pharmacokinetics and pharmacodynamics of asundexian. Clin Pharmacokinet. 2022;61(12):1681-1692.","journal-title":"Clin Pharmacokinet"},{"key":"e_1_3_5_8_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(22)00456-1"},{"key":"e_1_3_5_9_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(22)01588-4"},{"issue":"16","key":"e_1_3_5_10_2","first-page":"1195","article-title":"PACIFIC-AMI: safety of asundexian after acute myocardial infarction","volume":"146","author":"Rao SV","year":"2022","unstructured":"Rao SV, Kirsch B, Bhatt DL, et al. PACIFIC-AMI: safety of asundexian after acute myocardial infarction. Circulation. 2022;146(16):1195-1206.","journal-title":"Circulation"},{"key":"e_1_3_5_11_2","doi-asserted-by":"publisher","DOI":"10.1177\/10760296251365238"},{"key":"e_1_3_5_12_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2513880"},{"key":"e_1_3_5_13_2","article-title":"Care Research","author":"National Institute for Health","year":"2019","unstructured":"National Institute for Health. Care Research. 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Milvexian for the prevention of secondary stroke. Stroke. 2023;54(4):1120-1128.","journal-title":"Stroke"},{"key":"e_1_3_5_25_2","doi-asserted-by":"publisher","DOI":"10.1084\/jem.20112322"},{"key":"e_1_3_5_26_2","doi-asserted-by":"publisher","DOI":"10.1055\/a-1384-3715"},{"key":"e_1_3_5_27_2","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehaa612"},{"issue":"3","key":"e_1_3_5_28_2","first-page":"210","article-title":"Management of bleeding with non-vitamin K antagonist oral anticoagulants in the era of factor XI inhibitors","volume":"149","author":"Ruff CT","year":"2024","unstructured":"Ruff CT, Giugliano RP, Antman EM. Management of bleeding with non-vitamin K antagonist oral anticoagulants in the era of factor XI inhibitors. 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