{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,8]],"date-time":"2026-11-08T00:55:27Z","timestamp":1794099327709,"version":"4.8.0"},"reference-count":36,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2024,7,1]],"date-time":"2024-07-01T00:00:00Z","timestamp":1719792000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2024,7,1]],"date-time":"2024-07-01T00:00:00Z","timestamp":1719792000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Aliment Pharmacol Ther"],"published-print":{"date-parts":[[2024,9]]},"abstract":"<jats:title>Summary<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>The incidence of major gastrointestinal bleeding (GIB) in patients on low\u2010dose direct\u2010acting oral anticoagulants (DOACs) is relatively unknown. Estimates from randomised controlled trials (RCTs) are lacking.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>To assess GIB incidence and predictors from RCT data of patients on aspirin, low\u2010dose rivaroxaban, or both.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This was a secondary analysis of RCT data wherein patients received aspirin 100\u2009mg daily and rivaroxaban 2.5\u2009mg b.d., aspirin alone, or rivaroxaban 5\u2009mg b.d. Patients were followed from 2013 to 2016 at 602 centres. Outcomes included overall, upper, and lower GIB. We employed multivariable logistic regression to yield odds ratios (ORs) and 95% confidence intervals for potential exposures.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Among 27,395 patients, the annual incidence of GIB on rivaroxaban 2.5\u2009mg b.d. with aspirin was 801.7 per 100,000 compared with 372.3 in 100,000 for aspirin. Age (OR 4.16, 2.53\u20136.82 for \u226575 vs. 55\u201364), peptic ulcer disease (PUD, OR 1.57, 1.01\u20132.44), liver disease (OR 2.09, 1.01\u20134.33), hypertension (OR 1.42, 1.04\u20131.94), and smoking (OR 1.85, 1.26\u20132.73) were associated with overall GIB. Kidney disease (OR 1.68, 1.12\u20132.51) was significantly associated with upper GIB, whereas diverticular disease (OR 3.75, 1.88\u20137.49) was associated with lower GIB. Addition of rivaroxaban to aspirin was associated more with lower GIB (OR 2.82, 1.64\u20134.84) than upper GIB (OR 1.86, 1.18\u20132.92).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>We established incidences and identified risk factors for GIB in users of low\u2010dose DOACs. Novel risk factors included current or former smoking and diverticulosis. Future studies should aim to validate these risk factors.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/apt.18139","type":"journal-article","created":{"date-parts":[[2024,7,2]],"date-time":"2024-07-02T01:44:06Z","timestamp":1719884646000},"page":"737-748","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["Incidence and predictors of major gastrointestinal bleeding in patients on aspirin, low\u2010dose rivaroxaban, or the combination: Secondary analysis of the\n                    <scp>COMPASS<\/scp>\n                    randomised controlled trial"],"prefix":"10.1111","volume":"60","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6966-3908","authenticated-orcid":false,"given":"Nauzer","family":"Forbes","sequence":"first","affiliation":[{"name":"Department of Community Health Sciences University of Calgary  Calgary Alberta Canada"},{"name":"Division of Gastroenterology and Hepatology, Department of Medicine University of Calgary  Calgary Alberta Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Qilong","family":"Yi","sequence":"additional","affiliation":[{"name":"School of Epidemiology and Public Health University of Ottawa  Ottawa Ontario Canada"},{"name":"Population Health Research Institute  Hamilton Ontario Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3616-9292","authenticated-orcid":false,"given":"Paul","family":"Moayyedi","sequence":"additional","affiliation":[{"name":"Population Health Research Institute  Hamilton Ontario Canada"},{"name":"Division of Gastroenterology, Department of Medicine McMaster University  Hamilton Ontario Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jackie","family":"Bosch","sequence":"additional","affiliation":[{"name":"Population Health Research Institute  Hamilton Ontario Canada"},{"name":"Department of Rehabilitation Science McMaster University  Hamilton Ontario Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Deepak L.","family":"Bhatt","sequence":"additional","affiliation":[{"name":"Mount Sinai Fuster Heart Hospital Icahn School of Medicine at Mount Sinai  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Keith A. 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