TY - JOUR
T1 - Incidence and predictors of major gastrointestinal bleeding in patients on aspirin, low-dose rivaroxaban, or the combination
T2 - Secondary analysis of the COMPASS randomised controlled trial
AU - Forbes, Nauzer
AU - Yi, Qilong
AU - Moayyedi, Paul
AU - Bosch, Jackie
AU - Bhatt, Deepak L.
AU - Fox, Keith A.A.
AU - Eikelboom, John W.
N1 - Publisher Copyright:
© 2024 The Author(s). Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd.
PY - 2024/9
Y1 - 2024/9
N2 - Background: The incidence of major gastrointestinal bleeding (GIB) in patients on low-dose direct-acting oral anticoagulants (DOACs) is relatively unknown. Estimates from randomised controlled trials (RCTs) are lacking. Aims: To assess GIB incidence and predictors from RCT data of patients on aspirin, low-dose rivaroxaban, or both. Methods: This was a secondary analysis of RCT data wherein patients received aspirin 100 mg daily and rivaroxaban 2.5 mg b.d., aspirin alone, or rivaroxaban 5 mg 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. Results: Among 27,395 patients, the annual incidence of GIB on rivaroxaban 2.5 mg b.d. with aspirin was 801.7 per 100,000 compared with 372.3 in 100,000 for aspirin. Age (OR 4.16, 2.53–6.82 for ≥75 vs. 55–64), peptic ulcer disease (PUD, OR 1.57, 1.01–2.44), liver disease (OR 2.09, 1.01–4.33), hypertension (OR 1.42, 1.04–1.94), and smoking (OR 1.85, 1.26–2.73) were associated with overall GIB. Kidney disease (OR 1.68, 1.12–2.51) was significantly associated with upper GIB, whereas diverticular disease (OR 3.75, 1.88–7.49) was associated with lower GIB. Addition of rivaroxaban to aspirin was associated more with lower GIB (OR 2.82, 1.64–4.84) than upper GIB (OR 1.86, 1.18–2.92). Conclusions: We established incidences and identified risk factors for GIB in users of low-dose DOACs. Novel risk factors included current or former smoking and diverticulosis. Future studies should aim to validate these risk factors.
AB - Background: The incidence of major gastrointestinal bleeding (GIB) in patients on low-dose direct-acting oral anticoagulants (DOACs) is relatively unknown. Estimates from randomised controlled trials (RCTs) are lacking. Aims: To assess GIB incidence and predictors from RCT data of patients on aspirin, low-dose rivaroxaban, or both. Methods: This was a secondary analysis of RCT data wherein patients received aspirin 100 mg daily and rivaroxaban 2.5 mg b.d., aspirin alone, or rivaroxaban 5 mg 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. Results: Among 27,395 patients, the annual incidence of GIB on rivaroxaban 2.5 mg b.d. with aspirin was 801.7 per 100,000 compared with 372.3 in 100,000 for aspirin. Age (OR 4.16, 2.53–6.82 for ≥75 vs. 55–64), peptic ulcer disease (PUD, OR 1.57, 1.01–2.44), liver disease (OR 2.09, 1.01–4.33), hypertension (OR 1.42, 1.04–1.94), and smoking (OR 1.85, 1.26–2.73) were associated with overall GIB. Kidney disease (OR 1.68, 1.12–2.51) was significantly associated with upper GIB, whereas diverticular disease (OR 3.75, 1.88–7.49) was associated with lower GIB. Addition of rivaroxaban to aspirin was associated more with lower GIB (OR 2.82, 1.64–4.84) than upper GIB (OR 1.86, 1.18–2.92). Conclusions: We established incidences and identified risk factors for GIB in users of low-dose DOACs. Novel risk factors included current or former smoking and diverticulosis. Future studies should aim to validate these risk factors.
UR - http://www.scopus.com/inward/record.url?scp=85197272381&partnerID=8YFLogxK
U2 - 10.1111/apt.18139
DO - 10.1111/apt.18139
M3 - Article
C2 - 38952045
AN - SCOPUS:85197272381
SN - 0269-2813
VL - 60
SP - 737
EP - 748
JO - Alimentary Pharmacology and Therapeutics
JF - Alimentary Pharmacology and Therapeutics
IS - 6
ER -