Risk of post sphincterotomy bleeding with antiplatelet and anticoagulant use - A propensity-matched analysis of United States Collaborative Network

Background: Gastrointestinal (GI) bleeding following endoscopic retrograde cholangiopancreatography (ERCP) is a serious adverse event and most commonly occurs after endoscopic biliary and/or pancreatic sphincterotomy. While the strength of available evidence for post sphincterotomy GI bleeding risk is high for therapeutic warfarin and heparin, it remains unknown for clopidogrel and prasugrel. We conducted a retrospective United States (US)-based propensity-matched cohort study, to assess the risk of post sphincterotomy bleeding in patients on anticoagulant (AC) and antiplatelet (APT) therapy. Methods: We analyzed the US Collaborative Network in the TriNetX platform through December 27th, 2022, to include patients on APT and AC therapy who underwent ERCP within 7 days of hospitalization. One-to-one propensity-matching was performed. The primary outcome was the incidence of GI bleeding within 7 days of sphincterotomy. Secondary outcomes included need for blood transfusion, intensive care unit (ICU) care, and all-cause mortality within 30 days of bleeding. Results: Overall, 2,806 patients (1,806 in the AC and 1000 in APT cohorts) underwent ERCP with sphincterotomy. One-to-one (1:1) propensity score matching was performed for age, BMI >= 30, gender, race, ethnicity, diabetes mellitus, nicotine dependence, presence and severity of chronic kidney disease, cirrhosis, and thrombocytopenia between the cohorts. Patients in both AC and APT cohorts had an increased risk of post sphincterotomy bleeding compared to matched controls, adjusted odds ratio (aOR) 3.6 (95% Confidence Interval (CI) 2.58 - 5.06) and aOR 2.2 (95% CI 1.43 - 3.56), respectively. While heparin bridging therapy and concurrent use of aspirin did not further increase the risk of GI bleeding, resumption of AC within 24 hours post procedure did. Patients in neither cohort were at an increased risk for blood transfusion, ICU care or mortality. Conclusion: Our database analysis shows that patients on AC and APT are indeed at a higher risk of post sphincterotomy bleeding, compared to matched controls. Appropriate drug cessation period or alternative biliary decompression modalities may be utilized in these patients.