Key result
Taking direct oral anticoagulants was not significantly associated with an increased risk of delayed bleeding after endoscopic submucosal dissection compared to no medication (adjusted OR 2.4, 95% CI 0.41-13.73, P=0.335).
Why the study?
DOAC indications have expanded, but the risk of delayed bleeding in patients taking DOACs who undergo ESD for gastric neoplasms required evaluation.
Does DOAC use increase the risk of delayed bleeding in patients undergoing endoscopic submucosal dissection for gastric neoplasms?
Cohort (n=1,634)
No
Does DOAC use increase the risk of delayed bleeding in patients undergoing endoscopic submucosal dissection for gastric neoplasms?
Odds Ratio: 2.4 (95% CI 0.41–13.73)
Absolute Event Rate: 8.7% vs 2.1%
p-value: p=0.335
DOAC use with a 2-day periprocedural cessation strategy does not significantly increase the risk of delayed bleeding after endoscopic submucosal dissection for gastric neoplasms compared to no medication, after adjusting for patient factors.
May support brief DOAC cessation for gastric ESD; leaves open larger studies to confirm bleeding safety.
Direct oral anticoagulants (DOACs) are widely prescribed for the prevention of stroke in elderly patients with atrial fibrillation and approved indication for DOAC has been expanded. We aimed to evaluate the risk of delayed bleeding in patients who had taken DOAC and underwent endoscopic submucosal dissection (ESD) for gastric neoplasms. We included consecutive patients who underwent ESD between January 2016 and July 2019 in Seoul National University Hospital. Patients were divided into four groups (no med; no medication, DOAC, WFR; warfarin, anti-PLT; anti-platelet agent) according to the medications they had been taken before the procedure. We defined delayed bleeding as obvious post-procedural gastrointestinal bleeding sign including hematemesis or melena combined with hemoglobin drop ≥ 2 g/dL. Among 1634 patients enrolled in this study, 23 (1.4%) patients had taken DOAC and they usually stopped the medication for 2 days before the ESD and resumed within 1 or 2 days. We compared rates of delayed bleeding between groups. Delayed bleeding rates of the groups of no med, DOAC, WFR, and anti-PLT were 2.1% (32/1499) 8.7% (2/23), 14.3% (2/14), 11.2% (11/98), respectively (P < 0.001). However, there was no difference of delayed bleeding rate between no med and DOAC group after propensity score matching (no med vs DOAC, 1.7% vs 10.0%, P = 0.160). Taking DOAC was not associated statistically with post-ESD bleeding when adjusted by age, sex, comorbidities and characteristics of target lesion (Adjusted Odds Ratio: 2.4, 95% Confidence intervals: 0.41-13.73, P = 0.335). Crude rate of bleeding in DOAC users seemed to be higher than no medication group after performing ESD with 2 days of medication cessation. When adjusted by age, sex, and comorbidity, however, this difference seems to be small, which suggests that gastric post-ESD bleeding may be influenced by patients' underlying condition in addition to medication use.
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Choi et al. (2021) conducted a cohort in Early gastric neoplasms (early gastric cancer or gastric adenoma) (n=1,634). Direct oral anticoagulants (DOACs) vs. No medication was evaluated on Delayed bleeding (obvious post-procedural gastrointestinal bleeding sign with hemoglobin drop ≥ 2 g/dL and/or demand for RBC transfusion or emergent endoscopy within 4 weeks) (OR 2.4, 95% CI 0.41-13.73, p=0.335). Taking direct oral anticoagulants was not significantly associated with an increased risk of delayed bleeding after endoscopic submucosal dissection compared to no medication (adjusted OR 2.4, 95% CI 0.41-13.73, P=0.335).
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