Low-dose aspirin continuation during gastric ESD in patients with low thrombotic risk: a randomized trial

Objectives: The recommendation to discontinue low-dose aspirin (LDA) during the periprocedural period of endoscopic submucosal dissection (ESD) for early gastric cancer (EGC) remains controversial in patients at low thrombotic risk. If continuation of LDA does not increase bleeding risk, gastric ESD could be safely performed under sustained antiplatelet effects, benefiting patients. This study aimed to evaluate whether continuation of LDA is non-inferior to discontinuation regarding ESD-related bleeding risk in patients with low thrombotic risk. Methods: Patients with gastric mucosal neoplasms and low thrombotic risk who were taking LDA were eligible. Participants were randomly assigned to either the Discontinuation or Continuation group. No prophylaxis was performed except for cauterizing exposed vessels at the ulcer base. The primary endpoint was the incidence of ESD-related major bleeding. Results: A total of 551 patients were enrolled. In the modified intent-to-treat analysis, the incidence of ESD-related major bleeding (95% CI) was 7.6% (4.8–11) in the Discontinuation group (n=276) and 10% (6.9–14) in the Continuation group (n=275), yielding a risk difference of 2.5% (-2.3 to 7.4). The upper limit of the two-sided 90% CI (6.6%) exceeded the predefined non-inferiority margin (Δ5%, P = 0.157). The per-protocol analysis supported this negative result, with a risk difference of 4.4% (-0.5 to 9.5). Two patients in the Continuation group developed cerebral infarction. Conclusions: The non-inferiority of LDA continuation over discontinuation for ESD-related major bleeding in gastric ESD was not demonstrated. Therefore, discontinuation of LDA during the periprocedural period is recommended for patients with low thrombotic risk. (UMIN000013177)