Low-Dose Aspirin Continuation During Gastric Endoscopic Submucosal Dissection in Patients With Low Thrombotic Risk: A Randomized Trial.
Noriya Uedo, Takuji Gotoda, Kohei Takizawa et al.
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In 30 seconds
This randomized trial compared continuing versus discontinuing low-dose aspirin around gastric endoscopic submucosal dissection in patients with gastric mucosal neoplasms and low thrombotic risk. Among 551 enrolled patients, major bleeding occurred in 7.6% of the discontinuation group and 10% of the continuation group; the risk difference was 2.5% (-2.3 to 7.4). The upper limit of the 2-sided 90% confidence interval exceeded the prespecified noninferiority margin, so noninferiority of aspirin continuation was not demonstrated. Two patients in the continuation group developed cerebral infarction.
Key findings
- Major bleeding occurred in 7.6% with aspirin discontinuation and 10% with continuation; risk difference 2.5% (-2.3 to 7.4).
- The upper limit of the 2-sided 90% confidence interval was 6.6%, exceeding the predefined noninferiority margin (Δ5%, P = 0.157).
- Per-protocol analysis also did not demonstrate noninferiority, with a risk difference of 4.4% (-0.5 to 9.5).
- Two patients in the aspirin-continuation group developed cerebral infarction.
Why it matters
The trial addresses whether aspirin can be maintained during gastric ESD without an unacceptable increase in major bleeding among patients at low thrombotic risk. Because the study did not establish noninferiority, it does not support assuming that continuation is as safe as interruption for this outcome. The cerebral infarctions in the continuation group also underscore that thrombotic events occurred, although the abstract does not establish a comparative risk.
What to keep in mind
The findings apply to patients with low thrombotic risk undergoing gastric ESD; the abstract does not provide evidence for other risk groups or procedures.