Continuation of Low-Dose Aspirin in Peptic Ulcer Bleeding A Randomized Trial

Background: It is uncertain whether aspirin therapy should be continued after endoscopic hemostatic therapy in patients who develop peptic ulcer bleeding while receiving low-dose aspirin.

Objective: To test that continuing aspirin therapy with proton-pump inhibitors after endoscopic control of ulcer bleeding was not inferior to stopping
aspirin therapy, in terms of recurrent ulcer bleeding in adults with
cardiovascular or cerebrovascular diseases.

Design: A parallel randomized, placebo-controlled noninferiority trial, in which both patients and clinicians were blinded to the treatment
assignment, was conducted from 2003 to 2006 by using computer-generated
numbers in concealed envelopes. (ClinicalTrials.gov registration
number: NCT00153725)

Setting: A tertiary endoscopy center.

Patients: Low-dose aspirin recipients with peptic ulcer bleeding.

Intervention: 78 patients received aspirin, 80 mg/d, and 78 received placebo immediately after endoscopic therapy for 8 weeks. All patients received 72-hour infusion of pantoprazole followed by oral pantoprazole. All patients completed follow-up.

Measurements: The primary end point was recurrent ulcer bleeding within 30 days confirmed by endoscopy. Secondary end points were all-cause and specific-cause mortality in 8 weeks.

Results: 156 patients were included in an intention-to-treat analysis. Three patients withdrew from the trial before finishing follow-up. Recurrent
ulcer bleeding within 30 days was 10.3% in the aspirin group and 5.4%
in the placebo group (difference, 4.9 percentage points [95% CI, −3.6
to 13.4 percentage points]). Patients who received aspirin had lower
all-cause mortality rates than patients who received placebo (1.3% vs.
12.9%; difference, 11.6 percentage points [CI, 3.7 to 19.5 percentage
points]).Patients in the aspirin group had lower mortality rates
attributable to cardiovascular, cerebrovascular, or gastrointestinal
complications than patients in the placebo group (1.3% vs. 10.3%;
difference, 9 percentage points [CI, 1.7 to 16.3 percentage points]).

Limitations: Sample size is relatively small, and only low-dose aspirin, 80 mg, was used. Two patients with recurrent bleeding in the placebo group did not have further endoscopy.

Conclusion: Among low-dose aspirin recipients who had peptic ulcer bleeding, continuous aspirin therapy may increase the risk for recurrent bleeding but potentially reduces mortality rates. Larger trials are needed to confirm these findings.

Full text at Annals