Is There a Subgroup of Patients with Forrest IB (Oozing) Peptic Ulcer Bleeding At Increased Risk of Re-Bleeding?

Abstract

Background: A dichotomy exists among peptic ulcer bleeds (PUB) of oozing appearance (Forrest class Ib), in that a clot or visible vessel is apparent in some cases. Whether such stigmata increase the risk of re-bleeding remains unknown. As part of a recent study of acid-suppressive therapy after successful endoscopic therapy for PUB with high-risk stigmata [1], we report a re-assessment by the study Endpoint Committee (EpC) of re-bleeding among patients (pts) with Forrest Ib (oozing) ulcers to determine whether a subgroup indeed exists that exhibits increased risk of re-bleeding. Methods: In this double-blind, randomized clinical trial (NCT00251979), intravenous esomeprazole (80mg infusion over 30min, then 8mg/h for 71.5h) was compared with matching placebo for prevention of re-bleeding after successful endoscopic hemostasis of PUB. All patients had a single bleeding gastric or duodenal ulcer (≥5 mm diameter, treated endoscopically). Post-infusion, both groups received open-label oral esomeprazole 40mg qd for 27d. As part of the present analysis, the rate of clinically significant re-bleeding (large volume hematemesis, presence of 2 of 3 possible clinical signs of re-bleeding [recurrent melena, drop in Hct, unstable BP or pulse]) within 30d was evaluated for those with Forrest Ib ulcers before endoscopic hemostasis. Baseline ulcer photo documentation was independently re-evaluated by the EpC (DMJ and RS) and Forrest Ib ulcers were further subclassified according to the presence/absence of a clot or visible vessel. Results: A total of 273 pts with Forrest Ib ulcers and available photo documentation were evaluated and reclassified. There was agreement among the EpC on the presence of a clot or visible vessel, respectively, in 90 pts (33.0%). In such pts, the re-bleeding rate was 10.0% (9/90) vs 0% (0/29) in those where the EpC agreed on the absence of a clot or visible vessel (p=.09). In the remaining cases, where the EpC did not agree on the presence/absence of a clot or visible vessel, the re-bleeding rate was 6.5% (10/154). Hence, the re-bleeding rate in the Forrest Ib subgroup with a clot or visible vessel was similar to that of the overall study population (10.7%). Conclusions: Among PUB pts with Forrest Ib (oozing) ulcers, a subgroup with both a clot or a visible vessel and oozing appears to have an increased risk of re-bleeding vs those with only oozing and no additional stigmata. Modification of the Forrest Ib classification may therefore increase its precision in identifying PUB pts with a higher risk of re-bleeding.Supported by AstraZeneca R&D, Mölndal, Sweden[1] Sung JJY, et al. GUT 2008;57 Suppl. II: A70