158 Transarterial Angiographic Embolization vs. Surgery in Patients With Bleeding Peptic Ulcers Uncontrolled At Endoscopy; A Multicenter Randomized Trial

Abstract

Background Further bleeding after endoscopic hemostasis to bleeding peptic ulcers is associated with an at least 3-fold increase in mortality. We sought to determine if preemptive angiographic embolization (AE) to high risk ulcers can reduce further bleeding and improves patients' outcome. Method Patients with bleeding gastro-duodenal ulcers that required endoscopic hemostasis were enrolled if they fulfilled one of the following criteria; Forrest I a bleeding, ulcer size hypotensive (systolic blood pressure < 90 mmHg) or hemoglobin ≤ 9g/dl. They were randomized to undergo angiographic embolization within 12 hours of endoscopy plus an intravenous infusion of high dose proton pump inhibitor (IV-PPI) or IV-PPI alone. Our primary endpoint was re-bleeding within 30 days of randomization. Results Between January 2010 to October 2013, 222 patients were randomized (AE 109, no AE 113). One and 3 patients were excluded after randomization. Baseline characteristics were similar between groups; mean age 65.3 vs. 67.7), in patient bleeding (19.2 vs. 18.6%), mean transfusion before randomization (2.53 vs. 2.6u),mean systolic BP (109 vs. 105mmHg). In the AE group, mean time to angiography was 4.2 (SD 3.3) hour. Of 109 randomized to AE, 16(14.7%) did not receive AE; 6 of 16 re-bled and 3 died (2 after surgery and 1 from major bleeding), 10 without further bleeding and one died. On an ITT analysis, further bleeding occurred in 8/109 (7.3%) and 12/113 (10.6%) of AE and no AE group respectively (P=0.39, OR, 95%CI=0.67; 0.26-1.70). On a PP analysis, further bleeding occurred in 4/ 91 (4.4%) patients in the AE group compared to 12/110 (10.9%) patients on iv-PPI alone (P=0.089; OR, 95%CI=2.66, 0.8-8.5). There was no 30 day mortality in the AE group (0/ 91 vs. 5/110, P=0.065). Hospitalization and blood transfusion were less in the AE group (6.9 vs. 8.7 days, P=0.2 and 1.2 vs. 1.9U, P=0.09 respectively). Reduction in re-bleeding after AE was seen mostly in patients with ulcers≥1.5cm in size (2/40 vs. 10/43, P=0.027) [Figure 1]. Conclusions Early angiographic embolization after endoscopic hemostasis to patients with gastro-duodenal ulcers ≥1.5cm in size reduces re-bleeding.