title: Supplementary arteriel embolization an option in high-risk ulcer bleeding--a randomized study.
abstract: OBJECTIVE
  One of the major challenges in peptic ulcer bleeding (PUB) is rebleeding which is associated with up to a fivefold increase in mortality. We examined if supplementary transcatheter arterial embolization (STAE) performed after achieved endoscopic hemostasis improves outcome in patients with high-risk ulcers.
  
  
  METHODS
  The study was designed as a non-blinded, parallel group, randomized-controlled trial and performed in a university hospital setting. Patients admitted with PUB from Forrest Ia - IIb ulcers controlled by endoscopic therapy were randomized (1:1 ratio) to STAE of the bleeding artery within 24 h or continued standard treatment. Randomization was stratified according to stigmata of hemorrhage. Patients were followed for 30 days. Primary outcome was a composite endpoint where patients were classified into five groups based on transfusion requirement, development of rebleeding, need of hemostatic intervention and mortality. Secondary outcomes were rebleeding, number of blood transfusions received, duration of admission and mortality.
  
  
  RESULTS
  Totally 105 patients were included. Of the 49 patients allocated to STAE 31 underwent successful STAE. There was no difference in composite endpoint. Two versus eight patients re-bled in the STAE and control group, respectively (Intention-to-treat analysis; p = .10). After adjustment for possible imbalances a strong trend was noted between STAE and rate of rebleeding (p = .079).
  
  
  CONCLUSIONS
  STAE is potentially useful for preventing rebleeding in high-risk PUB. STAE can safely be performed in selected cases with high risk of rebleeding. Further studies are needed in order to confirm these findings; ClincialTrials.gov number, NCT01125852.
authors.affiliation: Department of Medical Gastroenterology, Odense University Hospital , Søndre Boulevard 29, 5000 Odense C , Denmark.
authors.forename: Stig Borbjerg
authors.initials: SB
authors.lastname: Laursen
authors.forename: Jane Møller
authors.initials: JM
authors.lastname: Hansen
authors.forename: Poul Erik
authors.initials: PE
authors.lastname: Andersen
authors.forename: Ove B
authors.initials: OB
authors.lastname: Schaffalitzky de Muckadell
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001803:Blood Transfusion; D003131:Combined Modality Therapy; D004621:Embolization, Therapeutic; D005260:Female; D016558:Hemostasis, Endoscopic; D017052:Hospital Mortality; D006801:Humans; D008297:Male; D008875:Middle Aged; D010438:Peptic Ulcer Hemorrhage / Q000401:mortality / Q000628:therapy*; D019233:Retreatment; D018570:Risk Assessment; D055502:Secondary Prevention