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A Comparison of Surgery vs. Transcatheter Angiographic Embolization in theTreatment of Non-Variceal Upper Gastrointestinal Bleeding Uncontrolled byEndoscopy. a Comparison of Surgery vs. Angiographic Embolization in theTreatment of Upper Gastrointestinal Bleeding Uncontrolled by EndoscopyDaphne Ang, Eng Kiong Teo, Andrew Gee Seng Tan, Salleh Ibrahim, Tiing Leong Ang,Kwong Ming Fock

Background: The management of patients with recurrent non-variceal upper gastrointestinalbleeding (NVUGIB) who have failed endoscopic therapy is challenging. Emergency surgeryafter unsuccessful endoscopic therapy is associated with significant post-operative morbidity.Percutaneous transcatheter arterial embolisation(TAE) is an alternative to surgery but remainscontroversial. Aims:(1)Compare rebleeding rates and mortality after TAE compared to salvagesurgery for NVUGIB following failure of endoscopic haemostasis and (2)Compare postprocedural complications and length of stay. Methods: Retrospective single centre study ofconsecutive patients who underwent TAE between May 2007 and December 2010 comparedwith patients treated surgically between January 2004 and December 2010. Patient demo-graphics, co-morbidities, rebleeding rates, length of stay (LOS)and mortality were evaluated.Results: Thirty (32.3%) [23M:7F; mean age 66.5 ± 15.6 years] and 63(67.7%)[41M:22F;mean age 68.2 ± 15.0 years, pNS] patients underwent TAE and surgery after a mean numberof 1.7 ± 1.0 and 2.1 ± 1.1 gastroscopies (pNS) respectively for recurrent NVUGIB. Theprevalence of ischaemic heart disease (IHD) (66.7% vs 33.3%, p=0.002) was higher in theTAE compared to the surgical group but no differences in the prevalence of chronic renalimpairment (43.3% vs 27.0%, pNS), chronic obstructive pulmonary disease (33.3% vs23.8%, pNS) or diabetes mellitus (43.3% vs 33.3%, pNS) were observed. Transarterialembolisation was associated with significantly higher rebleeding rates compared to surgery(n=14[46.7%]vs n=8[12.7%],p=0.001) but overall mortality (30.0% vs 28.6%,pNS) and 30-day mortality (16.7% vs 19.0%,pNS)were comparable. The overall complication rates (46.7%vs 60.3%, pNS) and length of stay (45.1±9.8 vs 25.5±18.1 days, p=0.06) were not significantlydifferent between the TAE and surgical groups respectively. By multivariate analysis, TAEwas associated with significantly higher rebleeding rates compared to surgery (OR 6.67,95% CI2.14-16.88). Multivariate analysis revealed that survival outcome was not influencedby TAE or surgery. The need for intensive care unit stay was significantly associated withmortality [OR 13.53,95% CI (1.53-119.50)]. Summary: Despite the higher rebleeding ratesin TAE treated patients, post procedural complications, LOS and mortality rates were similar.The role of TAE in patients with low surgical risks needs to be further defined by prospectiverandomized controlled trials.

Su1788

New Oral Anticoagulants and the Risk of Gastrointestinal Bleeding - aSystematic ReviewIngrid L. Holster, Vera E. Valkhoff, Ernst J. Kuipers, Eric T. Tjwa

Background: A new generation of oral anticoagulants (OAC), consisting of direct thrombinand factor Xa inhibitors, has recently been introduced based on promising efficacy results.The risk of gastrointestinal bleeding (GIB) should be considered before introduction in dailyclinical practice since eligible patients often use concomitant low dose aspirin (ASA) and/orthienopyridines, both known for their increased GIB risk. Furthermore, no direct antagonist iscurrently available hampering urgent hemostatic possibilities. Aim: To compare GIB risk ofthe new OAC with standard therapy (ST) for cardiovascular prophylaxis. Methods: Wesystematically searched PubMed until Nov.2011, to identify all randomized controlled trialscomparing the new OAC (dabigatran, rivaroxaban, apixaban, edoxaban, betrixaban, andximelagatran) with ST (vit. K antagonists, ASA, low-molecular-weight heparin (LMWH).The primary outcome was GIB risk. Secondary outcomes were risk of major or clinicallyrelevant bleeding (according to the ISTH criteria), and efficacy outcomes which differed foreach indication of OAC use. Results: We identified 133 trials. After exclusion of studies notfulfilling inclusion criteria, 34 studies remained (n=116,882); 19 studies on thromboprophyl-axis after orthopedic surgery (n=40,787), 7 trials on stroke prevention in atrial fibrillation(AF; n=58,060), 5 trials on treatment of deep vein thrombosis (n=5,437), and 3 trials ontreatment of acute coronary syndrome (n=12,598). Of all included studies, 33 providedresults on primary efficacy outcomes, 32 on major or clinically relevant bleeds, and 16 onGIB separately. Primary efficacy outcomes showed non-inferiority (n=15) or superiority (n=17) to ST in all but 1 trial. The risk of major or clinically relevant bleeding was similar toST in 22 trials (range reported HR 0.93-1.13), lower in 3 trials (range reported HR 0.63-0.68), but higher in 7 trials (range reported HR: 2.21-5.19). The GIB risk was similarbetween groups in 14 trials (range reported RR 0.86-0.89), whereas it was increased withnew OACs in 2 trials on AF (n=32,377; RR 1.5; 95% CI 1.19-1.89 resp. OR 1.47; 95% CI1.2-1.81). The concomitant use of ASA was around 30% in these trials. Of the 18 trials notseparately reporting GIB risk, the cumulative occurrence of major or clinically relevantbleeding per total studied population was, compared to ST, increased with new OACs in 2trials (171/4,566), similar in 15 (659/13,348) and not reported in 1 trial. Conclusions: Thenew OACs are non-inferior to superior in terms of cardiovascular prophylaxis. However,their risk profile in terms of GIB is similar. The GIB risk may be even higher during long-term use in patients with AF. Future treatment regimens encompassing these novel agentsshould anticipate this risk. The benefit of measures aiming at reducing the GIB risk shouldbe evaluated.

Su1789

Time to Upper Gastrointestinal Bleeding in NSAID and Low-Dose AspirinUsers; Results of a Prospective Cohort StudyNicolette L. de Groot, Matthijs P. Hagenaars, Helena M. Verkooijen, Peter D. Siersema,Martijn G. van Oijen

Background: Patients using non-steroidal anti-inflammatory drugs (NSAIDs) and low-doseaspirin are at an increased risk of developing upper gastrointestinal bleeding (UGIB). Bothmedications have been reported to increase the risk 3-fold, but there are differences regarding

S-504AGA Abstracts

dosing with NSAIDs being used at higher dosages than aspirin, usage patterns with NSAIDsmostly being used for shorter periods while low-dose aspirin is mostly used for the remaininglifetime and pathophysiology of adverse events. Aim: We sought to investigate whether timeto occurrence of UGIB was also different between NSAID and low-dose aspirin users.Methods: From a large anonymized health insurance company database all low-dose aspirinand NSAIDs users (age ≥18 years) between 2007 - 2010 were identified. Patients werefollowed during the time that medication was used until they developed UGIB, deceasedor end of treatment period. Time to development of UGIB was calculated for low-doseaspirin users and NSAID users and presented as incidence rates (defined as events subdividedby personyears of follow-up). Time to event was stratified in 4 timeframes, i.e., 0-14 days,15-30 days, 31-90 days and a longer period of drug use. Results: In total, 1505 UGIBepisodes were identified, 378 (25%) of which occurred in 889,057 NSAID users and 1127(75%) in 256,098 low-dose aspirin users. Mean time to follow-up was 37 days in NSAIDusers and 512 days in low-dose aspirin users (p<0.01). NSAID users had a significantlyshorter mean time to event of 120 days (standard deviation [SD] 200) and median of 36days (interquartile range [IQR] 117) than low-dose aspirin users with a mean of 319 days(SD 275) and a median of 245 days (IQR 392), p<0.01). The incidence rate of UGIB per1,000 patients years of follow-up was the highest within 14 days after start of drug use (4and 6 GI bleeds for NSAID and low-dose aspirin use, respectively, see Figure), whereasincidence rates in the other timeframes were equal and not different between NSAID andlow-dose aspirin users. Conclusions: Upper GI bleeding occurred after a significantly longertime of low-dose aspirin use compared to NSAID use. However, after correcting for follow-up the risk was comparable between the two groups, with a slightly higher risk within thefirst 14 days of drug use. This emphasizes the need for continuous monitoring of all patients,which should start immediately after initiation of NSAID and low-dose aspirin use.

Su1790

Adverse Cardiovascular Outcome After Gastrointestinal Bleeding; Incidenceand Risk FactorsNicolette L. de Groot, Brennan M. Spiegel, Sundip S. Karsan, Carl Nordstrom, Bradley J.Snyder, Peter D. Siersema, Martijn G. van Oijen

Background: Patients admitted for gastrointestinal (GI) bleeding are often hemodynamicallyinstable, hospitalized and undergo a change in medical therapy, e.g. discontinuation of low-dose aspirin therapy. As these are all cardiovascular (CV) risk factors, these patients are atincreased risk for adverse CV events. It is unclear whether acute GI bleeding increases therisk for adverse CV events. Current studies demonstrate worse CV outcomes in high riskpatients, thereby likely overstating the actual relationship. Aims: To study 1) the incidenceof adverse CV outcomes after hospitalization for GI bleeding; 2) predictors for adverse CVoutcomes; and 3) the effect GI bleeding and CV outcomes on mortality and length of hospitalstay. Methods: We studied patients admitted with GI bleeding in a University-based VAmedical center from 1996-2008. Prior to data collection, we created a detailed a prioriconceptual model to delineate variables that predict outcomes in GI bleeding, including:Charlson comorbidity index, age, medication use, history of cirrhosis, bleeding type, vitalsigns, laboratory results, receipt of PPI, endoscopic findings and treatment. An adverse CVoutcomewas defined as a newly diagnosedmyocardial infarction, angina pectoris, resuscitatedcardiac arrest, congestive heart failure, severe arrhythmias, transient ischemic attack orischemic stroke. Chi-squared analysis or Fisher's exact test were used to identify risk factorsassociated with adverse cardiovascular outcomes. Results: In total 673 patients with 814confirmed upper and lower GI bleeds were indentified and included. From admission to30 day follow up, 76 patients died (11.3%). Six adverse CV events (0.74%) were recordedin a time span of 30 days previous to the GI bleed, and 11 events (1.4%) after admissionfor GI bleeding (one fatal event occurred 28 days after the GI bleeding). The most commonCV event was newly diagnosed congestive heart failure (6 out of 11 events). Risk factorsfor an adverse CV outcome after a GI bleed were; use of low-dose aspirin (60% vs 26%,p=0,02), clopidogrel (20% vs 3.4%, p=0,04), a normal nasogastric lavage (60% vs 21.5%,p=0.01), the amount of units blood transfused (mean of 6.4 vs 4 units, p=0.01) and aconfirmed lower GI bleed (20.0% vs 5.2%, p= 0.09). Undergoing upper endoscopy, wasassociated with a lower risk of adverse CV outcomes (20% vs 61.1%, p=0.02). Patients withan adverse CV outcome had a longer length of hospital stay (35 vs 9 days, p <0.01).Conclusions: The incidence of an adverse CV outcome within 30 days after admission ofpatients with upper and lower GI bleeding is low. Patients admittedwith lower gastrointestinalbleeding are more prone to experience an adverse CV event. Patients using aspirin orclopidogrel are at higher risk of experiencing an adverse CV event and likely represent ahigher risk population.