Predicting Mortality in Non-Variceal Upper Gastrointestinal Bleeders: Validation of the Italian PNED Score and Prospective Comparison With the Rockall Score Am J Gastroenterol 2010;105:1284–1291 Department of Gastroenterology R4 Hyunjin Park

Introduction Mortality from non-variceal UGI bleeding(UGIB) –Still amounts of 5–10% –Scoring system for the prediction of mortality Aggressive management strategies for improving outcomes Correctly allocating the adequate level of care and resources –The Rockall scoring system

Introduction ‘Progetto Nazionale Emorragia Digestiva (PNED)’ study 1 –Predictors of 30-day bleeding-related mortality Advanced age (over 80 years) Low hemoglobin levels at presentation(<7g/dL) Presence of severe comorbidity (renal failure, neoplasia, liver cirrhosis) Recurrent bleeding Worsening health status (ASA class 3 or 4)

Purposes The aims of this study –To prospectively evaluate the performance of PNED score in validation cohort –To comparing the accuracy the PNED score vs the Rockall score

Methods – The PNED initiative and data collection Software for endoscopic reporting system –Cartella Clinica Endoscopia Digestiva, Bracco, Italy –Distributed to 23 participating sites –15 : community hospitals, 8 : tertiary care institutions Data collection –Identification of subjects daily in the accident and emergency department, the wards, the endoscopy unit, the operating theater, and from blood transfusion records and admission data –Specially trained research assistants –Coordinator : checking and returning a completed form –All data : downloaded into a central database on a monthly basis

Methods - Patients Between April 2007 and May 2008 Patients for the study –1,548 patients -> 1,360 patients non-variceal UGIB –Clinical evidence of overt UGIB on admission History of hematemesis/coffee ground vomiting, melena, hematochezia within 24h, documented by nursing or medical staff –In-hospital bleeding –Upper GI endoscopy : variceal bleeding – excluded Comorbidity Cardiac diseases including MI, CHF Chronic pulmonary diseases Acute and chronic liver disease Gastrointestinal or biliary diseases Acute and chronic renal diseases Vascular disorders Cerebrovascular disease Diabetes mellitus and endocrine diseases Hematologic disorders Presence of any malignancy Cardiac diseases including MI, CHF Chronic pulmonary diseases Acute and chronic liver disease Gastrointestinal or biliary diseases Acute and chronic renal diseases Vascular disorders Cerebrovascular disease Diabetes mellitus and endocrine diseases Hematologic disorders Presence of any malignancy

Methods - Definitions Definitions –“Bleeding-related” death : Any death occurring within 30 days of the index bleeding episode –Continued or persistent bleeding Failure to control arterial bleeding endoscopically Presence of bloody nasogastric aspirate Shock with HR>100 beats/min, SBP<100mmHg, or both The need for substantial replacement of blood or fluid volume (need of >4 units of blood in 6h) –Recurrent bleeding Recurrent vomiting of fresh blood, melena, or both Shock or a decrease in Hb at least 2 g/dL after initial successful treatment Confirmed by a second endoscopy

Methods - Data collection By endoscopists at the end of the procedure Baseline demographic data –Clinical presentation and severity of the bleeding –Significant comorbid condition and seriousness (ASA score) –Endoscopic findings, treatments and clinical outcomes –Other baseline characteristics Physical examination findings and laboratory data Concurrent medication taken in the 7 days before Time elapsed from the onset of bleeding Drug therapy administered before and after endoscopy Duration of hospital stay and Calculate the Rockall score Follow-up –Total of 30 days –Discharged to other health-care facilities : to keep the diary –Discharged to home : direct telephone or personal contact

Methods - Statistics Clinical data : the χ 2 test or Fisher ’ s exact test The predictive risk for mortality (PNED score) –Multiple stepwise logistic regression –Proportional to the odds ratio(OR) –Score 0(zero) : none of the identified risk factors –Low risk : score 0 – 4, medium : 5 – 8, and high : > 8 Comparing the performance of the PNED vs Rockall score –ROC curve –The areas under the correlated ROC curves STATA soft ware system, version 10.0 (StataCorp Lp, College Station TX)

Results

High-risk stigmata 42.9% Low-risk stigmata 57.1%

Results

Results – Medication vs Mortality 14 patients : none of them died OR : 0.40, protective Heparin OR 2.89 Warfarin, Ticlopidin, Coxibs etc. : no significant impact on mortality Heparin OR 2.89 Warfarin, Ticlopidin, Coxibs etc. : no significant impact on mortality

PNED score?

Am J Gastroenterol 2008;103:1639–1647

Results

Conclusion The Italian 10-point score for the prediction of death was successfully validated in this independent population of patients with non-variceal gastrointestinal bleeding. The PNED score is accurate and superior to the Rockall score. Further external validation at the international level is needed.