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1 ESC CONGRESS 212 Comparing the predictive validity of three contemporary bleeding risk 1 scores in acute coronary syndrome 1 José Ramón González-Juanatey University Clinical Hospital of Santiago de Compostela. SPAIN Emad Abu-Assi, Sergio Raposeiras-Roubin, Pilar Cabanas-Grandío, Rosa M Agra- Bermejo, Belén Alvarez-Alvarez, Cristina Cambeiro-Gonzalez, Saleta Fernandez, Marta Rodríguez-Cordero, Carlos Peña-Gil, José Ramón Gonzalez-Juanatey

2 Presentation Disclosure No conflicts of interest related with this presentation

3 Bleeding Risk Scores in ACS AIMS METHODS RESULTS CONCLUSIONS

4 Heterogeneity The Definitions Mild Moderate Severe Life threatening Fatal Clinical relevant Superficial Internal Alarming Procedure related CABG related

5 Heterogeneity The Definitions/SCORES (ACS / PCI) TIMI OASIS ISTH GRACE COURAGE CRUSADE HERO REPLACE/ ISAR-REACT ACUITY HORIZONS CURE ESSENCE STEEPLE PLATO HERO HIT ISTH BARC Endorsed by the EMA Plus cessation criterion pdfs/human/press/pr/574en.pdf

6 AIMS We compared the performance of contemporary bleeding RS in ACS ACTION. USA. Registry ACS CRUSADE. USA. Registry NSTEACS MEHRAN. Internt. Clinical Trials

7 Bleeding Risk Scores in ACS AIMS METHODS RESULTS CONCLUSIONS

8 METHODS We calculated the ACTION, CRUSADE, and Mehran bleeding RS, and evaluated their performance for predicting their own major bleeding events and TIMI serious (major or minor) bleeding episodes, in patients with either non-st-elevation ACS (NSTEACS) or STelevation myocardial infarction (STEMI) Calibration (Hosmer Lemeshow test, HL) and discrimination (c-statistic) for the three RS were computed and compared.

9 METHODS

10 METHODS

11 Bleeding Risk Scores in ACS AIMS METHODS RESULTS CONCLUSIONS

12 RESULTS

13 RESULTS

14 RESULTS

15 RESULTS

16 RESULTS

17

18 Bleeding Risk Scores in ACS AIMS METHODS RESULTS CONCLUSIONS

19 For RS-specific major bleeding, ACTION and CRUSADE showed the best prognostic discrimination in STEMI (c=.74 and.791, respectively; p=.4), and in NSTEACS (c=.791 and.81; p=.4); being CRUSADE significantly superior to Mehran et al. in both ACS types (p<.5). For TIMI serious bleeding, ACTION and CRUSADE displayed the highest c-index values in both STEMI (.724 and.7, respectively; p=.) and NSTEACS (c=.7 and.744, respectively; p=.6); however, calibration of ACTION was poor in both ACS types (HL p<.5). All RS performed well in patients undergoing coronary arteriography using either a radial or femoral approach (all c.718); however, their discriminative capacity was modest in patients not undergoing coronary arteriography and in those previously on oral anticoagulant (all c<.7). CONCLUSIONS

20 CONCLUSION Of contemporary bleeding RS, the CRUSADE score was found to be the most accurate quantitative tool for NSTEACS and STEMI patients undergoing coronary arteriography. Eur Heart J (Acute CV Care) 212. On line July 19

21 Back-up slides

22 ACTION major bleeding criteria -Intracranial hemorrhage - Documented or suspected - Retroperitoneal bleed, -Absolute hemoglobin decrease of 4 g/dl (baseline to nadir) - Any red cell blood transfusion with baseline hemoglobin 9 g/dl, or - Any red cell transfusion with hemoglobin <9 g/dl and a suspected bleeding event CRUSADE major beeding criteria - Intracranial bleeding, - Documented retroperitoneal bleeding, - Absolute hematocrit decrease of 12% (baseline to nadir), - Any red blood cell transfusion in which baseline hematocrit was 28%, or - Any bleeding in which hematocrit was <28% with clinically documented bleeding Mehran et al major bleeding criteria -Intracranial or intraocular bleeding, - Access site hemorrhage requiring intervention, - Reduction in hemoglobin of 4 g/dl without or g/dl with an overt bleeding source, or - Blood product transfusion. TIMI bleeding criteria Major: intracranial haemorrhage, fatal bleeding (that directly results in death within 7 days), or clinically overt bleeding (including on imaging) associated with in haemoglobin 5 g/dl. Minor: any clinically overt bleeding (including o imaging), resulting in haemoglobin 5 g/dl.

23 CRUSADE major bleeding scoring system Baseline Hct (%) Points Baseline crcl (ml/min) Points HR on admission (beat/min) Points SBP on admission (mm Hg) Points < > Gender Points Heart failure on admission Points Prior vascular disease Points Diabetes Points Men Women 8 No Yes 7 No Yes 7 No Yes 6

24 ACTION major bleeding scoring system Age (years) Weight (kg) Points Baseline creatinine (mg/dl) On dialysis Points Peripheral artery disease Heart failure on admission Non Heart failure Only Heart failure with shock No Yes Points Baseline Hb (g/dl) Points < Diabetes mellitus No Yes Points Points HR on admission (beat/min) Points SBP on admission (mm Hg) Electrocardiographic changes No ST-segment changes ST-segment depression or transient elevation Points Points ST-segment elevation 7 Points Gender Points Home Warfarin Use Points 15 Men Women 4 No Yes 2

25 Mehran et al major bleeding scoring system Gender Age (years) points points <5 Male Female Baseline serum creatinine (mg/dl) points < White blood cell count (giga/l) points < Presentation Antithrombotic medications points points SETMI 6 NSTEMI-Raised biomarkers 2 Heparin plus glycoprotein IIb/IIIa inhibitor NSTEMI-Normal biomarkers Bivalirudin monotherapy -5

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