1. Comparison of the New Mayo Clinic Risk Scores and Clinical SYNTAX Score in Predicting Adverse Cardiovascular Outcomes following Percutaneous Coronary Intervention at the Philippine Heart Center Helenne Joie M. Brown, MD

2. Ischemic Heart Disease Risk Stratification Background Management Quality Control Evaluation of health economics

3. Objective Clinical Prognostic Value In-hospital and 30-day Mortality and MACCE New Mayo Clinic Risk Scores

4. Study Design Prospective Cohort Study Inclusion Criteria All patients who underwent percutaneous coronary intervention at the Philippine Heart Center during the period of April 1, 2011 to September 30, 2011, aged > 18 years were included. Exclusion Criteria Patients with no baseline systolic function.

5. Study Design Sample Size The computed sample size was > 460 based on 95% confidence level and 80% power to detect statistical significance at assumed difference in area under the curve of 10%. The assumption was based on the paper of Garg et al which presented an AUC of 0.89 for MACE. Garg S et al. A New Tool for the Risk Stratification of Patients with Complex Coronary Artery Disease: The Clinical SYNTAX Score. Circ Cardiovasc Interv. 2010;3:317-326.

6. Study Design Study Maneuver Ischemic Heart Disease PCI Cardiovascular history and risk factors Coronary Angiogram 2 Interventional Cardiologists

7. Clinical New Mayo Clinic Risk Scores Study Design Study Maneuver Age Serum creatinine LVEF Preprocedural shock = 9 points MI < 24 hours = 4 points CHF on presentation = 3 points PAD = 2 points CSS = [SYNTAX Score] x [modified ACEF score]

8. Clinical New Mayo Clinic Risk Scores Study Design Study Maneuver Age Serum creatinine LVEF Preprocedural shock MI < 24 hours CHF on presentation PAD CSS = [SYNTAX Score] x [modified ACEF score]

9. Clinical New Mayo Clinic Risk Scores Study Design Study Maneuver Risk Stratification Low-risk: < 15.6 Moderate risk: >15.6 <27.5 High risk: >27.5 Mortality Prediction Very low risk: 0-5 Low-risk: 6-7 Moderate risk: 8-10 High risk: 11-12 Very high risk: 13+ MACCE Prediction Very low risk: 0-2 Low-risk: 3-5 Moderate risk: 6-90 High risk: 10-13 Very high risk: 14+ Outcomes In-hospital and 30-day all-cause mortality and MACCE

10. Clinical New Mayo Clinic Risk Scores Study Maneuver Risk Stratification Low-risk: < 15.6 Moderate risk: >15.6 <27.5 High risk: >27.5 Mortality Prediction Very low risk: 0-5 Low-risk: 6-7 Moderate risk: 8-10 High risk: 11-12 Very high risk: 13+ MACCE Prediction Very low risk: 0-2 Low-risk: 3-5 Moderate risk: 6-90 High risk: 10-13 Very high risk: 14+ Outcomes In-hospital and 30-day all-cause mortality and MACCE Results N = 482

11. Variable n = 482 MeanSD Age, + SD, years59.8+ 11.4 Serum Creatinine, mg/dl1.2+ 0.9 Creatinine Clearance, ml/min 74.1+ 29.6 LVEF, %55.3+ 9.4 Table 1. Baseline and Procedural Variables Results

12. Variable n= 482 No.% Gender Male Female 367 115 76.1 23.9 Myocardial Infarction < 24 hours9820.3 Unstable Angina17636.5 Non-elective PCI8217.0 Diabetes mellitus17536.3 Current and previous smoker25352.5 Hypertension37377.4 Dyslipidemia37377.4 CHF on presentation6413.3 Table 1. Baseline and Procedural Variables Results

13. Variable n= 482 No.% NYHA Class III or IV224.6 PAD234.8 Previous PCI408.3 Previous CABG296.0 Previous MI13828.6 Previous CVA204.1 Family History of IHD8617.8 Table 1. Baseline and Procedural Variables Results

14. Variable n= 482 No.% Meds at Screening ASA42588.2 Clopidogrel29861.8 B-blockers23348.3 ACE inhibitors/ARBs40584.0 Statins44692.5 Table 1. Baseline and Procedural Variables Results

15. Clinical New Mayo Clinic Risk Scores Risk Stratification Low-risk: < 15.6 Moderate risk: >15.6 <27.5 High risk: >27.5 Mortality Prediction Very low risk: 0-5 Low-risk: 6-7 Moderate risk: 8-10 High risk: 11-12 Very high risk: 13+ MACCE Prediction Very low risk: 0-2 Low-risk: 3-5 Moderate risk: 6-90 High risk: 10-13 Very high risk: 14+ Outcomes In-hospital and 30-day all-cause mortality and MACCE Results N = 482

16. Event n= 482 No.% Mortality224.6 Myocardial Infarction51 Emergency CABG10.2 CVA91.9 Table 2. In-hospital Mortality and MACCE following PCI Results

17. Figure 1. ROC Curve for In-hospital Mortality for the New Mayo Clinic Risk Score (NMCRS) for Predicting Mortality, the NMCRS for Predicting MACE and the Clinical Syntax Score (CSS).

18. Figure 6. ROC Curve for In-hospital Composite Endpoints for the New Mayo Clinic Risk Score (NMCRS) for Predicting Mortality, the NMCRS for Predicting MACE and the Clinical Syntax Score (CSS).

19. Clinical New Mayo Clinic Risk Scores Risk Stratification Low-risk: < 15.6 Moderate risk: >15.6 <27.5 High risk: >27.5 Mortality Prediction Very low risk: 0-5 Low-risk: 6-7 Moderate risk: 8-10 High risk: 11-12 Very high risk: 13+ MACCE Prediction Very low risk: 0-2 Low-risk: 3-5 Moderate risk: 6-90 High risk: 10-13 Very high risk: 14+ Outcomes In-hospital and 30-day all-cause mortality and MACCE Results N = 482

20. Event n= 482 No.% Mortality92 Myocardial Infarction92 Emergency CABG00 CVA10.2 Table 2. 30-day Mortality and MACCE following PCI Results

21. Figure 2. ROC Curve for In-hospital Myocardial Infarction for the New Mayo Clinic Risk Score (NMCRS) for Predicting Mortality, the NMCRS for Predicting MACE and the Clinical Syntax Score (CSS).

22. Figure 3. ROC Curve for In-hospital CVA for the New Mayo Clinic Risk Score (NMCRS) for Predicting Mortality, the NMCRS for Predicting MACE and the Clinical Syntax Score (CSS).

23. Figure 4. ROC Curve for 30-day Mortality for the New Mayo Clinic Risk Score (NMCRS) for Predicting Mortality, the NMCRS for Predicting MACE and the Clinical Syntax Score (CSS).

24. Figure 7. ROC Curve for 30-day Composite Endpoints for the New Mayo Clinic Risk Score (NMCRS) for Predicting Mortality, the NMCRS for Predicting MACE and the Clinical Syntax Score (CSS).

25. Figure 8. ROC Curve for In-hospital and 30-day Composite Endpoints for the New Mayo Clinic Risk Score (NMCRS) for Predicting Mortality, the NMCRS for Predicting MACE and the Clinical Syntax Score (CSS).

26. versus Age Serum creatinine LVEF Garg et al. A New Tool for the Risk Stratification of Patients with Complex Coronary Artery Disease: The Clinical SYNTAX Score. Circ Cardiovasc Interv. 2010;3:317-326.  predictors of adverse outcomes after revascularization Ranucci et al. Risk of Assessing Mortality Risk in Elective Cardiac Operations: Age, Creatinine, Ejection Fraction, and the Law of Parsimony. Circulation. 2009;119:3053-3061.  not subject to interobserver variability

27. Risk Stratification Mortality PredictionMACCE Prediction Outcomes In-hospital and 30-day all-cause mortality and MACCE Results Clinical variables Clinical + angiographic variables

28. versus “… despite exclusion of angiographic variables, the NMCRS can accurately estimate peri-procedural risk from PCI.” Singh et al. Bedside Estimation of Risk from Percutaneous Coronary Intervention: The New Mayo Clinic Risk Scores. Mayo Clin Proc June 2007;82(6):701-708. Our study demonstrated that the prognostic utility of the NMCRS for predicting mortality and MACCE can be extended to estimation of mortality and MACCE 30 days after a patient undergoes PCI.

29. versus all-comers study: 1-, 2- 3-vessel CAD 2- or 3-vessel CAD Excluded: Previous PTCA Left Main CAD Overt CHF LVEF < 30% Hx of TIA Hx of transmural MI Utility: long-term outcomes

30. Conclusion This study demonstrates the superior ability of a risk stratification tool which uses purely clinical variables, i.e. (1) the NMCRS for Predicting Mortality to predict in-hospital mortality and composite MACCE and (2) the NMCRS for Predicting MACE to predict 30-day mortality and composite MACCE, when compared with the CSS which uses angiographic and clinical variables.

31. Recommendation We therefore recommend the use of the New Mayo Clinic Risk Score for risk stratification of patients who will undergo PCI.  simple bedside tool  expedient for both the physician and patient in decision-making for revascularization  superior discriminative ability over the Clinical Syntax Score for peri-procedural and 30-day adverse outcomes

32. Good afternoon.