1. Validation of Mayo Clinic Risk Adjustment Model for In-Hospital Mortality following Percutaneous Coronary Interventions using the National Cardiovascular Data Registry Mandeep Singh; Eric D. Peterson*; Sarah Milford- Beland*; John S. Rumsfeld,# John A. Spertus** Mayo Clinic, Rochester, DCRI* (S.M-B, E.P.), Mid America Heart Institute** (J.A.S.), Denver VA Medical Center# (J.S.R.) Mandeep Singh; Eric D. Peterson*; Sarah Milford- Beland*; John S. Rumsfeld,# John A. Spertus** Mayo Clinic, Rochester, DCRI* (S.M-B, E.P.), Mid America Heart Institute** (J.A.S.), Denver VA Medical Center# (J.S.R.) No Financial Disclosure or Conflict of Interest

2. BACKGROUND Predictive models can assist patients and clinicians in decision-making and informed consent. Existing PCI risk models include angiographic variables limiting routine clinical use. Mayo Clinic Risk Score (MCRS) for in-hospital mortality is based on pre-procedural clinical and non-invasive assessment. MCRS can potentially serve as a risk assessment aid to patients/physicians before coronary angiography for PCI. Predictive models can assist patients and clinicians in decision-making and informed consent. Existing PCI risk models include angiographic variables limiting routine clinical use. Mayo Clinic Risk Score (MCRS) for in-hospital mortality is based on pre-procedural clinical and non-invasive assessment. MCRS can potentially serve as a risk assessment aid to patients/physicians before coronary angiography for PCI.

3. Background External validation of the MCRS is lacking The NCDR cath-PCI registry presents an ideal opportunity to validate the MCRS Study population: Index PCI for 309,351 patients in NCDR participating hospital between January 2004 and March 2006. Outcome: In-hospital mortality during the hospital admission following PCI. External validation of the MCRS is lacking The NCDR cath-PCI registry presents an ideal opportunity to validate the MCRS Study population: Index PCI for 309,351 patients in NCDR participating hospital between January 2004 and March 2006. Outcome: In-hospital mortality during the hospital admission following PCI.

4. CP1246788-1 Risk score PointsScore Age (yr)See below____ Creatinine (mg/dL)See below____ LV ejection See below____ fraction (%) Preprocedural shock9____ MI within 24 hours4____ CHF on presentation3____ (without AMI or shock) Peripheral2____ vascular disease Total score____ PointsScore Age (yr)See below____ Creatinine (mg/dL)See below____ LV ejection See below____ fraction (%) Preprocedural shock9____ MI within 24 hours4____ CHF on presentation3____ (without AMI or shock) Peripheral2____ vascular disease Total score____ Estimated risk of death (%) 80 70 60 50 40 30 20 10 5 4 3 2 1 0.5 0.1 20304050607080901234567891011020406080 Age (yr) Creatinine (mg/dL) LV ejection fraction (%) 2 2 1 1 0 0 1 1 2 2 3 3 4 4 5 5 1 1 0 0 1 1 3 3 2 2 4 4 5 5 6 6 4 4 3 3 2 2 1 1 0 0 Mayo Clinic Risk Score (MCRS) Mortality Mortality C-index=0.90

5. Statistical Methods Using the MCRS equation, predicted probabilities of death were calculated for each patient in the NCDR population. Patients with the same predicted mortality score were grouped together, and within each group, the observed (O) mortality rate was calculated. The O vs. E (expected) mortality rates for these groups were plotted and we used H-L method for calibration Model discrimination was assessed using ROC, or c- statistic, for the entire population and within pre- specified subgroups. Using the MCRS equation, predicted probabilities of death were calculated for each patient in the NCDR population. Patients with the same predicted mortality score were grouped together, and within each group, the observed (O) mortality rate was calculated. The O vs. E (expected) mortality rates for these groups were plotted and we used H-L method for calibration Model discrimination was assessed using ROC, or c- statistic, for the entire population and within pre- specified subgroups.

6. Statistical Methods (Cont.) The analysis was refined to include recalibration of the MCRS equation using the ACC population For this recalibrated model, patients with the same predicted mortality score were again grouped together. O vs. E mortality rates were plotted. Calibration: Hosmer-Lemeshow method. Internal validation of the new model using NCDR PCI patients April 2006, March 2007. The analysis was refined to include recalibration of the MCRS equation using the ACC population For this recalibrated model, patients with the same predicted mortality score were again grouped together. O vs. E mortality rates were plotted. Calibration: Hosmer-Lemeshow method. Internal validation of the new model using NCDR PCI patients April 2006, March 2007.

7. Patient Characteristics by In-Hospital Mortality in the NCDR VariableNumber (%)Mortality p Age <60Y114,844 (37.12)0.60<0.0001 ≥80Y 34383 (11.11)3.22 Congestive heart failure Yes27003 (8.73)5.25<0.0001 No282,321 (91.26)0.84 Acute Myocardial infarction Yes68116 (22.02)3.44<0.0001 No 241,128 (77.95)0.60 Peripheral vascular disease Yes36568 (11.82)2.18<0.0001 No272,768 (88.17)1.10 Cardiogenic shock Yes6314 (2.04)24.83<0.0001 No303,007 (97.95)0.73 Renal failure Yes16323 (5.28)3.89<0.0001 No293,012 (94.72)1.08 VariableNumber (%)Mortality p Age <60Y114,844 (37.12)0.60<0.0001 ≥80Y 34383 (11.11)3.22 Congestive heart failure Yes27003 (8.73)5.25<0.0001 No282,321 (91.26)0.84 Acute Myocardial infarction Yes68116 (22.02)3.44<0.0001 No 241,128 (77.95)0.60 Peripheral vascular disease Yes36568 (11.82)2.18<0.0001 No272,768 (88.17)1.10 Cardiogenic shock Yes6314 (2.04)24.83<0.0001 No303,007 (97.95)0.73 Renal failure Yes16323 (5.28)3.89<0.0001 No293,012 (94.72)1.08

8. Frequency of the Risk, based on the MCRS of Patients Undergoing PCI % Risk Score Frequency (%)

9. Discrimination of the MCRS CP1246782-7 GroupN MCRS (Min- Max)C-index Overall309,3510-250.884 Shock/ AMI699204-250.873 Age <4056271-210.938 Age 65+1515170-250.858 CHF270033-250.82 Creatinine <0.7104911-200.797 Creatinine >1.2668391-250.875 Multivessel Dx1505790-250.87 Female1041100-240.872 Diabetes 980810-240.878 GroupN MCRS (Min- Max)C-index Overall309,3510-250.884 Shock/ AMI699204-250.873 Age <4056271-210.938 Age 65+1515170-250.858 CHF270033-250.82 Creatinine <0.7104911-200.797 Creatinine >1.2668391-250.875 Multivessel Dx1505790-250.87 Female1041100-240.872 Diabetes 980810-240.878

10. Observed versus expected in-hospital mortality using the original MCRS prediction equation

11. O vs. E in-hospital mortality with recalibrated quadratic MCRS, internal validation sample (433,045) O=5,177; E=5,310 deaths (difference 2.5 per 100) c index= 0.885

12. Summary and Conclusions External validation of the MCRS using NCDR confirms its broader applicability. The MCRS has high discrimination for in- hospital mortality using 7 clinical/non-invasive variables. Most variables can be obtained at the time of first visit. This may help the operator to individualize the risk of procedural death from PCI, and to counsel patients at the time of PCI. External validation of the new, recalibrated MCRS model is, however, required. External validation of the MCRS using NCDR confirms its broader applicability. The MCRS has high discrimination for in- hospital mortality using 7 clinical/non-invasive variables. Most variables can be obtained at the time of first visit. This may help the operator to individualize the risk of procedural death from PCI, and to counsel patients at the time of PCI. External validation of the new, recalibrated MCRS model is, however, required.