Contemporary Predictors of Procedural Mortality Among Patients Undergoing

PCI: Results From National Cardiovascular

Data Registry (NCDR)

Eric D Peterson, David Dai, Elizabeth R DeLong, Sunil V Rao,Matthew T Roe, Kalon K L Ho, Mandeep Singh, John S Rumsfeld, Richard E Shaw, William S Weintraub, Ralph G Brindis, John A

Spertus on behalf of the NCDR Registry Participants

Disclosure Statement

Research support provided by the American College of Cardiology National Cardiovascular Data Registry

Background

• Prior models have estimated risks of percutaneous coronary intervention (PCI) mortality. Yet, these have limitations:– Representing older patient populations– Selected centers or regions– Limited number of procedures– Incomplete clinical or angiographic detail– Failed to develop user-friendly formats

Objectives

We propose to use the ACC-NCDR PCI database,the nation’s largest interventional data repository to:

• Develop a contemporary PCI mortality risk model for those receiving primary PCI and elective procedures

• Internally validate the NCDR PCI model– overall and among selected sub-populations

• Determine the incremental prognostic value of angiographic factors beyond pre-cath risk factors

• Develop user-friendly PCI risk score for bedside risk estimation

Methods: Populations

• Development Sample – 302,958 PCI at 470 participating NCDR centers– Jan, 2004 – March, 2006 (v3 data only)– Divided into development (60%) and 1st validation

(40%)

• 2nd Validation Sample– 285,440 PCI at 608 participating NCDR centers– April, 2006 – April, 2007 (v3 data only)

• Exclusions– Not first PCI (57%)– Transfer out (1%)– Missing 2+ candidate variables (<1%)

Methods (2)

• Model Development – Multivariate logistic regression– Backward selection from 34 candidate variables

including demographics, risk factors, cardiac status, cath lab visit, and PCI procedures

• Model Validation– Model discrimination measured using c-index

(ranging from 0.5 for chance discrimination to 1.0 for perfect prediction)

– Model calibration examined by comparing average observed and predicted values within risk groups

Patient Clinical Characteristics (1)

Development (181,775)

1st validation (121,183)

2nd validation (285,440)

Age 63.9±12.1 63.9±12.1 64.1±12.1

Female 33.4% 33.3% 33.3%

Caucasian 87.2% 87.1% 85.6%

BMI (kg/m2) 29.6±6.3 29.7±6.3 29.8±6.3

Prior MI (>7days)

29.1% 29.1% 27.3%

Prior CHF 10.1% 10.0% 9.9%

Diabetes

– Non-insulin 21.5% 21.7% 22.3%

– Insulin 10.0% 10.0% 10.3%

Patient Clinical Characteristics (2)

Development (181,775)

1st validation (121,183)

2nd validation (285,440)

Mean GFR* (+/-SD) 73.6±30.5 73.5±29.0 73.2±28.1

Dialysis Dependent 1.6% 1.5% 1.5%

Cerebral Vascular Disease

10.9% 11.1% 11.1%

Peripheral Vascular Disease

11.7% 11.7% 11.9%

Chronic Lung Disease 16.0% 16.0% 15.8%

Prior PCI 35.1% 35.4% 36.6%

NYHA Class IV 18.3% 18.3% 18.8%

Cardiogenic Shock 1.9% 1.8% 1.7%* Glomerular Filtration Rate (GRF) assessed by MDRD formula

Procedural CharacteristicsDevelopment (181,775)

1st validation (121,183)

2nd validation (285,440)

LVEF 52.7±13 52.7±13 52.7±13

PCI Status

- Elective 49.3% 49.3% 50.2%

- Urgent 36.1% 35.6% 34.7%

- Emergency 14.4% 14.5% 15.0%

- Salvage 0.2% 0.2% 0.2%

Highest Risk Lesion

-pLAD 18.2% 18.2% 18.2%

-Left Main 1.7% 1.8% 1.8%

-Total Occlusion

11.0% 10.7% 14.9%

Multivessel PCI 14.0% 13.9% 14.1%

In Hospital Mortality

1.2%

4.8%

0.7%

1.3%

4.8%

0.7%

1.2%

4.7%

0.6%

0%

1%

2%

3%

4%

5%

6%

Overall STEMI Other

Mo

rta

lity

Ra

te

Develop Sample 1st Validation 2nd Validation

Full and Pre-Cath Risk Models

Full Model † Precath Simple Model

Label O.R. 95% CI Wald Chi-Sq O.R. 95% CI Wald

Chi-Sq

Cardiogenic Shock 8.35 7.40 9.44 1168.

3 12.19 10.86

13.68

1804.7

GFR for STEMI ‡ 0.77 0.74 0.80 181.9 0.77 0.75 0.78 377.6

Age (for age>70) ‡ 1.71 1.57 1.88 125.8 1.76 1.60 1.91 150.9

Age (for age<=70) ‡ 1.55 1.44 1.69 115.3 1.52 1.40 1.64 107.9

PCI Status-Salvage STEMI §

14.55

8.39

25.21 91.1 21.45 12.5

736.6

1 126.3

PCI Status- Emerg. STEMI § 2.07 1.3

0 3.31 9.2 2.65 1.68 4.18 17.6

PCI Status- Urgent STEMI § 1.09 0.6

4 1.83 0.1 1.25 0.75 2.07 0.7

NYHA Class IV for STEMI 1.21 1.0

5 1.39 6.7 1.61 1.46 1.79 81.7

Chronic Lung Disease 1.48 1.31 1.66 43.0 1.52 1.36 1.71 52.9

Peripheral Vascular Disease 1.53 1.3

5 1.74 42.4 1.67 1.48 1.89 67.8

Previous History - CHF 1.29 1.13 1.47 13.9 1.75 1.54 1.98 77.3

† Full model includes: Prior PCI, PreOp IABP, Ejection Fraction, Coronary Lesion >= 50%: Subacute Thrombosis, Total pre-procedure Occlusion, Diabetes treatment, SCAI Lesion Class 2 or 3, BMI for STEMI/non STEMI, Prior Dialysis for STEMI/non STEMI , Highest risk status for non-STEMI, NYHA Class IV for NSTEMI‡ Per 10 unit increase. § Versus Elective

PCI Risk Score System

Age <60 ≥60,<70 ≥70,<80 ≥80

0 4 8 14Cardiogenic Shock No Yes

0 25Prior CHF No Yes

0 5PVD No Yes

0 5CLD No Yes

0 4GFR <30 30-60 60-90 >90

18 10 6 0NYHA Class 4 No Yes

0 4PCI Status (STEMI) Elective Urgent Emergent Salvage

12 15 20 38PCI Status (Other) Elective Urgent Emergent Salvage

0 8 20 42

Points Mortality 0 0.0%5 0.1%10 0.1%15 0.2%20 0.3%25 0.6%30 1.1%35 2.0%40 3.6%45 6.3%50 10.9%55 18.3%60 29.0%65 42.7%70 57.6%75 71.2%80 81.%85 89.2%90 93.8%95 96.5%100 98.0%

Discrimination: C-Indices Sample Full Model Risk Score

N C-Index C-Index

Development 181,775 0.926 0.911 1st Validation 121,183 0.925 0.9012nd validation 285,440 0.924 0.905 Subgroups STEMI 39,889 0.902 0.884 Other 245,551 0.892 0.862

Women 95,106 0.911 0.893 Men 190,334 0.930 0.911

Age>70 92,381 0.901 0.880 Age<=70 193,059 0.927 0.906

Diabetes92,974 0.924 0.903 No Diabetes 192,466 0.923 0.906

Calibration for Full Model

Events by Clinical Risk Groups in Validation Sample

0

5

10

15

20

25

30

35

40

45

50

0.0-0.5 0.5-1.0 1.0-2.0 2.0-5.0 5.0-7.5 7.5-15. 15.-30. 30.+

Predicted Risk Group (%)

Obse

rved

Ris

k (%

)

0

5

10

15

20

25

30

35

40

45

50

0.0-0.5 0.5-1.0 1.0-2.0 2.0-5.0 5.0-7.5 7.5-15. 15.-30. 30.+

Predicted Risk Group (%)

Obse

rved

Ris

k (%

)

Full Model Risk Score

Limitations

• Voluntary participation • Limited auditing of data source• Only internal validation of model• No core lab angiographic readings• No data on functional status• Outcomes limited in in-hospital

mortality

Conclusions

• We developed a highly predictive contemporary mortality model for PCI

• Angiographic variables add modestly to risk assessment

• Model accurate in – Overall, <75 >75, women vs men, DM vs not, – STEMI vs other – Low vs high risk groups

Hospital CharacteristicsDevelopment (181,775)

1st validation (121,183)

2nd validation (285,440)

Number of Beds 463±221 463±220 454±225

Location

- Rural 12.6% 12.6% 12.1%

- Urban 61.0% 61.3% 61.2%

Teaching 60.1% 60.0% 54.6%

Region

- West 14.1% 14.3% 16.2%

- Northeast 9.0% 9.9% 10.4%

- Midwest 36.9% 36.7% 35.8%

- South 36.5% 36.8% 37.6%

Mean Annual PCIVolume

1151±762 1151±763 1159±807