1. PCI Appropriateness: Evidence and Tools Direct US
Michael Guiry, MBA, RPA-C
Director Cardiology Services
New York Presbyterian
Columbia University Medical Center

2. Michael Guiry, RPA-C, MBA
Consulting Fees:
The Medicines Company

3. PCI Appropriateness Guidelines
American College of Cardiology Foundation (ACCF), Society for Cardiac Angiography and Interventions (SCAI), American Association for Thoracic Surgery (AATS), American Heart Association (AHA), and American Society of Nuclear Cardiology (ASNC) have published: PCI Appropriate Use Criteria (AUC). J Am Coll Cardiol. 2009;53:

4. PCI Appropriateness Guidelines
6 professional societies
Writing committee/17 member technical panel
180 clinical scenarios
Appropriate: Scores of 7 to 9 – likely to improve health outcomes or survival
Inappropriate: Scores of 1 to 3 – unlikely to improve health outcomes or survival
Uncertain: Scores of 4 to 6 – coronary revascularization may be acceptable (more research/patient information required to classify)

5. PCI Appropriateness Guidelines
Indications were developed considering
Clinical Presentation (acute, stable, etc.)
Severity of Angina (CCS classification)
Extent of Ischemia on Noninvasive Testing and presence/absence of other prognostic factors
CHF, depressed LVEF, Diabetes
Extent of Medical Therapy
Extent of Anatomic Disease
1, 2, 3 vessel disease, with or without prox LAD involvement or LM disease

6. Low-Risk Findings on Noninvasive Imaging Study And Asymptomatic (Patients Without Prior CABG)
Noninvasive testing
Symptoms/Rx
Burden of disease

7. Patel MR, et al. Circulation. 2009;119:1330-1352.
ACCF/SCAI/STS/AATS/AHA/ASNC 2009 Appropriateness Criteria for Coronary Revascularization
Patel MR, et al. Circulation. 2009;119:

8. PCI Appropriateness Guidelines
Rationale:
The increasing prevalence of coronary artery disease (CAD), advances in surgical and percutaneous techniques for revascularization as well as concomitant medical therapy for CAD, and the costs of revascularization have resulted in heightened interest regarding the appropriateness of coronary revascularization.
Clinicians, payers, and patients are interested in the specific benefits of revascularization.

9. Variation in Care PCI Rates per 1,000 Medicare Enrollees13 .5 to 38 .1
(63) 11
to <
(53) 10 .0
(75) 8 3
(62)
Not Populated 9

10. Concerns of overuse

11. PCI Appropriateness Guidelines
Important Notice: appropriateness criteria are intended to assist patients and clinicians, but are not intended to diminish the acknowledged difficulty or uncertainty of clinical decision making and cannot act as substitutes for sound clinical judgment and practice experience

12. CHD Mortality 1950-2005 Annual Reviews ICD-7 (420) ICD-8 (410-413)
1959
1956
1953
1962
1971
1968
1965
1974
1983
1980
1977
1986
1995
1992
1989
1998
2001
2004
100
Per 100,000 population
200
300
400
500
600
Ford ES, Capewell S. 2001
Annual Rev. public Health 32:5-22

13. US Revascularization Rates
From the Beginning of the decade to 2008 – PCI is Down!
Epstein et al, JAMA 201;306:1769

14. Appropriateness of PCI Procedures in the US
PCI indication
‘Appropriate’
‘Uncertain’
‘Inappropriate’
Total
ACS
350,469 (98.6%)
1,055 (0.3%)
3,893 (1.1%)
355,417
Non-ACS
72,911 (50.4%)
54,988 (38.0%)
16,838 (11.6%)
144,737
423,380 (84.6%)
56,043 (11.2%)
20,731 (4.1%)
500,154
Abbreviations: ACS, acute coronary syndrome; PCI, percutaneous coronary intervention.
Chan et al, Appropriateness of Percutaneous Coronary Intervention JAMA 2011;306:53–61

15. What is the Evidence of Overuse?
CHD Mortality is dropping even today
Overall revascularization rates are dropping
PCI rates are dropping
“Inappropriate” use is less than 5%
So….if there’s is no systematic overuse and procedures are dropping then there must be systematic under treatment

16. Hazards of Underutilization
9300 Patients with recent onset chest pains
57% appropriate patients did not get angio median follow-up: three years
Angio +
Angio –
Death or ACS
11%
22%
HR : 2.5
Hemingway et al, Annals of Int Med 2008;248:221

17. Appropriateness Ratings by Low-Risk Findings on Noninvasive Imaging Study and Asymptomatic

18. If the goal is best outcomes, we need to monitor for potential underuse
Overuse may cost money
Underuse costs lives

19. Courage: Freedom from Angina
PCI is Superior to Med Rx for Angina Relief
PCI + OMT
OMT
P<0.001
P=0.005
P=0.010
P=0.30
P<0.001
P<0.001
Angina-free (%)
P=0.35
Months
32 % Crossover at a Median of 10.8 months
Weintraub et al, N Engl J Med 2008;359:

20. COURAGE: Angina Frequency
Top Tercile (weekly)
PCI plus OMT
OMT
P Value
First
Baseline
0.75
1 month
<0.001
3 months
6 months
0.02
12 months
0.09
24 months
0.03
36 months
0.94
Weintraub et al, N Engl J Med 2008;359: 20

21. OAT: The Occluded Artery Trial Angina during follow-up
Hochman JS et al. NEJM 2006;355:

22. Courage: Safety Endpoint at 4.6 Years
40%
P<0.001
At mean
10.8 mos
11%
P=NS
13%
P=NS
At mean
10 mos
% of Patients
PCI
OMT
PCI
OMT
PCI
OMT
Death
Spontaneous MI
Revascularization
NEJM 2007;356: ; AHJ 2006;151:1173-9

23. COURAGE as a QOL Study
In cases of moderate symptoms PCI provides immediate and superior symptomatic relief vs “OMT” (i.e., crossovers are Rx failure) with no cost of MI, death or CABG
Even in the least symptomatic groups “OMT” cannot match PCI and crossovers
QOL measures always favor PCI
Continued OMT is expensive
QOL measures favor PCI
And OMT is not cheap

24. COURAGE: Meds Can Make You Feel Worse! Angina Frequency
Bottom Tercile (none)
PCI plus OMT
OMT
P Value
Third
Baseline
97 + 5
0.61
1 month
0.002
3 months
0.67
6 months
0.02
12 months
24 months
0.64
36 months
0.31
Weintraub et al, N Engl J Med 2008;359: 24

25. Health Care Reform 2 Years Later
2010
2014
2018
Passage of Affordable Care Act (ACA)
Value Based Purchasing
Individual Mandate/ Exchanges
Full Implementation

26. Value-Based Purchasing
Medicare Payment Withholds Starting FY 2013
Medicare Penalties for Readmissions
Medicare Penalties for Not Reporting
Medicare Penalties for Meaningful Use

27. Hospital Value-Based Purchasing
MEASURE
FY2013
Process of Care (Core Measures)
70%
Patient Experience (HCAHPS)
30%
FY2014
45%
30%
Outcomes (30-day Mortality)
25 %

28. QUALITY
COST
VALUE =

29. Value: The Payor Perspective
High Quality Service
Lower Cost per Unit
Reduced Utilization

30. PCI Appropriateness Guidelines
Important Notice: appropriateness criteria are intended to assist patients and clinicians, but are not intended to diminish the acknowledged difficulty or uncertainty of clinical decision making and cannot act as substitutes for sound clinical judgment and practice experience

31. PCI Appropriateness
Given the widespread use of PCI, the appropriateness of these procedures in certain indications is being questioned
Good clinical practice requires continuing examination of appropriateness of care
Establishment of a proactive quality assessment review process will protect hospitals and their practitioners
In the future, payers will request documentation of appropriateness criteria as condition of payment