1. Coronary Artery Disease and its Treatments
Edward L. Hannan, Ph.D., MS, MS, FACC
Distinguished Professor
and Associate Dean for Research Emeritus
University at Albany School of Public Health

4. Background on NYS Cardiac Data
Late 1980s:
Large differences in hospital CABG mortality rates
Failed federal effort to evaluate quality of care
Led to effort to develop clinical database and use it assess risk-adjusted mortality for hospitals
Followed by similar efforts in valve surgery, PCI and pediatric cardiac surgery
Also, surgeon and cardiologist level data are now released

5. Background on NYS Cardiac Data, Cont’d
Now several other states release similar data, and the federal government also release risk-adjusted mortality data and uses it for Medicare reimbursement
These releases remain controversial with some hospitals and doctors, particularly cardiologists
The NYS cardiac datasets have also been used to conduct numerous studies on a variety of topics, including:

6. Background on NYS Cardiac Data, Cont’d
Comparison of different types of PCI, different types of CABG surgery, and comparison of stents with CABG surgery
Examinations of appropriateness and access to procedures
Comparisons of different ways of performing procedures
Impact of volume and experience on outcomes

7. Earlier Talk (4/17/14) (1) Coronary Heart Disease: Symptoms, Tests and
Treatments (medical therapy, stents (PCI), coronary
artery bypass graft (CABG) surgery)
(2) Use of appropriateness criteria to evaluate med therapy vs. stents for patients without acute coronary syndromes (heart attack or unstable angina)
(3) Comparison of CABG surgery and drug-eluting stents for patients with multi-vessel coronary artery disease
(4) Once CABG Surgery or Angioplasty Has Been Chosen, How to Obtain Information on Relative Quality of Hospitals and Surgeons/Cardiologists

8. Today’s Talk (1) Briefly review findings from previous talk on
appropriateness of PCI (stents) vs medical therapy
and findings that compared PCI and CABG surgery
(2) Discuss recent studies that reflect
updates/changes in the earlier findings
(3) Remind you of NYS Dept. of Health reports that
evaluate outcomes for PCI and CABG surgery

9. Angioplasty vs. Medical Therapy for Stable CAD
Stable Coronary Artery Disease: Previously diagnosed CAD without angina, or angina that has remained stable (frequency, duration, causes, ease of relief) for at least 60 days.
Should the initial management strategy for patients with stable CAD be PCI with medical management or intensive medical and lifestyle intervention?
According to criteria developed by the American College of Cardiologists (ACC), appropriateness of PCI vs medical therapy for these patients depends on a combination of factors such as
number of coronary vessels diseased (from cardiac catheterization),
amount of exertion required to cause chest pain,
stress test results, and
amount of medical therapy being used.
For each combination of these factors, the ACC has designated PCI as appropriate, uncertain, or inappropriate compared to medical therapy alone

10. Journal of the American College of Cardiology 2012;59:1870-1876.
Appropriateness of Coronary Revascularization for Patients Without Acute Coronary Syndromes
Journal of the American College of Cardiology 2012;59:
Edward L. Hannan, PHD, Kimberly Cozzens, MA, Zaza Samadashvili, MD, Gary Walford, MD, Alice K. Jacobs, MD, David R. Holmes, JR, MD, Nicholas J. Stamato, MD, Samin Sharma, MD, Ferdinand J. Venditti, MD, Icilma Fergus, MD, Spencer B. King III, MD
Objective: The purpose of this study was to determine appropriateness
of stenting (also called PCI) vs medical therapy alone performed in New York for patients with stable coronary artery disease (no heart attack or unstable angina) or previous CABG surgery.

11. Background:
The American College of Cardiology Foundation (ACCF) and 6 other societies recently published joint appropriateness criteria for coronary revascularization.
Methods:
Data from patients who underwent stenting with stable coronary artery disease in New York in 2009 and 2010 were used to assess appropriateness
Results:
Of the patients who could be rated, 36.1% were appropriate, 14.3% were inappropriate, and 49.6% were uncertain.
A total of 91% of the patients undergoing PCI who were classified as inappropriate had 1- or 2-vessel disease without proximal left anterior descending artery disease and had no or minimal anti-ischemic medical therapy.

12. Cost and Policy Implications
These results indicate that more than $50 million/per year in NYS is being spent on stents for patients who don’t need them
As a result of this study, information was fed back to hospitals identifying types of patients receiving stents that were inappropriate
Note: Stenting is the best treatment for patients with evolving ST-elevation heart attack.

13. Journal of the American College of Cardiology, 2017;69:1234-1242
Changes in Percutaneous Coronary Interventions Deemed “Inappropriate” by Appropriate Use Criteria
Journal of the American College of Cardiology, 2017;69:
Edward L. Hannan, PHD, Zaza Samadashvili, MD, Kimberly Cozzens, MA, Foster Gesten, MD, Alda Osinaga, MD,
Douglas G. Fish, MD, Constance L. Donahue, AUD, Ronald J. Bass, BA, Gary Walford, MD, Alice K. Jacobs, MD,
Ferdinand J. Venditti, MD, Nicholas J. Stamato, MD, Peter B. Berger, MD, Samin Sharma, MD, Spencer B. King III, MD

14. BACKGROUND
Recent studies have demonstrated relatively high rates of stenting classified as “inappropriate.”
The New York State Department of Health shared rates with hospitals and provided additional information about the nature of patients rated as inappropriate.
OBJECTIVE
The objective was to examine changes over time in the number and rate of inappropriate stents.
METHODS Appropriate use criteria were applied to stents performed in New York in patients with stable CAD in periods before (2010 through 2011) and after (2012 through 2014) efforts were made to decrease inappropriateness rates. Changes in the number of appropriate PCIs were also assessed.

15. RESULTS
The percentage of inappropriate stents for all patients dropped from 18.2% in 2010 to 10.6% in 2014 (from 15.3% to 6.8% for Medicaid patients, and from 18.6% to 11.2% for other patients).
The total number of stents in patients with stable CAD that were rated as inappropriate decreased from 2,956 patients in 2010 to 911 patients in 2014, a reduction of 69%.
For Medicaid patients, the decrease was from 340 patients to 84 patients, a decrease of 75%.
For a select set of higher-risk scenarios, there were higher numbers of appropriate PCIs per year in the period from 2012 to 2014.
CONCLUSIONS
The inappropriateness rate for PCIs and the use of PCI for elective procedures in New York has decreased substantially between 2010 and This decrease has occurred for a large proportion of PCI hospitals.

16. Earlier Comparison of CABG Surgery and Drug-Eluting Stents

17. New England Journal of Medicine
Drug-Eluting Stents vs. Coronary-Artery Bypass Grafting in Multivessel Coronary Disease
Edward L. Hannan, Ph.D., Chuntao Wu, M.D., Ph.D., Gary Walford, M.D., Alfred T. Culliford, M.D., Jeffrey P. Gold, M.D., Craig R. Smith, M.D., Robert S.D. Higgins, M.D., Russell E. Carlson, M.D., and Robert H. Jones, M.D.
New England Journal of Medicine
Volume 358(4):
January 24, 2008

18. PCI (Stents) vs. CABG Surgery, Cont’d.
This study compares mortality and myocardial infarction (heart attack) rates at 18 months for patients with 2- or 3-vessel disease undergoing each of these procedures
Results: For patients with three-vessel disease, the adjusted mortality rate was 6.0% for CABG versus 7.3% for stenting (P = 0.03) and the adjusted rate of heart attack was 7.9% for CABG versus 10.3 for stenting (P<0.001).
For patients with two-vessel disease, the adjusted mortality rate was 4.0% for CABG versus 5.4 for stenting (P = 0.003); the adjusted rate of heart attack was 5.5% for CABG vs 7.5% for stenting (P<0.001).
Patients undergoing CABG also had much lower rates of repeat procedures.

19. Conclusions
For patients with multivessel disease, CABG continues to be associated with lower mortality rates than does treatment with drug-eluting stents and is also associated with lower rates of death and myocardial infarction and repeat procedures

20. Bangalore S, Guo Y, Samadashvili Z, Xu J, Hannan EL
Everolimus-Eluting Stents or Bypass Surgery for Multivessel Coronary Disease New England Journal of Medicine 2015;372:
Bangalore S, Guo Y, Samadashvili Z, Xu J, Hannan EL

21. BACKGROUND
Results of trials and registry studies have shown lower long-term mortality after coronary-artery bypass grafting (CABG) than after stenting among patients with multivessel disease.
However, these previous analyses did not evaluate stenting with second-generation drug-eluting stents.
METHODS
We compared the adjusted outcomes in patients with multivessel disease who underwent CABG and stenting with the use of everolimus-eluting stents.

22. RESULTS
Among 34,819 eligible patients, 9223 patients received everolimus eluting stents and 9223 who underwent CABG had similar propensity scores and were included in the analyses.
At a mean follow-up of 2.9 years, everolimus eluting stents were associated with a similar risk of death (3.1% per year and 2.9% per year, respectively; hazard ratio, 1.04; 95% confidence interval [CI], 0.93 to 1.17; P = 0.50),
Stents had higher risks of heart attack (1.9% per year vs. 1.1% per year; hazard ratio, 1.51; 95% CI, 1.29 to 1.77; P<0.001) and repeat procedures (7.2% per year vs. 3.1% per year; hazard ratio, 2.35; 95% CI, 2.14 to 2.58; P<0.001),
Stents had a lower risk of stroke (0.7% per year vs. 1.0% per year; hazard ratio, 0.62; 95% CI, 0.50 to 0.76; P<0.001).
The higher risk of heart attack with stents than with CABG was not significant among patients with complete revascularization but was significant among those with incomplete revascularization (P = 0.02 for interaction).

23. Complete Revascularization:
All major vessels that are diseased have been successfully stented

24. In a contemporary clinical-practice registry study, the risk of death
CONCLUSIONS
In a contemporary clinical-practice registry study, the risk of death
associated with everolimus-eluting stents was similar to that
associated with CABG surgery.
Stenting was associated with a higher risk of heart attack (among patients with incomplete revascularization) and repeat procedures but a lower risk of stroke.
There were no differences in heart attack rates between stenting and CABG surgery among patients who were completely revascularized.

25. Incomplete revascularization for percutaneous coronary interventions: Variation among operators, and association with operator and hospital characteristics American Heart Journal 2017;186:
Hannan EL, Zhong Y, Jacobs AK, Ling FSK, Berger PB, Walford G, Venditti FJ, King SB III

26. Results
Incomplete revascularization occurred for 63%of all patients and was significantly associated with higher 3-year mortality (adjusted hazard ratio 1.35, 95%CI ) than for CR.
A total of 96%of all attempted CRs were successful.
Cardiologists with 15 or fewer years in practice (the lowest half) used IR significantly more (65% vs 61%, adjusted odds ratio [AOR] 1.17, 95% CI ) than other operators,
Cardiologists with annual volumes of 171 or lower (the lowest 3 quartiles) used IR more than other cardiologists (68% vs 60%,AOR1.35, 95%CI ).
Also, hospitals with annual volumes of 645 and lower (the lowest 50%of hospitals) used IR more (67% vs 62%, AOR 1.46, 95% CI ) than other hospitals.

27. Conclusions
Patients without heart attacks who receive stents with IR continue to have higher
medium-term (3-year) risk-adjusted mortality rates.
There is a large amount of variability among cardiologists in the use of IR.
Cardiologists who have been in practice longer, and higher-volume cardiologists and hospitals have lower rates of IR.
Failed attempts at CR occur very infrequently. In other words, IR occurs mainly as a result of a decision made prior to stenting.

28. Summary and Overall Conclusions
Inappropriate stenting for patients without a heart attack or unstable angina has decreased substantially, resulting in considerable cost savings (estimated $40 million/year in NY).
New appropriateness criteria have just been published. In the light of a new study showing a mortality benefit of stenting patients with stable CAD (rather than just a reduction in angina), this process will have to be revisited.

29. Summary and Conclusions, Cont’d
Another feature of the new appropriateness criteria is that they advocate “shared decision making”, whereby physicians share evidence with patients, and then work with patients to choose the treatment that best aligns with each patient’s values and concerns.
Patients need to be aware of this because not all physicians are familiar with the appropriateness criteria/prepared to the implement the criteria.

30. Summary and Conclusions, Cont’d
Outcomes for stenting of patients with severe coronary artery disease (2 or 3 vessels diseased) have improved compared to CABG surgery as a result of the newest generation of drug-eluting stents. Incomplete revascularization is still very prevalent for stenting, and the use of more complete revascularization would seemingly lead to even better relative results for stenting compared to CABG surgery More studies, especially randomized controlled trials, are needed to confirm these conclusions. For patients with severe coronary artery disease, pros and cons of stents vs. CABG as well as up-to-date evidence should be discussed with referring physicians.

31. Information Supplied to Hospitals and the Public
Annual Report With Risk-Adjusted Mortality Rates for Hospitals for the Latest Year
Also Contains Risk-Adjusted Mortality for Surgeons for Latest Three Years Combined

32. New York State Department of Health Initiatives Regarding CABG Surgery and PCI Quality
Development of Public Reporting of Outcomes for CABG Surgery and Angioplasty
Reports since 1989 for CABG surgery and since 1992 for angioplasty.