AHA Scientific Sessions, November 5, 2007

1. The Use of Percutaneous Coronary Intervention in Patients with Class I Indications for Coronary Artery Bypass Graft Surgery: Data from the National Cardiovascular Data Registry Andrew D. Frutkin1, Sameer K. Mehta1, John House1, John A. Spertus1, David J. Cohen1, John Rumsfeld2, Steven P. Marso1 presented on behalf of the NCDR 1Mid America Heart Institute, University of Missouri-Kansas City 2Denver Veterans Administration Medical Center, University of Colorado AHA Scientific Sessions, November 5, 2007

2. Authors’ Disclosures The Use of Percutaneous Coronary Intervention in Patients with Class I Indications for Coronary Artery Bypass Graft Surgery: Data from the National Cardiovascular Data Registry Andrew Frutkin: no relationships Sameer Mehta: none John House: none John Spertus: • Research grant: NIH, Lilly, Roche Diagnostics, CV Outcomes, Inc. • Ownership interest: Health Outcomes Sciences and Outcomes Instruments • Consultant: National Cardiovascular Registry David Cohen: • Research Grant: Cordis, Boston Scientific John Rumsfeld: • Consultant: National Cardiovascular Registry Steven Marso: • Research Grant: American Diabetes Association, Boston Scientific, Volcano, Inc., Amylin. • Consultant: Sanofi-Aventis, Volcano, Inc.

3. Background • Coronary artery bypass graft surgery (CABG) has been the standard therapy for patients with severe, multivessel coronary artery disease (CAD). • Multi-vessel, percutaneous coronary intervention (PCI) achieves similar freedom from angina, myocardial infarction and death as CABG but at a greater cost of early, repeat revascularization.

4. Background • Drug eluting stents (DES) reduce repeat revascularization, raising the expectation that DES may enhance PCI outcomes in multivessel CAD. • Widespread adoption of DES has been associated with increased use of PCI in select groups of patients with multivessel CAD. • Huang et al. CCI. 2006;68: 868-872 • Gogo et al. AJC. 2007:99: 1222-1226 • Randomized trials (SYNTAX, FREEDOM) will compare multivessel PCI with DES versus CABG.

5. Hypothesis Since the introduction of DES, PCI has been increasingly used to treat patients who have AHA/ACC Class I indications for CABG.

6. Methods (1) • National Cardiovascular Data Cath/PCI Registry • January 1, 2001 to September 30, 2006 • Version 2 and Version 3 data sets • Included only centers that consistently reported diagnostic catheterization data

7. Methods(2) • Inclusion criteria AHA/ACC Class 1 Indications for CABG • Left main > 50% stenosis • Proximal LAD and circumflex artery > 70% • Three vessels > 50% • At least two vessels > 50% and ejection fraction < 50% • Proximal LAD > 50% and ejection fraction < 50% • Angina, two vessel including proximal LAD > 50%, and positive stress test • Exclusion criteria • STEMI, emergency or salvage CABG, prior CABG, prior PCI, valve disease

8. Methods (3) • Confirmed temporal trends of DES use for all PCI • Determined temporal trends of PCI among patients with Class I CABG indications • Three periods defined by DES use: • Pre-DES era Prior to 4/1/2003, date of Cypher stent approval • DES-diffusion era 4/1/2003 to 12/31/2004, time to achieve > 75% DES use Rao et al. AJC. 2006;97:1478-1481. • DES era 1/1/2005 to 9/30/2006, prior to FDA meeting on DES safety

9. Methods (4) • Compared the rate of increase in PCI in each era among patients with Class I CABG indications • Multivariable, hierarchical model (controlling for center) Model variables Age, sex, race, acute coronary syndrome, congestive heart failure, ejection fraction, diabetes, renal failure, cerebrovascular disease, peripheral vascular disease, prior MI, hypertension, tobacco use, left main stenosis > 50%, number of diseased vessels, quarterly time factor. • Determined the likelihood of PCI per incremental increase in DES use by center.

10. Proportion of DES Use Per Total PCI Pre-DES Era DES Era DES Diffusion

11. P < 0.001 for all

12. Class I Indications for CABG P < 0.001 for all

13. PCI Center Characteristics *P = 0.002, †P < 0.001

14. Pre-DES DES-Diffusion DES P < 0.001 34.7% As DES Use Increased, PCI Use Increased among Patients with Class I CABG Indications 29.4% 33.4%

15. P = 0.02 40  = 0.2 % / month  = 0.1% / month  = 0.1% / month 30 Pre-DES Pre-DES Predicted DES Diffusion DES Diffusion Predicted DES 20 0 10 20 30 40 50 60 70 Time (months) Rate of Increase of PCI in Patients with Class I CABG Indications was Greatest in the DES Era % of Patients Undergoing PCI

16. DES-Diffusion vs Pre-DES 1.21 (1.18, 1.24) DES vs DES-Diffusion 1.19 (1.16, 1.22) DES vs Pre-DES 1.44 (1.40, 1.48) 1 2 <<< Less Likely More Likely >>> PCI Attempted The Likelihood of PCI in Patients with Class I CABG Indications was Greatest in the DES Era

17. 1.4 10% increase in DES use associated with a 4 % increase in PCI 1.3 Likelihood of PCI 1.2 1.1 1 0 20 40 60 80 100 DES Use by Center (% of total PCI) Likelihood of PCI in Patients with Class 1 CABG Indications Increased with DES Adoption

18. Conclusions • Nationally, the widespread adoption of DES has been associated with an increased use of PCI among patients with AHA/ACC Class I indications for CABG. • This change in practice pattern precedes clinical trial evidence that may support PCI as the standard revascularization strategy in patients with severe multivessel coronary artery disease.

19. Limitations • Association study • Cannot determine causal relationship between DES use and increased PCI • Cannot exclude the effect of other PCI technologies or adjunctive therapies that may have increased the use of multivessel PCI.

20. Thank you afrutkin1@saint-lukes.org

21. Additional Slides

22. Multivariable, Hierarchical Model of PCI Likelihood in a Patient with Class I Indications for CABG