1 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. Frutkin 1, Sameer K. Mehta 1, John House 1, John A. Spertus 1, David J. Cohen 1, John Rumsfeld 2, Steven P. Marso 1 presented on behalf of the NCDR 1 Mid America Heart Institute, University of Missouri-Kansas City 2 Denver Veterans Administration Medical Center, University of Colorado AHA Scientific Sessions, November 5, 2007

2 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 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 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: –Gogo et al. AJC. 2007:99: Randomized trials (SYNTAX, FREEDOM) will compare multivessel PCI with DES versus CABG.

5 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 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 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 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: –DES era 1/1/2005 to 9/30/2006, prior to FDA meeting on DES safety

9 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 DES Era DES Diffusion Pre-DES Era

11 Characteristics Pre-DES N = 67, 316 DES-Diffusion N = 97, 402 DES N = 100, 310 Age 67  12 Men67.8 %68.0 %68.6 % Caucasian89.8 %88.8 %86.6 % Acute coronary syndrome59.6 %57.5 %59.4 % Diabetes mellitus34.8 %35.1 %35.3 % Renal failure5.8 %6.7 %6.9 % Cerebral vascular disease13.5 %13.3 %12.7 % Peripheral vascular disease15.8 %14.6 %13.2 % Prior myocardial infarction20.5 %18.7 %16.4 % Current CHF14.4 %14.9 %15.1 % Ejection fraction < 50%48.1 % 49.7 % Diseased vessels15.3 %5.2 %5.3 % % 32.7 % %62.4 %62.0 % P < for all

12 Class I Indications for CABG Pre-Des N = 67, 316 DES-Diffusion N = 97, 402 DES N = 100, 310 Left main > 50% 15.8 %16.5 %17.3 % Left main equivalent 24.7 %24.6 %24.7 % 3 vessel disease > 50% 32.6 % 31.5 % Proximal LAD > 50% and LVEF < 50% 10.6 %10.2 %10.4 % 2 or more vessels > 50% and LVEF < 50% 9.8 %9.2 %9.7 % Angina, + stress test, and 2 vessels with proximal LAD >50% 6.5 %6.9 %7.4 % P < for all

13 PCI Center Characteristics Pre-DES 306 Centers DES-Diffusion 418 Centers DES 367 Centers # of PCI / center 833 ± ± ± 636 * PCI > 400 / center 71% 67% Onsite CABG 93%91%85% † Profit Type Government 1.6%1.4% Community 91% 92% University 7.2% 7.1% *P = 0.002,  † P < 0.001

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

15 Rate of Increase of PCI in Patients with Class I CABG Indications was Greatest in the DES Era % of Patients Undergoing PCI Time (months) Pre-DES Predicted DES Diffusion Predicted Pre-DES  = 0.1% / month DES Diffusion  = 0.1% / month DES  = 0.2 % / month P = 0.02

16 The Likelihood of PCI in Patients with Class I CABG Indications was Greatest in the DES Era 12 DES vs DES-Diffusion DES vs Pre-DES DES-Diffusion vs Pre-DES 1.21 (1.18, 1.24) 1.44 (1.40, 1.48) 1.19 (1.16, 1.22) <<< Less Likely PCI Attempted More Likely >>>

17 Likelihood of PCI in Patients with Class 1 CABG Indications Increased with DES Adoption 10% increase in DES use associated with a 4 % increase in PCI DES Use by Center (% of total PCI) Likelihood of PCI

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

21 Additional Slides

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