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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.

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slide1

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

authors disclosures
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.
background
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.
background1
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.
hypothesis
Hypothesis

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

methods 1
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
methods 2
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
methods 3
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

methods 4
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.
proportion of des use per total pci
Proportion of DES Use Per Total PCI

Pre-DES Era

DES Era

DES Diffusion

pci center characteristics
PCI Center Characteristics

*P = 0.002, †P < 0.001

as des use increased pci use increased among patients with class i cabg indications

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%

slide15

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

the likelihood of pci in patients with class i cabg indications was greatest in the des era

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
likelihood of pci in patients with class 1 cabg indications increased with des adoption

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
conclusions
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.
limitations
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.
slide20
Thank you

afrutkin1@saint-lukes.org

multivariable hierarchical model of pci likelihood in a patient with class i indications for cabg
Multivariable, Hierarchical Model of PCI Likelihood in a Patient with Class I Indications for CABG