Embed Size (px)
DESCRIPTION
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. - PowerPoint PPT Presentation
Citation preview
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. 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 City2Denver Veterans Administration Medical Center, University of
ColoradoAHA 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: noneJohn House: noneJohn 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: 868-872– Gogo et al. AJC. 2007:99: 1222-1226
• 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;97:1478-1481.
– 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 variablesAge, 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
10
Proportion of DES Use Per Total PCI
DES EraDES DiffusionPre-DES Era
11
CharacteristicsPre-DES
N = 67, 316
DES-DiffusionN = 97, 402
DESN = 100,
310
Age 67 12 67 12 67 12
Men 67.8 % 68.0 % 68.6 %
Caucasian 89.8 % 88.8 % 86.6 %
Acute coronary syndrome
59.6 % 57.5 % 59.4 %
Diabetes mellitus 34.8 % 35.1 % 35.3 %
Renal failure 5.8 % 6.7 % 6.9 %
Cerebral vascular disease
13.5 % 13.3 % 12.7 %
Peripheral vascular disease
15.8 % 14.6 % 13.2 %
Prior myocardial infarction
20.5 % 18.7 % 16.4 %
Current CHF 14.4 % 14.9 % 15.1 %
Ejection fraction < 50% 48.1 % 48.1 % 49.7 %
Diseased vessels 1 5.3 % 5.2 % 5.3 %
2 32.4 % 32.4 % 32.7 %
3 62.2 % 62.4 % 62.0 %
P < 0.001 for all
12
12
Class I Indications for CABGPre-DesN = 67,
316
DES-DiffusionN = 97, 402
DESN = 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 % 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 < 0.001 for all
13
13
PCI Center CharacteristicsPre-DES
306 Centers
DES-Diffusion418 Centers
DES367
Centers
# of PCI / center 833 ± 628
842 ± 665 754 ± 636
*
PCI > 400 / center
71% 71% 67%
Onsite CABG 93% 91% 85% †Profit Type
Government 1.6% 1.4% 1.4%Community 91% 91% 92%
University 7.2% 7.2% 7.1%*P = 0.002, †P < 0.001
14
14
As DES Use Increased, PCI Use Increased among Patients with Class I CABG
IndicationsPre-DES DES-Diffusion DES29.4% 33.4% 34.7% P < 0.001
15
15
Rate of Increase of PCI in Patients with Class I CABG Indications was Greatest in
the DES Era
% o
f P
atie
nts
Un
der
go
ing
PC
I
0 10 20 30 40 50 60 70Time (months)
20
30
40
Pre-DES Predicted
DES Diffusion Predicted
Pre-DES
= 0.1% / month
DES Diffusion
= 0.1% / month
DES
= 0.2 % / monthP = 0.02
16
16
The Likelihood of PCI in Patients with Class I CABG Indications was Greatest in
the DES Era
1 2
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 LikelyPCI Attempted
More Likely >>>
17
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
0 20 40 60 80 100
1
1.1
1.2
1.3
1.4
DES Use by Center (% of total PCI)
Lik
elih
oo
d o
f P
CI
18
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
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.
21
21
Additional Slides
22
22
Multivariable, Hierarchical Model of PCI Likelihood in a Patient with Class I Indications
for CABG
