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Revascularization in
Multivessel Disease: PCI vs. CABG for Non-Diabetic and
Diabetic Patients
Alan C. Yeung, MD
Medical Director, Cardiovascular Institute
Stanford University School of Medicine
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COURAGE2,287 stable patients with 1,2 or 3 vessel CAD
Randomized to optimal medical therapy or PCI
Boden et al., New Engl J Med 2007;356:1503-16.
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BARI-2D
BARI 2D Investigators. N Engl J Med 2009;360:2503-15.
2,368 stable CAD patients randomized
between CABG vs OMT or PCI vs OMT
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Importance of IschemiaAverage of only 8.2% ischemic myocardium in PCI arm of COURAGE
< 1/3 of patients had ≥ 10% ischemic myocardium!
Shaw, et al. Circulation 2008;117:1283-91.
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Hachamovitch, et al. Circulation 2003;107:2900-06.
With greater degrees of ischemia, there is a survival benefit for revascularization
P<0.001
Importance of Ischemia
10% Ischemic
Myocardium
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Assuming a large burden of ischemic
myocardium…
…what is the role for PCI or CABG?
…and how does diabetes impact the
decision?
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CABG vs. PCI: NY Registry
Hannan et al. New Engl J Med 2005;352:2174-83
Adjusted
Over 50,000 patients in NY state treated with either PCI or CABG
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CABG vs. PCI: ASCERT Registry
Weintraub, et al. New Engl J Med 2012;366:1457-76.
~ 189,000 stable patients ≥65 years old treated with either PCI or CABG
CABG
PCI
Mortality after propensity matching
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Randomized Trials
Hlatky, et al. Lancet 2009;373:1190-97.
Meta-Analysis of 10 randomized CABG vs. PCI trials
including >7,000 patients
Death
p=NS
Death or MI
p=NS
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Hlatky, et al. Lancet 2009;373:1190-97.
Impact of Diabetes
Meta-Analysis of CABG vs. PCI Trials
CABG and PCI
No Diabetes
CABG Diabetes
PCI Diabetes
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Hlatky, et al. Lancet 2009;373:1190-97.
Impact of Age
Meta-Analysis of CABG vs. PCI Trials
CABG and PCI
<55 Years
CABG 55-64 Years
PCI 55-64 Years
PCI ≥65 Years
CABG ≥65 Years
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SYNTAX Trial:
1800 patients with 3 vessel CAD randomized
to PCI with Taxus drug-eluting stents or
CABG
~28% diabetic
~33% with LM disease
4.6 stents per patient
Average of 86 mm of stent (1/3 with >100 mm)
Serruys, et al. N Engl J Med 2009;360:961-72
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SYNTAX
All-Cause Death at 12 Months
Serruys, et al. N Engl J Med 2009;360:961-72
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SYNTAX
Death from any cause, stroke or MI
Serruys, et al. N Engl J Med 2009;360:961-72
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SYNTAX
Repeat Revascularization at 12 months
Serruys, et al. N Engl J Med 2009;360:961-72
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SYNTAX
MACCE at 12 months
Serruys, et al. N Engl J Med 2009;360:961-72
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SYNTAX Score
Serruys, et al. N Engl J Med 2009;360:961-72
No. &
Location
of lesionLeft
Main
Tortuosity
3 VesselThrombus
BifurcationCTO
Calcification
SYNTAX
SCORE
Dominance
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SYNTAX
Similar outcomes with PCI vs CABG with lower SYNTAX score
Serruys, et al. N Engl J Med 2009;360:961-72
Lowest Tertile (SYNTAX score ≤ 22)
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SYNTAX
Worse outcomes with PCI vs CABG with higher SYNTAX score
Serruys, et al. N Engl J Med 2009;360:961-72
Intermediate Tertile (SYNTAX score 23-32)
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SYNTAX
Worse outcomes with PCI vs CABG with higher SYNTAX score
Serruys, et al. N Engl J Med 2009;360:961-72
High Tertile (SYNTAX score ≥ 33)
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SYNTAX: MACCE by Subgroup
CABG PCI
All LMN=705
LM+1VDN=138
LM isolatedN=91
LM+2VDN=218
LM+3VDN=258
3VD (All)N=1095
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SYNTAXOutcomes at 3 years: 3-Vessel Disease
Kappetein, et al. Eur Heart J 2011;32:2125-34
PCI
CABG
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SYNTAXOutcomes at 3 years: Diabetics
Kappetein, et al. Eur Heart J 2011;32:2125-34
PCI
CABG
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SYNTAX
5 Year Outcomes: All Cause Mortality
Mohr, et al. Lancet 2013;381:629-38
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SYNTAX
5 Year Outcomes: Myocardial Infarction
Mohr, et al. Lancet 2013;381:629-38
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SYNTAX
5 Year Outcomes: Stroke
Mohr, et al. Lancet 2013;381:629-38
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SYNTAX
5 Year Outcomes: Death, Stroke, or MI
Mohr, et al. Lancet 2013;381:629-38
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SYNTAX
5 Year Outcomes: Revascularization
Mohr, et al. Lancet 2013;381:629-38
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SYNTAX
5 Year Outcomes: MACCE
Mohr, et al. Lancet 2013;381:629-38
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SYNTAX
5 Year Outcomes: Lowest SYNTAX Tertile (0-22)
Mohr, et al. Lancet 2013;381:629-38
All Patients 3-Vessel CAD only
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SYNTAX
5 Year Outcomes: Middle SYNTAX Tertile (23-32)
Mohr, et al. Lancet 2013;381:629-38
All Patients 3-Vessel CAD only
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SYNTAX
5 Year Outcomes: Highest SYNTAX Tertile (>32)
Mohr, et al. Lancet 2013;381:629-38
All Patients 3-Vessel CAD only
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FREEDOM Trial
2005-2010: 1900 diabetics enrolled from 140
international centers
Mostly first generation drug-eluting stents
Mean SYNTAX score = 26
3.5 lesions stented/patient
Farkouh, et al. N Engl J Med 2012;367:2375-84
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FREEDOM Trial
Farkouh, et al. N Engl J Med 2012;367:2375-84
Early Outcomes
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FREEDOM Trial
Farkouh, et al. N Engl J Med 2012;367:2375-84
Late Outcomes
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FREEDOM Trial
Farkouh, et al. N Engl J Med 2012;367:2375-84
Mortality
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What have we learned?
Older patients, patients with more severe
CAD, and diabetics fare better with CABG
when compared to angiography-guided PCI
with first generation drug-eluting stents.
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How do we explain this?
Gersh and Frye. New Engl J Med 2005;352:2235
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Where do we go from here?
Stone GW. TCT 2012
3 Year Mortality Benefit of 2nd Generation DES
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Where do we go from here?
Stone GW. TCT 2012
3 Year MI Benefit of 2nd Generation DES
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Where do we go from here?
Distal
Pressure (Pd)
Proximal
Pressure (Pa)
FFR = Pd / Pa
during maximal flow
Pd
Pa
Pd / Pa = 60 / 100
FFR = 0.60
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New Engl J Med 2009;360:213-24.
3
8.79.5
11.1
18.3
1.8
5.76.5
7.3
13.2
0
5
10
15
20
Death MI Repeat
Revasc
Death/MI MACE
Angio-Guided FFR-Guided
p=0.02p=0.04
%
~40%
~35% ~30%
~35%
~30%
FAME Study: One Year Outcomes1005 patients with 2-3 vessel CAD randomized to angio or FFR-guided PCI
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FFR-Guided
Angio-Guided
730 days
4.5%
Pijls, et al. J Am Coll Cardiol 2010;56:177-184
FAME Study: Two Year OutcomesDeath/MI was significantly reduced from 12.9% to 8.4% (p=0.02)
Survival Free of MACE
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3VD (14%)
0VD (9%)
1VD (34%) 2VD (43%)
Angiographic
3 Vessel
Disease
Tonino, et al. J Am Coll Cardiol 2010;55:2816-21
Anatomic vs. Functional CAD
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Patel, et al. JACC 2012;59:857-881
Recently published Appropriate Use Criteria
Impact of SYNTAX Score on PCI
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Can we enhance the SYNTAX Score?
By incorporating FFR into the SYNTAX score,
termed “Functional SYNTAX Score” (FSS),
can we:
Convert high/medium risk SYNTAX score patients
to a lower risk group?
Improve our risk stratification of patients with
multivessel CAD undergoing PCI?
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Nam CW, et al. J Am Coll Cardiol 2011;58:1211-8
Functional SYNTAX Score
Without FFR
Reclassifies > 30% of Cases
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Nam CW, et al. J Am Coll Cardiol 2011;58:1211-8
Functional SYNTAX Score
Without FFR With FFR
Reclassifies > 30% of Cases
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P < 0.01
Functional SYNTAX Score
Nam CW, et al. J Am Coll Cardiol 2011;58:1211-8
32%
20%
34%59%
Discriminates Risk for Death/MI
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Where do we go from here?
By utilizing current generation DES
Applying FFR guidance to optimize ischemia
reduction and minimize stent complications
Optimizing medical therapy once ischemia has
been relieved to reduce plaque progression
Can we improve the results of PCI vs. CABG?
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FAME 3 Trial:All Comers with 3 V CAD
(not involving LM)
Heart team identifies lesions for PCI/CABG
and then patient is randomized
FFR-Guided PCI with 2nd Gen DES
Stent all lesions with FFR ≤ 0.80
(n=750)
Perform CABG based on
coronary angiogram
(n=750)
One Year follow-up for MACCE
Three Year follow-up for Death/MI/CVA