What to choose in stable CAD- Medical therapy only or PCI or CABG?

Samin K. Sharma, MD, FACC, FSCAI
Director, Clinical and Interventional Cardiology
President Mount Sinai Heart Network
Dean International Clinical Affiliation
Zena & Michael A. Wiener Professor of Medicine
Mount Sinai Hospital, New York, USA
What to choose in Stable CAD:
Medical Therapy Only or PCI or CABG
Disclosure: Speaker bureau for Abbott Vascular Inc, The Medicines Co.,
BSc, Angioscore, DSI/Lilly

What are the important clinical Questions
in Stable CAD?
• Does the patient have angina?
• Does the patient have ischemia?
• Does the patient have anatomic lesion concordant
with the ischemia (location)? Is lesion severe?
• Does the patient have anatomic lesions suitable
for revascularization; PCI vs. CABG?
• What is the optimal PCI strategy and endpoints?

• Appropriateness Use Criteria (AUC): PCI
vs. optimal medical therapy (GMT, MMT)
• Choice of Revascularization in Complex CAD:
CABG vs. PCI, or hybrid approach
Coronary Revascularization for Stable CAD:
Current Issues

Coronary Revascularization for Stable CAD:
Current Issues
• Appropriateness Use Criteria (AUC): PCI
vs. optimal medical therapy (GMT, MMT)
• Choice of Revascularization in Complex CAD:
CABG vs. PCI, or hybrid approach

Case# BP – 2/2/2010
• This is a 61 yr old male presenting with new onset mild
dyspnea and chest pain, CCS Class I
• Medical history: Angina CCS Class I, HTN, Hyperlipidemia;
Stress MPI suggestive of mild apical lateral ischemia. LVEF 60%
• Medications: ASA, Ramipril, Simvastatin
• Hemodynamics: LVEDP normal
I vessel CAD
Normal systolic LV dysfunction
No aortic stenosis

Cardiac Cath:
LM- Normal
LAD- Mild disease
LCx- Dominant
Mild disease
85% LPL1

Cardiac Cath:
LM- Normal
LAD- Mild disease
LCx- Dominant
Mild disease
85% LPL1
RCA- Non-dominant

Cardiac Cath:
LM- Normal
LAD- Mild disease
LCx- Dominant
Mild disease
85% LPL1
RCA- Non-dominant
LVEF- Normal

Current Treatment Breakdown (USA)
CDC MMWR Feb 16, 2007; Anderson et al, J Am Coll Cardiol 2002;39:1096
• 15 million Americans with reported
CAD (CDC survey)
• 2 million diagnostic caths yearly
• 1.2 million PCI (8% of CAD)
60% for UA
10% for AMI
30% for stable angina (ACC/NCDR)
• 350,000 CABG (2% of CAD)
• 13.5 million (approx 90%) remain
on medical therapy
ASA
Beta-blockers/Nitrates/Ca++
Statins
Blood pressure control
90% Medical
therapy
8% PCI
2% CABG

Trial Results: Medical Therapy vs. PCI in Stable CAD
Trial
Clinical Parameters
Mortality & MI Angina Relief
Repeat
Revascularization
RITA-2 No difference PCI PCI
ACME No difference PCI PCI
MASS No difference PCI No difference
AVERT No difference PCI No difference
MASS II No difference PCI No difference
COURAGE No difference PCI No difference
Superior Treatment Modality
Medical PCI No difference
‘PCI can be safely deferred in pts with stable CAD’
ACC/AHA PCI guidelines Circulation 2006

Optimal Medical Therapy with or without PCI
for Stable Coronary Disease: COURAGE Trial
Study Design
2287 patients
randomized
1149 pt assigned to PCI +
medical therapy group
Primary Outcome: Death and non-fatal MI at 5 yrs FU
Secondary Outcomes: Quality of life, use of
resources, cost-effectiveness
1138 pt assigned to
medical therapy
group
Boden et al. N Engl J Med 2007;356:1503

0
5
10
15
20
25
30
35
40
%
Death and MI Death, MI and Stroke Death Hospitalization for ACS Revascularization
19.0
P = 0.62
Optimal Medical Therapy with or without PCI
for Stable Coronary Disease: COURAGE Trial
Boden et al. N Engl J Med 2007;356:1503
Cumulative Rate of Events at 4.6 Yrs Follow-Up
PCI group (n = 1149)
Medical therapy group (n = 1138)
18.5
12.4 11.8
21.1
32.6
P = 0.56
P <0.001
7.6
20.0 19.5
8.3
P = 0.62
P = 0.38

COURAGE Trial: Nuclear Sub-study
Primary Endpoint of Death/MI @ 5Yrs: % with Ischemia
Reduction 5% Myocardium and it’s Impact (N = 314)
0
10
20
30
40
50
%
33.3 P = 0.004
19.8
(N = 159) (N = 155)
PCI + OMT OMT
Shaw L et al. Circulation 2008;117:1283
0
10
20
30
40
50
%
13.4
P = 0.037
24.7
(N = 82) (N = 232)
Ischemia reduction No ischemia reduction
>5%

Explanation for the Findings of COURAGE Trial
ACS/MI
(Unstable Plaque)
STABLE CAD
(Stable Plaque)
Vs.
 Thin fibrous cap
 Large lipid cores
 Fewer SMC
 More macrophages
 Less collagen
 Outward remodeling
(less occlusion)
 Thick fibrous cap
 Smaller lipid cores
 More SMC
 Few macrophages
 More collagen
 Inward remodeling
(more occlusion)
Plaque Rupture
MI/Death
Supply-Demand Mismatch
Ischemia/Angina
Treatment:
PCI
Medical Rx

ACCF/SCAI/STS/AATS/AHA/ASNC 2009
Appropriateness Criteria for Coronary
Revascularization
Patel et al. JACC 2009;53:530-553
Appropriateness Criteria for Coronary
Revascularization
Patel et al. JACC 2012;59:857.

Appropriateness Score Based on the
9-Point Continuum
• Appropriate Care, median score 7 to 9:
Procedures or treatments that fall into this category are considered an
appropriate option for individual care plans, although not always necessary,
depending on physician judgment and patient-specific preferences.
• May be Appropriate Care, median score 4 to 6:
Treatments or procedures in this classification are at times, an appropriate
option for management of patients in this population, due to variable
evidence or agreement regarding the benefits/risks ratio, potential benefit
based on practice experience in the absence of evidence; and/or variability in
the population.” Potential Efficacy of treatment in this category need to be
determined through consultation between the patient and the doctor based
on “clinical variables and patient preference.
• Rarely Appropriate Care, median score 1 to 3:
Treatments and conditions in this category are rarely an appropriate option
for management of patients in this population due to lack of a clear
benefit/risk advantage; rarely an effective option for individual car plans.
Exception should have documentation of the clinical reasons for proceeding
with this care option.

Appropriateness of Coronary Revascularization
Important Issues:
- Symptoms: asymptomatic, Class I-II vs. Class III-IV
- Non-invasive risk assessment: low, intermediate or high risk
- Maximal medical therapy: 2 Drugs-Nitrates, Ca+ B, B blocker or Ranexa
- Coronary Anatomy Findings

Appropriateness Criteria for Coronary Revascularization
Patel et al. JACC 2009;53:530-553
Grading of AP by the Canadian Cardiovascular Society Classification System
Class I
Ordinary physical activity does not cause angina, such as walking, climbing stairs. Angina
occurs with strenuous, rapid or prolonged exertion at work or recreation.
Class II
Slight limitation of ordiany activity. Angina occurs on walking or climbing stairs rapidly,
walking uphill, walking or stair climbing after meals or in cold, or in wind, or under
emotional stress, or only during the few hours after awakening. Angina occurs on walking
more than 2 blocks on the level and clilmbing more than one flight of ordinary stairs at a
normal pace and in normal condition.
Class III
Marked limitations in ordinary physical activity. Angina occurs on walking one to two
blocks on the level and climbing one flight of stairs in normal conditions and at a normal
pace.
Class IV
Inability to carry on any physical activity without discomfort – anginal symptoms may be
present at rest.

Patel et al. JACC 2009;53:530-553
Noninvasive Risk Stratification
High-Risk (greater than 3% annual mortality rate)
1. Severe resting left ventricular dysfunction (LVEF less than 35%)
2. High-risk treadmill score (score less than or equal to 11)
3. Severe exercise left ventricular dysfunction (exercise LVEF less than 35%)
4. Stress-induced large perfusion defect (particularly if anterior)
5. Stress-induced multiple perfusion defects of moderate size
6. Large, fixed perfusion defect with LV dilation or increased lung uptake (thallium-201)
7. Stress-induced moderate perfusion defect with LV dilation or increased lung uptake (thallium-201)
8. Echocardiographic wall motion abnormality (involving greater than two segments) developing at low
dose of dobutamine (less than or equal to 10 mg/kg/min) or at a low heart rate (less than 120 beats/min)
9. Stress echocardiographic evidence of extensive ischemia
Intermediate-Risk (1% to 3% annual mortality rate)
1. Mild/moderate resting left ventricular dysfunction (LVEF equal to 35% to 49%)
2. Intermediate-risk treadmill score (11 less than score less than 5)
3. Stress-induced moderate perfusion defect without LV dilation or increased lung intake (thallium-201)
4. Limited stress echocardiographic ischemia with a wall motion abnormality only at higher doses of
dobutamine involving less than or equal to two segments
Low-Risk (less than 1% annual mortality rate)
1. Low-risk treadmill score (score greater than or equal to 5)
2. Normal or small myocardial perfusion defect at rest or with stress
3. Normal stress echocardiographic wall motion or no change of limited resting wall motion
abnormalities during stress

Patel et al. JACC 2009;53:530-553
Appropriateness Ratings by Low-Risk Findings on Noninvasive
Imaging Study and Asymptomatic
Low Risk Findings on Noninvasive Study Asymptomatic
Symptoms
Med. Rx
Stress Test
Med. Rx
Class III or IV
Max Rx U A A A A High Risk
Max Rx U A A A A
Class I or II
Max Rx U U A A A
High Risk
No/min
Rx
U U A A A
Asymptomatic
Max Rx I I U U U Int. Risk
Max Rx U U U U A
Class III or IV
No/min Rx I U A A A
Int. Risk
No/min
Rx
I I U U A
Class I or II
No/min Rx I I U U U Low Risk
Max Rx I I U U U
Asymptomatic
No/min Rx I I U U U
Low Risk
No/min
Rx
I I U U U
Coronary
Anatomy
CTO of 1
vz; no
other
disease
1-2 vz.
disease;
no prox
LAD
1 vz.
Diseas
e of
prox
LAD
2 vz.
Diseas
e with
prox
LAD
3 vz.
diseas
e; no
Left
Main
Coronary
Anatomy
CTO of 1
vz; no
other
disease
1-2 vz.
disease;
no prox
LAD
1 vz.
disease
of prox
LAD
2 vz.
diseas
e with
prox
LAD
3 vz.
Disea
se; no
Left
Main

Patel et al. JACC 2009;53:530-553
Appropriateness Ratings by Intermediate-Risk Findings on
Noninvasive Imaging Study and CCS Class I or II Angina
Intermediate Risk Findings on Noninvasive Study CCS Class I or II Angina
Symptoms
Med. Rx
Stress Test
Med. Rx
Class III or IV
Max Rx A A A A A High Risk
Max Rx A A A A A
Class I or II
Max Rx U A A A A High Risk
No/min Rx U A A A A
Asymptomatic
Max Rx U U U U A Int. Risk
Max Rx U A A A A
Class III or IV
No/min Rx U U A A A Int. Risk
No/min Rx U U U A A
Class I or II
No/min Rx U U U A A Low Risk
Max Rx U U A A A
Asymptomatic
No/min Rx I I U U A Low Risk
No/min Rx I I U U U
Coronary
Anatomy
CTO of
1 vz; no
other
disease
1-2 vz.
disease;
no prox
LAD
1 vz.
diseas
e of
prox
LAD
2 vz.
disease
with
prox
LAD
3 vz.
disease;
no Left
Main
Coronary
Anatomy
CTO of
1 vz;
no
other
diseae
1-2 vz.
diseas
e; no
prox
LAD
1 vz.
diseas
e of
prox
LAD
2 vz.
diseas
e with
prox
LAD
3 vz.
diseas
e; no
Left
Main

Patel et al. JACC 2009;53:530-553
Appropriateness Ratings by High-Risk Findings on Noninvasive
Imaging Study and CCS Class III or IV Angina
High Risk Findings on Noninvasive Study CCS Class III or IV Angina
Symptoms
Med. Rx
Stress Test
Med. Rx
Class III or IV
Max Rx A A A A A
Class II or III
No/min Rx A A A A A
Asymptomatic
Max Rx U A A A A Int. Risk
Max Rx A A A A A
Class III or IV
No/min Rx A A A A A Int. Risk
No/min Rx U U A A A
Class I or II
No/min Rx U A A A A Low Risk
Max Rx U A A A A
Asymptomatic
No/min Rx U U A A A Low Risk
No/min Rx I U A A A
Coronary
Anatomy
CTO of
1 vz;
no
other
disease
1-2 vz.
diseas
e; no
prox
LAD
1 vz.
diseas
e of
prox
LAD
2 vz.
diseas
e with
prox
LAD
3 vz.
diseas
e; no
Left
Main
Coronary
Anatomy
CTO of
1 vz;
no
other
diseas
e
1-2 vz.
disease
; no
prox
LAD
1 vz.
diseas
e of
prox
LAD
2 vz.
diseas
e with
prox
LAD
3 vz.
disea
se; no
Left
Main

Case# BP – 2/2/2010
• This is a 61 yr old male presenting with new onset mild
dyspnea and chest pain, CCS Class I
• Medical history: Angina CCS Class I, HTN, Hyperlipidemia;
Stress MPI suggestive of mild apical lateral ischemia. LVEF 60%
• Medications: ASA, Ramipril, Simvastatin
• Hemodynamics: LVEDP normal
I vessel CAD
Normal systolic LV dysfunction
No aortic stenosis
No PCI was done as per guidelines.
Pt was discharged on Metoprolol XL 25mg daily and ISMN 30 mg daily

Case# BP – 4/23/2010
• Pt continued to have mild symptoms on Metoprolol XL/ISM
(not to say both patient and referring physician were upset with me)
• We brought patient back for elective PCI after 8 weeks of
MMT for continued symptoms

Cardiac Cath/PCI:
LM- Normal
LAD- Mild disease
LCx- Dominant
Mild disease
85% LPL1
RCA- Non-dominant
LVEF- Normal
PCI: Xience V DES
(3/28mm)

Case# BP – 4/23/2010
• Pt continued to have mild symptoms on Metoprolol and ISMN
(not to say both patient and referring physician were upset with me)
• We brought patient back for elective PCI for continued symptom
despite MMT
• Intervention: Successful intervention of LCx-LPL1 (DES – Xience V)
• Same day discharge with recommendations:
- ASA 81 mg daily lifelong and Prasugrel 5mg daily for 1 year
- Aggressive CAD risk factor modification
- Continue maximal medical therapy

0
10
20
30
40
50
60
70
80
90
100
84.6
11.6
1.1
11.2
0.3
38.0
4.1
98.6
50.4
Appropriate Uncertain Inappropriate
%
Appropriateness Use Criteria for PCI
ALL
ACS PCI (71%)
Elective PCI (29%)
AUC Criteria from ACC-NCDR Results (n=500,00)
Paul Chan. JAMA 2011;306:53.

Hannan E et al. JACC 2012;59:1870.

Appropriateness of Revascularization by PCI:
NY State vs. MSH for Stable CAD in 2010
38.4
48.2
13.4
51.8
44.6
3.7
0
10
20
30
40
50
60
70
Appropriate Uncertain Inappropriate
NYS NYS
NYS
MSH MSH
MSH
N Stable CAD % Not Rated %
NYS 14743 37.4 27.5
MSH 2575 62.3 13.7
%

MSH Appropriateness of Revascularization by PCI:
NYS Data Report
0
10
20
30
40
50
60
70
2010 2011 2012
51.8
59.8
66.6
%
Inappropriate Category of PCI
0
2
4
6
2010 2011 2012
3.7
4.7
3.9
Appropriate Category of PCI
%

Proportion of non-ACS PCI procedures at MSH classified
Inappropriate
AUC Metrics at MSH compared to US; ACC-NCDR
(n=1400 hospitals; >1.3 million PCIs) for Q1-3, 2013
Appropriateness of PCI
%

Referral for Invasive work up of Stable CAD Patient
Stable CAD scheduled for Cath
CCS Class III IV (<2 blocks < 1
flight ) and/or
High Risk Non Invasive study
(EF<35%, large perfusion)
NoYes
Appropriate
Class III
Angina
Appropriate > Antianginal
Asymptomatic or
Low Risk
Non Invasive Study
CCS Class I or II (> 2 blocks, > 1
flight) Not on MMT
Appropriate
Appropriate
Inappropriate
Intermediate on non invasive Study
(EF, Intermediate perfusion default
Appropriate
> 2Antianginal
If not
Inappropriate

Pattern and Intensity of Optimal Medical Therapy (OMT)
during PCI: Impact of COURAGE Trial:
Data from ACC-NCDR CathPCI Registry
0
10
20
30
40
50
60
70
80
90
100
PRE- COURAGE (n=173,416)
Post- COURAGE (n=293,795)
%
OMT Pre-PCI OMT Post-PCI
43.5
W Borden et al. JAMA 2011;305:1882
All Cases (N=467,211) COURAGE Trial type Cases (N=265,184)
40.0 41.1
61.8 64.3
44.7
63.5 66.0

Pattern and Intensity of Optimal Medical Therapy (OMT)
during PCI: Impact of COURAGE Trial:
Data fro ACC-NCDR CathPCI Registry
0
10
20
30
40
50
60
70
80
90
100
PRE- COURAGE (n=173,416)
Post- COURAGE (n=293,795)
%
43.5
W Borden et al. JAMA 2011;305:1882
All Cases (N=467,211) COURAGE Trial type Cases (N=265,184)
40.0 41.1
61.8 64.3
44.7
63.5 66.0
Implications: There is a large practice gap in medical care of PCI pts.
Important opportunity to develop innovative and aggressive strategies
to increase OMT in PCI pts, both before PCI (by referring MDs)
and
after PCI (by the Interventional team)

Schematic representation of various
functional hemodynamic measurements

Diagnostic IVUS
Intermediate or Inconclusive or Borderline
Angiographic Lesion in a Symptomatic Patient
Lumen CSA of <4mm2
Is associated with
Higher MACE
(for LM 6mm2)

FFR-guided PCI
Angio-guided PCI
Absolute Difference in MACE-Free Survival
5.3%
360 days
P=.02
FAME Trial: 1-Year Results
1. Improved outcomes
2. Decreased cost
3. Less contrast use
4. Similar procedure time
$6,007 vs $5,332, P<.001
Angio FFR
302 mL vs 272 mL, P<.001
70 min vs 71 min, P=.51
Tonino PA, et al. N Engl J Med. 2009;360:213
Avoid PCI of lesions
with FFR >0.80 even with
Angiographic >70% obst.

FAME II Trial: Flow Chart
Stable patients scheduled for 1,2 or 3 vessel DES stenting
FFR in all targets lesions
Follow-up after 1,6 months, 1,2,3,4 and 5 years
Randomized Trial Registry
At least 1 stenosis
with FFR < 0.80
When all FFR >0.80
OMT
OMTPCI + OMT
Randomization 1:1
50 % randomly
assigned to FU

FAME II Trial: Revascularization Status(%)
P<0.001
P<0.001
P<0.001
5.2% MT alone and 0.9% PCI
patients had MI or UA with ECG
changes requiring TVR
(HR 0.13; P=<0.001)
Bruyne et al., NEJM 2012:367:991

Optical Coherence Tomography (OCT):
Comparison of the 1st and 2nd Gen of Everolimus-
eluting Bioresorbable Vascular Scaffolds (BVS)

Baseline
Lesion LCBI: 259
Follow-up
Max10mm LCBI: 511
Max4mm LCBI: 802
Lesion LCBI: 177
Max10mm LCBI: 289
Max4mm LCBI: 474
Near Infra-Red Spectroscopy
Plaque Area
5.6mm2
Plaque Area
5.5mm2 FFR: 0.78
FFR: 0.74

Clinical Case: Complex Intervention of LM and MVD
• 73 yrs old M with new onset cresendo angina for one
month with mild SOB
• History: HTN, NIDDM, Hyperlipidemia, Recent (+)
MPS suggestive of septal/apical ischemia (LAD area)
• Medication: ASA, Metformin, Atorvastatin, Flomax
Started on Metoprolol XL 50 mg PO daily
• Referred for cardiac cath

• LM: distal 70-80% obstruction
• LAD: prox 80-90% obstruction
mid 50-60% obstruction
distal 70-80% obstruction
• LCx: prox 80-90% obstruction
OM1 – mild diffuse disease
OM2 90-95% obstruction
High lateral 30-50% obst.
Clinical Case: Complex LM and III V CAD

• LM: distal 70-80% obstruction
• LAD: prox 80-90% obstruction
mid 50-60% obstruction
distal 70-80% obstruction
• LCx: prox 80-90% obstruction
OM1 – mild diffuse disease
OM2 90-95% obstruction
High lateral 30-50% obst.

• RCA: 70% RPDA disease

• No wall motion abn,
no MR, LVEF 65%
Could not be enrolled
In FREEDOM Trial
Due to LM lesion

Complexity
Time Today
Complexity of PCI-treated Patients has
Historically Increased with Time
Left Main
3 V CAD (especially DM)
>1CTO
Bifurcation
Two Vessels
Small Vessels
Long Lesions
Single Vessel
CABG
PCI
Historically CABG is standard of care in patients
with Left Main & diffuse multi-vessel disease (especially in Diabetics)

• 73 yrs old M with new onset cresendo angina for one M
• History: HTN, NIDDM, Hyperlipidemia, Recent (+) MPS
suggestive of septal/apical ischemia (LAD area)
• Medication: ASA, Metformin, Atorvastatin, Flomax
started on Metoprolol XL 50mg, ISMN 30mg
• Cath: LVEDP normal, LVEF 65%, no AS
III vessel CAD
LM disease
Syntax score 32
What next?
CABG PCI with DES
Medical Rx

PCI (DES) vs. CABG for ULMCA Lesion
• Observational Data: - Main-Compare by Park
- Cedars-Sinai data by Lee
- Multicenter data by Chieffo
- Bolognese registry data
• Randomized Trials
- LEMANS Trial
- SYNTAX Trial (LM subset)
- PRE-COMBAT Trial

Limited Exclusion
Criteria
Previous
interventions (PCI or
CABG)
Acute MI with CPK>2x
Concomitant valve
De novo disease
Isolated left main
Revascularization in
all 3 vascular territories
3-vessel diseaseleft main +
1-vessel disease
left main +
2-vessel disease
left main +
3-vessel disease
Eligible Patients
SYNTAX Trial
Syntax Objective: To compare the MACCE rate at 12 months between patients
treated with TAXUS® stents vs. patients undergoing CABG for de novo 3VD
and/or LM disease. (*MACCE = major adverse cardiac and cerebrovascular
events; defined as death, stroke, MI, or repeat revascularization)
Serruys P et al. NEJM 2009;360:961.

• SYNTAX score is purely
an anatomic score of the
extent of CAD (>50%) in a pt
• Each lesion is assigned a
numerical number and then
sum of all lesions score
for a patient is
calculated to come up
with the final numerical
SYNTAX score
• Pt are divided in 3 groups:
Low <22
Intermediate 23-32
High >32

0
5
10
15
20
25
SYNTAX Trial: MACCE vs. SYNTAX Score
≤22 23-32 ≥33
MACCEat12Months(%)
14.7
13.6 12.0
16.7
10.9
23.4*†
SYNTAX Score
*P= 0.03 vs PCI with SYNTAX score ≤22
†P= 0.002 vs PCI with SYNTAX score 23-32
Trend for PCI: P=0.006
P < 0.001
CABG (n= 897)
TAXUS (n= 903)

CABG PCI P
Death 10.1% 8.9% 0.64
CVA 4.0% 1.8% 0.11
MI 4.2% 7.8% 0.11
Death,
CVA or
MI
14.9% 16.1% 0.81
Revasc 16.9% 23.0% 0.06
P=0.43
Overall
TAXUS (N=299)
CABG (N=275)
SYNTAX Trial: MACCE to 5 Years by
SYNTAX Score Tercile Low Scores (0-22)
32.1%
28.6%
Cumulative KM Event Rate ± 1.5 SE; log-rank P value
Months Since Allocation
CumulativeEventRate(%)
0 12 24
50
0
25
4836 60
Mohr et al., Lancet 2013;381:629.

CABG PCI
P
value
Death 12.7% 13.8% 0.68
CVA 3.6% 2.0% 0.25
MI 3.6% 11.2% <0.001
Death,
CVA or
MI
18.0% 20.7% 0.42
Revasc 12.7% 24.1% <0.001
Overall
TAXUS (N=310)
CABG (N=300)
SYNTAX Trial: MACCE to 5 Years by SYNTAX
Score Tercile Intermediate Scores (23-32)
36.0%
25.8%
Months Since Allocation
0 12 24
50
0
25
4836 60
P=0.008

Overall
TAXUS (N=290)
CABG (N=315)
SYNTAX Trial: MACCE to 5 Years by SYNTAX
Score Tercile High Scores (33)
P<0.001
44.0%
26.8%
CABG PCI
P
value
Death 11.4% 19.2% 0.005
CVA 3.7% 3.5% 0.80
MI 3.9% 10.1% 0.004
Death,
CVA or
MI
17.1% 26.1% 0.007
Revasc 12.1% 30.9% <0.001Months Since Allocation
0 12 24
50
0
25
4836 60

16 withdrew post-procedure
43 were lost to follow-up
947 Randomized to CABG*
18 underwent PCI/DES
26 withdrew prior to procedure
3 died prior to procedure
7 underwent neither PCI/DES or
CABG
953 Randomized to PCI/DES*
5 underwent CABG
3 withdrew prior to procedure
3 died prior to procedure
3 underwent neither PCI/DES or
CABG
FREEDOM Trial: TRIAL SCREENING & ENROLLMENT
32,966 Patients were screened for eligibility
3,309 were eligible (10%)
1,409 did not consent 1,900 consented (57%)
36 withdrew post-procedure
51 were lost to follow-up
*953 and 947 included ITT analysis using all available follow-up time post-randomization
Farkouh et al., N Engl J Med 2012;367:2375.

FREEDOM Trial: BASELINE CHARACTERISTICS
Characteristic PCI/DES CABG P-value
Angina 0.25
Stable 68% 71%
Unstable 32% 30%
LV Ejection Fraction (< 30%) 0.8% 0.3% 0.28
LV Ejection Fraction (< 40%) 3% 2% 0.07
EuroSCORE 2.7 ± 2.4 2.8 ± 2.5 0.52
SYNTAX score 26.2 ± 8.4 26.1 ± 8.8 0.77
No. of lesions 5.7 ± 2.2 5.4 ± 2.5 0.33
Chronic total occlusion 6% 6% 0.99
Bifurcation 22% 21% 0.06
Farkouh et al., N Engl J Med 2012;367:2375.

FREEDOM Trial: Estimates of Key Outcomes at
5 Years after Randomization
Primary Death MI Stroke CV Death
Endpoint
%
p=0.005
p=0.049
p=<0.001
p=0.003
p=0.12
PCI (n=943)
CABG (n=957)
Farkouh et al., N Engl J Med 2012;367:2375

FREEDOM Trial: SYNTAX Score Interaction
Farkouh et al., N Engl J Med 2012;367:2375

ACCF/AHA/SCAI Guidelines for Coronary Revascularization 2011:
Heart Team Approach to
UPLM or Complex CAD
GNL 2011

J Am Coll Cardiol 2014 Jul 18 and Circulation 2014 Jul 28 [Epub ahead of print]

Recommendation for CAD Revascularization
to Improve Survival
2012 Recommendations 2014 Focused Updated Recommendation Comment
Class lla Class l
1. CABG is probably
recommended in preference
to PCI to improve survival in
patients with multiple CAD
and diabetes mellitus,
particularly if a LIMA graft
can be anastomosed to the
LAD artery. (Level of
Evidence: B)
1. A Heart Team approach to
revascularization is recommended in
patients with diabetes mellitus and
complex multivessel CAD. (Level of
Evidence: C)
2. CABG is generally recommended
in preference to PCI to improve
survival in patients with DM and
multivessel CAD for which
revascularization is likely to
improve survival (3-vessel CAD or
complex 2-vessel CAD involving
the proximal LAD). Particularly if a
LIMA graft can be anastomosed to the
LAD artery, provided that patient is a
good candidate for surgery. (LOC: B)
Modified
recommendation
(changed Class of
Recommendation
from lla to l).
J Am Coll Cardiol 2014 Jul 18 and Circulation 2014 Jul 28 [Epub ahead of print]
New Recommendation

CABG PCI
Two-vessel CAD with proximal LAD stenosis A A
Three Vessel CAD with low CAD burden (i.e., three
focal stenosis, low SYNTAX score) A A
Three-vessel CAD with intermediate to high CAD burden (i.e., multiple
diffuse lesions, presence of CTO, or high SYNTAX score >32)/DM A U/I
Isolated left main stenosis A U
Left main stenosis and additional CAD with low CAD burden (i.e., one to two
vessel additional involvement, low SYNTAX score <33)
A U
Left main stenosis and additional CAD with intermediate to high
CAD burden (i.e., three vessel involvement, presence of CTO, or high
SYNTAX score >32)
A I
Method of Revascularization of Multi-vessel
and LM Coronary Artery disease

Update in the incorporation of SYNTAX Score and FREEDOM
Trial results for revascularization choices in patients with
extensive CAD
Following group of pts with complex CAD should be offered CABG as the first
choice for coronary revascularization;
1. Three vessel CAD and Syntax score >32
2. Three vessel CAD with prox LAD involvement and Syntax score >22
3. Three vessel CAD in a diabetic pt (irrespective of Syntax score or LAD location
4. Two vessel CAD in a diabetic pt with prox LAD involvement and Syntax >22
5. ULM CAD with Syntax score >32
•Patients with following co-morbidities could be excluded from routine CTS consultations:
1) Acute MI (STEMI or Non-STEMI)
2) Age >80 years old
3) Prior CVA/recent TIA
4) Severe COPD (FEV1 <1L) and on chronic bronchodilator therapy
5) BMI >50
6) Participation in IRB approved trial of PCI
•Also patient’s firm refusal for CABG should be entertained only after the CT surgery consultation outside the cath
room in the holding area or the telemetry unit.

Global Risk Classification (GRC) for CAD
Capodanno et al, Am Heart J 2010; 159:103

3VD vs LM COPD PVDGender
Syntax score Age CrCl LVEFPint = 0.30
Pint = 1.0
All other interaction P values <0.10
PCI
CABG
2
1
0
-1
-2
0 20 40 60
PCI
CABG
60 70 80 90
PCI
CABG
0 30 60 12090
PCI
CABG
10 20 30 5040 60
3VD LMS
PCI
CABG
F M
PCI
CABG
No Yes
PCI
CABG
No Yes
PCI
CABG
SYNTAX Score II: Designed to Objectively
Discriminate Between CABG and PCI
Interactions
LogHRLogHR
2
1
0
-1
-2
Farooq V et al. Lancet 2013;381:639.

6 month FU

EXCEL Trial (Evaluation of Xience Prime vs. CABG
for Examination of LM Disease)
LM disease (±1, 2 or 3 vessel disease) and a
SYNTAX score of ≤32
Randomize 2600 pts
ABBOTT Vascular
XIENCE Prime stent CABG
• The primary endpoint is the composite incidence of death, large MI or stroke at a
median FU duration of 3 years, powered for sequential non-inferiority and
superiority testing.
• The major secondary endpoint is the composite incidence of death, MI, stroke or
unplanned repeat revascularization. All patients will be followed for 5 years total.
Trial has finished enrollment
After 1800 cases

The Ischemia Trial
~8,600 patients with moderate to severe
ischemia by non-invasive testing
Blinded CT scan to rule out LM disease or normal coronaries
R
Invasive Strategy
(OMT + Cath, followed by PCI
or CABG as appropriate
Optimal Medical Therapy
(OMT – cath reserved for
refractory ischemia)
Primary endpoint: CV death or MI @ 5-Yrs
Major secondary endpoint: QOL
NHLBI funded

51258
NY State Annual Revascularization Volumes:
2004-2007-08-10-11-13
PCI vs. CABG
N
50046
51677
58178
59976
53223
14692
12988
11884 10324
11124
2003 2004 2005 2006 2007 2008 2009 2010 2011 2012-2103
70000
60000
50000
40000
30000
20000
10000
0
YEAR
PCI
CABG
11.3%
7.2%
54542
9985
17.4%
-AUC
Use
55158
9885
55758
9785 9685
47459
9562

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