Left Main Revascularization

in the US: Guidelines,

Appropriate Use Criteria
and Standards of Care
J effrey W. Moses, MD
Columbia University Medical Center
The Cardiovascular Research Foundation
Disclosure Statement of Financial Interest
I, Jeffrey W. Moses, MD am a consultant
with BSC (Consulting Fees/Honoraria)


Unprotected Left Main PCI in the US
NCDR PCI Registry:
4800 Left Main PCIs in 2011
Resources for Guidance
ACCF/AHA Guidelines
UAP/NSTEMI
SIHD
PCI
CABG
STEMI
ESC Guidelines
Revascularization
ACS
STEMI
Stable CAD
AUC
Angiography
Revascularization
GNL 2011
UPLM PCI to Improve Survival:
Setting of Acute Coronary Syndrome
Class Of Recommendation
LOE
IIaFor UA/NSTEMI if not a
CABG candidate
B
IIaFor STEMI when distal coronary
flow is <TIMI grade 3 and PCI can
be performed more rapidly and
safely than CABG
C
GNL 2011
Heart Team Approach for
UPLM (Unprotected Left Main)
or Complex CAD Revascularization
GNL 2011
UPLM Revascularization
to Improve Survival
Revasc
Method
Class Of Recommendation
LOE
CABG I B
PCI
IIaFor SIHD when low risk of PCI complications and high likelihood of good
long-term outcome (e.g., SYNTAX score of 22, ostial or trunk left main
CAD), and a signficantly increased CABG risk (e.g., STS-predicted risk of
operative mortality 5%)
B
IIbFor SIHD when low to intermediate risk of PCI complications and
intermediate to high likelihood of good long-term outcome (e.g., SYNTAX
score of <33, bifurcation left main CAD) and increased CABG risk (e.g.,
moderate-severe COPD, disability from prior stroke, prior cardiac surgery,
STS-predicted operative mortality >2%)
B
III: HarmFor SIHD in patients (versus performing CABG) with unfavorable
anatomy for PCI and who are good candidates for CABG
B
IIaFor UA/NSTEMI if not a CABG candidate
B
IIaFor STEMI when distal coronary flow is <TIMI grade 3 and PCI can be
performed more rapidly and safely than CABG
C
UPLM PCI to Improve Survival (SIHD)
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Class Of Recommendation
LOE
IIaFor SIHD when low risk of PCI complications
and high likelihood of good long-term outcome (e.g.,
SYNTAX score of 22, ostial or trunk left main CAD),
and a signficantly increased CABG risk (e.g., STS-
predicted risk of operative mortality 5%)
B
IIbFor SIHD when low to intermediate risk of PCI
complications and intermediate to high likelihood of
good long-term outcome (e.g., SYNTAX score of <33,
bifurcation left main CAD) and increased CABG risk
(e.g., moderate-severe COPD, disability from prior
stroke, prior cardiac surgery, STS-predicted operative
mortality >2%)
B
III: HarmFor SIHD in patients (versus performing
CABG) with unfavorable anatomy for PCI and who
are good candidates for CABG
B
Low
Hi
Hi Hi
Low Low
What About High
Risk for PCI
and CABG?
SIRTAX: SYNTAX Score Is Not a
Measure of Absolute Risk: Different
Stent, Different Outcomes
Girasis et al, Euro Heart J
2011; in press
M
A
C
E

1
Y

P=0.21
D
E
A
T
H

1
Y

P=0.35 P=0.95
CSS
LOW
n=282
60
%
CSS
MID
n=283
CSS
HIGH
n=283
P=0.001 P=0.98 P=0.46
50
40
30
20
10
0
9.0
SES PES
23.9
8.6
7.5
7.3
6.6
CSS
LOW
n=282
60
CSS
MID
n=283
CSS
HIGH
n=283
50
40
30
20
10
0
1.4
SES PES
4.9
2.1
0.0
0.7
1.5
0
Months Months
2-year HR
0.63 [0.49, 0.82]
p=<.001
5.6%
3.5%
2.1%
10.4%
5.9%
4.5%
2-year HR
0.56 [0.37, 0.82]
p=0.003
Multi-Vessel Treatment Single Vessel Treatment
XIENCE V
TAXUS
0 3 6 9 12 15 18 21 24

C
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D
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h
,

M
I

(
%
)

0
0 3 6 9 12 15 18 21 24
Number at Risk
XV
T
3457
2008
3357
1917
3273
1870
3194
1821
2746
1619
Number at Risk
790
532
760
491
738
475
724
458
656
417
5
10
15
5
10
15
Cardiac Death or MI Through 2 Years:
SPIRIT II,III,IV,COMPARE
Absolute Benefit Proportional to Anatomic Complexity
1-year HR
0.65 [0.47, 0.89]
p=0.006
3.7%
2.4%
1.3%
7.6%
3.8%
3.8%
1-year HR
0.49 [0.31, 0.79]
p=0.003
P
interaction
=0.58
Kereiakes et al. J ACC
2011;57:E1622
Kereiakes et al. J ACC Card Int
2010;3:1229
Sirolimus
Everolimus
SCAAR: EES vs. Gen 1 DES Diabetes
Mortality
Kedhi et al, J ACC 2012;
5:1141-1149
Vs. SES Vs. PES
HR 1.69; 95%CI: (1.06-2.72)
Time in months
Pacitaxel
Everolimus
0.00
0.02
0.04
0.06
0.08
0 3 6 9 12
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HR 2.02; 95%CI: (1.03-3.98)
Time in months
0.00
0.02
0.04
0.06
0.08
0 3 6 9 12
Montalescot et al, Euro Heart J
2013;34:2949-3003
Indications for Revascularization in
Stable Angina or Silent Ischemia
* With documented ischemia or Fractional Flow Reserve (FFR) <0.80 for angiographic diameter stenosis 50-90%
Subset of CAD by Anatomy Class Level
Left main >50%* I A
Any proximal LAD >50%* I A
2VD or 3VD with impaired LV function* I B
Proven large area of ischemia (>10% LV) I B
Single remaining patent vessel >50% stenosis* I C
I VD without proximal LAD and without >10% ischemia III A
For
prognosis
For
symptoms
Subset of CAD by Anatomy Class Level
Any stenosis >50% with limiting angina or angina
equivalent, unresponsive to OMT
I A
Dyspnoea/CHF and >10% LV ichemic/viability supplied
by >50% stenotic artery
IIa B
No limit symptoms with OMT III C
European Heart J ournal, 2010;31:2501-2555
European J ournal of Cardio-thoracic Surgery, 2010;38:S1-S52
Joint 2010 ESC EACTS
Guidelines on Myocardial
Revascularization
Indications for CABG vs. PCI in Stable Patients with
Lesions Suitable for Both Procedures and Low
Predicted Surgical Mortality
In the most severe patterns of CAD, CABG appears to offer a
survival advantage as well as a marked reduction in the need for
repeat revascularization
Joint 2010 ESC EACTS
Guidelines on Myocardial
Revascularization
Subset of CAD by Anatomy Favors CABG Favors PCI
1 VD or 2VD non-proximal LAD IIb C I C
1 VD or 2VD proximal LAD I A IIa B
3VD simple lesions, full functional revascularization
achievable with PCI, SYNTAX score <22
I A IIa B
3VD simple lesions, incomplete revascularization achievable
with PCI, SYNTAX score >22
I A III A
Left main (isolated or 1 VD, ostium/shaft) I A IIb B
Left main (isolated or 1 VD, distal bifurcation) I A IIb B
Left main + 2VD or 3VD, SYNTAX score <32 I A IIb B
Left main + 2VD or 3VD, SYNTAX score >33 I A III B
Montalescot G, et al.
Eur Heart J 2013;
34:2949-3003
PCI or CABG in SIHD with Ischemia
PCI or CABG in SIHD with LM Disease
Montalescot G, et al.
Eur Heart J 2013;
34:2949-3003
CABG PCI
Subset of CAD by anatomy ESC ACC ESC ACC
Heart team Approach for LM or complex CAD
I C I C I C I C
LM (isolated or 1VD, ostium/shaft)
I A I B IIa B IIa B
LM (isolated or 1VD, distal bifurcation)
I A I B IIb B IIb B III B
LM + 2VD or 3VD, SYNTAX scores <33
I A I B IIb B IIb B III B
LM + 2VD or 3VD, SYNTAX scores >32
I A I B III B IIb B III B
Appropriate Use Criteria
J Am Coll Cardiol 2012
AUC and Multivessel Revascularization
Patel et al, J ACC 2012;59:857-881
Method of Revascularization of Multivessel Coronary Artery Disease
Assumes CCS >2 or int/high risk non-invasives
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)
A U
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)
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)
A I
Symptoms Med. Rx
Class llI or
lV Max Rx U A A A A
Class I or lI
Max Rx U U A A A
Asympto-
matic Max
Rx
I I U U U
Class llI or
lV No/min
Rx
I U A A A
Class
I or lI
No/min Rx
I I U U U
Asympto-
matic
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.
disease
of prox.
LAD
2 vz.
disease
with
prox.
LAD
3 vz.
disease
no Left
Main
Low-Risk Findings on Non-invasive Study
Patel et al J ACC 2009 53
(February): 530-553
Asymptomatic
Stress Test Med. Rx
High Risk
Max Rx
U A A A A
High Risk
No/min
Rx
U U A A A
Int. Risk
Max Rx
U U U U A
Int. Risk
No/min
Rx
I I U U A
Low Risk
Max 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.
disease
of prox.
LAD
2 vz.
disease
with
prox.
LAD
3 vz.
disease
no Left
Main
Appropriateness Ratings by Low-Risk Findings on
Noninvasive Imaging Study and Asymptomatic
Whither Left Main?
The AUC Have Changed
J Am Coll Cardiol 2013;
61:130517.
Appropriate Appropriate
Uncertain May be appropriate
Inappropriate Rarely appropriate
Advanced CAD Method of
Revascularization
Angina Class III, and/or evidence of intermediate or
high risk non-invasive features
Note: 2009 ratings created pre-
SYNTAX And ISAR Left Main
2012 AUC Revasc Update

M

R
Criticisms of the AUC
Lack of adequate
representation of
interventional cardiology on
the technical panel
Lack of specific criteria for
stress testing
Inability to link stress test
results to coronary anatomy
Overdependence on pre-
procedure stress testing
Inadequate use of
angiographic variables
No accounting for FFR
and IVUS
Validity of NCDR
self-reported data

J Am Coll Cardiol Intv 2012;5:229-235.
Appropriateness Use Criteria Developed
Using a Modified Rand/Delphi Methodology
Define Appropriateness
for Coronary Revascularization
Coronary revascularization is appropriate
when the expected benefits, in terms of
survival or health outcomes (symptoms,
functional status, and/or quality of life) exceed
the expected negative consequences of the
procedure
How Do Patients Weigh Outcomes?
i.e., Who Defines Negative Consequences
224 respondents SYNTAX eligible for
3VD revascularization
Tong et al, Am Thor Surg
2012;94:1908
Relative Weight
Death 0.23
Stroke 0.18
Longevity 0.17
MI 0.14
Revascularization 0.11
Scenario Presented
Blinded 17% PCI
OPEN 27% PCI
PCI Choice: more familiarity
High socioeconomic status
PCI CABG
Hospital stay 2 day 4 day
Recovery 1 week 6 weeks
Death 6% 3%
MI 7% 3%
CVA 3% 2%
Revasc 20% 10%
Life expectancy 0 1 year
Tong et al, Am Thor Surg
2012;94:1908
The Expanded Heart Team
Joint 2010 ESC EACTS Guidelines
on Myocardial Revascularization
Clinical
Cardiologist
(non interventional)
The patient with
complex CAD
and
comorbidity
Referring physician
General
practitioner
Geriatrician
Nephrologist
Rehabilitation
Specialist
Neurologist Diabetologist
Anesthesiologist
Pneumologist Where is the patient?
Will We Even
Identify LM
Disease?
Algorithm for Risk Assessment of Patients
With SIHD
Consider coronary
revascularization to
improve survival
Consider coronary
revascularization to
improve symptoms
Regular
Monitoring
Test results suggest
high-risk coronary
lesion(s)?
Observe response
to Guideline-
Directed Medical
Therapy
Yes
Pharm MPI,
Echo, CCTA or
CMR
MPI or
Echo with
exercise
Indeterminate result
from functional
testing
Yes
No
No
Yes
No
No
Yes
Yes
LBBB on ECG?
Known stenosis of
unclear significance
being considered for
revascularization
CCTA
Successful
Treatment?
Special circumstances
(irrespective of ability
to exercise)
Algorithm for Guideline-Directed Medical
Therapy for Patients With SIHD
Consider
revascularization to
improve symptoms
Anginal Symptoms? No
Sublingual NTG
No
Successful
Treatment?
Yes
Yes
Yes
Yes
Yes
Serious
contraindication
Serious
contraindication
Persistent symptoms despite adequate trial of
Guideline-Directed Medical Therapy
Yes
No
Successful
Treatment?
Yes
Yes
No
Successful
Treatment?
Add/substitute
CCB and/or long-acting
nitrate if no
contraindication
Add/substitute ranolazine
Beta blocker if no
contraindication
(Esp. if prior MI, heart failure or
other indication)
ESC Algorithm for Initial Evaluation of Patients with
Clinical Symptoms of Angina
ESC Slide-set

2010 European Society of Cardiology

Algorithm for Initial Evaluation of Patients with Clinical Symptoms of Angina (2)
Medical Therapy +
Coronary
arteriography
Depending on level of
symptoms and
clinical judgment
Medical Therapy
Low risk
Annual CV mortality <1%
per year
Intermediate risk
Annual CV mortality 1-3%
per year
High risk
Annual CV mortality >3%
per year
Coronary
arteriography if not
already performed
If symptomatic control unsatisfactory,
consider suitability for
revascularization (PCI or CABG)
Evaluate response to medical therapy
High risk coronary
anatomy known to benefit
from revascularization?
NO
YES
Revascularize
Medical Therapy
AND
Coronary arteriography for
more complete risk
stratification and
assessment of need for
revascularization
AUC for Diagnostic Cath
Patel et al, J ACC
2012;59:857-881

Low Intermediate High
Asymptomatic Global CAD Risk I I U
Symptomatic Pretest Probability I U A
Suspected CAD: No Prior Noninvasive Stress Imaging
Risk Assessment
How to Treat: Pick Your Algorithm
50-year-old male hypertension with
typical angina class II
Pretest likelihood for CAD = 93%
Next Steps
US guidelines stress if not high risk
GDMT
ESC guidelines: quantitative MPI ,if
>10% or intermediate risk risk: Cath or
direct cath
AUC: Cath
Conclusions: LM Best Practices
Surgery remain the default strategy
UPLM stenting is NEVER appropriate in
low risk patients according to US
guidelines
ESC guidelines leave a bit more wiggle
room to the Heart Team
The US AUC are internally ambiguous
and conflict to some extent with the
guidelines (i.e., CTO, intermediate SS)