left main revascularization in the united states- guidelines, appropriate use criteria, and...

8/11/2019 Left Main Revascularization in the United States- Guidelines, Appropriate Use Criteria, And Standards of Care

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Left Main Revascularization

in the US: Guidelines,Appropriate Use Criteria

and Standards of Care

Jeffrey W. Moses, MD

Columbia University Medical CenterThe Cardiovascular Research Foundation


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Disclosure Statement of Financial Interest

I, Jeffrey W. Moses, MD am a consultant

with BSC (Consulting Fees/Honoraria)


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Resources for Guidance

ACCF/AHA Guidelines UAP/NSTEMI SIHD PCI CABG STEMI

ESC Guidelines Revascularization ACS STEMI

Stable CAD

AUC Angiography Revascularization


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GNL 2011


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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


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Heart Team Approach for

UPLM (Unprotected Left Main)

or Complex CAD Revascularization

GNL 2011


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UPLM Revascularization

to Improve Survival

RevascMethod 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), anda 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 2%)

B

III: Harm

For SIHD in patients (versus performing CABG) with unfavorable

anatomy for PCI and who are good candidates for CABGB

IIaFor UA/NSTEMI if not a CABG candidate B

IIaFor STEMI when distal coronary flow is


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UPLM PCI to Improve Survival (SIHD)

RiskofPCI

Complication

Lik

elih

oodof

Good

Lon

g-termO

utcom

e

CAB

GMortality

Risk

Class Of RecommendationLOE

IIaFor SIHD when lowrisk of PCI complications

and highlikelihood of good long-term outcome (e.g.,SYNTAX score of 22, ostial or trunk left main CAD),

anda 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 2%)

B

III: HarmFor SIHD in patients (versus performing

CABG) with unfavorableanatomy for PCI and whoare goodcandidates for CABG

B

Low

Hi

Hi Hi

Low Low


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What About High

Risk for PCIandCABG?


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SIRTAX: SYNTAX Score Is Not a

Measure of Absolute Risk: Different

Stent, Different Outcomes

Girasis et al, Euro Heart J2011; in press

MACE1Y

P=0.21

DEATH1Y

P=0.35P=0.95

CSSLOWn=282

60

%

CSSMIDn=283

CSSHIGHn=283

P=0.001P=0.98P=0.4650

40

30

20

10

0

9.0

SES PES

23.9

8.67.57.36.6

CSSLOWn=282

60

CSSMIDn=283

CSSHIGHn=283

50

40

30

20

10

01.4

SES PES

4.92.10.00.71.5


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0

Months Months

2-year HR

0.63[0.49, 0.82]

p=


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Sirolimus

Everolimus

SCAAR: EES vs. Gen 1 DES Diabetes

Mortality

Kedhi et al, JACC2012;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 12Cum

ulativeRiskofall-c

auseMortality

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


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Montalescot et al, Euro Heart J2013;34:2949-3003


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Indications for Revascularization in

Stable Angina or Silent Ischemia

* With documented ischemia or Fractional Flow Reserve (FFR) 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 anginaequivalent, unresponsive to OMT

I A

Dyspnoea/CHF and >10% LV ichemic/viability suppliedby >50% stenotic artery IIa B

No limit symptoms with OMT III C

European Heart Journ al ,2010;31:2501-2555

European Journ al of Cardio-thoracic Surgery, 2010;38:S1-S52

Joint 2010 ESCEACTS

Guidelines on MyocardialRevascularization


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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 asurvival advantage as well as a marked reduction in the need for

repeat revascularization Joint 2010 ESCEACTSGuidelines on Myocardial

Revascularization

Subset of CAD by Anatomy Favors CABG Favors PCI

1 VD or 2VDnon-proximal LAD IIb C I C

1 VD or 2VDproximal LAD I A IIa B

3VD simple lesions, full functional 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 33 I A III B


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Montalescot G, et al.Eur Heart J2013;

34:2949-3003

PCI or CABG in SIHD with Ischemia


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PCI or CABG in SIHD with LM Disease

Montalescot G, et al.Eur Heart J2013;

34:2949-3003


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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 BLM + 2VD or 3VD, SYNTAX scores 32 I A I B III B IIb B III B


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Appropriate Use Criteria

J Am Col l Cardio l 2012


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AUC and Multivessel Revascularization

Patel et al, JACC2012;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


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Symptoms Med. Rx

Class llI or

lV Max Rx U A A A AClass I or lI

Max Rx U U A A AAsympto-matic Max

RxI I U U U

Class llI or

lV No/minRx

I U A A A

Class

I or lINo/min Rx

I I U U U

Asympto-matic

No/min RxI 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 JACC2009 53(February): 530-553

Asymptomatic

Stress Test Med. Rx

High Risk

Max Rx U A A A AHigh Risk

No/min

Rx U U A A AInt. Risk

Max Rx U U U U AInt. Risk

No/min

RxI I U U A

Low Risk

Max Rx I I U U ULow RiskNo/min

RxI I U U U

Coronary

AnatomyCTO 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?


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The AUC Have Changed

J Am Coll Cardio l2013;61:130517.

Appropriate Appropriate

Uncertain May be appropriate

Inappropriate Rarely appropriate


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Advanced CADMethod of

RevascularizationAngina Class III, and/or evidence of intermediate or

high risk non-invasive features

Note: 2009 rating s created pre-

SYNTAX And ISAR Left Main2012 AUC Revasc Update

M

R


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Criticisms of the AUC Lack of adequate

representation of

interventional cardiology onthe 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 Col l Cardiol Intv2012;5:229-235.


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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,

funct ional status, and /or qual ity o f l i fe) exceedthe expected negative consequences of the

procedure


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How Do Patients Weigh Outcomes?

i.e., Who Defines Negative Consequences

224 respondents SYNTAX eligible for3VD revascularization

Tong et al, Am Thor Surg2012;94:1908

Relative Weight

Death 0.23

Stroke 0.18

Longevity 0.17

MI 0.14

Revascularization 0.11


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Scenario Presented

Blinded17% PCI

OPEN27% 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 Surg2012;94:1908


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The Expanded Heart Team

Joint 2010 ESCEACTS Guidelineson Myocardial Revascularization

Clinical

Cardiologist(non interventional)

The patient with

complex CADand

comorbidity

Referring physician

General

practitionerGeriatrician

Nephrologist

Rehabilitation

Specialist

NeurologistDiabetologist

Anesthesiologist

PneumologistWhere is the patient?


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Will We Even

Identify LMDisease?


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Algorithm for Risk Assessment of Patients

With SIHD

Consider coronary

revascularization to

improve survival

Consider coronaryrevascularization to

improve symptoms

Regular

Monitoring

Test results suggest

high-risk coronary

lesion(s)?

Observe responseto Guideline-

Directed Medical

Therapy

Yes

Pharm MPI,

Echo, CCTA or

CMR

MPI or

Echo with

exercise

Indeterminate result

from functional

testing

Yes

No

No

YesNo

No

Yes

YesLBBB on ECG?

Known stenosis of

unclear significance

being considered for

revascularization

CCTA

Successful

Treatment?

Special circumstances

(irrespective of ability

to exercise)


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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 ofGuideline-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)


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ESC Algorithm for Initial Evaluation of Patients with

Clinical Symptoms of Angina

ESC Slide-set2010 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 3%

per year

Coronary

arteriography if not

already performed

If symptomatic control unsatisfactory,

consider suitability for

revascularization (PCI or CABG)

Evaluate response to medical therapyHigh risk coronary

anatomy known to benefit

from revascularization?

NO

YES

Revascularize

Medical TherapyAND

Coronary arteriography for

more complete risk

stratification and

assessment of need for

revascularization


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AUC for Diagnostic Cath

Patel et al, JACC2012;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


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How to Treat: Pick Your Algorithm

50-year-old male hypertension withtypical angina class II

Pretest likelihood for CAD = 93%


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Next Steps

US guidelinesstress if not high risk GDMT

ESC guidelines: quantitative MPI ,if

>10% or intermediate risk risk: Cath ordirect cath

AUC: Cath


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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 wiggleroom to the Heart Team

The US AUC are internally ambiguousand conflict to some extent with the

guidelines (i.e., CTO, intermediate SS)

left main revascularization in the united states- guidelines, appropriate use criteria, and...

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