Why Perform CTO PCI Intervention: Evidence Based Review And Where Next

Dimitri Karmpaliotis, MD, PhD, FACC Associate Professor of Medicine

Columbia University Medical Center

Director of CTO, Complex and High Risk Angioplasty

NYPH/Columbia

Email: dk2787@columbia.edu

SOLACI 2017

Buenos Aires, Argentina, August 2, 2017

Financial Conflict of Interest Disclosure

• Speaker’s bureau: Abbot Vascular,

Medtronic, Boston Scientific

• Consultant: Vascular Solutions

I will Discuss

• Meta-Analyses

• Randomized Trials: EXPLORE,

DECISION CTO, EURO CTO Trial

• Registries: OPEN CTO

• Where Next?

Patients with multivessel disease often have

CTOs

CTO 18.4%

Patients with Coronary

Artery Disease

Fefer et al. JACC 2012.

Rates of CTO in

Multivessel Disease:

SYNTAX Trial

23%

BEST Trial

29%

FREEDOM Trial 6%

CABG n=266

Not Bypassed

n=81

ITT, Per Lesion

Bypassed

n=173

CABG n=254

12 were not treated with CABG

Overall 68.1 % of TO were

successfully bypassed

49.6% overall complete

revascularization in CTO subset

SYNTAX CTO Subset Procedural

Characteristics: Per Lesion Analysis

Serruys P, CRT 2009 [modified]; courtesy Prof Serruys and the SYNTAX investigators

• 26.2% patients with CTO

• CTO accounted for 266

lesions (7.4%)

Reason not bypassed:

Not intended to treat (n=12)

Diseased (n=11)

Inadequate conduit (n=2)

Too small (n=19)

Unable to find (n=1)

Other (n=36)

CAD Prognostic Index

More Complex Disease – Lower 5 Year Survival

* Assuming medical treatment only

ACC/AHA SIHD Guidelines

Survival – Ischemia and Mortality

% Ischemic Burden 0% 1- 5% 5-10% 11-20% >20%

Card

iac D

eath

Rate

7110 1331 718 545 252

Hachamovitch et al Circulation. 2003; 107:2900-2907

Collaterals are rarely sufficient to prevent

ischemia

Werner et al. Eur Heart J 2006.

Anti-Anginal Agents:

An Alternate Perspective

Non-Adherence

Polypharmacy

Side-Effects

Cost

Agent Issues for

Patients

“Hard Outcomes”

in SIHD

Beta-blockers Sluggishness,

fatigue

No benefit unless

post-MI or low EF

Nitrates Hypotension No benefit

Ca++ Channel

Blockers

Reasonably

tolerated No benefit

Ranolazine Cost No benefit

A point rarely discussed: For most patients, GDMT with the ability to affect “hard

endpoints” is limited to only aspirin, statins, and lifestyle modification

Limitations of the Evidence Base

(and guidelines based upon it)

Good Outcome Intermediate

Outcome Bad Outcome

Trial Outcomes

Risk

Stratification

Mean Treatment Difference

Adapted from J. Spertus

Evidence Based Medicine Does

Not Equal Randomized

Controlled Trials

Ischemic Heart Disease

Goals of Treatment

1. Improve Symptoms and Quality

of Life

Measured by “soft endpoints”

(i.e. angina/QOL scales)

2. Improve Prognosis

Measured by “hard endpoints” (i.e.

death, MI)

Long-Term Follow-up of Elective CTO

PCI: UK Central Cardiac Audit Database

George et al, JACC 2014

14,439 CTO procedures assessed over >2.5 yr FU

Successful CTO PCI and Complete Revasc. assoc w/ survival

Pancholy et al. Am J Cardiol 2013;111:525,

Christakopoulos et al. Am J Cardiol 2015;115:1367

Hoebers et al. Int J Cardiol 2015;187:90.

Explore Trial Design

Patients with

STEMI + CTO

LVEF and LVEDV

MRI at 4 month

• DesignGlobal, multi-center, randomized, prospective

two-arm trial with either PCI of the CTO or no

CTO intervention after STEMI.

Blinded evaluation of endpoints.

• Patients

Patients with STEMI treated with pPCI and

with a non-infarct related CTO.

• Objective

CTO-PCI < 7d No CTO-PCI

1:1

To determine whether PCI of the CTO

within 7 days after STEMI results in a

higher LVEF and a lower LVEDV

assessed by MRI at 4 months

Henriques et al J Am Coll Cardiol. 2016;68:1622-1632

Henriques et al J Am Coll Cardiol. 2016;68:1622-1632

What might have been the problem ?

In a randomized trial, the sick patients are not randomized

The real sick patients were already dead before they got

randomized

Downsides of CTO PCI

Case series reports

of “selected

successes:” Great

outcomes, Low Risk

Lower Success Rates

Greater Procedural

Risk

Few Skilled

Operators

Limited Familiarity of

Referring Providers

with CTO PCI

Common Conception of CTO PCI

Benefits vs. Risks Before the Hybrid Approach

Upsides of CTO PCI

From DECISION-CTO to EUROCTO,

Where Next?

Hypotheses

DECISION-CTO

OMT would be inferior to CTO-PCI

according to MACCE at 3 years

Hypotheses

DECISION-CTO

OMT would be inferior to CTO-PCI

according to MACCE at 3 years

EUROCTO

CTO PCI would significantly improve SAQ health status at 12 months

& would be safe compared to OMT at 3 years

[Death or MI]

Design

DECISION-CTO EUROCTO

Design Open label RCT Open label RCT

Setting Korea

19 centers

Europe

26 centers

Subjects CSA or ACS

[74% vs 26%]

CSA

Recruitment (N)

Target (N)

Time (Yrs)

815*

1284

6

407**

600/1200

3

Comparison OMT vs CTO-PCI OMT vs CTO-PCI

Primary Endpoint MACCE 3yr

[Death, MI, stroke, repeat

revascularisation]

SAQ health status 12M

Death, MI 3yr

* <10 cases/center/year

**Screening/Recruitment ratio 30-40%

DECISION-CTO EUROCTO

Previous MI 10% 21%

Previous PCI 17% 54%*

Previous

CABG

1% 11%

Diabetes 33% 32%

SVD

MVD

26%

74%

50%

50%

Patient demographics

*Trial protocol recommended pre-treatment of other disease before

randomisation

DECISION-CTO EUROCTO

JCTO score 2.3-2.2* 1.7-1.8

CTO PCI

Success

91.1% 86.3%

Retrograde 25% 36%

CTOs

Crossover

OMT>PCI

PCI>OMT

18%

16%

7.3%**

Missing data

[1ry Endpoint]

12-17% [„missing at random‟]

9%

* JCTO score high for 75% AWE

**OMT with ≥2 anti-anginals mandated in

protocol

DECISION-CTO

Primary Endpoint MACCE (ITT

analysis)

Primary End Point (Death, MI, Stroke, Any Repeat Revascularization)

ITT Population

No. at Risk

OMT 398 305 246 178 129 72

PCI 417 293 241 175 117 65

Years Since Randomization

Pro

ba

bilit

y (

%)

0 1 2 3 4 5

0

1 0

2 0

3 0

4 0

5 0

6 0

Crude HR 0.95 (95% CI, 0.74-1.22), P=0.67

Adjusted HR 0.91 (95% CI, 0.68-1.23), P=0.54

20.6%

19.6%

25.1%

26.3%

PCI

OMT

DECISION-CTO

Primary Endpoint MACCE (ITT

analysis)

Noninferiority Test for Primary End Point at 3-Year

Prespecified non-inferiority margin: 0.7

Lower 1-sided 97.5% CI

0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0 1.1 1.2 1.3 1.4 1.5

Event Rate Ratio 1.05

Non-inferiority P=0.008

Estimated 3-year Event Rate OMT: 19.6% PCI: 20.6%

Event Rate Ratio of 3-year MACE rate (PCI/OMT)

ITT Population

OMT was non-inferior to CTO-PCI

DECISION-CTO

Primary Endpoint MACCE DECISION-CTO

3yrs

EUROCTO

12 months

OMT PCI OMT PCI

MACCE 25.1% 26.3% 6.7% 5.2%

Death 7.9% 4.5% 0% 0.8%

MI

Procedural MI

Spontaneous

MI

9.4%

7.6%

1.8%

11.9%

10.1%

1.8%

0%

1.9%

Stroke 5% 1% 0.7% 0.8%

Repeat

revascularisatio

n

11.8% 14% 6.7%

[IDR]

2.9%

[IDR]*

70% of Patients in the OMTGroup in Decision CTO underwent PCI!!

EUROCTO

Primary Endpoint SAQ (ITT)

0

10

20

30

40

50

60

70

80

90

100

OMT PCI

Physical limitation

Anginalfrequency

Anginalstability

Treatmentsatisfaction

Quality oflife

Primary endpoint: SAQ health status (ITT)

For multiple testing the significance level is 0.01

BL FU BL FU BL FU BL FU BL FU BL FU BL FU BL FU BL FU BL FU

P=0.022

P=0.009P=0.049

P=0.89

P=0.47

*Higher score = less angina + better

QoL

DECISION-CTO

Secondary Endpoint SAQ Quality of Life Measures Over Time

0.0 1.0 6.0 12.0

30

40

50

60

70

80

90

100

6 Mon

303 309

P=0.29P=0.94 P=0.74

Baseline 12 Mon

244 242 231 222

1 Mon

P=0.58

264 277

(A) EQ-5D Visual Analogue Scale

Mea

nS

co

r e

0.0 1.0 6.0 12.0

30

40

50

60

70

80

90

100

305 312

P=0.80P=0.52 P=0.75

243 242 231 221

P=0.05

265 276

(B) SAQ, Physical Limitation

Mea

nS

co

r e

6 MonBaseline 12 Mon1 Mon

6.0 12.0

30

40

50

60

70

80

90

100

304 312

P=0.15P=0.24 P=0.35

244 244 231 222

P=0.17

265 276

(C) SAQ, Angina Stability

Mea

nS

cor e

6 MonBaseline 12 Mon1 Mon

30

40

50

60

70

80

90

100

304 313

P=0.62P=0.26 P=0.86

244 244 231 222

P=0.001

265 278

(D) SAQ, Angina Frequency

Me

an

Sco

r e

6 MonBaseline 12 Mon1 Mon30

40

50

60

70

80

90

100

304 313

P=0.96P=0.06 P=0.89

244 244 231 222

P=0.25

265 278

(E) SAQ, Treatment Satisfaction

Me

an

Score

6 MonBaseline 12 Mon1 Mon30

40

50

60

70

80

90

100

304 313

P=0.06P=0.28 P=0.90

244 244 231 222

P=0.81

265 278

(F) SAQ, Quality of Life

Mea

nS

cor e

6 MonBaseline 12 Mon1 Mon

ITT Population

PC

I OMT

*50% missing data

SAQ: Physical Limitation EUROCTO vs DECISION-CTO

0

10

20

30

40

50

60

70

80

90

100

OMT PCI

Physical limitation

Anginalfrequency

Anginalstability

Treatmentsatisfaction

Quality oflife

Primary endpoint: SAQ health status (ITT)

For multiple testing the significance level is 0.01

BL FU BL FU BL FU BL FU BL FU BL FU BL FU BL FU BL FU BL FU

P=0.022

P=0.009P=0.049

P=0.89

P=0.47

Quality of Life Measures Over Time

0.0 1.0 6.0 12.0

30

40

50

60

70

80

90

100

6 Mon

303 309

P=0.29P=0.94 P=0.74

Baseline 12 Mon

244 242 231 222

1 Mon

P=0.58

264 277

(A) EQ-5D Visual Analogue Scale

Mea

nS

co

r e

0.0 1.0 6.0 12.0

30

40

50

60

70

80

90

100

305 312

P=0.80P=0.52 P=0.75

243 242 231 221

P=0.05

265 276

(B) SAQ, Physical Limitation

Mea

nS

co

r e

6 MonBaseline 12 Mon1 Mon

6.0 12.0

30

40

50

60

70

80

90

100

304 312

P=0.15P=0.24 P=0.35

244 244 231 222

P=0.17

265 276

(C) SAQ, Angina Stability

Mea

nS

cor e

6 MonBaseline 12 Mon1 Mon

30

40

50

60

70

80

90

100

304 313

P=0.62P=0.26 P=0.86

244 244 231 222

P=0.001

265 278

(D) SAQ, Angina Frequency

Me

an

Sco

re

6 MonBaseline 12 Mon1 Mon30

40

50

60

70

80

90

100

304 313

P=0.96P=0.06 P=0.89

244 244 231 222

P=0.25

265 278

(E) SAQ, Treatment Satisfaction

Me

an

Scor e

6 MonBaseline 12 Mon1 Mon30

40

50

60

70

80

90

100

304 313

P=0.06P=0.28 P=0.90

244 244 231 222

P=0.81

265 278

(F) SAQ, Quality of Life

Mea

nS

cor e

6 MonBaseline 12 Mon1 Mon

ITT Population

SAQ: Angina Frequency EUROCTO vs DECISION-CTO

0

10

20

30

40

50

60

70

80

90

100

OMT PCI

Physical limitation

Anginalfrequency

Anginalstability

Treatmentsatisfaction

Quality oflife

Primary endpoint: SAQ health status (ITT)

For multiple testing the significance level is 0.01

BL FU BL FU BL FU BL FU BL FU BL FU BL FU BL FU BL FU BL FU

P=0.022

P=0.009P=0.049

P=0.89

P=0.47

0

10

20

30

40

50

60

70

80

90

100

OMT PCI

Physical limitation

Anginalfrequency

Anginalstability

Treatmentsatisfaction

Quality oflife

Primary endpoint: SAQ health status (ITT)

For multiple testing the significance level is 0.01

BL FU BL FU BL FU BL FU BL FU BL FU BL FU BL FU BL FU BL FU

P=0.022

P=0.009P=0.049

P=0.89

P=0.47

Quality of Life Measures Over Time

0.0 1.0 6.0 12.0

30

40

50

60

70

80

90

100

6 Mon

303 309

P=0.29P=0.94 P=0.74

Baseline 12 Mon

244 242 231 222

1 Mon

P=0.58

264 277

(A) EQ-5D Visual Analogue Scale

Mea

nS

co

r e

0.0 1.0 6.0 12.0

30

40

50

60

70

80

90

100

305 312

P=0.80P=0.52 P=0.75

243 242 231 221

P=0.05

265 276

(B) SAQ, Physical Limitation

Mea

nS

co

r e

6 MonBaseline 12 Mon1 Mon

6.0 12.0

30

40

50

60

70

80

90

100

304 312

P=0.15P=0.24 P=0.35

244 244 231 222

P=0.17

265 276

(C) SAQ, Angina Stability

Mea

nS

cor e

6 MonBaseline 12 Mon1 Mon

30

40

50

60

70

80

90

100

304 313

P=0.62P=0.26 P=0.86

244 244 231 222

P=0.001

265 278

(D) SAQ, Angina Frequency

Me

an

Sco

r e

6 MonBaseline 12 Mon1 Mon30

40

50

60

70

80

90

100

304 313

P=0.96P=0.06 P=0.89

244 244 231 222

P=0.25

265 278

(E) SAQ, Treatment Satisfaction

Me

an

Scor e

6 MonBaseline 12 Mon1 Mon30

40

50

60

70

80

90

100

304 313

P=0.06P=0.28 P=0.90

244 244 231 222

P=0.81

265 278

(F) SAQ, Quality of Life

Mea

nS

cor e

6 MonBaseline 12 Mon1 Mon

ITT Population

The Assigned and Actually Treated Strategies

0 1 2 3 4 5

0

10

20

30

40

50

60

Years Since Randomization

Cu

mu

lati

ve

In

cid

en

ce

(%

)

No. at Risk

OMT–OMT 315 246 194 135 99 57

PCI–PCI 346 250 209 150 98 52

OMT–PCI 72 60 53 44 31 17

PCI–OMT 65 45 33 26 20 14

P=0.02 by Log-Rank Test

OMT OMT

PCI PCI

OMT PCI

PCI OMT

PCI

OMT

DECISION-CTO

Primary Endpoint MACCE

(As-Treated analysis)

From DECISION-CTO to EUROCTO:

What have we learned?

CTO PCI multicenter RCTs can be done

High procedure success rates required

for clinical trial validity can be achieved

Summary of results EURO CTO

• Due to slow recruitment the number of patients in this study is below the preplanned number

• However, the results are relevant and demonstrate, that PCI of CTO improved the health status regarding angina frequency, physical limitations, and quality of life as compared to OMT, and improved the functional class

• In experienced hands, periprocedural risk was low, and the 12 months MACCE rate was comparable to OMT, but the long-term safety remains to be evaluated at 36 months (Primary safety endpoint)

From DECISION-CTO to EUROCTO:

What have we learned?

CTO PCI multicenter RCTs can be done

High procedure success rates required

for clinical trial validity can be achieved

From DECISION-CTO to EUROCTO: What have we learned?

Trials in a complex patient cohort are difficult to deliver:

Recruitment

Selection bias?

More symptomatic patients not recruited?

Procedure success & safety

Operator experience very important

Where to next?

Do we need another RCT in stable angina

with SAQ/QoL as primary endpoint?

Where to next?

Do we need another RCT in stable angina

with SAQ/QoL as primary endpoint?

Should we try to demonstrate benefit in

hard clinical endpoints in stable angina?

Where to next?

Do we need another stable angina trial

with SAQ/QoL as primary endpoint?

Should we try to demonstrate benefit in

hard clinical endpoints in stable angina?

DECISION-CTO

In As-Treated Analysis OMT was inferior to PCI

If there was no crossover N=1282 (original

target sample size) would achieve significance

[NNT=15]

Yves Louvard, Editorial, Cardiology Journal, Apr 2017

Risks of CTO PCI Benefits of CTO PCI

OPEN CTO Design

Design

• DESIGN: Prospective, non-

randomized, single-arm, multi-center

clinical evaluation of the Hybrid

CTO-PCI

• OBJECTIVE: To evaluate the

Success, safety, efficiency,

appropriateness, health status

outcomes, and costs of CTO-PCI

• PRINCIPAL INVESTIGATOR

• J. Aaron Grantham, MD, FACC

Saint Luke‟s Mid America Heart

Institute, Kansas City, Mo. USA

1000 consecutive patients enrolled between

Feb 2014 and July 2015 at 12 clinical sites in

the US

Comprehensive baseline clincal, angiographic,

and HS assessment

Clinical follow-up at

1,6, 12 months

Success Failure

Angina

Complicated

Efficient

Dyspnea

Uncomplicated

inefficient

OPEN CTO Sites

Alexian Brothers Medical

Center

Elk Grove Village, IL

Banner Health System

Phoenix and Mesa, AZ

Saint Luke’s Hospital

Mid America Heart

Institute

Kansas City, MO

Presbyterian Hospital/ Heart

Group Albuquerque, NM

PeaceHealth

Sacred Heart

Med. Ctr

Springfield, OR

Torrance Medical

Center

Torrance, CA

York

Hospital

York, PA

Columbia

University

Medical Center

NY, NY

PeaceHealth

St. Joseph Med. Ctr.

Bellingham, WA

Boone Hospital

Center

Columbia, MO

U. Washington

Seattle, WA

Strengths of OPEN CTO

• Auditing through NCDR

• Angiographic core lab analysis

• Centralized call center follow up (92%)

• CEC adjudication

• Broad spectrum of operators using a

single methodological approach

Baseline Patient and Lesion

Characteristics Patient Characteristic

Age (yrs) 65.4 ± 10.3

Male sex (%) 80.2%

BMI (Kg/m2 BSA) 30.8 ± 9.1

Heart Rate (bpm) 68.5 ± 12.8

Smoking (ever) 64.5%

Diabetes(%) 41.4%

Hypertension(%) 86.9%

Prior MI(%) 48.4%

Prior CABG(%) 36.9%

Prior PCI(%) 66.0%

Prior CHF(%) 22.6%

PAD(%) 17.4%

CKD>stage 1(%) 13.3%

EF (%) 51.1 ± 13.7

Angiographic Characteristic

CTO only (%) 86.2

Complete Revasc (%) 82.3

Target Vessel RCA (%) 60.5

LAD (%) 19.6

LCX (%) 13.3

Occlusion Length (mm) 29.9 ± 24.3

Length>20 mm (%) 54.8

Total lesion length (mm) 63.4 ± 28.6

JCTO score <3 (%) 81.2

JCTO score ≥3 (%) 19.7

Symptoms, Function

and Quality of Life

Survival Cardiomyopathy

CTO PCI Indications in 2017

Indications and Appropriateness

Primary Indication

Symptom relief

Ischemia Reduction

Staged procedure

Low EF

ACS

Other

Appropriateness

Unmappable

Appropriate

May be Appropriate

Rarely Appropriate

72%

81% “Appropriate” or “May

Be Appropriate”

3% Rarely Appropriate

Sapontis et al. Cor Artery Dis. 2017: doi:

10.1097/MCA.0000000000000439

Health Status Trajectory After CTO PCI

Physical Limitation

50

60

70

80

90

100

Baseline 1 Month 6 Months 1 Year

* * *

Summary Score

50

60

70

80

90

100

Baseline 1 Month 6 Months 1 Year

* * *

Success (N=862) Failure (N=138) * p<0.05

Angina Frequency

50

60

70

80

90

100

Baseline 1 Month 6 Months 1 Year

* * *

Quality of Life

40

50

60

70

80

90

100

Baseline 1 Month 6 Months 1 Year

* * *

Adjusted Early Health Status After CTO PCI

Angina Frequency

Physical Limitation

Quality of Life

Summary Score

7.7 (4.0, 11.5), p<0.001

6.3 (3.0-9.7), p<0.001

10.6 (6.2, 15.0), p<0.001

9.1 (5.9, 12.3), p<0.001

-10 -5 0 5 10 15

One Month SAQ Scores

Success vs. Failure

Mean Difference

Grantham et al. In review.

Successful CTO PCI and Dyspnea Symptoms

20% 24%

50% 36%

38% 36%

34%

34%

42% 40%

16% 30%

0%

20%

40%

60%

80%

100%

Successful PCI Failed PCI Successful PCI Failed PCI

RDS=3/4 RDS=1/2 RDS=0

1 month RDS Baseline RDS

P=0.5 P<0.001

80% reported dyspnea at baseline, 70% reported improved dyspnea

Qintar et al. Abstract TCT 2016

Complications

Khan et al. Cath Cardiovasc Interv 2015;85:781.

Unpublished Data from OPEN CTO

0,7

2,6

1,5

3,4

0,9

2,6

0,7

3,9

0,9

2,6

0,7

4,8

0

1

2

3

4

5

6

In-hospitalDeath

PeriproceduralMI

EmergentCABG

ClinicalPerforation

% w

ith

Ou

tco

me

Khan et al

OPEN-CTO Operator Reported

OPEN-CTO Core Lab

Procedural Mortality In Context

• 0.9% (95% CI 0.6-1.2%)

Mortality in NCDR registry 0.65%

Expected mortality by NCDR risk model

0.41%

Expected mortality of surgery from STS

risk calculator 1.67%

Predictors of MACCE

Unpublished Data from OPEN CTO

But do all CTOs or all lesions need

revascularization?

What is Optimal Revascularization:

1. Revascularization of all major epicardial vessels with > 50-70% stenosis?

or

2. Revascularization of all symptom/ischemia causing disease?

or

3. Revascularization of any vessel for which the incremental expected benefit exceeds the expected harm.

But do all CTOs or all lesions need

revascularization?

What is Optimal Revascularization:

1. Revascularization of all major epicardial vessels with > 50% stenosis?

or

2. Revascularization of all symptom/ischemia causing disease?

or

3. Revascularization of any vessel for which the incremental expected benefit exceeds the expected harm.

In MVD, the CTO often subtends the most

important territory of ischemia, but operators

chase other vessels

• 25% of PCI patients with CTO and a

positive stress test get PCI in a non-

CTO vessel not corresponding to the

area of ischemia!!

• Do not let your personal technical

limitations influence your ability to offer

the best patient-centered care.

Gallagher, Jaffer, Yeh. TCT16.

But do all CTOs or all lesions need

revascularization?

What is Optimal Revascularization:

1. Revascularization of all major epicardial vessels with > 50% stenosis?

or

2. Revascularization of all symptom/ischemia causing disease?

or

3. Revascularization of any vessel for which the expected benefit exceeds expected harm.

Retrograde CTO PCI May Present Unique

Risks in MVD Patients

Karmpaliotis et al. Circ Intv 2016.

Taking a step back may sometimes be the

best treatment

• Increasing number of high risk patients whose risk is not modifiable by our treatment.

• In such patients, optimal revascularization may NOT be complete revascularization.

Contributors of Risk

Lesion/Procedure

PatientPresentation

PatientSubstrate

Take Home Points • After a realistic discussion of risks and benefits

• CTO PCI is indicated in the setting of persistent symptoms despite best tolerated medical therapy

• CTO PCI may be considered in ASYMPTOMATIC patients

• High risk stress test/significant ischemic burden

• Ischemic cardiomyopathy, especially if PCI may impact transplant, VAD, ICD

• There is definitely a need for future randomized Trials

Take Home Points • There is definitely a need for future for well designed and

thoroughly executed randomized trials

• MVD and complete revascularization in Stable CAD and Patients with ACS

• Low EF with large Ischemic Burden

• Primary End Point should be Symptomatic Improvement

• Avoid Cross Over

• Robust Enrollment

• Surrogate End-Points Such as Reduction in Ischemic Burden

• Only in the sickest patients we could potentially show an improvement in “Hard End –Points” of Survival

How Do Our Patients

with Real Symptoms

Actually Feel After Revascularization?

Second

Edition TCT

2017

Thank You