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15-year Survival From CASS Registry, Left Main Disease Caracciolo E A et al... What We Know, Any Revascularization Treatment CABG or Stent Have No Survival Benefit Over Medical Treatme

Seung-Jung Park, MD, PhD

Professor of Medicine, University of Ulsan College of Medicine

Asan Medical Center, Seoul, Korea

Background of

“Surgery is Better”

First Randomized Trial

CABG vs Medical Treatment

From 1975 to 1979,

CASS Investigators, Circulation 1983;68:939-950

All Patients, EF < 0.50

MEDICALLY ASSIGNED SURGICALLY ASSIGNED

15-year Survival From CASS Registry,

Left Main Disease

Caracciolo E A et al Circulation 1995;91:2325-2334

Survival Benefit of CABG

CABG vs Medical Treatment

Velazquez EJ, et al NEJM 2011;364:1607-16

Surgical Treatment for Ischemic Heart Failure (STICH) Trial

1212 Patients with Stable Angina (<35% of LVEF),

Surgical (n=610, EF 27%) vs Medical (n=602, EF 28%)

All-Cause Mortality (STICH)

CABG

Velazquez EJ, et al NEJM 2011;364:1607-16

Patients with Ischemic Heart Failure (LVEF <35%)

Ischemic Left Ventricular Dysfunction (EF <35%)

Survival Benefit of CABG

Over Medication

1 Left Main Disease

2 3 Vessel Disease

with Moderate LV dysfunction ( EF>35% )

More Limited Benefit !

Is

Survival Free From Death and MI (COURAGE,n=2,287)

What We Know,

Any Revascularization Treatment

(CABG or Stent) Have No Survival Benefit

Over Medical Treatment Especially in Low Risk Patients with Small Ischemic Burden (<10%)

Stable Angina Treatment

Competitive to Surgery for LM and 3 VD

Survival Angioplasty

Large ischemic burden, Survival Benefit for LM and 3 VD with Moderate

LV Dysfunction Optimal Medical Treatment is Effective

PCI vs Surgery

Survival Angioplasty

For Left Main and 3 Vessel Disease

To Avoid Surgery !

Why PCI ?

Syntax All, 5 Year

1.04 1.02 1.26

All PCI patients (n=542 pairs) Bare-metal stents (n=207 pairs) Drug-eluting stents (n=542 pairs)

Death Composite of death,

Q-wave MI, or stroke

Target-vessel revascularization

MAIN COMPARE, 5 Year

Death /MI /Stroke

Park DW, et al JACC 2010;56:117-24

PRECOMBAT, 3 Year

Death /MI / Stoke

0 5 10 15

20

PCI CABG

Ischemia-Driven TVR

0 5 10 15

20

PCI CABG

No at Risk

PCI

CABG

300 300

270 278

253 264

4.0

9.0 3.7

8.0 2.7

6.0

223 230

p=0.014 p=0.049 p=0.025

Days Since Randomization

No at Risk

PCI CABG

300 300

275 280

259 267

2.7

7.0 2.3

6.0 1.7

4.3

229 233

p=0.015 p=0.059 p=0.026

PCI CABG

Days Since Randomization

Meta-Analysis

PCI vs CABG in LM Disease

Author Journal Year RCT Non-RCT Pts FU

Naik et al JACC Cardiovasc Interv 2009 2 8 3,773 3 yrs Lee et al Am J Cardiol 2010 2 6 2,905 1 yr Capodanno et al J Am Coll Cardiol 2011 4 0 1,611 1 yr Ferrante et al EuroIntervention 2011 4 0 1,611 1 yr Jiang et al Am J Cardiol 2012 0 25 7,230 ≤3 yrs Jang et al Am J Cardiol 2012 3 9 5,079 1 yr Desch et al Herz 2013 4 0 1,611 2 yrs

Sa et al Eur J Cardiothorac Surg 2013 3 13 5,674 1 yr Alam et al Circulation J 2013 4 23 11,148 5 yrs Athappan et al JACC Cardiovasc Interv 2013 3 21 14,203 5 yrs

Sa et al Rev Bras Cir Cardiovasc 2013 1 4 2,914 5 yrs

Li et al TRIALS 2014 4 17 8,413 5 yrs

PCI vs CABG for LM Disease

12 Meta-Analyses, 2009-2014

Desch et al Herz 2013;38:48-56

Risk Ratio (95% CI)

0.74 (0.46, 1.19) 1.19 (0.69, 2.06) 0.26 (0.10, 0.69) 1.94 (1.43, 2.61)

Events Total Total

Favors DES Favors CABG

Jang JS et al Am J Cardiol 2012;110:1411–1418

Test for overall effect: Z=1.97 (p=0.05)

Time

Point

No of Studies

Sample Size

Lower limit

Upper limit p-Value 0.938 0.659 1.337 0.72 1.011 0.739 1.383 0.95 1.149 0.608 1.633 0.44 0.829 0.619 1.110 0.20

Temporal Changes

of MACE

Odds Ratio (95% Confidence Interval) Author Year FU Death MI Stroke TVR D/MI/Stroke

PCI Better

Hazard Ratio (95% Confidence Interval) Author Year FU Death MI Stroke TVR D/MI/Stroke

PCI Better

PCI Better

PCI Better

Outcomes of PCI Is Getting Better Over Time !

15 Years of Temporal Changes

In PCI vs CABG For LM Disease

Data from ASAN MAIN Registry

Adjusted Hazard Ratios of MACCE

Between CABG and PCI

New Data from ASAN MAIN registry, 2014

Repeat Revascularization

0.1 1 10

PCI better CABG better

100

New Data from ASAN MAIN registry, 2014

Adjusted Hazard Ratios of MACCE

Between CABG and PCI

1 Stoke is Higher in CABG

2 TVR is Higher in PCI

3 Outcomes of PCI with DES is Comparable

with CABG, Even Better Survival !

PCI vs CABG Left Main Disease

1 LM Disease is Totally Different Disease Entity

Why, Outcomes of LM PCI

Is Getting Better ?

MACCE to 5 Years, SYNTAX

0 12 24 36 48 60

Patric W Serruys, Presentation TCT 2012

CABG PCI P value

Outcomes of PCI is Good in LM Revascularization

Why

Outcomes of Surgery is Bad, Outcomes of PCI is Good ?

Vessel Easy to Perform Procedure Plenteous Operator’s

Experiences May Influence Good Clinical Outcomes with PCI

Atherosclerotic Progression of Native Coronary Artery

Disease May Influence the Long-term Clinical Outcomes

Native Coronary Artery Patency After Coronary Artery Bypass Surgery,

David Pereg.et al, J Am Coll Cardiol Intv 2014;7(7):761-767

My Thought !

1 LM Disease is Totally Different Disease Entity

Why, Outcomes of LM PCI

Is Getting Better ?

PCI

BMS Early DES Late DES

Unadjusted 2-Year Incidence Rate

(Per 100 Person-Year)

Data from ASAN MAIN registry (n=2,360), 2014

1 LM Disease is Totally Different Disease Entity

Integrated Use of FFR and IVUS Can Improve the Clinical Outcomes

Why, Outcomes of LM PCI

Is Getting Better ?

Outcome Changes,

After Routine Use of IVUS (98%) and FFR (52%) For LM Disease Treatment ,

AMC Data 2014

Before Routine Use

After Routine Use

New Data from AMC Registry, 2014

Death, MI, Stroke or Repeat Revascularization

(LM + 3VD)

CABG Decreased After FFR

Left Main Disease

P<0.01

29%

Before Routine

Use of FFR

After Routine Use of FFR

Distal LM Stent Technique

Stent Crossover Increased

Treated Vessel Territory

RCA or LCX Are Not Frequently Treated Anymore !

(LM + 3VD)

1 Overall Clinical Outcomes Were Improved After the

Routine Use of FFR, Mainly Due to Reduced Rate of Any Repeat Revascularization of PCI

2 Better Concept of PCI is more important for better

outcomes Less surgery, less DES and simplified the procedure can improve outcomes

With Concurrent CABG at 1 Year and It Had Reduced Role of CABG As The Primary Treatment Strategy

Impact of FFR for

LM or 3 VD Treatment In Real Practice

ACC/AHA Guidelines 2011

Elective PCI for LM Stenosis

or Ostial or shaft LM

I IIa IIb III

50

B

or Bifurcation LM

or COPD, disabled stroke, redo CABG

but good CABG candidate

ESC Guidelines 2011

Elective PCI for LM Stenosis

LM with isolated or 1 VD and ostial or shaft

51

LM with isolated or 1 VD and bifurcation LM

I IIa IIb III

B

B

B

TAXUS (N=181) CABG (N=171)

Low Scores 0-22 Intermediate Scores 23-32 High Scores >33

Background of Current Guideline

MACCE to 5 Years by SYNTAX Score,

SYNTAX LM Subset

Current Guidelines Allows 2/3 of LM Disease

(Low, and Intermediate Syntax tertile) Would Be Good Candidate for PCI !

Does High Syntax Score,

Impact of FFR on

3 Vessel Disease

Tonino et al, JACC 2010;55:2816-2821

Functionally, Significant

3VD (14%)

2VD (43%)

0VD (9%)

Functionally Significant

• LM with 1 or 2 Vessel Disease,

• LM with Functionally, True 3 Vessel Disease,

IIa IIb

IIb IIIb

Park SJ et al, NEJM 2011 May 5;364(18):1718-27, Winjs W et al ESC/EACTS guidelines Eur Heart J 2010, Levin GN et al ACC/AHA guidelines JACC 2011;58:44-122, Capodanno et al, JACC 2011;58:1426-32

Functional Approach, 2014

Guidelines for LM PCI

LM Disease is

Not Surgical Disease Anymore

Data Clearly Support Our Practice !

Meta-Analysis of RCTs BARI 2D

FREEDOM

SYNTAX

PCI vs CABG

Multi-Vessel Disease

Meta-analysis of 10 RCTS, 7,812 Patients Treated with

Balloon Angioplasty or BMS vs CABG:

More Strokes in CABG

Study, year Risk difference (95% CI)

Surviving patients/all patients

P=0.002 PCI better CABG better

Ann Int Med 147:708, 2007

Total mortality* (n/N) 5-year mortality (%)† Hazard ratio (95% CI)* P value‡

Treatment Effect in Subgroups

CABG better PCI better

Age>65 yeas

Diabetes

Hlatky MA et al Lancet 2009;373:1190

1 No Difference in Mortality and Death or MI

between the two group

in Diabetics and Older Age (>65year)

PCI vs CABG

In Multi-Vessel Disease

PCI with Balloon PTCA and BMS

Diabetic Concerns

for Multivessel Disease,

BARI 10-Year Survival

in Patients with Diabetes

PTCA vs CABG in Multi-Vessel Disease

From 1988 to 1991

BARI 2D: PCI vs Medical Treatment

(Lower Risk Patients, DM)

(death, MI, or stroke)

Diff [95%CI] = 0.5% [-2.0%, 3.1%]

100

The BARI 2D Study Group.NEJM 2009;360:2503-15

BARI 2D: CABG vs Medical Treatment

(Higher Risk Patients, DM)

The BARI 2D Study Group.NEJM 2009;360:2503-15

(death, MI, or stroke)

PCI CABG P value

Death / MI / Stroke at 5 Year

Farkouh et al, NEJM 2012 November 4

FREEDOM (Diabetics and MVD)

1 Diabetes was associated with more complex coronary lesion

morphology and Injury responses of stented segment should

be more exaggerated with accelerated atherogenesis and

active inflammatory process, which tended to have increased MACE with PCI

2 CABG was superior to PCI with DESs In patients with

diabetes and advanced CAD (predominantly, 3 VD)

However, we need more data with the concept of functional approach and new DES

Diabetic Concerns;

We Need More Data

DES vs CABG

In Multi-Vessel Disease

Limited DES Studies

SYNTAX, All

5 Year Outcomes

Synergy between percutaneous intervention with TAXUS and Cardiac surgery

Syntax All, 5 Year

SYNTAX 3 VD,

5 Year Outcomes

Patric W Serruys, Presentation TCT 2012

SYNTAX Trial

Complete Revascularization, Small Vessel Included (>1.5 mm)

Procedural Characteristics

PCI Randomized Cohort

TAXUS N=903

Stent Number in SYNTAX Trial

WIJNS.pdf

1 Complete Revascularization of All vessel,

Can Make a Worst Clinical Outcomes

Syntax Concept of PCI Is Outdated from Current Practice !

Message from SYNTAX, 5 Year Outcomes

1 Smart “New DES”

2 Better Concept of PCI,

What is Changing Now ?

2014

Sarno et al, Eur Heart J 2012

New DES is Clearly Better !

Primary Endpoint at 2 years: Death + MI + Repeat R + Stroke

R

BEST Study

Patients with Multi-vessel Disease

PI : Park Seung-Jung

1 Smart “New DES”

2 Better Concept of PCI ;

Functional Angioplasty

What is Changing Now ?

2014

Revascularization with Optimal Medical treatment

Good Clinical Outcomes

Impact of FFR on

3 Vessel Disease

Tonino et al, JACC 2010;55:2816-2821

Functionally, Significant

3VD (14%)

2VD (43%)

0VD (9%)

Patients with Angiographically

Primary Endpoint at 2 years: Death + MI + Repeat R + Stroke

R

PI ; William Fearon,MD

We need absolutely new data, about the future

multi-vessel disease under the concept of

functional angioplasty, integrated use of FFR and IVUS

The Game Is Not Over,

Just Begun !

PCI vs CABG

in Multi-Vessel Disease, 2014

Thank You !!

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