Optimal Revascularization

in Multivessel Disease

and Coronary CTO

Dr Simon Walsh MD FRCP FSCAI

Consultant Cardiologist

Belfast Trust

Speaker's name: Simon Walsh

Consulting and Research Funding: Abbott Vascular

Consulting and Research Funding: Boston Scientific

Research Funding: Nitiloop

Consulting: Vascular Solutions

Potential Conflicts of

Interest

Why treat CTOs at all?

• “Patients are protected by collaterals”

• “The lesions can’t get any worse”

• “It’s too difficult, the risks outweigh the benefits”

• “Success rates are too low”

• My personal favourite - “There is no mortality benefit”

The “protection” from collaterals

Mortality benefit in stable angina with PCI?

RITA 2 - 7 yrs. Henderson et al. JACC 2003;42:1161 FAME 2. de Bruyne et al. NEJM 2012;367:991

To treat or not to treat?

A 65 yr old male with limiting angina despite

medical therapy

To treat or not to treat?

A 65 yr old male with limiting angina despite

medical therapy

To treat or not to treat?

A 65 yr old male with limiting angina despite

medical therapy

To treat or not to treat?

A 65 yr old male with limiting angina despite

medical therapy

The symptom burden and treatment benefits

are the same if not more for CTO PCI

• Compared pts with successful SVCAD PCI

• 141 CTO pts and 1616 pts with non-CTO lesions

• Compared standardised measures of symptoms (SAQ/RDS), function

and QoL (EQ5D)

• CTO pts worse at baseline

• Benefit to the same endpoint after a successful procedure

CCI 2014;84:629-634

Current evidence in stable disease?

OPEN ATERY CTO

Mortality Benefit

Reduced Angina

Improved exercise

capacity

Improved QoL

X

✔︎

X

✔︎ ✔︎

✔︎ ✔︎

✔︎

Maybe inferred

from non-

randomised data

Established for CTO PCI

• Clear symptomatic and QoL benefits

• Successful opening reduces mortality versus failed

• CTO as non-culprit in STEMI doubles mortality risk from

acute MI

• Potential to increase LV function in ischaemic

cardiomyopathy with viable myocardium

• Potential to reduce arrhythmia

The treatment paradox: CTO is a

barrier to PCI

388 US centres

>35,000 CTOs/>640,000 angiograms

Indication for cardiac surgery excluded from

analysis (valve disease)

Grantham et al. JACC Int 2009;2:479

>8,000 sequential angiograms

Cleveland Clinic

CTO strong predictor of PCI not being

performed (OR 0.26, 022-0.31; p<0.0001)

Christofferson et al. Am J Cardiol 2005;95:1088

Current Practice: Patients

undergoing angiography with CTO

Patients with CTO offered PCI

10 - 15%

Optimal Revascularization -

Agreed??

• Patients with CAD should have “optimal revascularization” by PCI or

CABG

• Viable and ischaemic myocardium should be revascularized

• <5% of LV mass with residual ischaemia

Where has PCI PLC gone wrong in

the past?

11,249 patients having PCI in NY state 2003-2004

Predictor of MACE - 2 diseased vessels with a CTO

Hannan et al. JACC Int 2009;2:17-25

• Observational data from BCIS

mandatory returns

• 5 calendar years of data (05-09

inclusive)

• 13,443 pts undergoing attempted

CTO PCI

• Overall success rate 71%

• Mortality data linked from unique

patient number from Office for

National Statistics

George et al. JACC 2014;64:235-43

The Syntax Trial: A Lucky

Miss

Mohr et al. Lancet 2013;381:629-38

CTO in Syntax?

Very poor technical outcomes with PCI

Farooq et al. JACC 2013;61:282-94

Cause of a Poor Outcome in Syntax?

Incomplete Revascularization

• Residual Syntax score >8 associated with 35.3% mortality at 5 years

follow-up

Farooq et al. Circulation 2013;128:141-151

CTO: The biggest per lesion

contributor to the Syntax score

Likely the largest contributor to the

residual Syntax score too

Contemporary CTO Practice &

Results

What is possible?

The necessary skill sets to facilitate the hybrid approach?

Antegrade

Wire Escalation

Antegrade

Dissection

Re-entry

Retrograde wire

escalation

Retrograde

Dissection

Re-entry

Hybrid CTO PCI

• Success requires

flexbility in approach

• No dogma

• Open the artery safely,

but open the artery

• Apply every option you

have to help the patient

• Aim for efficiency (i.e.

safety)

The Hybrid Algorithm for CTO PCI

initial approaches

Dual Catheter Angiography

1. Clear proximal cap

2. Good distal target

3. Length < 20mm

Antegrade Retrograde

yes no

Wire

escalation

Dissection Reentry

(crossboss-stingray)Wire

escalation

Dissection Reentry

(reverse CART)

yes yes nono

The Hybrid Algorithm for CTO PCI

provisional approaches

Dual Catheter Angiography

3. Length < 20mm

Antegrade Retrograde

yes no

Wire

escalation

Dissection Reentry

(crossboss-stingray)Wire

escalation

Dissection Reentry

(reverse CART)

yes yes nono

Dissection Reentry

(reverse CART)

Dissection Reentry

(crossboss-stingray)

fail

fail

fail

fail

1. Clear proximal cap

2. Good distal target

When you stall:

CHANGE STRATEGY

CTO PCI: Integration of good

technology with the right skill mix

Good principles and fundamental to hybrid: Exit

failure modes early - don’t waste time failing

X

X

X

180 minutes??

4 Gray??300 mls contrast??

This can be taught and transferred

Sharma et al. Open Heart 2015;2:e000228. doi:10.1136/openhrt-2014- 000228

0

10

20

30

40

50

60

70

Easy (0)

Intermediate (1)

Difficult (2)

V Difficult (≥3)

Japanese 2012 data

1553 procedures

44 hospitals

Presented: NY CTO 2014

Belfast CTO data

2012 / 13

305 procedures

Per lesion success 91%

0

17,5

35

52,5

70

Easy (0) Intermediate (1) Difficult (2) V Difficult (≥3)

Belfast JCTO

Different complexity, different

pathology?

Post CABG 30% vs 9%

Optimal Revascularization -

Agreed??

• Patients with CAD should have “optimal revascularization” by PCI or

CABG

• Viable and ischaemic myocardium should be revascularized

• <5% of LV mass with residual ischaemia

Multi-vessel CAD and complete

revascularization: We can and must do

better in 2015

Contemporary complete

revascularization: The

portfolio matters

3v

CAD?

iFR negative

FFR = 0.86

iFR negative

FFR = 0.94

Now single vessel CTO

CrossBoss Stingray

Syntax 2 is not just

simple 3vCAD

With no Guidezilla, no PCI!

New technology gets

us from….

Calcium

rCART for RCA CTO

You need all the tools to

get the right result for the

patient

CTO crossing

Threader

HSRA

Guidezilla

38mm Synergy stents

Deliverable NC balloons

Putting the portfolio together

Durability of Outcome for

CTO PCI, DES Choice

and Vessel Healing

70

Morino et al. JACC CI 2011;4:213-21

Complexity

Success

UK data: Complexity not reliably amenable to wire

based strategies

Is there a downside to dissection

and re-entry?

• All CTOs are not wire cases

• Anatomy should inform strategy, not dictate to attempt

or not

• As complexity rises, advanced techniques are needed

for success

• Healing is crucial for durability and long-term results

• Individual patients demonstrate vast differences in

bleeding risk and DAPT tolerability

rCART case 4 months after CTO PCI

After 5mm NC and then tentative 6mm balloon inflation

Appearance 20 months after index

PCI

IC-143313-AB AUG2013 Slide

Polymer and drug applied as ultra-thin abluminal coating

Synchronized drug release and polymer absorption

Polymer gone shortly after completion of drug elution at 3 months

SYNERGY™ Everolimus-Eluting Stent with

Synchrony™ Bioabsorbable Coating

SYNERGYStent Strut Cross Sections

Arterial Wall

Data on file at BSC. The SYNERGY stent is an investigational device in the US and not for sale.

PLGA bioabsorbable

polymer only on

abluminal surface

PVDF durable polymer

360º around stent strut

PROMUS Element

PLGA

Polymer

Everolimus

Drug

Abluminal

Coating

Coating

Microstructure

SYNERGY

Stent

IC-143313-AB AUG2013 Slide

Boston Scientific data on file; World J Cardiol 2011 March 26; 3(3): 84-92;

Garg, S, J Am Coll Cardiol. 2010;56(10s1):S43-S78. doi:10.1016. Presented by Stephen Windecker, MD, TCT2012.

The Synergy Stent is an investigational device in the US and not for sale.

Polymer: PLGA

Absorption Time: 3-4m

% R

ecovery

Time (months)

The SYNERGY Stent polymer absorbs shortly after drug elution is complete at 3 months

Drug Release and Polymer Absorption Profiles

SYNERGY™

Everolimus

PLGA

Nobori™ and

Biomatrix Flex™

% R

ecovery

Polymer: PLA

Absorption Time: >9m

BA9

PLA

Orsiro™

% R

ecovery

Time (months)

Polymer: PLLA

Absorption Time: >12m

Time (months)

Sirolimus

PLLA

(molecular

weight

change)

% R

ecovery

Time (months)

Absorb™

BVS

Scaffold: PLLA

Polymer: PDLLA

Absorption Time: 3y

Everolimus

PDLLA

Complex RCA occlusion with SVG

failure

Belfast 2 case 4 clip 2

Acute result after RDR - note distal

dissection planes

Belfast 2 case 4 clip 19

6/12 follow-up

Picton follow up 63_3

BSc CTO: Investigator Sponsored Research

CTO Indication (US) & Safety (Sub-Intimal Stenting) with Synergy Stent

Prospective, Multi-Center, Single Arm

N=200 Patients

PI: Dr Simon Walsh, United Kingdom

RECHARGE

REGISTRY

CONSISTENT

Enrolling

Enrolling

Safety & Effectiveness of Hybrid Algoithm & CrossBoss and Stingray Technologies

Prospective, Multi-Centre, Non-Randomised Clinical Registry

N=1000 coronary CTO procedures, acute results

PI: Professor Jo Dens, Belgium

OPEN CTO

Long-term outcome from contemporary CTO PCI (US)

Prospective, Multi-Centre, Non-Randomised Clinical Registry

N=1000 coronary CTO procedures

PI: Dr Aaron Grantham, Mid American Heart Institute

Enrolling

Synergy in Belfast

Non-study cases - clinical indication

for bioabsorbable polymer stent

• Audit of clinical outcomes - 1st 100 cases

• At present, management imposed limits on use

due to cost

• Use is biased towards complex disease and

patients at high-risk of bleeding

• Majority stopping DAPT at 3 months

Patients• N=100

• Mean Age 72 ± 10

• 37% >75 years old, 8% >85 years old

• 25% Diabetic

• 35% ACS

• 12 surgical turn-down at MDM, 16 revascularization after

prior CABG

• Mean Euroscore 11.37

Short DAPT Indication

16%

28%

10%

26%

20%

Frail/Elderly

Anticoagulation

Non-cardiac Op

Bleeding Risk

Other

Complex Disease

13

36

9

37

10

92

0

25

50

75

100

Mean Syntax Score 22.7 ± 12.1

PCI & Outcomes

• Mean Syntax score 22.7 (range 6-53)

• 58=tertile 1, 20=tertile 2, 22=tertile 3

• Mean 1.4 lesions per patient

• Mean 2.7 stents per patient

• Mean stent length 75.3 ± 41.5

PCI & Outcomes

• 76% off DAPT at 3 months

• 0 stent thrombosis

• 4 TLR by 6 months/144 lesions (2.8%)

• 1 non-TLR

• 10 non-cardiac ops/procedures 3-6 months

• 5 non-cardiac deaths by 6 months (2 Ca, 1 AAA, 1

sepsis, 1 vascular post TAVI)

Clinical Trials & Synergy

• Syntax 2 - 57 cases, 1 TVR, 0 ST

• Ideal LM - 12 cases, 0 TVR, 0 ST

• Consistent CTO, 22 cases, 0 TVR, 0 ST

• Celtic Bifurcation, 13 cases, 0 TVR, 0 ST

• ~200 cases, complex disease - no stent

thrombosis

Conclusions

• Default: Complete revascularization should be

considered mandatory

• Optimal revascularization means opening CTOs where

myocardium is viable and ischaemic

• Almost every lesion can be treated

• Provided you have the rights skills and tools

• Complete revascularization with Synergy leads to

excellent short & medium term outcomes

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