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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