1. PCI of CTO improved health status regarding physical limitations, angina frequency, mobility and activity compared to OMT and improved functional class significantly.
2. In experienced hands, periprocedural risk was low, and the 12-month MACE rate was comparable to OMT, but long-term safety remains to be evaluated at 36 months.
3. Successful revascularization of CTO is associated with reduced mortality, while complete revascularization seems to confer an advantage over partial revascularization.
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CTO: How to define success
1. Tony Gershlick
Professor Interventional Cardiology
University Hospitals of Leicester UK
EURO CTO 2018
CTO :- How to define success
Leicester Cardiovascular Biomedical Research
Centre
2. Origin
Mid 16th century: from Latin successus, from the verb
succedere ‘come close after’ (see succeed)
“The accomplishment of an aim or purpose”.
Being successful means the achievement
of desired visions and planned goals
3. Patient presents with CV symptoms
Make clinical diagnosis
Check it is ischaemia
Treat 1-2 anti-anginal
Patient still has CV symptoms
Need to do something else
4. Symptoms
? IHD
Non Invasive test
CMR/ Stress Echo/ MPS
Ischaemia
Viability
Angio (ACS)
Incidental CTO finding
yes
no
IB >10%
yes
Angio
CTO
Angiogram
5. Guidelines
The 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention recommended CTO PCI
in patients with clinical indications and suitable anatomy when performed by operators with appropriate
expertise (Class IIa, Level of Evidence [LOE] B)
The 2014 European Society of Cardiology and European Association for Cardio-Thoracic Surgery
guidelines on myocardial revascularization recommend CTO PCI to be considered in patients with
expected ischemia reduction in a corresponding myocardial territory and/or angina relief (Class IIa,
LOE B). They recommend an initial anterograde approach and consideration of a retrograde approach
if this fails or a primary retrograde approach in selected patients (Class IIb, LOE C)
The ACC/AATS/AHA/ASE/ASNC/SCAI/SCCT/STS 2017 Appropriate Use Criteria for Coronary
Revascularization in Patients With Stable Ischemic Heart Disease have eliminated the separate criteria
for CTO lesions as was the case in the 2012 guidelines. Currently, indications for revascularization in
SIHD are determined irrespective of whether the lesion is a CTO.26 The indication for revascularization
of a coronary artery lesion, whether CTO or severe stenosis, is based on symptoms, the extent of
antianginal medications, and the risk of ischemia
6. If you follow these rules
(symptoms with objective ischaemia despite medication)
then defining success is dead easy !!!
Because it is then the resolution of symptomatic objective ischaemia
9. with permission
Patient “satisfaction” Is that success ???
Later that day pre discharge
Us : “We managed to get
through
the blockage and got a good
result”
10.
11. Negative predictors of clinical success
Diabetes, hypertension, PVD, stroke/TIA, current
smoker, history of MI, prior CABG and prior PCI
Ostial CTO, >45 degree tortuosity, blunt stump,
bridging collaterals, moderate-to-severe
calcification, multivessel disease, RCA and non-LAD
CTO
Age >75 years was an additional negative predictor of
clinical success (OR 0.68; 95% CI 0.48 to 0.96) but not
technical success
Left main CTO was a significant predictor of
decreased clinical success after exclusion of one
outlier (OR 0.17; 95% CI 0.03 to 0.86).
12. A Randomized Multicentre Trial to
Evaluate the Utilization of
Revascularization or Optimal Medical
Therapy for the Treatment of Chronic
Total Coronary Occlusions
Gerald S. Werner, MD PhD
on behalf of the
EURO CTO trial investigators
13. Success Failure
Decision as per
usual clinical care
Medical Rx CABG
Efficacy: Health status @ 12 and 36 months
Safety: Death, non-fatal myocardial infarction (ITT, PP) @ 36 months
Repeat Exercise Tolerance Test (ETT) for objective assessment of ischemia @ 12m and 36months
Single-vessel disease
CTO only
Multivessel CAD
including CTO
Treat non-occlusive disease
by PCI before CTO with DES
Angina or
angina-
equivalent
symptoms
Randomisation 2:1
PCI DES + OMT
n=259
OMT
n=137
Study flow chart
48%
29%
Ongoing angina
despite OMT
n=10 (7.3%)
Clinically
indicated
interim PCI
14. 0
10
20
30
40
50
60
70
80
90
100
BL FU BL FU BL FU BL FU BL FU
OMT PCI
Physical
limitation
Anginal
frequency
Anginal
stability
Treatment
satisfaction
Quality of
life
Primary endpoint: SAQ health status (ITT)
P=0.04 P=0.02 P=0.06
15. EQ-5D changes during follow-up
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
BL FU BL FU BL FU BL FU BL FU BL FU
No Moderate Severe
Mobility Activity Pain/discomfort
OMT PCI OMT PCI OMT PCI
P=0.001P<0.001P=0.005
17. Summary of results
• demonstrate, that PCI of CTO improved the health status
regarding physical limitations, angina frequency, mobility and
activity as compared to OMT, and improved the functional
class significantly
• In experienced hands, periprocedural risk was low, and the 12
months MACE rate was comparable to OMT, but the long-term
safety remains to be evaluated at 36 months (Primary safety
endpoint)
How real world is this trial ?
18. Methods
• Analysis of the UK Central Cardiac Audit Database
• Procedures between Jan 1st 2005 – Dec 31st 2009
• 326 398 PCI procedures
• 15 492 elective CTO procedures on 13 443 patients
• Mortality data from the Medical Research Information Service
(MRIS)
What we want, what we really, really want is ………………………mortality data !!!
19. Successful revascularisation is associated with reduced mortality
Conclusion:
A randomised clinical
trial will require
>> 10 000 CTO patients
21. If the patient has been appropriately selected
(symptoms, non-invasive evidence ischaemia in viable myocardium
despite anti-anginal medication)
Hierarchical determinant of success
① No complications
② TIMI 3 Flow with good run off
③ Improved quality of life (longer term)
④ Objective improvements in ischaemia testing
⑤ Long term survival
22. But we do need to have definition/understanding
of what we mean by success in our heads before we take on expensive
procedure that not risk free
Appropriate patient selection is all :
symptomatic, viable myocardium & evidence ischaemia and you can
reverse these over long sustained period and you have success…..
23. “Success is 10% inspiration and 90% perspiration”
Thomas Edison
THIS DOES NOT HAVE TO BE A TRUE-ISM IN PCI-CTO
“Things done well and with a care, exempt
themselves from fear.” William Shakespeare
28. AWE is no longer a stand alone- succeed or fail- strategy
antegrade
dissection re-
entry
antegrade
wiring
Retro-grade
But it has to be done properly to optimise success
Having bail-out ADR/ Retrograde options should not mean you
are merely “having a go”
29. CTO- pre-requisites –
i. Symptoms
ii. Evidence of reversible ischaemia
iii. Useful collaterals
iv. You know what you are doing (wires)
Patient issues