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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: [email protected]
SOLACI 2017
Buenos Aires, Argentina, August 2, 2017
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Financial Conflict of Interest Disclosure
• Speaker’s bureau: Abbot Vascular,
Medtronic, Boston Scientific
• Consultant: Vascular Solutions
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I will Discuss
• Meta-Analyses
• Randomized Trials: EXPLORE,
DECISION CTO, EURO CTO Trial
• Registries: OPEN CTO
• Where Next?
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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%
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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)
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CAD Prognostic Index
More Complex Disease – Lower 5 Year Survival
* Assuming medical treatment only
ACC/AHA SIHD Guidelines
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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
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Collaterals are rarely sufficient to prevent
ischemia
Werner et al. Eur Heart J 2006.
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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
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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
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Evidence Based Medicine Does
Not Equal Randomized
Controlled Trials
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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)
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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
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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.
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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
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Henriques et al J Am Coll Cardiol. 2016;68:1622-1632
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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
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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
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From DECISION-CTO to EUROCTO,
Where Next?
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Hypotheses
DECISION-CTO
OMT would be inferior to CTO-PCI
according to MACCE at 3 years
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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]
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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%
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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
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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
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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
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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
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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!!
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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
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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
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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
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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
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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)
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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
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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)
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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
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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
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Where to next?
Do we need another RCT in stable angina
with SAQ/QoL as primary endpoint?
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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?
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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
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Risks of CTO PCI Benefits of CTO PCI
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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
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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
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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
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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
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Symptoms, Function
and Quality of Life
Survival Cardiomyopathy
CTO PCI Indications in 2017
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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
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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
* * *
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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.
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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
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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
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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%
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Predictors of MACCE
Unpublished Data from OPEN CTO
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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.
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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.
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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.
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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.
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Retrograde CTO PCI May Present Unique
Risks in MVD Patients
Karmpaliotis et al. Circ Intv 2016.
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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
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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
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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
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How Do Our Patients
with Real Symptoms
Actually Feel After Revascularization?
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Second
Edition TCT
2017
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Thank You