C A R D I O L O G Y G R A N D R O U N D S Title: Chronic Total Occlusion Interventions: what is missing in 2016
Speaker(s): Emmanouil S. Brilakis, MD, PhDProfessor of Medicine University of Texas Southwestern Medical School
Date & Time: Monday, January 4, 2016, 7:00 – 8:00 AM
Location: ANW Education Building, Watson Room
OBJECTIVES At the completion of this activity, the participants should be able to:
1. Recognize the prevalence and clinical implications of coronary chronic total occlusion (CTO)s. 2. Examine the advantages and disadvantages of contemporary treatment options for coronary CTOs. 3. Determine the gaps of knowledge in the contemporary approach to coronary CTOs.
ACCREDITATION Physician: This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of Allina Health and Minneapolis Heart Institute Foundation. Allina Health is accredited by the ACCME to provide continuing medical education for physicians.
Allina Health designates this live activity for a maximum of 1.0 AMA PRA Category 1 Credit(s)TM. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Nurse: This activity has been designed to meet the Minnesota Board of Nursing continuing education requirements for 1.2 hours of credit. However, the nurse is responsible for determining whether this activity meets the requirements for acceptable continuing education.
DISCLOSURE STATEMENTS Moderator(s)/Speaker(s) As of December 28, 2015, Dr. Brilakis discloses the following financial relationships: consulting/speaker honoraria from Abbott Vascular, Asahi, Boston Scientific, Elsevier, Somahlution, St Jude Medical, and Terumo; research support from InfraRedx and Boston Scientific; spouse is employee of Medtronic .
Planning Committee Dr. Michael Miedema, and Jolene Bell Makowesky have declared that they do not have any conflicts of interest associated with the planning of this activity. Dr. Robert Schwartz declared the following relationships ‐ stockholder: Cardiomind, Interface Biologics, Aritech, DSI/Transoma, InstyMeds, Intervalve, Medtronic, Osprey Medical, Stout Medical, Tricardia LLC, CoAptus Inc, Augustine Biomedical; scientific advisory board: Abbott Laboratories, Boston Scientific, MEDRAD Inc, Thomas, McNerney & Partners, Cardiomind, Interface Biologics; options: BackBeat Medical, BioHeart, CHF Solutions; speakers bureau: Vital Images; consultant: Edwards LifeSciences.
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Allina Health - Learning & Development - 2925 Chicago Ave - MR 10701 - Minneapolis MN 55407
1
Emmanouil S. Brilakis, MD, PhDDirector, Cardiac Catheterization Laboratories
VA North Texas Healthcare System
Professor of Medicine
UT Southwestern Medical School
Emmanouil S. Brilakis, MD, PhDDirector, Cardiac Catheterization Laboratories
VA North Texas Healthcare System
Professor of Medicine
UT Southwestern Medical School
Minneapolis Heart InstituteCardiology Grand Rounds
January 4, 2016
CTO PCI in 2016: what is missing?
Consulting/speaker honoraria: Abbott Vascular, Asahi, Boston Scientific, Elsevier, Somahlution, Terumo, St Jude
Employment (spouse): Medtronic
Grants: InfraRedx, Boston Scientific
VA - I01-CX000787-01
VA CSP#571 – DIVA
ES Brilakis: Disclosures
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I believe in the value of CTO PCI
Another disclosure…
Proximal RCA CTO – LAO viewCTO: occlusion in the coronary artery with TIMI 0 flow of ≥3 months duration
3
CTO prevalence: Canadian registry
0
2000
4000
6000
8000
10000
12000
14000
16000
CABG STEMI Coronary angio
CTO
No CTO
Fefer P et al. J Am Coll Cardiol. 2012;59(11):991-997
# of pts
54% 10%
14.7%
18.4% among pts with CAD
Jeroudi O et al. CCI 2013
Prevalence of CTOs and choice of revascularization in Dallas VAMC
Diagnostic caths 1/2011 to 12/2012: 2,193Unique patients: 1,699
No prior CABG; n=1,355CAD ; n=1,015
Prior CABG; n=344
CTO, n=319, 31% CTO, n=305, 89%
PCIn=16150%
Medical Rxn=6119%
CABGn=9730%
PCIn=18260%
Medical Rxn=12140%
CABGn=20.6%
5
2000-2011
77% success3.0% MACE
Frequency of CTO complications65 studies - 18,061 Patients
Patel V et al – JACC Intv 2013
0.20.1 <0.01
2.5
3.1
0.2
2.9
0.3 0.30.6 0.4
3.8
<0.01
7
Brilakis ES. Manual of coronary CTO interventions. Elsevier 2013
Antegrade crossing
Brilakis ES. Manual of coronary CTO interventions. Elsevier 2013
Retrograde crossing
8
Brilakis ES. Manual of coronary CTO interventions. Elsevier 2013
Antegrade dissection/re-entry
What is “hybrid”?
an offspring resulting from cross-breeding
Υβρίδιο
9
“the approach that focuses on opening the occluded vessel, using all feasible techniques
(antegrade, retrograde, true-to-true lumen crossing or re-entry) in the most safe, effective, and
efficient way”
“Hybrid” approach to CTO
Birth of the hybrid algorithmJan 2011 – Bellingham, WA
10
Hybrid CTO crossing algorithm
Brilakis, Grantham, Rinfret, Wyman, Burke, Karmpaliotis, Lembo, Pershad, Kandzari, Buller, De Martini, Lombardi, Thompson. JACC Intv 2012
RCA CTO
19
Threader
1st line
2nd line
Brilakis ES. Manual of coronary CTO interventions. Elsevier 2013
Approach to “balloon uncrossable” CTO
“Balloon Uncrossable” CTO
• Inflate 1.20-1.5 mm balloon, Threader, Glider• Rupture balloon in vessel (grenadoplasty)
• Tornus, Corsair, Finecross• Wire “cutting”
• Guide catheter extensions• Anchor balloon strategies
• Laser• Rotational atherectomy
• Subintimal: external “crush” - retrograde
• Subintimal: distal anchor
combinations3rd line
4th line
24
IVUS after stenting
1. Hybrid is key!2. Scratch and go for proximal cap
ambiguity3. CrossBoss knuckle for going
around old stent4. Gaia for redirection5. Threader to get through6. “Double blind stick and swap”
to re-enter
Conclusions
25
71
29
82
2
59
41
86
1.5
60
40
86
1.6
64
36
90
2.2
91
9
69
0
80
20
85
00
20
40
60
80
100
Antegrade Retrograde Overall Majorcomplications
%
2006
2007
2008
2009
2010
2011
Karmpaliotis, Michael, Brilakis, Lombardi, Kandzari et al. JACC Intv 2012;5:1273-9Michael, Karmpaliotis, Brilakis, Lombardi, Kandzari et al. Am J Cardiol 2013;112:488-492
CTO PCI: before hybrid
30%
N=1,363•Peacehealth Bellingham, WA •Piedmont Atlanta, GA •Dallas VAMC/UTSW
San Diego VAMC and University of California, CA
M. Patel
Torrance Medical Center, CA,
M.R. Wyman
PROspective Global REgiStry for the Study of CTO interventions
Appleton Cardiology, WI,
K. Alaswad
Piedmont Heart Institute, GA,D. KandzariN. Lembo
Mid America Heart Institute, MO, J.A.
Grantham
Dallas VAMC and UTSW, TX,
E.S. Brilakis
Massachusetts General Hospital, MA,
F. JafferB. Yeh
Medical Center of the Rockies, CO, A. Doing
Minneapolis VA Medical Center, MN,
S. Garcia
Banner Samaritan Medical Center, AZ,
A. Pershad
Providence Health Center, TX, C.
Shoultz
PeaceHealth St. Joseph Medical
Center, WA, W. Lombardi
Henry Ford, MI, K. Alaswad
Little Rock VAMC, B. Uretsky
Baylor Dallas, TX,J. ChoiHouston VAMC,
TX, A. Denktas
Denver VAMC, CO,
E. Armstrong
Columbia University, NY,
D. Karmpaliotis
Houston Methodist, TX,
A. Shah
Carolina East MC, NC D. Jessup
23 sites sponsors: DVARC and UTSWNational coordinator: BV RanganDatabase manager: A Karasakis
TulaneN Abi-Rafeh, O
Mogabgab
UPMCC. Toma
26
1/2012 to 3/2015
11 centers, 1,036 lesionsTechnical success: 91%Major complications: 1.7%
•Appleton Cardiology, WI•Columbia University, NY•Dallas VAMC/UTSW, TX•Massachusetts General Hospital, MA•Medical Center of the Rockies, CO•Peaceheath Bellingham, WA •Piedmont Heart Institute, GA•St Luke’s Mid America Heart Institute, MO•Torrance Medical Center, CA •VA Minneapolis, MN•VA San Diego and UCSD, CA
43
26
31
AntegradeAntegrade dissection/re-entryRetrograde
68
3644
0
20
40
60
80
100
Techniques Used
%
AntegradeAntegrade DRRetrograde
Successful technique
PROspective Global REgiStry for the Study of CTO interventions
Christopoulos, Karmpaliotis, Alaswad, Yeh, Jaffer, Wyman, Lombardi, Menon, Grantham, Kandzari, Lembo, Moses, Kirtane, Parikh, Green, Finn, Garcia, Doing, Patel, Bahadorani, Tarar, Christakopoulos, Thompson,
Banerjee, Brilakis. Int J Cardiology 2015;198:222-228
87.2
93.7
78.1
90.0
70
80
90
100
2006-2011 2012-2013
%
No prior CABGPrior CABG
Pre Hybrid era
Michael, Karmpaliotis, Brilakis, Abdullah, Kirkland, Mishoe, Lembo, Kalynych, Carlson, Banerjee, Lombardi, Kandzari.
Heart 2013;99:1515-8
∆=9.1%P<0.001
Christopoulos, Menon, Karmpaliotis, Alaswad, Lombardi, Grantham, Michael, Patel, Rangan, Kotsia, Lembo, Kandzari,
Lee, Kalynych, Carlson, Garcia, Banerjee, Thompson, Brilakis. Am J Cardiol 2014;113:1990-4
CTO PCI: success and prior CABG
N=1,3633 US sitesPrior CABG: 37%Complications: 1.5% vs. 2.1%Retrograde: 27.1% vs. 46.7%
∆=3.7%P=0.092
Hybrid era
N=6306 US sitesPrior CABG: 37%Complications: 2.5% vs. 0.8%Retrograde: 34% vs. 39%
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∆=4.8%p=0.18
N=642In-stent restenosis=69 (10.7%), De novo lesions=5736 US centers
Major complications: ISR 2.9% vs. De novo 1.6%
Christopoulos, Karmpaliotis, Alaswad, Lombardi, Grantham, Rangan, Kotsia, Lembo, Kandzari, Lee, Kalynych, Carlson, Garcia, Banerjee, Thompson, Brilakis.
Catheter Cardiovasc Interv. 2014;84:646-51
In-stent restenosisPROspective Global REgiStry for the Study of CTO interventions
89.9
87.0
93.291.8
70
80
90
100
Technical success Procedural success
%ISR De novo
∆=3.3%p=0.31
Success and target vessel
Target vessel
RCA (61%)
LAD (21%)
LCX (18%)
75%
80%
85%
90%
95%
100%
RCA LAD LCX
Technical success
97%
87%
p=0.013
93%
N=6366 US centersRetrograde more frequently in RCA intervention:Initial strategy (26%), final successful strategy (33%)
PROspective Global REgiStry for the Study of CTO interventions
Christopoulos, Karmpaliotis, Wyman, Alaswad, McCabe, Lombardi, Grantham, Marso, Kotsia, Rangan, Garcia, Lembo, Kandzari, Lee, Kalynych, Carlson, Thompson, Banerjee, Brilakis.
Can J Cardiol 2014;30:1588-94
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Radial vs femoral access
N=6506 US centersTransradial (17%): mainly Appleton WITechnical success: 92.6% femoral vs. 93% radial, p=0.87
PROspective Global REgiStry for the Study of CTO interventions
Alaswad, Menon, Christopoulos, Lombardi, Karmpaliotis, Grantham, Marso, Wyman, Pokala, Patel, Kotsia, Rangan, Lembo, Kandzari, Lee, Kalynych, Carlson, Garcia, Thompson, Banerjee, Brilakis. Cath Cardiovasc Intv 2015;85:1123-29
Patients, Procedures, and Patient Reported Health Status
A First Report from the OPEN CTO Trial Investigators
J. Aaron Grantham, MD, FACC
Saint Luke’s Mid America Heart Institute, Kansas City,MO USA
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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
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
30
OPEN CTO Results
119 ± 72 min
89%
265 ± 194 ml
2.5 ± 1.9 Gy
Complications
In Hospital Frequency
Death 0.9%
MI 2.4%
Emergent surgery 0.6%
Perforation 6.0%
Clinical perforation 4.9% (82%)
Bleeding Access 4.0%
Radiation injury 0.1%
30 Day Frequency
Death 1.3%
Rehospitalization 14.7%
Unplanned 12.1%
Revascularization 2.6%
Planned 2.6%
PCI 2.3%
CABG 0.3%
Skin change 3.1%
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59.0
1.6
96.0
0.8
0
20
40
60
80
100
Procedural Success MACE
%
CTO Non-CTO
p < 0.001
p < 0.001
CTO PCI in NCDRProcedural success and MACE
594,510 procedures22,365 CTO PCI2009-2013
Brilakis, Banerjee, Karmpaliotis, Lombardi, Tsai, Shunk, Kennedy, Spertus, Holmes, Grantham.J Am Coll Cardiol Intv 2015;8:245–53
0.4
0.8
0.10.3
2.7
0.30.4
0.1 0.1
1.9
0
1
2
3
Death Urgent CABG Stroke Tamponade MI
%
CTO Non-CTO
p < 0.001
p < 0.001
MACE
p < 0.001
p < 0.001
P = 0.05
Brilakis, Banerjee, Karmpaliotis, Lombardi, Tsai, Shunk, Kennedy, Spertus, Holmes, Grantham.J Am Coll Cardiol Intv 2015;8:245–53
32
244.0
30.0
187.0
15.0
0
50
100
150
200
250
Contrast Fluoroscopy time
CTO Non-CTO
p < 0.001
p < 0.001
Procedural efficiency
Brilakis, Banerjee, Karmpaliotis, Lombardi, Tsai, Shunk, Kennedy, Spertus, Holmes, Grantham.J Am Coll Cardiol Intv 2015;8:245–53
Goals of CTO PCI
What is missing 1Consistently achieve good results
among various centers and operators
33
How to get there?
Motivation – the right people
Education
Standardization of techniques
New devices
Richard St. John. www.ted.com
8 secrets to success
34
The only way to do great work is to love what you do. If you haven’t found it yet, keep looking. Don’t
settle. As will all matters of the heart, you’ll know it when
you find it.Steve Jobs
1.
10,000 hour rule
2.
38
CTO basics
1.Approach: femoral – consider 45 cm sheath
2.Guide: 7 or 8 French – supportshort/shortened 90 cm
3.Virtually always: dual injections
4.Anticoagulation: heparin5.Monitor radiation: AK6.Ready to manage complications:
perforation - tamponade
2.
CTO cart
Short wires
Long wires
FinecrossCorsair
CoilsDelivery microcatheters
2.
39
Keep organized2.
PROspective Global REgiStry for the Study of CTO interventions
Patient radiation dose
40
Brilakis ES. Manual of coronary CTO interventions. Elsevier 2013
↓ fps – better X-rayRepositioning
Using radiation only when necessary
Shielding
Structural
CTO
Peripheral
Congenital
3.
41
1. By whom? Entire cath team
2. How long? 15-30 min
3. How?
Studying the CTO
1. Proximal cap ambiguity
2. Lesion length
3. Quality of distal vessel
4. Collaterals
3.
Brilakis, Grantham, Rinfret, Wyman, Burke, Karmpaliotis, Lembo, Pershad, Kandzari, Buller, De Martini, Lombardi, Thompson. JACC Intv 2012
Hybrid CTO algorithm4.
42
2004-2007The “early” years
2007-2010“Growth” years
2010- “Mature” years….
CTO PCI in Dallas VAMC5.
Michael, Karmpaliotis, Brilakis, Alomar, Abdullah, Kirkland, Mishoe, Lembo, Kalynych, Carlson, Banerjee, Luna, Lombardi, Kandzari. Catheter Cardiovasc Interv 2015;85:393-9
CTO PCI: the learning curve
•Peacehealth Bellingham, WA •Piedmont Atlanta, GA •Dallas VAMC/UTSW
6.
43
only 8 operators performed 50 or more CTO PCI per year.
Brilakis, Banerjee, Karmpaliotis, Lombardi, Tsai, Shunk, Kennedy, Spertus, Holmes, Grantham.J Am Coll Cardiol Intv 2015;8:245–53
7.
45
Can we simplify CTO PCI?
Morino, Y. et al. JACC Intv 2011;4:213-221
J-CTO Score
494 native CTO lesionsCrossing within 30 minutes
46
Progress CTO score
Christopoulos, Kandzari, Yeh, Jaffer, Karmpaliotis, Wyman,
Alaswad, Lombardi, Grantham, Moses, Christakopoulos, Tarar, Rangan, Lembo, Garcia, Cipher, Thompson, Banerjee, Brilakis.
JACC Intv 2015; in press
J-CTO score and CTO PCI approach
PROspective Global REgiStry for the Study of CTOinterventions
J-CTO score validation
Procedural time and J-CTO score
1/2012 to 7/20146 centers, n=650 lesions
Christopoulos, Wyman, Alaswad, Karmpaliotis, Lombardi, Grantham, Yeh, Jaffer, Cipher, Rangan, Christakopoulos, Kypreos, Lembo, Kandzari, Garcia, Thompson, Banerjee, Brilakis.
Circ Cardiovasc Interv. 2015;8:e002171
47
CTO technique: opinions differ!Especially about dissection/re-entry
Nagoya Heart Center
Asian-Pacific CTO Club Algorithm
49
101
Total Length 1900mm
SLIP-COAT® Coating Length 400mm
Coil Length 150mm 0.36mm (0.014inch) PTFE coat
Various models for different situations and/or lesions
Diameter :0.26mm (0.010”) - 0.36mm (0.014”)Tip load :1.7gfDiameter :0.28mm (0.011”) - 0.36mm (0.014”)Tip load :3.5gfDiameter :0.30mm (0.012”) - 0.36mm (0.014”)Tip load :4.5gf
ASAHI Gaia First
ASAHI Gaia Second
ASAHI Gaia Third
Successful DevicesGaia guidewires
51
After multiple balloons
and Ostial-Flash
Contrast: 320 mLFluroscopy time: 73.2 minAK: 3.9 Gray
Ratchet Handle for FAST-Spin Technique
Atraumatic 1 mm Distal Tip
CrossBoss
Successful Devices
52
R
Wire escalation(n=123)
CrossBoss(n=123)
• Crossing time (1⁰ efficacy endpoint)
• MACE (1⁰ efficacy endpoint)
• Success• Total procedure time• Fluoroscopy time• AK radiation dose• Contrast volume• Equipment use
246 pts
Hospital DC
referred for antegrade CTO
PCI
12 sites: US, Canada, UKsponsors: Boston ScientificPI: ES Brilakis
Stingray® Coronary CTO Re-Entry SystemTarget and re-enter the true lumen from a subintimal position in
coronary arteries
180°opposed and offset exit
ports for selective guidewire re-entry
Self-orienting, flat balloon hugs the vessel, positioning one exit port toward the true lumen
Stingray Guidewire’s angled tip and distal probe are designed for facilitated re-entry into the true lumen
2 radiopaque marker bands
53
Prodigy catheter
CenterCross™ Self‐expanding anchor Coaxial alignment Central 3F lumenFDA Cleared – (Peripheral & Coronary)
MultiCross™ Self‐expanding anchor Coaxial alignment Three independent lumensFDA Cleared – (Peripheral & Coronary)
54
NovaCross microcatheter
• Guidewire positioning and support microcatheter for improving CTO crossability
• Outward curving of helical scaffold at distal end provides support and control of guidewire’s distal tip
• Extends distally up to 5cm to assist in inter-occlusion guidewire penetration
Goals of CTO PCI
What is missing 2
Useful new equipment to facilitate procedures and increase success
rates
55
Goals of CTO PCI
Why open a CTO?
Patient Physician
1.↓ angina1.↑ LV function2.↓consequences of
future ACS3.↓arrhythmias4.↓CABG5.↓nitrate use…
1. Help pts2. Improve PCI
skills3. ↑ PCI volume
56
Early Health Status Changes in CTO-PCI
0
10
20
30
40
50
60
70
80
90
100
SAQ AF SAQ PL SAQ QoL
Baseline
1 Month
Patient Reported Angina
Early Health Status Changes in CTO-PCI
0
1
2
3
4
5
6
7
RDS PHQ
Baseline
1 Month
Patient Reported Dyspnea and Depression
58
Odds Ratios of most commonly reported clinical outcomes based on subgroup.
Outcome StentsNon‐Stents
DESNon‐DES
CTO duration
≥ 3 months n/N (%)
CTO duration
≤ 3 months n/N (%)
Studies published before 2008
Studies published after 2008
All‐cause Mortality
0.44* 0.50* 0.51* 0.52* 0.47* 0.60* 0.50* 0.54*
MACE 0.45* 0.60* 0.38* 0.60* 0.57* 0.49* 0.60* 0.42*
MI 0.35* 0.95 0.39* 0.94 0.52 0.92 0.89 0.58*
CABG 0.15* 0.23* 0.12* 0.18* 0.16* 0.20* 0.22* 0.14*
25 studies25,486 pts
Christakopoulos G, Christopoulos G, Carlino M, Jeroudi O, Roesle M, Rangan BV, Abdullah S, Grodin J, Kumbhani D, Vo M, Luna M, Alaswad K, Karmpaliotis D, Rinfret S, Garcia S, Banerjee S, Brilakis ES. Am J Cardiol 2015
Claessen, B. et al. J Am Coll Cardiol Intv 2009;2:1128-1134
Impact of CTO on outcomes post STEMI
59
Complete vs. incomplete revascularization
Garcia S, Sandoval Y, Roukoz H, Adabag S, Canoniero M, Yannopoulos D, Brilakis ES. J Am Coll Cardiol. 2013;62:1421-1431
89,883 Patients
RR = 0.71 [0.65-0.77], p<0.001 .
12,259 out of 89,883 (13%) died during follow
up.
Mortality benefit in patients treated with CABG (RR 0.70; 95%
CI:0.61-0.80, p<0.001) and PCI (RR 0.72, 95% CI:0.64-0.81, p<0.001.
Mortality benefit did not vary with definition of
CR.
61
Interventional cardiologist
Fixed vs Growth mindset
Martinez-Rumayor et al. JACC Cardiovasc Interv
2012;5:e31-32
How CTO equipment can help in non-CTO
cases!
62
CTO Revascularization: Economic Outcomes
0
2,000
4,000
6,000
8,000
10,000
12,000
Total DirectCosts
ProceduralCosts
ContributionMargin
CTO, N=154
Non-CTO, N=1,847Cost (Dollars)
P<0.001
P<0.001P=0.58
$10,870
$7,436
$6,230
$3,060
$5,173
$5,730
~
Balloon angioplasty catheters$600 vs $304
Guidewires$715 vs $174
Stents$3,590 vs $2,036
Karmpaliotis D. CCI 2013
63
CTO Revascularization: Economic Outcomes
0
2,000
4,000
6,000
8,000
10,000
12,000
Total DirectCosts
ProceduralCosts
ContributionMargin
CTO, N=154
Non-CTO, N=1,847Cost (Dollars)
P<0.001
P<0.001P=0.58
$10,870
$7,436
$6,230
$3,060
$5,173
$5,730
Karmpaliotis D. CCI 2013
What has CTO PCI been proven to achieve in RCTs?
64
The impact of PCI for concurrent CTO on left ventricular function in STEMI patients
José PS Henriques, MDAcademic Medical Center of the University of Amsterdam,
Amsterdam, The Netherlands
A randomised multicenter trial
The Evaluating Xience and left ventricular function in PCI on occlusiOns afteR STEMI (EXPLORE) trial
R.J. van der Schaaf, Co-PI
Explore Trial Design
Patients withSTEMI + 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
65
CTO-PCI (n=136) No CTO-PCI (n=144) Difference (95%CI) p
LVEF (%) 44·1 (12·2) 44·8 (11·9) -0·8 (-3·6 to 2·1) 0·597
Primary Endpoint #1 (LVEF @ 4m)
CTO-PCI (n=136) No CTO-PCI (n=144) Difference (95%CI) p
LVEDV (mL) 215·6 (62·5) 212·8 (60·3) 2·8 (-11·6 to 17·2) 0·703
Primary Endpoint #2 (LVEDV @ 4m)
66
LVEF – Subgroup analyses
CTO-PCI treatment armCTO-PCI (n=147)
Number of days from primary PCI to CTO PCI (mean, SD) 5 (+2)
Number of days from randomization to CTO PCI (mean, SD) 2 (+2)
Multiple CTO arteries treated 6 (4%)
Technique CTO procedure Antegrade only 124 (84%)
Retrograde 23 (16%)
Crossboss/ Stingray 5 (3%)
PCI successful, self-reported 117 (80%)
PCI successful, corelab adjudicated 106 (72%)
Everolimus eluting stent 95 (90%)
Number of stents used (median, IQR) 2 (1-3)
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Goals of CTO PCI
What is missing 3Definitive proof of the benefits (or
lack thereoff) of CTO PCIi.e. RCT
DECISION-CTODrug-Eluting Stent Implantation Versus Optimal Medical Treatment in Patients With Chronic Total
Occlusion
1,284 patients enrolled at 26 centers in Korea and 11 centers in Asia-pacific region
•Primary outcome: All cause death, MI, stroke, and any revascularization for 3 years after randomization
•Secondary Outcomes: • All Death (Cardiac death) at 3 & 5 years • Angina class; Quality of life at 3 & 5 years• MI, stroke, any revascularization, CTO-vessel
related revascularization, hospitalization due to ACS, LV function (at 3 years & 5 years)
PI: Seung-Jung Park, MD,PhD
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Not all (patients with) CTOs are the same…
Improve symptoms Improve symptoms& reduce mortality
Single vessel CTO – Prior CABGCTO and Multivessel
disease
Why RCT for CTO PCI is needed
RCT
1. We now can do it
2. We need to know what CTO PCI can and cannot do
3. To improve CTO PCI
4. Payors will be asking for it
QualityQuantityof life
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1. CTOs are common2. CTO PCI can be achieved with
high success and low complication rates at experienced centers – what about the rest?
3. CTO revascularization can most likely provide significant clinical benefits – when are we going to prove it beyond any doubt?
Conclusions