the rationale behind the cto pci - livemedia.gr · 62 eu sites + 23 us sites cto syntax trial...
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Prof Georgios Sianos, MD, PhD, FESC
Aristotle University
AHEPA University Hospital
Thessaloniki, Greece
A’ Cardiology DepartmentAHEPA University Hospital
Aristotle Universityof Thessaloniki
THE RATIONALE BEHIND THE CTO PCI
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❖ INCIDENCE❖ CTO AND CABG❖ COMPLETENESS OF
REVASCULARISATION AND CTO ❖ ISCHEMIC BURDEN AND CTO❖ CTO PCI AND SURVIVAL❖ CTO PCI AND ANGINA❖ SUCCESS RATES AND COMPLICATIONS❖ TRAINING❖ GUIDELINES
OUTLINE
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The CTO Conundrum…55 y.o male with HTN, HLD, 4 months of exertional angina
Nuclear stress test positive for inferior wall ischemia with normal EF
Pt Twin brother….
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CAN YOU PLEASE HELP ME TO INTERPRET THIS IMAGE …..
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The Canadian Multicenter Chronic Total Occlusions Registry
Variability in Percutaneous Treatment of CTOFefer et al. JACC 2012
- CTO identified in 18.4% of 1,697 pts
- Only 40% had history of prior MI, 26% had Q waves in CTO distribution
- Attempt rate varied among hospitals from 1% to 16%
- CTO PCI attempted in only 10% of patients with 70% success
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23 US Sites62 EU Sites +
CTO SYNTAX Trial
TAXUS*
n=903CABGn=897
PCIn=198
CABGn=1077
Two Registry ArmsRandomized ArmsN=1800
Heart Team (surgeon & interventionalist)
Amenable for only one treatment approach
vs
Amenable for bothtreatment options
Stratification: LM and Diabetes
Total Occlusion26.2%
Total Occlusion27.0%
*TAXUS Express; Site-reported, patient-based
Total Occlusion59.3%
Total Occlusion39.1%
Farooq et al. J Am Coll Cardiol 2013; Serruys CRT 2011
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J Escaned et al EHJ 2017 0, 1-11
Syntax II Study -CTO Recanalisation
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3,8
96,2
CTO Non-CTO
234 of 1,387 sites (17%) never performed CTO PCIOperators % CTO PCI IQR: 0.3% to 4.9%
594,510 procedures22,365 (3,8%)
572,145
Brilakis et al, JACC Cardiovasc Interv. 2015 Feb;8(2):245-53
Procedural Outcomes of CTO PCIA Report From the NCDR (National Cardiovascular Data Registry)
CTO PCI between July 1, 2009, and March 31, 2013
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59.0
1.6
96.0
0.80
20
40
60
80
100
Procedural Success MACE
%
CTO Non-CTO
p < 0.001
p < 0.001
Procedural success and MACE
594,510 procedures22,365 CTO PCI (3.8%)
Brilakis et al, JACC Cardiovasc Interv. 2015 Feb;8(2):245-53
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CTOs: The Fox and the Grapes
CCI 86:771-778 (2015)
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CTO AND CABG from SYNTAXFarooq et al. JACC 2013; 61: 282-94
PCINo revasc.
51%
CABGNo revasc.
32%
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Metanalysis of complete (CR) vs incomplete (IR) Revascularization
Garcia et al JACC 2013;62:1421–31.
28 were observational studies, 5 were subgroup analysis of RCTs, 1 was a subgroup analysis of a non-RCT, and 1 was a single- center RCT comparing CR versus IR. Of the 39 study entries, 34 (87%) used an anatomic definition of CR, 2 (5%) a functional definition, 2 (5%) a numerical definition, and 1 (2.5%) multiple definitions of CR.
CABG PCI
Garcia et al JACC 2013;62:1421–31.
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SYNTAX trialIncomplete revascularization predicts adverse outcomes
Farooq V et al Circulation. 2013;128:141-151
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An Interventional Risk Treatment ParadoxNegative Impact of CTO Treatment on Clinical Outcomes in SYNTAX Trial
Farooq et al. J Am Coll Cardiol 2013; Serruys CRT 2011
• CTO Prevalence
— PCI 26.3%, CABG 36.4%
• CTO Location
— 68.1% in proximal/mid vasculature
• PCI success rate 49.4%
• Only 32% of CTOs bypassed
• Presence of CTO strongest independent predictor of incomplete revascularization (HR 2.70)
4-Year MACCE
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An Interventional Risk Treatment ParadoxCTO Treatment in the ACUITY trial
rSS >0–2
(n = 523)
rSS >2–8
(n = 578)
rSS >8
(n = 501)P Value
All Groups
Severe calcification 0 (0%) 10 (1.7%) 59 (11.8%) <0.001
Chronic total occlusion 1 (0.2%) 58 (10.0%) 216 (43.1%) <0.001
Bifurcation/trifurcation 0 (0%) 179 (30.9%) 287 (57.3%) <0.001
Aorto-ostial lesion 1 (0.2%) 4 (0.7%) 14 (0.3%) <0.001
Lesion length >20 mm 3 (0.6%) 143 (24.7%) 351 (70.1%) <0.001
Small vessel/diffuse disease* 409 (78.2%) 303 (52.4%) 264 (52.7%) <0.001
Généreux et al J Am Coll Cardiol 2012;59:2165–74
As baseline SYNTAX score increases,Extent of revascularization decreases and rSS increases
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6.7%
3.7%3.3%
1.0%
2.9%
4.8%
1.8% 2.0%
0%
2%
4%
6%
8%
10% Medical Rx Revasc
Survival Benefit with Revascularization Stratified by Ischemic Risk
% Total Myocardium Ischemic
1- 5% 5-10% 11-20% >20%
Car
dia
c D
eat
h R
ate
1331 56 718 109 545 243 252 267
P <.0001
Hachamovitch et al Circulation. 2003; 107:2900-2907
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• 13,969 pts undergoing SPECT MPI at Cedars-Sinai Hospital, LA between 1991-1997.
• Mean FU=8.7+3.3 years
• There was a survival benefit associated with early revascularization across a range of clinically meaningful ischemia (>10% myocardium) but in the absence of extensive scar (>10% myocardium) .
Interaction between Ischemia, Scar and Revascularization on Survival
Hachamovitch R, et al. European Heart Journal 2011;32:1012
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Changes in myocardial ischemic burden following percutaneous coronary intervention of chronic total occlusions
Safley DM et al. Catheter Cardiovasc Interv. 2011;78(3):337-43
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Changes in myocardial ischemic burden following percutaneous coronary intervention of chronic total occlusions
Safley DM et al. Catheter Cardiovasc Interv. 2011;78(3):337-43
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Tamburino C, et al. Am Heart J. 2013;165:133
CTO Meta-Analysis (I) and MORTALITY
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Khan MF, et al. CCI:2013;82:95
Successful PCI recanalization of a CTO (vs. failed PCI) appears to beassociated with improved long-term survival and overall clinical outcomes.
CTO Meta-Analysis (II) and MORTALITY
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CTO Meta-Analysis (III) and MORTALITY Pancholy SB, et al. Am J Cardiol 2013;111:521
Successful CTO-PCI using a predominantly stent-based strategy is associated with a significant reduction in short- and long-term mortality compared to unsuccessful CTO-PCI
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Joyal D, et al. Am Heart J, 2010.
CTO Meta-Analysis (IV) and MORTALITY
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Christakopoulos, et al. Am J Cardiol 2015
CTO Meta-Analysis (V) and MORTALITY
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George, et al. JACC 2014;235-43.
Improved Long-Term Survival with Successful CTO-PCIRetrospective Analysis of BCIS Database
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• Heterogeneous definitions of CTOs
• Lack of standardized CTO recanalization techniques
• Observational studies, mostly small single-center
• Potential for bias (CTO success vs. failed)
• Over-fitting of multivariate analysis models
• No stratification according to ischemic burden
• Lack of stratification according to the SYNTAX score
• Limited information on completeness of revascularization
• Limited data on OMT strategies
• Lack of systematic LVEF assessment
• Lack of CABG group for comparison
• Lack of a multi-center prospective randomized trial
Limitations of studies assessing survival according to CTO PCI success
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CTO PCI Impact on Angina and Quality of LifeFACTOR study
Grantham JA et al., Circ Cardiovasc Qual Outcomes. 2010;3:284-290)
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Quality of Life Benefits of Percutaneous Coronary Intervention for Chronic Occlusions
(n:147 patients with CTO PCI matched to 1.616 non-CTO PCI patients)
Safley et al, Catheterization and Cardiovascular Interventions (2013)
Health Status Assessments at Baseline and 6 months after PCI
* The SAQ (Seattle Angina Questionnaire) is a 19-item questionnaire which assesses symptoms, functioning and quality of life in patientswith coronary artery disease
Baseline Physical Limitation (73.0 vs. 77.4, P: 0.039) and EQ5D Visual Analogue Scale (VAS) scores (66.4vs. 70.8, P: 0.005) were lower for CTO.
At 6-month follow up all SAQ scores improved (P< 0.05 vs. baseline for all) and were equivalentfor CTO and Non-CTO (P: NS for all).
VAS scores remained lower for CTO, but improved inboth groups (P< 0.05 vs. baseline for both).
Symptom relief supports CTO PCI to improvepatients’ quality of life.
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Euro CTO trial-primary endpoint
From Werner GS at PCR Congress, Paris 2017
Seattle Angina Questionnaire healt status at 12 months
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Quality of life-OPEN CTO registry
Sapontis J, …. Grantham J Am Coll Cardiol Intv 2017;10:1523–34
Seattle Angina Questionnaire
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J Am Coll Cardiol Intv VOL. 10, NO. 15, 2017
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Wijeysundera et al, EuroIntervention 2014;9:1165-1172
Relationship between initial treatment strategy and quality oflife in patients with coronary chronic total occlusions
(387 CTO patients enrolled consecutively undergoing non-urgent coronary angiogramcompleted the Seattle Angina Questionnaire (SAQ) and EQ-5D at baseline and at one year.
Strategies were: i) medical therapy, ii) PCI to non-CTO, iii) PCI to CTO, and iv) CABG.)
Changes in EQ-5D (EQ-5D covers five dimensions of health: mobility,
self-care, usual activities, pain/discomfort, andanxiety/depression)
Baseline 1 year
Patients with CTO territory revascularization had significant improvements in self-reported quality of life
Changes in physical limitation sub-domain of Seattle Angina Questionnaire
Baseline 1 year
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Impact of CTO in Patients with ACS
Author StudyPopulation/ N
(%) CTOStudy
DurationHR (95% CI) for
MortalityP Value
ClaessenJACC Intv 2009
SingleCenter
3,277 STEMI/ 420 (13%)
5 years 1.9 (1.4-2.8) <0.001
Lexis CCI 2011
TAPAS1,071 STEMI/ 90
(8%)2.1 years 2.41* (1.26-4.61) 0.008
ClaessenEHJ 2011
HORIZONS-AMI
3,602 STEMI/ 297 (8%)
3 years 1.97 (1.19-3.25) <0.01
RamunddalCRT 2012
SCAAR17,730 NSTEMI/
1,621 (9%)6 years 1.69 (1.40-2.04) <0.001
*Cardiovascular mortality
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only 8 operators performed 50 or more CTO PCI per year.
Operator CTO PCI Volume Association With Procedural Success and Complications
Brilakis et al, JACC Cardiovasc Interv. 2015 Feb;8(2):245-53
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PROCEDURAL SUCCESS RATE OVER THE STUDY PERIOD(P<0.001 FOR TIME AND OPERATOR)
80,5
83,2
85,6
87,6
60
65
70
75
80
85
90
95
100
2008-2009 2010-2011 2012-2013 2014-2015
Pro
ced
ura
l su
cce
ss (
%)
Years
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RetrogradeDissectionRe-entry
(RDR)
RetrogradeWire Escalation
(RWE)
AntegradeDissectionRe-entry
(ADR)
AntegradeWire Escalation
(AWE)
TRAINING!!!!!!!Four Options To Crossing CTOs
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The Continuum of CTO PCI
DissectionReentry
Antegrade
Retrograde
Adoption of only 1 or 2 of thes limbs will limit the
patients that can be treated on the basis of coronary
anatomy
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HYBRID algorithm
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EuroIntervention. 2012 May 15;8(1):139-45
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CONSENSUS ON THE INDICATION
❖ CTO recanalisation is indicated in patients with symptoms and evidence of ischemia.
❖ In patients with prior Q-wave myocardial infarction viability should be confirmed.
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EHJ invited editorial
In press
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CONSENSUS ON THE INDICATION