THE RATIONALE BEHIND THE CTO PCI - Livemedia.gr · 62 EU Sites + 23 US Sites CTO SYNTAX Trial...
Transcript of THE RATIONALE BEHIND THE CTO PCI - Livemedia.gr · 62 EU Sites + 23 US Sites CTO SYNTAX Trial...
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
❖ 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
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….
CAN YOU PLEASE HELP ME TO INTERPRET THIS IMAGE …..
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
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
J Escaned et al EHJ 2017 0, 1-11
Syntax II Study -CTO Recanalisation
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
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
CTOs: The Fox and the Grapes
CCI 86:771-778 (2015)
CTO AND CABG from SYNTAXFarooq et al. JACC 2013; 61: 282-94
PCINo revasc.
51%
CABGNo revasc.
32%
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.
SYNTAX trialIncomplete revascularization predicts adverse outcomes
Farooq V et al Circulation. 2013;128:141-151
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
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
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
• 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
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
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
Tamburino C, et al. Am Heart J. 2013;165:133
CTO Meta-Analysis (I) and MORTALITY
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
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
Joyal D, et al. Am Heart J, 2010.
CTO Meta-Analysis (IV) and MORTALITY
Christakopoulos, et al. Am J Cardiol 2015
CTO Meta-Analysis (V) and MORTALITY
George, et al. JACC 2014;235-43.
Improved Long-Term Survival with Successful CTO-PCIRetrospective Analysis of BCIS Database
• 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
CTO PCI Impact on Angina and Quality of LifeFACTOR study
Grantham JA et al., Circ Cardiovasc Qual Outcomes. 2010;3:284-290)
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.
Euro CTO trial-primary endpoint
From Werner GS at PCR Congress, Paris 2017
Seattle Angina Questionnaire healt status at 12 months
Quality of life-OPEN CTO registry
Sapontis J, …. Grantham J Am Coll Cardiol Intv 2017;10:1523–34
Seattle Angina Questionnaire
J Am Coll Cardiol Intv VOL. 10, NO. 15, 2017
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
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
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
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
RetrogradeDissectionRe-entry
(RDR)
RetrogradeWire Escalation
(RWE)
AntegradeDissectionRe-entry
(ADR)
AntegradeWire Escalation
(AWE)
TRAINING!!!!!!!Four Options To Crossing CTOs
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
HYBRID algorithm
EuroIntervention. 2012 May 15;8(1):139-45
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.
EHJ invited editorial
In press
CONSENSUS ON THE INDICATION