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