European Registry Update Jacques Koolen MD PhD Aristotle University of Thessaloniki A’ Cardiology Department AHEPA University Hospital 1

Disclosure Statement of Financial Interest Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Affiliation/Financial Relationship Company Biotronik consultant

EuroCto Club Founding Meeting Paris 14.12.2006 Carlo Di Mario Gerald Werner Joachim Büttner Dariusz Dudek Nicolaus Reifart George Sianos Alfredo Galassi Jaques Koolen Hans Bonnier 3

Euro Intervention Published May 2007 Published May 2008

1983 lesions with CTO Galassi, A.R. et al. J Am Coll Cardiol. 2015; 65(22):2388–400.

Euro CTO Club Membership

ERCTO REGISTRY p for trend <0.001

Numbers of Procedures and Rate of Procedural Success (mean 75.3%) (mean 16.5%) Overall Antegrade Retrograde

Procedural Success According to J-CTO Score and Operator Experience >50 cases, 35 centers, 530 patients enrolled <100 cases, 5 centers, 303 patients enrolled >100 cases 4 centers, 562 patients enrolled

Patient characteristics (17626 procedures) 85.1% male Age 63.9±10.9% BMI 28.0±14.0 kg/m2 Comorbidities: Diabetes 28.6% COPD 5.1% Peripheral artery disease 9.2% Prior MI 42.3% Prior CABG 13.7% Prior PCI 49.6%; at CTO territory 14.8%

Procedural characteristics Occlusion duration 12 [5-14] months* CTO length 25 [18-38] mm* Procedure duration 90 [60-130] min* Fluro time 33 [19-55] min* Contrast volume 250 [180-380] ml* In-stent CTO 7.4% Involving bifurcation 12.1% Previous attempts 24.3% (20.5% one, 3.3% two, 0.5% three or more) Transradial access 23.2% * summarized as median [25th-75th percentile]

Patient characteristics 17,626 percutaneous revascularization procedures involving CTOs (mean age of patients at the time of the procedure 63.9±10.9 years; 85% male) Parameter Years 2008-2009 (N=3,027) 2010-2011 (N=4,812) 2012-2013 (N=5,473) 2014-2015(1/2) (N=4,314) p value (for trend) Age (years) 63.2±11.7 64.0±10.7 63.9±10.8 64.3±10.7 <0.001 Male gender 84.3% 85.8% 85.6% 84.5% 0.924 BMI (kg/m2) 26.3 27.6 28.7 Diabetes 26.5% 28.3% 28.9% 29.9% 0.002 Smoking 38.1% 31.6% 24.6% 26.9% Dyslipidemia 72.4% 72.9% 77.6% 73.8% 0.003 Hypertension 68.4% 71.9% 74.7% 75.9% Peripheral arterial disease 9.7% 8.9% 9.0% 9.6% 0.880 Renal insufficiency 0.0% 1.1% 1.5% 1.7% Prior stroke history 2.6% 3.1% 2.3% 2.5% 0.191 Prior MI history 40.2% 41.0% 35.2% 35.1%

Patient characteristics (cont’d) Parameter Years 2008-2009 (N=3,027) 2010-2011 (N=4,812) 2012-2013 (N=5,473) 2014-2015(1/2) (N=4,314) p value (for trend) Prior PCI 48.9% 51.8% 46.9% 51.2% 0.881 Prior PCI to the CTO territory 19.0% 21.3% 11.3% 9.6% <0.001 In-stent CTO 4.8% 7.9% 8.1% Prior CABG history 14.9% 12.6% 14.2% 13.4% 0.540 Prior CABG to the CTO territory 9.1% 8.9% 0.837 CTO artery   LMA 0.5% 0.6% 0.3% 0.4% LAD 25.7% 24.9% 26.5% 23.8% LCx 14.5% 15.5% 15.6% RCA 47.2% 49.8% 52.8% 56.7% VenG 3.5% 2.8% 0.9% ArtG 0.0% 0.1% 0.2% Other 7.0% 3.2% 2.3% Vessel diameter (mm) 2.87±0.40 2.92±0.42 2.92±0.44 2.94±0.43

Temporal trends in utilization of techniques and materials   Years 2008-2009 (N=3,027) 2010-2011 (N=4,812) 2012-2013 (N=5,473) 2014-2015(1/2) (N=4,314) p value (for trend) Contralateral contrast injection 38.5% 44.9% 55.9% 66.1% <0.001 Number of guidewires used 3.1±2.4 3.3±2.7 3.4±2.7 3.9±3.6 Number of balloons used 2.5±2.1 2.5±1.9 2.6±2.0 2.7±2.2 0.002 Transradial access 16.2% 19.4% 22.2% 33.5% Intravascular ultrasound 2.1% 3.2% 10.8% 12.8% Retrograde approach 10.2% 14.9% 26.3% 30.8% Externalization of retrograde wire 0.3% 2.9% 12.2% 16.5% Corsair microcatheter 2.6% 16.4% 34.2% 39.2% Tornus catheter 7.0% 4.7% 3.0% Crossboss crossing catheter 0.4% 1.5% 3.4% Stingray re-entry system 0.7% 1.8% Rotational atherotomy 1.0% 0.8% 1.2%

Wires to start according to stiffness Soft: 1 g or less Intermediate: >1 g and ≤3 g Moderately stiff: >3 g and <9 g Stiff: ≥9 g

Wires to cross according to stiffness

Small, but significant, increase (p<0 Small, but significant, increase (p<0.001) in procedure duration and fluoroscopy time, and a decrease in contrast volume

J-CTO score

Peri-procedural mortality

Perforations

Any peri-procedural complication* * death, myocardial infarction, stent thrombosis, stroke, perforation, vascular complications, need for emergency surgical intervention or PCI, hemoglobin reduction by >3 g/dl

Changes in Angina and Dyspnea Status After Retrograde CTO PCI Galassi, A.R. et al. J Am Coll Cardiol. 2015; 65(22):2388–400.

Conclusions The number of CTO procedures are ~2.500 per/year. This number is expected to increase with the expansion of the membership The complexity of the CTOs attempted over time significantly increased Success rates are increasing reaching 88% Procedural complication rates are remaining low (in the range of 4.5%) with a tendency of increased perforations In hospital MACE rates are very low (0,5%).

Conclusions The number of the retrograde procedures is increasing over time (reaching 30.8 %) as well as the use of IVUS (12.8%) and the radial approach (33,5%) Medium stiffness GW are increasingly used contributing to the success in more than 50% of the cases. This reflects the adoption in routine clinical practice of the GAIA family JCTO score is a poor predictor of outcomes especially for the retrogarde procedures

In-hospital MACCE

JCTO score p=0.011

Overall, J-CTO was higher in failed cases… p<0.01

while in antegrade ones…

Mean values with 95% confidence intervals of estimated duration and length of CTOs, over the time period 2008-2015. Duration Length Occlusion duration increased from 23.2±40.6 months in 2008-9 to 34.7±53.1 in 2014-15 (p for trend<0.001), CTO length increased from 29.1±17.7 mm to 31.2±20.8 (p for trend<0.001)

Procedural Complications and In-Hospital Outcomes in Retrograde Lesions

Angina severity

Procedural success

SAVE THE DATE … ›› 8th Experts "Live" CTO Workshop 2016 Krakow, Poland Sept 30th – Oct 01st, 2016 Krakow, Poland ECC-President Alfredo R. Galassi, Italy Course Directors Co-Director Jaroslaw Wójcik, Poland George Sianos, Greece Leszek Bryniarski, Poland Nicolas Boudou, France

In the ROC analysis the J-CTO score is a poor predictor of failure (non-significant) in retrograde cases c-statistic 0.522 (95% CI 0.499-0.544) Specifically in retrograde cases:

Web based ERCTO Registry

2015 and on 10 % reabstraction of CTO records (n = 250/ year), masked and reviewed by a second abstractor

Statistical analysis Continuous variables were summarized as mean±standard deviation and compared with one-way analysis of variance. Categorical ones were summarized as percentages and compared with the chi square test. Temporal trends were tested for significance with polynomial contrast analysis (for continuous variables) or the Cochran-Armitage test (for categorical ones). Although the reported results are based on analysis of original data, analyses were repeated after accounting for missing values, using multiple imputation methods, to confirm that the original results were not sensitive to missing value-related bias. IBM SPSS Statistics v. 22 software package (IBM Corporation, Armonk, NY, USA) and R language were used for all analyses. Two-sided p values of less than 0.05 were considered as indicative of statistical significance.

However, the predictive value of the J-CTO score for procedural failure was mediocre c-statistic 0.568 (95% CI 0.556-0.579)

Euro CTO Club Membership

European Registry of CTO (ERCTO) a prospective real-world registry that includes patients with one or more CTO lesions in major coronary arteries or saphenous vein grafts 44 centers across Europe all patients undergoing CTO PCI at these centers between January 2008 and June 2015 were registered prospectively using a web-based electronic data collection interface (17,626 percutaneous revascularization procedures) no exclusion criteria the treatment indication was symptomatic myocardial ischemia and/or evidence of reversible myocardial ischemia by perfusion imaging or stress testing, as proposed at the EuroCTO Club’s position paper procedural details (demographic data, techniques applied, equipment used, fluoroscopy, complication rate) were prospectively recorded

Flowchart of the Study Population Patients included in the multicenter European Registry of CTOs (ERCTO) Registry from 2008 to 2012.

16 european centres across europe