CARDIOLOGY GRAND ROUNDS

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1 CARDIOLOGY GRAND ROUNDS Title: Chronic Total Occlusion Interventions: what is missing in 2016 Speaker(s): Emmanouil S. Brilakis, MD, PhD Professor 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. PLEASE SAVE A COPY OF THIS FLIER AS YOUR CERTIFICATE OF ATTENDANCE Signature: My signature verifies that I have attended the above stated number of hours of the CME activity. Allina Health - Learning & Development Chicago Ave - MR Minneapolis MN 55407

2 Minneapolis Heart Institute Cardiology Grand Rounds January 4, 2016 CTO PCI in 2016: what is missing? Emmanouil S. Brilakis, MD, PhD Director, Cardiac Catheterization Laboratories VA North Texas Healthcare System Professor of Medicine UT Southwestern Medical School ES Brilakis: Disclosures Consulting/speaker honoraria: Abbott Vascular, Asahi, Boston Scientific, Elsevier, Somahlution, Terumo, St Jude Employment (spouse): Medtronic Grants: InfraRedx, Boston Scientific VA - I01-CX VA CSP#571 DIVA 1

3 Another disclosure I believe in the value of CTO PCI Proximal RCA CTO LAO view CTO: occlusion in the coronary artery with TIMI 0 flow of 3 months duration 2

4 CTO prevalence: Canadian registry # of pts % among pts with CAD 14.7% CTO No CTO % 10% 0 CABG STEMI Coronary angio Fefer P et al. J Am Coll Cardiol. 2012;59(11): Prevalence of CTOs and choice of revascularization in Dallas VAMC Diagnostic caths 1/2011 to 12/2012: 2,193 Unique patients: 1,699 No prior CABG; n=1,355 CAD ; n=1,015 Prior CABG; n=344 CTO, n=319, 31% CTO, n=305, 89% PCI n=161 50% Medical Rx n=61 19% CABG n=97 30% PCI n=182 60% Medical Rx n=121 40% CABG n=2 0.6% Jeroudi O et al. CCI

5 Goals of CTO PCI Goals of CTO PCI Success + complications 4

6 % success 3.0% MACE Frequency of CTO complications 65 studies - 18,061 Patients < <0.01 Patel V et al JACC Intv

7 Patel V et al JACC Intv 2013 CTO crossing techniques Retrograde Dissection Reentry Antegrade 6

8 Antegrade crossing Brilakis ES. Manual of coronary CTO interventions. Elsevier 2013 Retrograde crossing Brilakis ES. Manual of coronary CTO interventions. Elsevier

9 Antegrade dissection/re-entry Brilakis ES. Manual of coronary CTO interventions. Elsevier 2013 Υβρίδιο What is hybrid? an offspring resulting from cross-breeding 8

10 Hybrid approach to CTO the approach that focuses on opening the occluded vessel, using all feasible techniques (antegrade, retrograde, true-totrue lumen crossing or re-entry) in the most safe, effective, and efficient way Birth of the hybrid algorithm Jan 2011 Bellingham, WA 9

11 Hybrid CTO crossing algorithm Brilakis, Grantham, Rinfret, Wyman, Burke, Karmpaliotis, Lembo, Pershad, Kandzari, Buller, De Martini, Lombardi, Thompson. JACC Intv 2012 RCA CTO 10

12 Proximal LAD Retrograde failed 11

13 Proximal cap?? Lateral 12

14 AL 0.75 Confianza Pro 12 scratch and go Aka move the cap 13

15 Proximal dissection 1.5x8 mm anchor Knuckle started 14

16 Distal RCA ISR Wire is out! 15

17 CrossBoss Pilot 200 Some progress.. 16

18 Getting closer.. Going the wrong way 17

19 Gaia redirection Gaia redirection 18

20 Threader Approach to balloon uncrossable CTO Balloon Uncrossable CTO Inflate mm balloon, Threader, Glider Rupture balloon in vessel (grenadoplasty) 1 st line Tornus, Corsair, Finecross Wire cutting Guide catheter extensions Anchor balloon strategies Laser Rotational atherectomy 2 nd line combinations 3 rd line Subintimal: external crush - retrograde Subintimal: distal anchor 4 th line Brilakis ES. Manual of coronary CTO interventions. Elsevier

21 Sticking UP Sticking down 20

22 Swap 21

23 Confirm 1 Confirm 2 22

24 IVUS post crossing Final 23

25 IVUS after stenting Conclusions 1. Hybrid is key! 2. Scratch and go for proximal cap ambiguity 3. CrossBoss knuckle for going around old stent 4. Gaia for redirection 5. Threader to get through 6. Double blind stick and swap to re-enter 24

26 Peacehealth Bellingham, WA Piedmont Atlanta, GA Dallas VAMC/UTSW % CTO PCI: before hybrid % N=1, Antegrade Retrograde Overall Major complications Karmpaliotis, Michael, Brilakis, Lombardi, Kandzari et al. JACC Intv 2012;5: Michael, Karmpaliotis, Brilakis, Lombardi, Kandzari et al. Am J Cardiol 2013;112: PROspective Global REgiStry for the Study of CTO interventions PeaceHealth St. Joseph Medical Center, WA, W. Lombardi Appleton Cardiology, WI, K. Alaswad Minneapolis VA Medical Center, MN, S. Garcia Massachusetts General Hospital, MA, F. Jaffer B. Yeh Torrance Medical Center, CA, M.R. Wyman San Diego VAMC and University of California, CA M. Patel Banner Samaritan Medical Center, AZ, A. Pershad Medical Center of the Rockies, CO, A. Doing Denver VAMC, CO, E. Armstrong Mid America Heart Institute, MO, J.A. Grantham Little Rock VAMC, B. Uretsky Providence Health Center, TX, C. Shoultz 23 sites sponsors: DVARC and UTSW National coordinator: BV Rangan Database manager: A Karasakis Houston VAMC, TX, A. Denktas Henry Ford, MI, K. Alaswad Dallas VAMC and UTSW, TX, E.S. Brilakis Baylor Dallas, TX, J. Choi Houston Methodist, TX, A. Shah UPMC C. Toma Columbia University, NY, D. Karmpaliotis Carolina East MC, NC D. Jessup Piedmont Heart Institute, GA, D. Kandzari N. Lembo Tulane N Abi-Rafeh, O Mogabgab 25

27 PROspective Global REgiStry for the Study of CTO interventions % 40 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 68 Antegrade Antegrade DR Retrograde /2012 to 3/ centers, 1,036 lesions Technical success: 91% Major complications: 1.7% Successful technique Antegrade Antegrade dissection/re-entry Retrograde Techniques Used 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: CTO PCI: success and prior CABG Pre Hybrid era Hybrid era =9.1% P< No prior CABG Prior CABG =3.7% P= % N=1,363 3 US sites Prior CABG: 37% Complications: 1.5% vs. 2.1% Retrograde: 27.1% vs. 46.7% N=630 6 US sites Prior CABG: 37% Complications: 2.5% vs. 0.8% Retrograde: 34% vs. 39% Michael, Karmpaliotis, Brilakis, Abdullah, Kirkland, Mishoe, Lembo, Kalynych, Carlson, Banerjee, Lombardi, Kandzari. Heart 2013;99: Christopoulos, Menon, Karmpaliotis, Alaswad, Lombardi, Grantham, Michael, Patel, Rangan, Kotsia, Lembo, Kandzari, Lee, Kalynych, Carlson, Garcia, Banerjee, Thompson, Brilakis. Am J Cardiol 2014;113:

28 PROspective Global REgiStry for the Study of CTO interventions In-stent restenosis =3.3% p= =4.8% p= ISR 91.8 De novo % Technical success Procedural success N=642 In-stent restenosis=69 (10.7%), De novo lesions=573 6 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: PROspective Global REgiStry for the Study of CTO interventions Success and target vessel LCX (18%) Target vessel LAD (21%) RCA (61%) 100% 95% 90% 85% 80% Technical success 93% 97% p= % 75% RCA LAD LCX N=636 6 US centers Retrograde more frequently in RCA intervention: Initial strategy (26%), final successful strategy (33%) Christopoulos, Karmpaliotis, Wyman, Alaswad, McCabe, Lombardi, Grantham, Marso, Kotsia, Rangan, Garcia, Lembo, Kandzari, Lee, Kalynych, Carlson, Thompson, Banerjee, Brilakis. Can J Cardiol 2014;30:

29 PROspective Global REgiStry for the Study of CTO interventions Radial vs femoral access N=650 6 US centers Transradial (17%): mainly Appleton WI Technical success: 92.6% femoral vs. 93% radial, p=0.87 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: 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 28

30 OPEN CTO Design Design DESIGN: Prospective, nonrandomized, single-arm, multicenter clinical evaluation of the Hybrid CTO-PCI OBJECTIVE: To evaluate the Success, safety, efficiency, appropriateness, health status outcomes, and costs of CTO-PCI 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 PRINCIPAL INVESTIGATOR J. Aaron Grantham, MD, FACC Saint Luke s Mid America Heart Institute, Kansas City, Mo. USA Success Angina Efficient Complicated Failure Dyspnea inefficient Uncomplicated 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 (%)

31 OPEN CTO Results 89% 119 ± 72 min 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% 30

32 CTO PCI in NCDR Procedural success and MACE 100 p < % CTO Non-CTO 594,510 procedures 22,365 CTO PCI p < Procedural Success 1.6 MACE 0.8 Brilakis, Banerjee, Karmpaliotis, Lombardi, Tsai, Shunk, Kennedy, Spertus, Holmes, Grantham. J Am Coll Cardiol Intv 2015;8: MACE 3 p < CTO Non-CTO % 1 0 p < p < p < P = Death Urgent CABG Stroke Tamponade MI Brilakis, Banerjee, Karmpaliotis, Lombardi, Tsai, Shunk, Kennedy, Spertus, Holmes, Grantham. J Am Coll Cardiol Intv 2015;8:

33 Procedural efficiency 250 p < CTO Non-CTO p < Contrast Fluoroscopy time Brilakis, Banerjee, Karmpaliotis, Lombardi, Tsai, Shunk, Kennedy, Spertus, Holmes, Grantham. J Am Coll Cardiol Intv 2015;8: Goals of CTO PCI What is missing 1 Consistently achieve good results among various centers and operators 32

34 How to get there? Motivation the right people Education Standardization of techniques New devices 8 secrets to success Richard St. John. 33

35 1. 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 2. 10,000 hour rule 34

36 2. Studying

37 2. Interventional Journals 2. 36

38 2. Proctoring Is Google Glass the answer to CTO proctoring shortage? 37

39 2. CTO basics 1.Approach: femoral consider 45 cm sheath 2.Guide: 7 or 8 French support short/shortened 90 cm 3.Virtually always: dual injections 4.Anticoagulation: heparin 5.Monitor radiation: AK 6.Ready to manage complications: perforation - tamponade 2. Coils Delivery microcatheters CTO cart Finecross Corsair Short wires Long wires 38

40 2. Keep organized PROspective Global REgiStry for the Study of CTO interventions Patient radiation dose 39

41 fps better X-ray Repositioning Using radiation only when necessary Shielding Brilakis ES. Manual of coronary CTO interventions. Elsevier CTO Structural Congenital Peripheral 40

42 3. Studying the CTO 1. By whom? Entire cath team 2. How long? min 3. How? 1. Proximal cap ambiguity 2. Lesion length 3. Quality of distal vessel 4. Collaterals 4. Hybrid CTO algorithm Brilakis, Grantham, Rinfret, Wyman, Burke, Karmpaliotis, Lembo, Pershad, Kandzari, Buller, De Martini, Lombardi, Thompson. JACC Intv

43 5. CTO PCI in Dallas VAMC The early years Growth years Mature years. 6. CTO PCI: the learning curve Peacehealth Bellingham, WA Piedmont Atlanta, GA Dallas VAMC/UTSW Michael, Karmpaliotis, Brilakis, Alomar, Abdullah, Kirkland, Mishoe, Lembo, Kalynych, Carlson, Banerjee, Luna, Lombardi, Kandzari. Catheter Cardiovasc Interv 2015;85:

44 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:

45 8. Patient testimonial after right coronary artery chronic total occlusion intervention 44

46 Can we simplify CTO PCI? J-CTO Score 494 native CTO lesions Crossing within 30 minutes Morino, Y. et al. JACC Intv 2011;4:

47 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 PROspective Global REgiStry for the Study of CTO interventions J-CTO score validation J-CTO score and CTO PCI approach 1/2012 to 7/ centers, n=650 lesions Procedural time and J-CTO score Christopoulos, Wyman, Alaswad, Karmpaliotis, Lombardi, Grantham, Yeh, Jaffer, Cipher, Rangan, Christakopoulos, Kypreos, Lembo, Kandzari, Garcia, Thompson, Banerjee, Brilakis. Circ Cardiovasc Interv. 2015;8:e

48 CTO technique: opinions differ! Especially about dissection/re-entry Nagoya Heart Center Asian-Pacific CTO Club Algorithm 47

49 The usual fate of new CTO devices The graveyard of CTO devices Safe Cross 48

50 Successful Devices Gaia guidewires 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 ASAHI Gaia First ASAHI Gaia Second ASAHI Gaia Third Diameter :0.26mm (0.010 ) mm (0.014 ) Tip load :1.7gf Diameter :0.28mm (0.011 ) mm (0.014 ) Tip load :3.5gf Diameter :0.30mm (0.012 ) mm (0.014 ) Tip load :4.5gf 49

51 LIMA Gaia only wire to reach NOT Pilot 200 CP 12 Fielder XT 50

52 After multiple balloons and Ostial- Flash Contrast: 320 ml Fluroscopy time: 73.2 min AK: 3.9 Gray Successful Devices CrossBoss Ratchet Handle for FAST-Spin Technique Atraumatic 1 mm Distal Tip 51

53 Hospital DC 246 pts referred for antegrade CTO PCI R 12 sites: US, Canada, UK sponsors: Boston Scientific PI: ES Brilakis CrossBoss (n=123) Wire escalation (n=123) Crossing time (1⁰ efficacy endpoint) MACE (1⁰ efficacy endpoint) Success Total procedure time Fluoroscopy time AK radiation dose Contrast volume Equipment use Stingray Coronary CTO Re-Entry System Target and re-enter the true lumen from a subintimal position in coronary arteries 180 opposed and offset exit ports for selective guidewire re-entry 2 radiopaque marker bands 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 52

54 Prodigy catheter CenterCross Self expanding anchor Coaxial alignment Central 3F lumen FDA Cleared (Peripheral & Coronary) MultiCross Self expanding anchor Coaxial alignment Three independent lumens FDA Cleared (Peripheral & Coronary) 53

55 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 interocclusion guidewire penetration Goals of CTO PCI What is missing 2 Useful new equipment to facilitate procedures and increase success rates 54

56 Goals of CTO PCI Why open a CTO? Patient 1. angina 1. LV function 2. consequences of future ACS 3. arrhythmias 4. CABG 5. nitrate use Physician 1. Help pts 2. Improve PCI skills 3. PCI volume 55

57 Early Health Status Changes in CTO-PCI Patient Reported Angina SAQ AF SAQ PL SAQ QoL Baseline 1 Month Early Health Status Changes in CTO-PCI Patient Reported Dyspnea and Depression Baseline 1 Month 1 0 RDS PHQ 56

58 CTO meta-analyses Success + complications Success vs failure EF/STEMI Stents 57

59 Odds Ratios of most commonly reported clinical outcomes based on subgroup. 25 studies 25,486 pts Outcome Stents Non Stents DES Non 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* * * CABG 0.15* 0.23* 0.12* 0.18* 0.16* 0.20* 0.22* 0.14* 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 Impact of CTO on outcomes post STEMI Claessen, B. et al. J Am Coll Cardiol Intv 2009;2:

60 Complete vs. incomplete revascularization 89,883 Patients 12,259 out of 89,883 (13%) died during follow up. Mortality benefit in patients treated with CABG (RR 0.70; 95% CI: , p<0.001) and PCI (RR 0.72, 95% CI: , p< Mortality benefit did not vary with definition of CR. RR = 0.71 [ ], p< Garcia S, Sandoval Y, Roukoz H, Adabag S, Canoniero M, Yannopoulos D, Brilakis ES. J Am Coll Cardiol. 2013;62:

61 Proc (Bayl Univ Med Cent) 2015;28(2): Made a difference for this one! 60

62 Interventional cardiologist Fixed vs Growth mindset How CTO equipment can help in non-cto cases! Martinez-Rumayor et al. JACC Cardiovasc Interv 2012;5:e

63 CTO Revascularization: Economic Outcomes Cost (Dollars) P< ,000 $10,870 10,000 8,000 $7,436 6,000 4,000 P<0.001 $6,230 $3,060 Balloon angioplasty catheters $600 vs $304 Guidewires $715 vs $174 Stents $3,590 vs $2,036 P=0.58 $5,730 $5,173 ~ CTO, N=154 Non-CTO, N=1,847 2,000 0 Total Direct Costs Procedural Costs Contribution Margin Karmpaliotis D. CCI

64 CTO Revascularization: Economic Outcomes 12,000 P<0.001 $10,870 10,000 Cost (Dollars) 8,000 6,000 4,000 $7,436 P<0.001 $6,230 $3,060 $5,173 P=0.58 $5,730 CTO, N=154 Non-CTO, N=1,847 2,000 0 Total Direct Costs Procedural Costs Contribution Margin Karmpaliotis D. CCI 2013 What has CTO PCI been proven to achieve in RCTs? 63

65 The Evaluating Xience and left ventricular function in PCI on occlusions after STEMI (EXPLORE) trial The impact of PCI for concurrent CTO on left ventricular function in STEMI patients A randomised multicenter trial José PS Henriques, MD Academic Medical Center of the University of Amsterdam, Amsterdam, The Netherlands R.J. van der Schaaf, Co-PI Explore Trial Design Patients Patients with STEMI treated with ppci and with a non-infarct related CTO. Design Global, multi-center, randomized, prospective two-arm trial with either PCI of the CTO or no CTO intervention after STEMI. Blinded evaluation of endpoints. CTO-PCI < 7d Patients with STEMI + CTO 1:1 No CTO-PCI Objective 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 LVEF and LVEDV MRI at 4 month 64

66 Primary Endpoint #1 4m) 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) Primary Endpoint #2 4m) CTO-PCI (n=136) No CTO-PCI (n=144) Difference (95%CI) p LVEDV (ml) (62 5) (60 3) 2 8 (-11 6 to 17 2)

67 LVEF Subgroup analyses CTO-PCI treatment arm CTO-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) 66

68 Goals of CTO PCI What is missing 3 Definitive proof of the benefits (or lack thereoff) of CTO PCI i.e. RCT DECISION-CTO Drug-Eluting Stent Implantation Versus Optimal Medical Treatment in Patients With Chronic Total Occlusion PI: Seung-Jung Park, MD,PhD 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) 67

69 PI: Gerald Werner, MD Superiority Non-inferiority 2011 PCI guidelines 68

70 Han H et al. J Am Coll Cardiol 2015;65:

71 Not all (patients with) CTOs are the same Single vessel CTO Prior CABG CTO and Multivessel disease Improve symptoms Improve symptoms & reduce mortality Why RCT for CTO PCI is needed 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 RCT Quality Quantity of life 70

72 Conclusions 1. CTOs are common 2. 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? 71

73 CTO PCI is a Journey When you start on the way to Ithaca, wish that the way be long, full of adventure, full of knowledge Constantine P. Cavafy 72