Le# main treatment with Stentys stent. Carlo Briguori, MD, PhD Clinica Mediterranea Naples, Italy

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1 Le# main treatment with Stentys stent Carlo Briguori, MD, PhD Clinica Mediterranea Naples, Italy

2 Disclosure Statement of Financial Interest I, Carlo Briguori DO NOT have a financial interest/ arrangement or affiliagon with one or more organizagons that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentagon.

3 Challenges for distal LM PCI Ä Large vessel diameter difference between LM and LAD-LCX (Tapering) Ä Bifurcation angle too wide Ä Need for optimal stent expansion and apposition Ä stent thrombosis

4 The Sizing Dilemma LM = 5.6 mm Proximal LAD = 3.4 mm

5 Finet s adapation of the Murrary s law

6 Stent Sizing

7 BifurcaGon LM Kang S-J et al. Circ Cardiovasc Interv. 2011;4:

8 Maximal achievable MLD * Scanning electronic microscopy (SEM) Foin N et al. Eurointervention 2013;8:1315

9 Stent selecgon LM bifurcagon 9

10 Dedicated Devices Device needed which could: 1. Reduce complexity sized to the vessel proximally and distally enable side- branch access 2. Improve safety less metal beper apposigon

11 STENTYS Self- Apposing Stent Self-expanding nitinol stent deployed by retracting a sheath (no balloon) Bare or Paclitaxel-eluting with ProTeqtor biostable polymer 6 French, single-wire, rapid exchange Disconnecting struts over full length * for side-branch access Disconnectors along the stent Disconnectable interconnector Disconnection * Except the first and last 2mm

12 Easy selecgon of stent size Size Length in vessel (mm) Vessel Diameter Maximum Inner Diameter Side-Branch Diameter (mm) Small Medium Large ~2.5 to 3.0mm 4.2mm >2.20 ~3.0 to 3.5mm 5.3mm >2.25 ~3.5 to 4.5mm 6.6mm >

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14 STENTYS for treatment of the LM bifurcagon Ä Pilot study Ä Between February 2012-September 2013 Ä 75 consecutive patients with LM bifurcation stenosis with tapered anatomy Ä > 1mm difference in reference diameter between proximal MV (LM) and distal MV (LAD or LCX) Ä 2) bifurcation distal or β angle of 30 to 70, and Ä 3) one of the following: a) acute coronary syndrome and/or hemodynamic instability, b) high surgical risk defined as the Society of Thoracic Surgeons (STS) score 10, and/or European System for Cardiac Operative Risk Evaluation (EuroSCORE) of 6, c) refusal to undergo CABG, d) suitable anatomy and lesion characteristics for stenting, d) no contraindications to prolonged dual antiplatelet therapy. Briguori C et al. Catheter Cardiovasc Interv 2015; Sep 1;86(3):E

15 STENTYS for treatment of the LM bifurcagon Ä Control group Ä patients treated with second-generation balloon expandable DES in the same period at the New Tokyo Hospital (Chiba, Japan). Each patient in the Control group was selected from the database in order to be marched to a patient treated in the STENTYS-DES group using the propensity score method. The following matching variables were selected Ä a) presence of tapered anatomy ; Ä b) distal ULMCA lesion Ä c) bifurcation lesion type according to the Medina s classification; Ä d) reference vessel size, minimal lumen diameter (MLD), and lesion length, and Ä e) SYNTAX score. Briguori C et al. Catheter Cardiovasc Interv 2015; Sep 1;86(3):E

16 STENTYS for treatment of the LM bifurcagon Ä Primary endpoints: Ä Device success, defined as the ability to insert the stent into the target lesion, Ä Angiographic success, defined as a <30% residual stenosis in MV and SB with TIMI 3 flow in both vessels post-procedure, Ä IVUS success, achieved when satisfying the criteria of optimal stent expansion, and optimal minimal CSA within each segment, Ä Procedural success, defined as lesion success without any in-hospital major adverse cardiac events (MACE). Briguori C et al. Catheter Cardiovasc Interv 2015; Sep 1;86(3):E

17 Clinical CharacterisGcs STENTYS PES group (n=75) Control group (n=75) Age, years 65 ± 9 70 ± 9 <0.001 Male 58 (77%) 59 (78.5%) 0.75 Diabetes mellitus Insulin-treated Symptoms Silent ischemia Stable angina Unstable angina 32 (42.5%) 13 (17%) 2 (2.5%) 58 (77.5%) 16 (21%) 32 (42.5%) 13 (17%) 1 (1.5%) 55 (73.5%) 18 (24%) Left Ventricular Ejection Fraction, % 52 ± 9 55 ± Previous MI 24 (32%) 21 (28%) 0.51 Systemic Hypertension 59 (79%) 54 (72%) 0.27 Active smoking 12 (16 %) 12 (16%) 1.00 egfr (ml/min/1,73 m 2 ) <60 80 ± (17%) 75 ± (25%) Critical stenosis of RCA 40 (53%) 40 (53%) 1.00 NERS score* 16 [5-34] 7 [1-24] <0.001 Euroscore logistic* 6 [2-54] 4 [1-46] STS score 10 SYNTAX score Low Intermediate High 14 [5-57] 50 (66.5%) 24 ± 8 26 (48%) 27 (36%) 12 (16%) 11[4-76] 47 (62.5%) 25 ± 9 29 (38.5%) 30 (40%) 16 (21.5%) p

18 Angiographic CharacterisGcs LM lesion location With ostial disease With whole trunk With body&distal Isolated bifurcation Medina classification 1:1:1 1:1:0 1:0:0 STENTYS PES group (n=75) 0 16 (21%) 10 (13%) 49 (57%) 43 (57%) 28 (38%) 4 (5%) Control group (n=75) 0 16 (21%) 10 (13%) 49 (57%) 26 (34.5%) 43 (57.5%) 6 (8%) p Bifurcation angle ( ) 71 ± ± Briguori C et al. Catheter Cardiovasc Interv 2015; Sep 1;86(3):E131-9

19 Procedural CharacterisGcs STENTYS PES group (n=75) Control group (n=75) p Radial approach 4 (5%) 21 (28%) <0.001 Hemodynamic support 3 (4%) 3 (4%) 1.00 Direct stenting Rotational atherectomy 7 (9%) 11 (14.5%) 34 (45%) 7 (9.3%) < Disconnection 68 (90.5%) - - SB stenting 9 (12%) 11 (15%) 0.63 T 9 (100%) 0 Minicrush 0 7 Culotte 0 4 FKB 41 (56.4%) 42 (56%) 0.94

20 MV stent diameter (mm) Stent/distal LM ratio Stent/POC ratio Stent/ostial LAD ratio Procedural CharacterisGcs STENTYS PES group (n=75) 3.29 ± ± ± ± 0.24 Control group (n=75) 3.44 ± ± ± ± 0.24 p < <0.001 Final balloon diameter (mm) 3.62 ± ± 0.51 <0.001 Nominal stent over-expansion <0.50 mm mm >0.75 mm 27 (36%) 38 (51%) 10 (13%) 3 (4%) 13 (17%) 59 (79%) <0.001 Final stent length (mm) 55 ± ± Stent/patient ratio 2.2 ± ± Maximal inflation pressure, atm 20 ± 4 18 ± 4 <0.001 Stent implanted to treat ULMCA stenosis STENTYS PES Xience Xience Prime Xience Xpedition Resolute Integrity Primus Element Nobori 75 (100%) (9.5%) 23 (30.5%) 19 (25.5%) 12 (16%) 2 (2.5%) 12 (16%)

21 QuanGtaGve coronary artery analysis Main Vessel Side branch LM proximal to POC POC Ostial LAD Ostial LCX Stentys group Control group Stentys group Control gropu Stentys group Control group Stentys group Control group Reference diameter,mm 4.12 ± ± ± ± ± ± ± ± 0.69 Diameter stenosis, % pre-proc post-proc 51.75± ± ±20.34* *4.77± ± ± ±16.43* 9.53± ± ±3.68* 49.65±25.4* 8.48±5.16# 20.98± ± ±19.31* 8.97±7.92 MLD, mm pre-proc post-proc 2.01± ± ±0.73* 3.93± ± ± ±0.64* 2.88±0.86# 1.33± ± ±0.71* 3.00± ± ±0.62* 1.97±0.73* 2.34±0.73* * p>0.05; # p<0.001; p=0.002 between groups Briguori C et al. Catheter Cardiovasc Interv 2015; Sep 1;86(3):E131-9

22 QuanGtaGve coronary artery analysis Briguori C et al. Catheter Cardiovasc Interv 2015; Sep 1;86(3):E131-9

23 Post- stengng intravascular ultrasound finding

24 Results STENTYS group Control group

25 1- year clinical follow- up STENTYS DES group (n=75) Control group (n=75) p All cause death 3 (4%) 1 (1.3%) 0.62 Cardiac 3 (4%) 1 (1.3%) 0.62 Non-cardiac 0 0 Myocardial infarction 2 (2.6%) 1 (1.3) 1.00 Repeat revascularization 1 (1.3%) 5 (6.6%) 0.21 Stent thrombosis 2 (2.6%) 1 (1.3%) 1.00 Cumulative events 7 (9.3%) 7 (9.3%) 1.00

26 Results Ä SB stenting = 13 patients (22.4%) Ä Additional DES in the MV = 32 patients (55%) due to: Ä Longer lesions, or Ä Additional lesions 26

27 Case 1

28 5.56 mm 4.96 mm 4.37 mm 1.97 mm 2.04 mm 2.11 mm 3.37 mm 2.82 mm

29 Case 1 Stentys x 27 mm & Nobori 3.0 x 24 mm

30 20.26 mm mm mm mm mm 4.05 mm 3.67 mm mm mm mm 8.79 mm mm 2

31 Case 2

32 Case 2 Stentys x 27 mm & Resolute Integrity 3.5 x 12 mm

33 Case 2

34 Case 2

35 Os#al LAD POC 8,74 mm2 3,88\3,51 mm 10.8 mm2 2.84\4.33mm 13,79 mm2 4.66\5.0mm LM prox to POC mm2 4.51/35.26 mm 23,39mm2 5.4\6.42mm

36 Ostial LAD POC LM prox to POC MSA = mm 2 MSA = mm 2 MSA = mm 2 Stentys x 27 mm

37 OCT 3 months follow- up Uncovered struts 9.2% Malapposed struts 0.3% Stentys x 22 mm

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40 Results Ä Stentys DES was succefully deployed in all the 24 patients w/o the need of any other additional DES in the MV. Ä In one case the was excessive protrusion of the Stentys DES into the aorta (device failure).

41 Ä Small sample size Ä Non-randomized design LimitaGons Ä Stentys PES Ä Paclitaxel-eluting Ä Learning curve for optimal deployment

42 XposiGon S

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47 Unprotected distal LM treated by XposiGon S Ä 80 y female Ä Diabetes mellits (insulin-treated) Ä CKD (egfr = 35 ml/kg/1.73 m 2 ) Ä NSTEMI & acute pulmonary edema Ä Ecocardiography: Ä LVEF <30% Ä Severe valvular aortic stenosis Ä Coronary angiography: Ä severe 3VD involving distal LM 47

48 Unprotected distal LM treated by XposiGon S

49 Unprotected distal LM treated by XposiGon S Hemodynamic support with 2.5 L Impella (ABIOMED)

50 Unprotected distal LM treated by XposiGon S Xposition S 3.5/4.5 x 22 mm

51 Unprotected distal LM treated by XposiGon S

52 Conclusions Ä Pilot studies suggest that the self-expanding properties of the STENTYS PES (P) offer a valid alternative for the treatment of the distal ULMCA lesions. Ä The new Xposition S seems to solve some technical issues of previous STENTYS PES stent Ä Validation is a major issue and randomized studies in ULMCA lesions comparing Xposition S to conventional balloon-expandable DES and to CABG are needed