STENTYS for Le, Main Sten2ng. Carlo Briguori, MD, PhD Clinica Mediterranea Naples, Italy
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1 STENTYS for Le, Main Sten2ng 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 affilia2on with one or more organiza2ons that could be perceived as a real or apparent conflict of interest in the context of the subject of this presenta2on.
3 The Sizing Dilemma LM = 5.6 mm Proximal LAD = 3.4 mm
4 Stent Sizing
5 Bifurca2on LM Kang S-J et al. Circ Cardiovasc Interv. 2011;4:
6 Maximal achievable MLD * Scanning electronic microscopy (SEM) Foin N et al. Eurointervention 2013;8:1315
7 Stent selec2on LM bifurca2on 7
8 Site of recrossing Foin N et al. International J Cardiol 2013
9 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 berer apposi2on
10 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
11 Easy selec2on 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 >
12 STENTYS Disconnec2on in a bifurcated tube
13 STENTYS for treatment of the LM bifurca2on 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. 13
14 STENTYS for treatment of the LM bifurca2on 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. 14
15 STENTYS for treatment of the LM bifurca2on 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). 15
16 Clinical Characteris2cs STENTYS DES 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
17 Angiographic Characteris2cs 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 DES 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 ± ±
18 Procedural Characteris2cs STENTYS DES 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
19 Procedural Characteris2cs MV stent diameter (mm) Stent/distal LM ratio Stent/POC ratio Stent/ostial LAD ratio STENTYS DES 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 DES 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%)
20 Quan2ta2ve 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
21 Post- sten2ng intravascular ultrasound finding STENTYS DES group Control group p (n = 75) (n = 75) Proximal LM above the POC CSA, mm 2 EEM area at the CSA, mm 2 CSA <8.2 mm 2 Symmetry index Incomplete stent apposition ± ± ± ± ± (4%) 0.83 ± < POC CSA, mm 2 CSA <7.2 mm 2 Incomplete stent apposition ± ± (6.6%) 0 < LAD ostium CSA, mm 2 EEM area at the CSA, mm 2 CSA <6.3 mm 2 Symmetry index Incomplete stent apposition ± ± (5.4%) 0.86 ± ± ± (5.4%) 0.82 ± < LCX ostium, CSA, mm 2 EEM area at the CSA, mm 2 CSA <5.0 mm 2 Symmetry index Incomplete stent apposition 7.19 ± ± (56%) 0.83 ± ± ± (54.5%) 0.83 ± <
22 Results STENTYS group Control group
23 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
24 Case 1
25 5.56 mm 4.96 mm 4.37 mm 1.97 mm 2.04 mm 2.11 mm 3.37 mm 2.82 mm
26 Case 1 Stentys x 27 mm & Nobori 3.0 x 24 mm
27 20.26 mm mm mm mm mm 4.05 mm 3.67 mm mm mm mm 8.79 mm mm 2
28 Case 2
29 Case 2 Stentys x 27 mm & Resolute Integrity 3.5 x 12 mm
30 Case 2
31 Case 2
32 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
33 Ostial LAD POC LM prox to POC MSA = mm 2 MSA = mm 2 MSA = mm 2 Stentys x 27 mm
34 OCT 3 months follow- up Uncovered struts 9.2% Malapposed struts 0.3% Stentys x 22 mm
35 Limita2ons Ä Small sample size Ä Non-randomized design Ä Differences in clinical practice and ethnicity between the 2 centers
36 Conclusions Ä The present pilot study suggests that the selfexpanding properties of the STENTYS DES (P) offer a valid alternative for the treatment of the distal ULMCA lesions. Ä Long-term results and larger studies are warranted to confirm this preliminary result. Validation is, indeed, still a major issue and randomized studies in ULMCA lesions comparing this dedicated device to conventional balloon-expandable DES and to CABG are needed
Le# main treatment with Stentys stent. Carlo Briguori, MD, PhD Clinica Mediterranea Naples, Italy
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