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Le stent biobasorbable Bernard Chevalier ICPS Massy / GCS Creil.

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Presentation on theme: "Le stent biobasorbable Bernard Chevalier ICPS Massy / GCS Creil."— Presentation transcript:

1 Le stent biobasorbable Bernard Chevalier ICPS Massy / GCS Creil

2 © 2009 Abbott Laboratories Pipeline product. Currently in development at Abbott Vascular. Not available for sale. In the last five years, I received research grants or speaker fees or I am/was consultant for: Abbott Vascular, Asahi, Astra Zeneca, AVI, Boston Scientific, Biotronik, Colibri, Cook, Cordis, Daichi-Sankyo, Eli-Lilly, Iroko, Medtronic, Terumo. I am currently minor shareholder & general mamager of CERC

3 © 2009 Abbott Laboratories Pipeline product. Currently in development at Abbott Vascular. Not available for sale. Limitations des stents permanents

4 © 2009 Abbott Laboratories Pipeline product. Currently in development at Abbott Vascular. Not available for sale. Conformabilité (R) Echapement (R) Malapposition (T) Retard de cicatrisation (T) Elution permanente de drogue (T) « Jailing » des branches Interference MSCT

5 © 2009 Abbott Laboratories Pipeline product. Currently in development at Abbott Vascular. Not available for sale. Atheroprogression Zones de low shear stress (mailles) Alteration vasomotricité Alteration fonction endotheliale Alteration adaptation diamètre au stress V Conformabilité

6 © 2009 Abbott Laboratories Pipeline product. Currently in development at Abbott Vascular. Not available for sale. Bioabsorbable concept: BVS « SCAFFOLD »

7 © 2009 Abbott Laboratories Pipeline product. Currently in development at Abbott Vascular. Not available for sale. What is the Minimum Duration of Radial Scaffolding? Serruys PW, et al., Circulation 1988; 77: 361. n = 342 patients (n = 93 at 30-day F/U; n = 79 at 60-day F/U; n = 82 at 90-day F/U; n = 88 at 120-day F/U) The lumen appears to stabilize approximately three months after PTCA. p < 0.00001 Quantitative angiographic study in 342 consecutive patients at 1, 2, 3, and 4 months

8 © 2009 Abbott Laboratories Pipeline product. Currently in development at Abbott Vascular. Not available for sale. Poly Lactide - Hydrolysis Lactide PLAPLA  Molecular Weight H2OH2O Hydrolysis Mass Loss Krebs Cycle Mass Transport CO 2 + H 2 O R O R′O H2OH2O+R O OH HO+ carboxylic acidalcohol PLA – Poly Lactic Acid

9 © 2009 Abbott Laboratories Pipeline product. Currently in development at Abbott Vascular. Not available for sale. Bioresorbable Polymer: ABSORB Everolimus/PDLLA Matrix Coating Thin coating layer Amorphous (non-crystalline) 1:1 ratio of Everolimus/PLA matrix Conformal Coating, 2-4  m thick Controlled drug release PLLA Backbone Highly crystalline Provides device integrity Processed for increased radial strength Polymer backbone Drug/polymer matrix

10 © 2009 Abbott Laboratories Pipeline product. Currently in development at Abbott Vascular. Not available for sale. ABSORB Cohort A: 5-year clinical results Hierarchical 6 Months 30 Patients 12 Months 29 Patients** 24 Months 29 Patients** 60 Months 29 Patients** Ischemia Driven MACE***1 (3.3%)*1 (3.4%)* Cardiac Death0 (0.0%) MI1 (3.3%)*1 (3.4%)* Q-Wave MI0 (0.0%) Non Q-Wave MI1 (3.3%)*1 (3.4%)* Ischemia Driven TLR0 (0.0%) by PCI0 (0.0%) 0 (0.%) by CABG0 (0.0%) 0 (0.%) *Same patient – this patient also underwent a TLR, not qualified as ID-TLR (DS = 42%) **One patient missed the 9, 12, 18 month and 2, 3, and 4 year visits; one patient died from a non-cardiac cause 706 days post procedure ***MACE – Composite endpoint comprised of cardiac death, myocardial infarction (MI) and ischemia-driven target lesion revascularization (TLR) by PCI or CABG Serruys, PW, TCT, 2011

11 © 2009 Abbott Laboratories Pipeline product. Currently in development at Abbott Vascular. Not available for sale. Serruys, PW, TCT, 2011

12 © 2009 Abbott Laboratories Pipeline product. Currently in development at Abbott Vascular. Not available for sale. ABSORB Vasomotor Function Testing Serruys, PW, et al. Lancet 2009; 373: 897-910. The reappearance of vasomotion in the proximal, distal, as well as treated segments in response to methergin or acetylcholine suggests that vessel vasoreactivity has been restored and that a physiological response to vasoactive stimulus might occur anew.

13 © 2009 Abbott Laboratories Pipeline product. Currently in development at Abbott Vascular. Not available for sale. BVS Device Optimization Objectives Cohort A Cohort B Photos taken by and on file at Abbott Vascular. More uniform strut distribution Higher radial strength Storage at room temperature Improved device retention Unchanged: Material, coating and backbone Strut thickness Drug release profile Total degradation Time

14 © 2009 Abbott Laboratories Pipeline product. Currently in development at Abbott Vascular. Not available for sale. Study Design of ABSORB Cohort B Sponsor: Abbott Vascular Primary Investigators: –PW Serruys MD, PhD –J Ormiston MD DSMB: J Tijssen PhD, M Wiemer MD, P Urban MD CEC: C Hanet MD, R Tölg MD, V Umans MD Angiographic, IVUS and OCT Corelab: Cardialysis Prospective, open label, FIM 3.0 x 18mm devices to treat up to 2 lesions ≤ 14mm in length 12 sites Europe, Australia, New Zealand B de Bruyne, MD D Dudek, MD L Thuesen, MD P Smits, MD B Chevalier, MD D McClean, MD J Koolen, MD S Windecker, MD R Whitbourn, MD I Meredith, MD, PhD 101 patients enrolled between 19 March and 6 November 2009 QCA, IVUS, OCT, IVUS VH Group B1 (n = 45) Baseline 6 12 24 Months Group B2 (n = 56)

15 © 2009 Abbott Laboratories Pipeline product. Currently in development at Abbott Vascular. Not available for sale. Late Lumen Loss is Similar to XIENCE V Through 2 Years Cumulative Late Loss curves of ABSORB Cohort B and Xience V Serruys, PW, TCT, 2011

16 © 2009 Abbott Laboratories Pipeline product. Currently in development at Abbott Vascular. Not available for sale.

17 © 2009 Abbott Laboratories Pipeline product. Currently in development at Abbott Vascular. Not available for sale.

18 © 2009 Abbott Laboratories Pipeline product. Currently in development at Abbott Vascular. Not available for sale. Minimal LD 1.58 mm Mean LD 2.12 mm MLD 2.46 mm Mean LD 2.72mm Mean LD ∆-0.6mm (-22%) Minimal LD 2.32 mm Mean LD 2.67 mm Mean LD ∆+0.55mm (+26%) Preprocedure FUP before vasomotion 5 Min. After Methergine After Nitro Post procedure QCA post procedure MLD 2.45mm Late Loss: -0.01mm Serruys, PW. ACC 2011 Mean LD ∆-0.6mm (-22%) Mean LD ∆+0.55mm (+26%) SE2935049 Rev. B Information contained herein intended for healthcare professionals from outside the US only.

19 © 2009 Abbott Laboratories Pipeline product. Currently in development at Abbott Vascular. Not available for sale. 91° 88° 128°

20 © 2009 Abbott Laboratories Pipeline product. Currently in development at Abbott Vascular. Not available for sale. MACE: Cardiac death, MI, ischemia-driven TLR TVF: Cardiac death, MI, ischemia-driven TLR, ischemia-driven TVR No scaffold thrombosis by ARC or Protocol 30 Days6 Months9 Months12 Months N = 101 Cardiac death (%)0000 Myocardial Infarction % (n)2.0 (2)3.0 (3) Q-wave MI0000 Non Q-wave MI2.0 (2)3.0 (3) Ischemia driven TLR % (n)02.0 (2) 4.0 (4) CABG0000 PCI02.0 (2) 4.0 (4) Hierarchical MACE % (n)2.0 (2)5.0 (5) 6.9 (7) Hierarchical TVF % (n)2.0 (2)5.0 (5) 6.9 (7) ABSORB Cohort B, Group 1&2 Clinical Results - Intent to treat

21 © 2009 Abbott Laboratories Pipeline product. Currently in development at Abbott Vascular. Not available for sale. XV Includes only patients with single 3.0 x 18mm stent BVS Includes all patients MACE rate in Pts treated with BVS (Cohort B, n=101) vs. a single 3x 18 mm EES (Spirit I+II+III, n=227)

22 © 2009 Abbott Laboratories Pipeline product. Currently in development at Abbott Vascular. Not available for sale. BL 2Y6M Resolved ISA Non Discernible Persistent ISA ISA incomplete stent apposition Late acquired ISA Resolved ISA Non Discernible Apposed Bioresorption and vessel wall integration are a reality. Serruys, PW, PCR, 2010

23 © 2009 Abbott Laboratories Pipeline product. Currently in development at Abbott Vascular. Not available for sale. Bioresorption at jailed side branch is a real phenomenon Okamura et al., EHJ, 2010

24 © 2009 Abbott Laboratories Pipeline product. Currently in development at Abbott Vascular. Not available for sale. First 200 Pts ABSORB EXTEND Follow-up *Patient was treated with a metallic DES, not ABSORB Abizaid, A., TCT, 2011 30 Days6 Months Non-hierarchicalN = 200 Cardiac Death % (n)00.5 (1)* Myocardial Infarction % (n)2.0 (4) Q-wave MI1.0 (2) Non Q-wave MI1.0 (2) Ischemia driven TLR % (n)0.5 (1) CABG00 PCI0.5 (1) Hierarchical MACE % (n)2.0 (4)2.5 (5) Hierarchical TVF % (n)2.0 (4)3.0 (6)** **One additional ischemia driven non-TL TVR treated by CABG

25 © 2009 Abbott Laboratories Pipeline product. Currently in development at Abbott Vascular. Not available for sale. BVS size usage with vessel dimensions Post dilatation with NC balloon < 2.75 mm Post dilatation with NC balloon < 3.25 mm

26 DREAMS provides scaffolding and paclitaxel release up to 3 months Mg alloy Initial Mg degradation Stable drug carrier layer Controlled drug release Mg degradation completed Drug release completed Degradation of polymer ongoing Conversion of degradation product completed Drug carrier layer degradation completed Beginning of structural disintegration Mg degradation product Polymer acute3 months6 months9 months Mg Scaffolding Paclitaxel release Mg + 2H 2 O  Mg(OH) 2 + H 2 Soft Hydroxyapatite Biodegradation Bioabsorption

27 BIOSOLVE-I 6-month IVUS** Results Contribution to lumen loss Post implantation Loss of scaffolding area In-stent neointima 6-month Follow-up Scaffold Degradation 0.35 mm 0.33 mm 0.68 mm LLL 0.57 mm 0.51 mm 1.08 mm LLL 39% less 35% less37% less 53% 47% * Erbel R. et al., Lancet 2007;369:1869-75, Waksman et.al, JACC 2009, 312-320 ** N= 12 evaluable IVUS runs (volumetric) available at 6-month follow-up for cohort 1 PROGRESS BIOSOLVE-I

28 © 2009 Abbott Laboratories Pipeline product. Currently in development at Abbott Vascular. Not available for sale. L’absorption complète est confirmée Les résultats sont équivalents aux DES récents Grâce à un processus lent Lésions plus complexes Le temps de la comparaison randomisée est venu (Absorb II) Des effets spécifiques sur la cicatrisation artérielle Vasomotricité, conformabilité, remodelage positif, pas de stimulus pour la néoathérogénèse Possibles bénéfices à long terme Début d’un long programme clinique Mais mise sur le marché en 2012 !?! Conclusion


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