Le stent biobasorbable. Bernard Chevalier ICPS Massy / GCS Creil.
Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.
Le stent biobasorbable Bernard Chevalier ICPS Massy / GCS Creil
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
Conformabilité (R) • Echapement (R) • Malapposition (T) • Retard de cicatrisation (T) • Elution permanente de drogue (T) • « Jailing » des branches • Interference MSCT
Atheroprogression • Zones de low shear stress (mailles) • Alteration vasomotricité • Alteration fonction endotheliale • Alteration adaptation diamètre au stress V • Conformabilité
What is the Minimum Duration of Radial Scaffolding? Quantitative angiographic study in 342 consecutive patients at 1, 2, 3, and 4 months 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) p < 0.00001 p < 0.00001 The lumen appears to stabilize approximately three months after PTCA. Serruys PW, et al., Circulation 1988; 77: 361.
Poly Lactide - Hydrolysis PLA – Poly Lactic Acid PLA H2O Molecular Weight Hydrolysis Lactide O O Mass Loss R + H2O R + HO R′ O R′ OH carboxylic acid alcohol Mass Transport CO2 + H2O Krebs Cycle
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 Drug/polymer matrix Polymer backbone
Hierarchical 6 Months30 Patients 12 Months29 Patients** 24 Months29 Patients** 60 Months29 Patients** Ischemia Driven MACE*** 1 (3.3%)* 1 (3.4%)* 1 (3.4%)* 1 (3.4%)* Cardiac Death 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) MI 1 (3.3%)* 1 (3.4%)* 1 (3.4%)* 1 (3.4%)* Q-Wave MI 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) Non Q-Wave MI 1 (3.3%)* 1 (3.4%)* 1 (3.4%)* 1 (3.4%)* Ischemia Driven TLR 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) by PCI 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.%) by CABG 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.%) ABSORB Cohort A: 5-year clinical results * 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
ABSORB Vasomotor Function Testing 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. Serruys, PW, et al. Lancet 2009; 373: 897-910.
BVS Device Optimization Objectives • 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 Cohort A Cohort B Photos taken by and on file at Abbott Vascular.
Study Design of ABSORB Cohort B Group B1 (n = 45) QCA, IVUS, OCT, IVUS VH Baseline 12 6 24 Months Months Months Group B2 (n = 56) • 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
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
QCA post procedure Preprocedure Post procedure MLD 2.45mm After Nitro FUP before vasomotion 5 Min. After Methergine Minimal LD 1.58 mm Mean LD 2.12 mm Minimal LD 2.32 mm Mean LD 2.67 mm MLD 2.46 mm Mean LD 2.72mm Mean LD ∆-0.6mm (-22%) Mean LD ∆-0.6mm (-22%) Mean LD ∆+0.55mm (+26%) Mean LD ∆+0.55mm (+26%) Late Loss: -0.01mm SE2935049 Rev. B Information contained herein intended for healthcare professionals from outside the US only. Serruys, PW. ACC 2011
88° 91° 128°
ABSORB Cohort B, Group 1&2Clinical Results - Intent to treat No scaffold thrombosis by ARC or Protocol MACE: Cardiac death, MI, ischemia-driven TLR TVF: Cardiac death, MI, ischemia-driven TLR, ischemia-driven TVR
MACE rate in Pts treated with BVS (Cohort B, n=101)vs. a single 3x 18 mm EES (Spirit I+II+III, n=227) XV Includes only patients with single 3.0 x 18mm stent BVS Includes all patients
Bioresorption and vessel wall integration are a reality. Apposed Lateacquired ISA Resolved ISA Non Discernible 6M 2Y BL Persistent ISA Resolved ISA Non Discernible ISA incomplete stent apposition Serruys, PW, PCR, 2010
Bioresorption at jailed side branch is a real phenomenon Okamura et al., EHJ, 2010
First 200 Pts ABSORB EXTEND Follow-up * Patient was treated with a metallic DES, not ABSORB ** One additional ischemia driven non-TL TVR treated by CABG Abizaid, A., TCT, 2011
BVS size usage with vessel dimensions Post dilatation with NC balloon < 2.75 mm Post dilatation with NC balloon < 3.25 mm
DREAMS provides scaffolding and paclitaxel release up to 3 months Mg alloy Mg degradation product Polymer Bioabsorption Biodegradation acute 3 months 6 months 9 months Paclitaxel release Scaffolding Soft Hydroxyapatite Mg + 2H2O Mg(OH)2 + H2 Mg Mg • 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
53% 47% 0.35 mm 0.33 mm 0.68 mm LLL 39% less 37% less 35% less BIOSOLVE-I 6-month IVUS** Results ScaffoldDegradation 6-month Follow-up Post implantation In-stent neointima Loss of scaffolding area Contribution to lumen loss 0.57 mm 0.51 mm 1.08 mm LLL PROGRESS BIOSOLVE-I * 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
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