Ảnh hưởng của các phát kiến, cải tiến trong tim mạch can thiệp đến thực hành lâm sàng

Innovation in Stent Platform/Structure and Clinical Impacts Alan C Yeung, MD Li Ka Shing Professor of Medicine Chief, Division of Cardiovascular Medicine Stanford University School of Medicine Conflict of Interest • Abbott Medical Advisory Board • Medtronic Coronary Scientific Advisory Board • Boston Scientific Executive Physician Council Stanford Three Clinical Needs in New DES • Late Stent Thrombosis • Restenosis of DES • DAPT needs Stanford Stanford Stanford Three Clinical Needs in New DES • Late Stent Thrombosis • Restenosis of DES • DAPT needs Stanford Durability of Antirestenotic Efficacy Cumulative LLL in ABSORB Cohort B and Patients Treated With EES TLR with Everolimus-Eluting Stent Through Years – ISAR TEST 16 (N=652) % 12.8 12 8.8 9.9 0.5 30 days year Serruys PW Presented at TCT 2011 years years Byrne R et al J Am Coll Card 2011; 58:1325-31 Etiology of DES events beyond year Very late thrombosis and restenosis Possible causes Uncovered stent struts (thrombosis) Persistent stimulation of SMCs, from adherent fibrin and/or loss of normal vessel curvature Abnormal shear stress from protruding struts and/or loss of cyclic strain relief (compliance mismatch) Chronic inflammation due to late foreign body reactions and polymer hypersensitivity Positive remodeling with strut malapposition Strut fracture Neoatherosclerosis Technische Universität München Polymer Coatings and Arterial Healing • Most clinically effective durable polymer DES coatings contain methacrylate polymer e.g PBMA (Cypher SES, Xience EES, Resolute ZES)* • PBMA degrades to the monomer methacrylic acid which has proven cellular toxic effects# *Cypher, Xience, Resolute Product information; # Curcio et al Circulation Journal 2011 Stent designs tested (n=15 for each design) 10 10 OCT including pre TLR measurement *Δ +1.71mm2 *Δ +0.88mm2 Serial OCT *Δ +1.16mm2 Post Procedure *Δ -0.44mm2 *Δ -1.20mm2 year *Δ -1.76mm2 *Δ +0.68mm2 *Δ +0.93mm2 Months mm-6 V 12 18 24 30 36 Scaffold area in cohort B1 Scaffold area in cohort B2 Mean lumen area in cohort B1 Mean lumen area in cohort B2 Min scaffold area in cohort B1 Min scaffold area in cohort B2 Min lumen area in cohort B1 Min lumen area in cohort B2 Neointimal area in cohort B1 Neointimal area in cohort B2 year Bioresorbable Stent vs Metallic Stents • Theoretical benefits • Technical performance • Clinical Data Stanford BRS Desired Features • • • • • Scaffold profile Radial force Visibility Post dilatation without fracture Degradation time Evolution of DES Technology First Gen Second Gen TAXUS Liberte Resolute Integrity Xience Xpedition Promus PREMIER 96 µm 89 µm 81 µm 81 µm 14µm/side 6µm / side 8µm / side 8µm / side Durable Polymer Stents Cypher TAXUS Express Strut Thickness 140 µm 132 µm Coat Thickness 7µm / side 16µm/side Biomatrix Nobori Synergy Strut Thickness 120 µm 125 µm 74µm Coat Thickness 10 µm 20 µm µm Bioabsorbable Polymer Stents First Generation Future Technologies Fully Bioresorbable Stents BVS ELIXIR DESolve DREAMS II Polymer Free Stents BIOFREEDOM Drug Filled Stent Strut Thickness 150 µm 150 µm 150 µm 112 86 Coat Thickness µm / side [...]... Neoatherosclerosis: Transformation of Neointimal Hyperplasia to Necrotic Core in BMS and DES 6-mo Taxus %NC 8% %DC 2% 9-mo Taxus %NC 28% %DC 8% 22-mo Taxus %NC 39% %DC 20% 48-mo BMS %NC 40% %DC 25% Kang SJ et al AJC 2010;106:1561-1565 57-mo BMS %NC 57% %DC 15% Stanford Three Clinical Needs in New DES • Late Stent Thrombosis • Restenosis of DES • DAPT needs Stanford RESOLUTE Pooled Timing of Permanent Discontinuation... 24 2.2 2 Pre Met Nitro meanldia_stent_vas3 meanldia_stent_vas2 meanldia_stent_vasfp Shielding of plaque Sealing and shielding of plaques as a result of scaffold implantation : can the scaffold cap the plaque? Absorb BVS and neointimal formation Gene Expression: Absorb BVS Smooth Muscle Cell Phenotype Markers * At one year in the porcine model p= 7.06E-04 * * * • Multiple early markers of SMC differentiation... Durable Polymer Coated Stent Bioabsorbable Polymer Coated Stent Bioabsorbable Scaffold Abbott/Boston Medtronic BIOSENSORS Terumo Translumina Boston BIOTRONIK Abbott Xience/Promus Resolute BioMatrix Ultimaster Yukon Choice PC Synergy Orsiro Absorb CoCr/PtCr-EES CoNi-ZES 316L-BES CoCr-SES 316L-SES PtCr-EES CoCr-SES PLLA-EES 74 µm 60 µm 150 µm Abluminal Circumferential Circumferential 4 µm 4-7 µm/side... in perspective New Generation Durable Polymer Coated Stent Bioabsorbable Polymer Coated Stent Bioabsorbable Scaffold Abbott/Boston Medtronic Terumo Translumina Boston BIOTRONIK Xience/Promus Resolute Ultimaster Yukon Choice PC Synergy Orsiro CoCr/PtCr-EES CoNi-ZES CoCr-SES 316L-SES PtCr-EES CoCr-SES 74 µm 60 µm Strut thickness 81 µm 91 µm 80 µm 87 µm Polymer coating Circumferential 7-8 µm/side Circumferential... Discontinuation and ST through 3 years There were only 2 events out to 3 years among patients permanently discontinuing DAPT after completing one month of DAPT There were no new ST events between 24 and 36 months Timing of Permanently Discontinued DAPT And ST Through 3 Years 10.0% Subsequent ST (ARC Def/Prob) (%) 8.0% 6.35% 6.0% 4.0% 2.46% 2.0% 0.0% Not Permanently Discontinued # of pts at risk at baseline # of