Stents actifs: tous gaux? Philip Urban Hpital de La Tour, Genve 31 - PowerPoint PPT Presentation

Stents actifs: tous égaux? Philip Urban Hôpital de La Tour, Genève 31 janvier – 2 février 2018

The first clinical coronary stent, March 1986

Mrs. G.D. 1936 Lausanne, June 12, 1986

1991 2017

SYNTAX trial (Taxus PES) - 5 year ARC stent thrombosis (per patient) P. Serruys, TCT 2012

The new generation of DES

SORT-OUT IV @ 4 years – Lisette Okkels Jensen 2774 patients

“All animals are equal, but some animals are more equal than others”

Mechanical properties of DES • strut thickness • longitudinal deformation • radial force & recoil • maximal expansion • sidebranch access • strut rupture

Byrne R et al. Eur Heart J 2015; 36: 3320 – 3331

Longitudinal distortion John Ormiston – TCT 2014

John Ormiston – TCT 2014

Over-expansion capacity and stent design model Ng J et al Int J Cardiol 2016; 221:171-9 7 6 5,8 5,8 5,7 5,6 6 5,2 5 4 3 2 1 0 Ultimaster Synergy Xience (3.5- Orsiro (3.5- Resolute Biomatrix (3.5-4.0) (4.0) 4.0) 4.0) Onyx (4.5- Alpha (3.5- 5.0) 4.0)

Side branch access

TCT 2016 Stent fracture with 2 nd G DES Kim D-K, Busan, South Korea Incidence of stent fracture • 1046 patients • FU for 3 years • Angio/IVUS/OCT

Stent fracture with 2 nd G DES TCT 2016 Kim D-K, Busan, South Korea

Circulation 2014; 129:211 NEOATHEROSCLEROSIS  204 lesion from 149 autopsy studies  EES superior for ST, % uncovered struts, inflammation score  but comparable incidence of neoatherosclerosis

European Heart Journal 2016; 37: 1208 – 16 Ruptured neoatherosclerotic plaque

Do some of these differences impact clinical results, or are they ?

2 nd G permanent vs. biodegradable polymer NEXT (2y) Bioscience 1617 BD-BES vs 1618 PP-EES 1063 BD-SES vs 1056 PP-EES Pilgrim T et al Lancet 2014 Natsuaki M et al JAMA 2014 60µ CocCr + BD polymer vs. 81µ CoCr + P polymer 120µ stainless steel + BD polymer non-inferiority trials vs. 81µ CoCr + Perm. polymer

BIOFLOW V Kandzari et al Lancet 2017; 390: 1843-52 • 1334 patients with SCAD or ACS randomized 2:1 • 60µ CoCr bio-resorbable polymer SES vs. 81µ CoCr durable polymer EES • Primary EP = TLF = superiority of BP SES (driven by lower rates of MI) “We defined peri-procedural myocardial infarction according to the protocol-defined modified ARC criteria as a CK MB, if available, or troponin measured within 48 h of the interventional procedure elevated > 3 x ULN”.

amount of data duration of FU new features surrogate EPs Interventional « front-running »

Is the coating really necessary?

BioFreedom ™ Drug Coated Stent Selectively micro-structured surface holds drug in abluminal surface structures Proprietary Highly Lipophilic Limus drug 1 1 Advantages : • Avoid any possible polymer-related adverse effects • Rapid drug transfer to vessel wall (98% within one month 2 ) • Good fit with short DAPT 1 Data on file at Biosensors Intl. 2 Tada et al Circ Cardiovasc Interv. 2010;3:174-183

Primary Endpoints and Major Bleeding at 1 Year DCS BMS Efficacy (cd-TLR) Safety (cardiac death, MI, ST) Bleeding (BARC 3-5 ) % % 12 % Cumulative Percentage with Event 15 9.8% 12.9% 9 7.3% 12 9 6 7.2% 9.4% 6 5.1% 3 3 HR 0.71, (95% CI = 0.56 ‒ 0.91) p for superiority < 0.001 p < 0.0001 for non-inferiority HR 0.50, (95% CI = 0.37 ‒ 0.69) 0 p = 0.005 for superiority 0 0 90 180 270 390 Days 0 90 180 270 390 Days Urban P et al. N Engl J Med 2015;373:2038-47

Interest for short DAPT ?

2 nd G DES: 14 other trials of short DAPT (3 months or less) Status limus Trial stent type patients experimental arm DAPT control arm kinetics November 2017 DES superior to BMS 2 nd G biodegradable 1200 1 month or 6 months BMS & slow for MACE SENIOR (1) Synergy EES polymer elderly (>75) (operator discretion) same DAPT (efficacy + safety combined) BMS arm of LEADERS LEADERSFREE II BioFreedom DCS polymer-free fast 1200 HBR 1 month follow-up FREE DCS arm of LEADERS FREE III CoCr BioFreedom Polymer-free fast 370 HBR 1 month enrolling LEADERS FREE 3020 DES & YONSEI UNIVERSITY BioFreedom DCS polymer-free fast 1 month enrolling low risk SCAD 6-12 months DAPT 906 ISAR DAPT Coroflex ISAR polymer-free matrix slow 3 months 6 months DAPT enrolling low risk SCAD Cre8 1532 SCAD 1 month ReCre8 polymer-free slow R-ZES same DAPT enrolling SES all-comers ACS 12 months 2000 2 nd G BD polymer EVOLVE SHORT DAPT Synergy EES slow 3 months single arm trial enrolling HBR 4300 2 nd G BD polymer MASTER DAPT Ultimaster SES slow 1 month guidelines enrolling HBR 2 nd G BD polymer vs. Orsiro SES vs. slow 2132 HOST-IDEA 3 months 1 year DAPT enrolling Coroflex ISAR polymer-free matrix slow SCAD (no OAC) 3000 low/med risk STOPDAPT-2 Xience EES 2 nd G permanent polymer slow 1 month 1 year DAPT enrolling success PCI Polyzene-F 840 EES or R-ZES & COBRA-REDUCE Cobra PzF na 2 weeks enrolling nanocoating on AVK or NOAC 6 months DAPT POEM Synergy EES 2 nd G BD polymer slow 1000 HBR 1 month single arm trial enrolling XIENCE 90 Xience EES Permanent polymer Slow 2000 HBR 3 months Single arm trial enrolling (Xience Short DAPT) Resolute Onyx DES Permanent polymer Slow vs. ONYX ONE vs. 2000 HBR 1 month 1 month planned vs.Polymer-free Fast BioFreedom DCS 1) Varenne O et al. Lancet 2017 (on line)

Conclusions (I)  Over the 16 years since their impact on ISR was first documented, metallic polymer DES have improved very significantly  Whether biodegradable offer clinical benefit vs. current (“2 nd G”) permanent polymers is not yet determined  The incidence of late events induced by strut fractures and neoathersclerosis could become reasons for preferring one DES over another, but waiting for that information will require patience

Conclusions (II)  HBR patients are fast becoming the focus of major interest. They require novel strategies that are adapted to their specific needs  The polymer-free BA-9 DCS (with 1 month DAPT) and the biodegradable polymer EES (with 1 or 6 months DAPT) have been shown to be superior to a BMS  All major DES are now being evaluated for their safety with short or very short DAPT. The results of those trials may well become another major reason for preferring one DES over another

Thank you