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

5,8 5,7 5,6 5,2 6 5,8 1 2 3 4 5 6 7 Ultimaster (3.5-4.0) Synergy (4.0) Xience (3.5- 4.0) Orsiro (3.5- 4.0) Resolute Onyx (4.5- 5.0) Biomatrix Alpha (3.5- 4.0)

Side branch access

Stent fracture with 2nd G DES

Kim D-K, Busan, South Korea

TCT 2016 Incidence of stent fracture

• 1046 patients
• FU for 3 years
• Angio/IVUS/OCT

Stent fracture with 2nd G DES

Kim D-K, Busan, South Korea TCT 2016

Circulation 2014; 129:211

• 204 lesion from 149 autopsy studies
• EES superior for ST, % uncovered struts, inflammation score
• but comparable incidence of neoatherosclerosis

NEOATHEROSCLEROSIS

European Heart Journal 2016; 37: 1208–16

Ruptured neoatherosclerotic plaque

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

?

Bioscience

1063 BD-SES vs 1056 PP-EES Pilgrim T et al Lancet 2014

NEXT (2y)

1617 BD-BES vs 1618 PP-EES Natsuaki M et al JAMA 2014

non-inferiority trials

2nd G permanent vs. biodegradable polymer

120µ stainless steel + BD polymer

• vs. 81µ CoCr + Perm. polymer

60µ CocCr + BD polymer

• vs. 81µ CoCr + P 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,

• r troponin measured within 48 h of

the interventional procedure elevated > 3 x ULN”.

Interventional « front-running »

amount of data duration of FU new features surrogate EPs

Is the coating really necessary?

1 Data on file at Biosensors Intl. 2 Tada et al Circ Cardiovasc Interv. 2010;3:174-183

BioFreedom™ Drug Coated Stent

Selectively micro-structured surface holds drug in abluminal surface structures Proprietary Highly Lipophilic Limus drug

Advantages:

• Avoid any possible polymer-related

adverse effects

• Rapid drug transfer to vessel wall

(98% within one month2)

• Good fit with short DAPT

Primary Endpoints and Major Bleeding at 1 Year

Urban P et al. N Engl J Med 2015;373:2038-47

Efficacy (cd-TLR) Safety (cardiac death, MI, ST)

90 180 270 390 Cumulative Percentage with Event 3 6 9 12 Days

9.8% 5.1%

p for superiority < 0.001 HR 0.50, (95% CI = 0.37‒0.69) %

12.9%

BMS DCS

90 180 270 390 3 6 9 12 Days

9.4%

HR 0.71, (95% CI = 0.56‒0.91) p < 0.0001 for non-inferiority p = 0.005 for superiority 15 %

Bleeding (BARC 3-5)

%

7.3% 7.2%

Interest for short DAPT ?

Trial stent type

limus kinetics patients experimental arm DAPT control arm

Status

November 2017 SENIOR (1) Synergy EES 2nd G biodegradable polymer slow 1200 elderly (>75) 1 month or 6 months (operator discretion) BMS & same DAPT DES superior to BMS for MACE (efficacy + safety combined) LEADERSFREE II BioFreedom DCS polymer-free fast 1200 HBR 1 month BMS arm of LEADERS FREE follow-up LEADERS FREE III CoCr BioFreedom Polymer-free fast 370 HBR 1 month DCS arm of LEADERS FREE enrolling YONSEI UNIVERSITY BioFreedom DCS polymer-free fast 3020 low risk SCAD 1 month DES & 6-12 months DAPT enrolling ISAR DAPT Coroflex ISAR polymer-free matrix slow 906 low risk SCAD 3 months 6 months DAPT enrolling ReCre8 Cre8 SES polymer-free slow 1532 all-comers SCAD 1 month ACS 12 months R-ZES same DAPT enrolling EVOLVE SHORT DAPT Synergy EES 2nd G BD polymer slow 2000 HBR 3 months single arm trial enrolling MASTER DAPT Ultimaster SES 2nd G BD polymer slow 4300 HBR 1 month guidelines enrolling HOST-IDEA Orsiro SES vs. Coroflex ISAR 2ndG BD polymer vs. polymer-free matrix slow slow 2132 SCAD (no OAC) 3 months 1 year DAPT enrolling STOPDAPT-2 Xience EES 2nd G permanent polymer slow 3000 low/med risk success PCI 1 month 1 year DAPT enrolling COBRA-REDUCE Cobra PzF Polyzene-F nanocoating na 840

• n AVK or NOAC

2 weeks EES or R-ZES & 6 months DAPT enrolling POEM Synergy EES 2nd G BD polymer slow 1000 HBR 1 month single arm trial enrolling XIENCE 90 (Xience Short DAPT) Xience EES Permanent polymer Slow 2000 HBR 3 months Single arm trial enrolling ONYX ONE Resolute Onyx DES vs. BioFreedom DCS Permanent polymer vs.Polymer-free Slow vs. Fast 2000 HBR 1 month 1 month planned

2nd G DES: 14 other trials of short DAPT (3 months or less)

1) Varenne O et al. Lancet 2017 (on line)

 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 (“2nd 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 (I)

 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

Conclusions (II)

Thank you