stents actifs: tous égaux?hightech-cardio.org/usrfile/presentation/2018/s5-in040.pdf · 2018. 8....
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Stents actifs: tous égaux?
Philip Urban
Hôpital de La Tour, Genève
31 janvier – 2 février 2018
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The first clinical coronary stent, March 1986
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Mrs. G.D. 1936 Lausanne, June 12, 1986
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1991
2017
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SYNTAX trial (Taxus PES) - 5 year ARC stent thrombosis (per patient)
P. Serruys, TCT 2012
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The new generation of DES
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SORT-OUT IV @ 4 years – Lisette Okkels Jensen
2774 patients
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“All animals are equal, but some animals are more equal than others”
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Mechanical properties of DES
• strut thickness
• longitudinal deformation
• radial force & recoil
• maximal expansion
• sidebranch access
• strut rupture
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Byrne R et al. Eur Heart J 2015; 36: 3320–3331
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Longitudinal distortion
John Ormiston – TCT 2014
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John Ormiston – TCT 2014
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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
0
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)
ResoluteOnyx (4.5-
5.0)
BiomatrixAlpha (3.5-
4.0)
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Side branch access
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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
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Stent fracture with 2nd G DES Kim D-K, Busan, South Korea
TCT 2016
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Circulation 2014; 129:211
204 lesion from 149 autopsy studies
EES superior for ST, % uncovered struts, inflammation score
but comparable incidence of neoatherosclerosis
NEOATHEROSCLEROSIS
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European Heart Journal 2016; 37: 1208–16
Ruptured neoatherosclerotic plaque
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Do some of these differences impact clinical results, or are they
?
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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
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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”.
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Interventional « front-running »
amount of data duration of FU
new features surrogate EPs
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Is the coating really necessary?
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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
1 1
Advantages: • Avoid any possible polymer-related
adverse effects
• Rapid drug transfer to vessel wall
(98% within one month2)
• Good fit with short DAPT
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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)
0
90 180 270 390
Cu
mu
lative P
erc
en
tage
with
Eve
nt
3
6
9
12
Days 0
9.8%
5.1%
p for superiority < 0.001
HR 0.50, (95% CI = 0.37‒0.69)
%
12.9%
BMS DCS
0
90 180 270 390
3
6
9
12
Days 0
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%
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Interest for short DAPT ?
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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 on 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)
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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)
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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)
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Thank you