Are Current DES the Final Answer? BioFreedom TM : the Polymer-Free Biolimus A9TM Coated Stent Biosensors Lunch Symposium 25 th April 2013 Prof. Stephen WL Lee, JP 李偉聯 MD FRCP(Lon. Edin. Glas.) FHKCP FHKAM FACC FSCAI Chief of Cardiology, Professor & Senior Consultant Department of Medicine, Queen mary Hospital, University of Hong Kong
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Are Current DES the Final Answer?BioFreedomTM: the Polymer-Free Biolimus A9TM Coated Stent
Biosensors Lunch Symposium
25th April 2013
Prof. Stephen WL Lee, JP 李偉聯MD FRCP(Lon. Edin. Glas.) FHKCP FHKAM FACC FSCAI
Chief of Cardiology, Professor & Senior Consultant
Department of Medicine, Queen mary Hospital, University of Hong Kong
Speaker’s name: Stephen Wai-luen LEE
(Queen Mary Hospital, University of Hong Kong)
I have the following potential conflicts of interest to report:
Research contracts
Consulting
Employment in industry
Stockholder of a healthcare company
Owner of a healthcare company
Other(s)
I do not have any potential conflict of interest to declare
Potential conflicts of interest
x
The stents were provided by Biosensors as investigational devices.
The Core Laboratory Charges are supported by Biosensors.
PCI objective = purely for achieving revascularization
= without complicated issues of
• Acute failure
• Restenosis
• Stent thrombosis
• Prolonged DAPT
• BleedingBut many DES still show Poor Stent Healing :-drug cytotoxicity, polymer hypersensitivity, local inflammatory reactions, loss endothelial and vasomotor functions
• Stent thrombosis
• MACE
All current DES = can achieved neointimal suppression
Is stent thrombosis genuine ?
• Most powerful histological predictor of stent thrombosis = endothelial coverage• Most powerful surrogate indicator of endothelialization = neointimal coverage• Best morphometric predictor of LST = ratio of uncovered to total stent struts
Finn et al. Circulation 2007;115;2435-2441
Pooled Analysis of Data Comparing SES With BMSEstimated 4-year cumulative incidence of
stent thrombosis, death, MI, and TLR
2.0
1.5
1.0
0.5
0.00 1 2 3 4
Years Since Procedure
Ste
nt
Th
rom
bo
sis
(%
)
Sirolimus stent (1.2%)
Bare-metal stent (0.6%)
P=.20
10
6
4
2
00 1 2 3 4
Years Since Procedure
Sirolimus stent (6.4%)
Bare-metal stent (6.2%)
P=.86
8
Myo
card
ial In
farc
tio
n (
%)
30
20
10
00 1 2 3 4
Years Since Procedure
Bare-metal stent (23.6%)
P<.001
25
5
15T
arg
et-
Lesio
n
Reva
sc
ula
rizati
on
(%
)
Sirolimus stent (7.8%)
Years Since Procedure
10
6
4
2
00 1 2 3 4
Sirolimus stent (6.7%)
Bare-metal stent (5.3%)
P=.23
8
Death
(%
)
Stone et al. N Engl J Med. 2007;356:998-1008
2.0
1.5
1.0
0.5
0.00 1 2 3 4
Years Since Procedure
Ste
nt
Th
rom
bo
sis
(%
)
Paclitaxel stent (1.3%)
Bare-metal stent (0.9%)
P=.30
Pooled Analysis of Data Comparing PES With BMSEstimated 4-year cumulative incidence of
stent thrombosis, death, MI, and target lesion revasc.
10
8
6
2
00 1 2 3 4
Years Since Procedure
De
ath
(%
)
Paclitaxel stent (6.1%)
Bare-metal stent (6.6%)
P=.68
4
10
8
6
2
00 1 2 3 4
Years Since Procedure
Myo
card
ial In
farc
tio
n (
%)
Paclitaxel stent (7.0%)
Bare-metal stent (6.3%)
P=.66
4
30
25
20
5
00 1 2 3 4
Years Since Procedure
Targ
et-
Lesio
n
Reva
sc
ula
rizati
on
(%
)
Paclitaxel stent (10.1%)
Bare-metal stent (20.0%)
P<.00115
10
Stone et al. N Engl J Med. 2007;356:998-1008
Cardiac
DeathTV-MI CI-TLRDeath
Cardiac death
or TV-MI
ARC ST
Def/Prob
RESOLUTE All Comers – Simple Patients
Clinical Outcomes to 12 MonthsR-ZES EES
(n=376) (n=396)
P=0.79 P=0.50 P=0.70 P=0.48 P=0.12 P=0.49
%
Stefanini et al., JACC 2011
Cardiac
DeathTV-MI CI-TLRDeath
ARC ST
Def/Prob
%
RESOLUTE All Comers – Complex Patients
Clinical Outcomes to 12 Months
P=0.02 P=0.24 P=0.90 P=0.58 P=0.26 P=0.80
R-ZES EES
(n=764) (n=756)
Cardiac death
or TV-MI
Stefanini et al., JACC 2011Resolute-US Trial: similar results between the 2 stents
Biolimus-A9™ Eluting Stent
• Biolimus is a semi-synthetic sirolimus analogue with 10x higher lipophilicity and similar potency as sirolimus.
• Biolimus is immersed at a concentration of 15.6 g/mm into a biodegradable polymer, polylactic acid, and applied solely to the abluminal stent surface by a fully automated process.
• Biolimus is co-released with polylactic acid and completely desolves into carbon dioxide and water after a 6-9 months period.
• The stainless steel stent platform has a strut thickness of 120 m with a quadrature link design.
LEADERS ‘All-comers’ Trial
Clinically-Indicated TVR
* p-value for superiority
Serruys et al., oral abstract presentation, TCT 2012