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Proven superiority of the BioMatrix FlexTM stent in STEMI patients at 2 years2
Proven safety and efficacy of the BioMatrix FlexTM stent confirmed out to 2 years in an “All-Comers” population2
Limus Eluted from A Durable versusERodable Stent Coating
Randomized (1:1),Single-Blind, Multi-Center Study
9 mo
10 Sites in Europe
“Real World”: SVG, De Novoor Restenotic Coronary Artery Lesions,Chronic Stable Angina, Silent Ischemia,
Acute Coronary Syndromes
98.8%
1 yr 97.6%
2 yr 97.0%
Clinical Follow-Up
BioMatrix FlexTM
n= 857Cypher® SelectTM
n= 850
Primary Endpoint:Non-inferiority for cardiac death, MI, or
clinically indicated TVR at 9 months
LEADERSmet its primary endpoint
1
Relative reduction of MACE of 12%
BioMatrix FlexTM
proves low Late Loss
1
In-Stent Late Loss at 9 months0.13 mm BioMatrix FlexTM
vs. 0.19 mm Cypher® SelectTM
The cumulative incidence of MACE continues to diverge over time in favor of the BioMatrix Flex™ stent compared to the Cypher® Select™ stent.
-16%-12%
20
15
10
5
00 3 6 9 12 15 18 21 24
Months
MAC
E %
1 yearHR 0.88 [0.66 to 1.17]
p = 0.37*
MAC
E %
8.1%
19.3%
MACE= Cardiac Death, MI, or clinically indicated TVR *p value for superiority
-57.8%
BioMatrix FlexTM
Cypher® SelectTM
p <0.01*
n = 135 n = 140
2 yearsHR 0.84 [0.65 to 1.08]
p = 0.18*
MACE = Cardiac Death, MI, or clinically indicated TVR *p values for superiority
15.4%
12.1%
10.7% 13.0%
BioMatrix Flex, Biolimus A9 and BA9 are trademarks or registered trademarks of Biosensors International Group, Ltd. in the United States and other countries.
All cited trademarks are the propertyof their respective owners.
Not available for sale in the United Statesand certain other countries.
BIOSENSORS EUROPE SARue de Lausanne 291110 Morges - SwitzerlandTel. +41 (0)21 804 80 00Fax: +41 (0)21 804 80 01
BIOSENSORS INTERVENTIONAL TECHNOLOGIES PTE LTDBlk 10 Kaki Bukit Avenue 1#06-01/04 - Kampong Ubi Industrial Estate Singapore 417942Tel. +65 6213 5725 – Fax: +65 6213 5737
Post-hoc Analysis
BIOMATRIX FLEX - LEADERS LEAFLET = VERSO207x297 (to be slided inside the BioMatrix Flex Brochure)
No VLST after dual anti-platelet therapydiscontinuation with the BioMatrix FlexTM stent2
Signs of safety benefits for theBioMatrix FlexTM stent beyond 1 year2
Definite Stent Thrombosis - Very Late Stent Thombosis (VLST) per ARC definition
Superior strut coverage with theBioMatrix FlexTM stent compared
to the Cypher® SelectTM stent
LEADERS OCT Sub Studyat 9 months3
Lesions with at least 5%uncovered struts4
Cypher® SelectTM
n=26(n strut=6476)
39.4
BioMatrix FlexTM
n=20(n strut=4592)
3.6
%
0
10
20
30
40
p=0.005
10x
Superior stent apposition with theBioMatrix FlexTM stent compared
to the Cypher® SelectTM stent
Lesions with at least5% malapposed struts4
Cypher® SelectTM
n=26(n strut=6476)
6.7
BioMatrix FlexTM
n=20(n strut=4592)
0.3
%
0
2
4
6
8
p=0.04
20x
Lower rate of very late stent thrombosis with the BioMatrix FlexTM stent compared to the Cypher® SelectTM stent in an “All-Comers” population
3.0
2.5
2.0
1.5
1.0
0.5
0.0
2.22.5
1.2
0 0N=0/154 N=2/165 N=0/484 N=3/479
0.6
p = 0.73*
Patient who discontinued DAPTOverall Population
2 Y ST in LEADERS ST after DAPT ST after DAPT d/c < 12 M d/c > 12 M
Effect of DAPT Discontinuation
No VLST after DAPTdiscontinuationwas observed in the BioMatrix FlexTM group.Between 12 and 24 months, nearly 500 "All-Comers" patients were off DAPT.
REFERENCES
1. Windecker, S. et al., Biolimus-eluting stent with biodegradable polymer versus Sirolimus-eluting stent with durable polymer for coronary revascularization (LEADERS): a randomised non inferiority trial; The Lancet 2008; 372 No. 9644: 1163-1173
3. Barlis, P. et al., An optical coherence tomography study of a biodegradable vs. durable polymer-coated limus-eluting stent: a LEADERS trial sub-study; European Heart Journal (2010) 31, 165-176
4. Di Mario, C., OCT: Differences between biodegradable and durable polymers - Insights from the LEADERS trial, oral presentation, TCT 2008
• SIRTAX: Billinger, M. et al., Two-year clinical outcome after implantation of sirolimus-eluting and paclitaxel-eluting stents in diabetic patients; European Heart Journal (2008) 29, 718-725
• Bern/Rotterdam: Wenaweser, P. et al., Incidence and correlates of drug-eluting stent thrombosis in routine clinical practice: 4-year results from a large 2-institutional cohort study; J Am Coll Cardiol 2008;52:1154-1140
6. ”On-label” trials
• STEALTH I: Grube, E., Safety and Performance Evaluation of Biosensors Biolimus A9TM Eluting Stent (BioMatrixTM) STEALTH I: a 3-year safety follow-up, e-poster, TCT 2007
• Nobori I: Chevalier, B. et al., Nobori I Long term results: 2 years phase 1&2 and 3 years phase 1, EuroIntervention
• Endeavor IV: Leon, M.B., Zotarolimus-eluting Stent update, ACCi2 2009; The DES Summit, March 27-30, 2009; Orlando, FL
• SPIRIT III: Stone, G.W. et al, Randomized Comparison of Everolimus-Eluting and Paclitaxel-Eluting Stents, Circulation 2009;119:680-686
7. Based on currently available published data of randomized clinical trials in “All-Comers” population
*p value for superiority
0.2
0.50.6
0.5
0.1
0.8 0.8
1.0
0.3
BES
0
Very Late Stent Thrombosis in perspective
BES PES
NO
BO
RI
I
SES/PESSES/PES
BE
RN
RO
TT
ER
DA
M
NO
BO
RI
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ST
EA
LTH
I
SES
LEA
DE
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SIR
TAX
BES
LEA
DE
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EN
DE
AVO
R I
V
EN
DE
AVO
R I
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SP
IRIT
III
SP
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III
ZES PES EES PES
0
“All-Comers” Trials5
Definite (ARC)
For descriptive purposes only - RCTs with different protocols should not be compared
“On-Label” Trials6
Definite/Probable (ARC)
The VLST rate of the BioMatrix
FlexTM stent is the lowest as reported in the “All-Comers”multicenter RCTs7.
Biodegradable Polymer Durable Polymer
In the BioMatrix FlexTM group, VLST were limited to SVGs, which are excluded from the “On-Label” trials reported for the 1st generation of DES using durable polymers.
3.0
2.5
2.0
1.5
1.0
0.5
0.00 3 6 9 12 15 18 21 24
Ste
nt
Thro
mbos
is (
%)
Ste
nt
Thro
mbos
is (
%)
Months
Zoom at 1% scale p = ns
+0.2%
2.5%
2.0%2.2%
2.0%
+0.5%
BioMatrix FlexTM
Cypher® SelectTM
BioMatrix FlexTM
Cypher® SelectTM
10
81
8-0
00
-EN
- R
ev.0
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www.biosensors.com
BIOMATRIX FLEX - LEADERS LEAFLET = VERSO207x297 (to be slided inside the BioMatrix Flex Brochure)