whyi likethe devax axxess stent…
TRANSCRIPT
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Why I like theDEVAX AXXESS stent …
Dr. Christophe DuboisUniversity Hospital Leuven
Belgium
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The holy grail of dedicated bifurcationstent technology ?
• Flexible sizing
• Ease of use / predictable acute outcome
• Conformance to vessel contour without disruption of the
stent or coating
• Preservation of the side branch
• Single metal layer
• Better long term outcomes /Enhanced safety
• Cost/Benefit balance
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AXXESS Stent
• Nitinol material conforms to the anatomy of the vessel/lesion
• BA9 drug reduces restenosis in side branch
• Allows optimal size selectionand placement of additional stents
• Easy delivery with fully compatible Rx catheter system
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Delivery System
Sheath actuator
Safety lock
Flush port
Sheath markers
AXXESSstent
Stent deployed by sheath retraction
The DIVERGE Trial
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Two Vessel Coverage• A self expanding stent can span
both sides of the carina at once• The flared distal end enhances
this ability• The nitinol material will conform
to the shape of the bifurcation
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Example of Stent Conformity
Final AngiogramPV: Axxess + Cypher
SB: PTCA
Stent Boost Imaging showsSB ostial coverage
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AXXESSn = 43
□ Bare metal version of Axxess Stent□ Safety and effectiveness study□ Six-month follow-up completed
AXXESS PLUSn = 139
□ Evaluated drug-eluting Axxess stent to bare metal stent
□ Safety and effectiveness study□ Follow up through 3 years complete
DIVERGEn = 302
□ International safety and effectiveness study□ Evaluated best practices from AXXESS PLUS□ Follow up through 12 months complete
AXXENTn = 33
□ Multi-center pilot study for Axxess Left Main stent□ 12 months follow-up complete□ Study showed potential for effective LMCA
intervention
Over 500 Patients Studied
AXXESS Clinical Experience
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AXXESS PLUS: Key Findings
BASELINE QCA- Side Branch N = 136Lesion length (mm) 7.43
Reference vessel diameter (mm) 2.34MLD (mm) 0.88% DS 62.2
PROCEDURE RESULT –Side Branch
No Tx(N = 26)
PTCA only(N = 40)
Stent – DES(N = 70)
Lesion success* (%) 96.2 77.5† 97.1
FOLLOW-UP QCA - Side Branch
Late lumen loss (mm) 0.24 0.19 0.21
Restenosis (%) 12.0 25.0 7.9
* Attainment of < 50% residual stenosis of the target lesion using any combination of percutaneous devices; † P = 0.003 vs. stent (DES)
Lesion Success and Restenosis were improved by presence of SB stent:
Grube E. et al, Am J Cardiol 2007;99:1671-97
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Optimal Technique
Pre Final
Based on AXXESS PLUS findings, the Axxess procedure was modified to obtain an optimal outcome
in the SB (<30% residual stenosis post procedure)
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DIVERGE Results
Procedure Outcomes (n = 302)AXXESS stent placed 99.0%
Optimal placement (core lab assessment) 95.3%
Branch vessel stents 1.67/patient
Final mean diameter stenosis 22.2% (PV)18.0% (SB)
Angiographic success(Final DS < 50% by QCA) 99.3%
Procedure success (Angio success without in-hospital MACE)
96.7%
Verheye S., Agostoni P., Dubois C. et al, J Am Coll Cardiol 2009;53:1031-9
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Stent Distribution Patterns
AXXESS only: 12.3%
AXXESS + PV + SB: 64.7%
SB Stent: 68.7%
AXXESS + PV: 17.7%
AXXESS + SB: 4.0%
The DIVERGE TrialVerheye S., Agostoni P., Dubois C. et al, J Am Coll Cardiol 2009;53:1031-9
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Angiographic Outcomes
Any in-bifurcation restenosis:6.4% (9/140 at 9 months)
Side Branch RS3 pts 2 pts
4 pts
Parent Vessel RS
Both
Proximal edge:2.8% SB stent:
4.8%(105 SB stents)
Distal PV Cypher:2.1%
AXXESS:0.7%
Location Analysis:
Verheye S., Agostoni P., Dubois C. et al, J Am Coll Cardiol 2009;53:1031-9
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DIVERGE at 9 months
DIVERGE TRIAL 9 months Clinical OutcomesN completing follow up (%) 300 (99.3)All-cause MACE 7.7%
Any death 0.7%Q wave MI 1.0%Non-Q wave MI 3.3%Ischemia-driven TLR 4.3%
Sub acute stent thrombosis (ARC- any) 0.7%Late Stent thrombosis (ARC- any ) 0.3%
Verheye S., Agostoni P., Dubois C. et al, J Am Coll Cardiol 2009;53:1031-9
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Impact of Optimizing Therapy
Kaplan Meier 1 Year Event Free Survival
*25% Δ; p = 0.09
*
Unpublished data
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Durable Outcomes
139 108 102 99 92Number at risk
MAC
E Fr
ee (%
)
0
10
20
30
40
50
60
70
80
90
100
Time in Years
0 1 2 3 4
4 year Kaplan Meier CurveAXXESS PLUS Trial4 Events Years 1-483% MACE Free
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The holy grail of dedicated bifurcationstent technology ?
ü Flexible sizing
ü Ease of use / predictable acute outcome
ü Conformance to vessel contour without disruption of the
stent or coating
ü Preservation of the side branch
ü Single metal layer
ü Better long term outcomes /Enhanced safety
ü Cost/Benefit balance
95% - 97% - 99%
AXXESS PLUSDIVERGE
?