Why I like theDEVAX AXXESS stent …

Dr. Christophe DuboisUniversity Hospital Leuven

Belgium

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

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

Delivery System

Sheath actuator

Safety lock

Flush port

Sheath markers

AXXESSstent

Stent deployed by sheath retraction

The DIVERGE Trial

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

Example of Stent Conformity

Final AngiogramPV: Axxess + Cypher

SB: PTCA

Stent Boost Imaging showsSB ostial coverage

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

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

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)

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

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

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

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

Impact of Optimizing Therapy

Kaplan Meier 1 Year Event Free Survival

*25% Δ; p = 0.09

*

Unpublished data

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

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

?