axxess - European Bifurcation Club

AXXESSTM – The Self-

Expanding Bifurcation DES

– Device Overview and Clinical DataClinical Data

Ricardo A. Costa

Instituto Dante Pazzanese de Cardiologia

São Paulo, Brazil

Ricardo A. Costa

Instituto Dante Pazzanese de Cardiologia

São Paulo, Brazil

7777thththth European Bifurcation Club European Bifurcation Club European Bifurcation Club European Bifurcation Club –––– Lisbon, Portugal, October 14 2011Lisbon, Portugal, October 14 2011Lisbon, Portugal, October 14 2011Lisbon, Portugal, October 14 2011

AXXESS Biolimus A9-Coated Stent � Self-expanding nickel-

titanium (Nitinol) alloy

� Conical shape

� Proximal and distal gold

markers to facilitate

implantation

� Coated with Biolimus A9™

DEVICE DESCRIPTION

2

� First self-expanding coronary stent to incorporate a drug

� First drug-eluting stent dedicated for the treatment of

diseased coronary bifurcation lesions

� Coated with Biolimus A9

using a bioabsor-bable

polymer matrix (PLA) in a

dose of 22 µg/mm of

stent length

New Molecular Entity

• Sirolimus analog

• Same macrocyclic “limus” family

• C55H87NO14

• More lipophilic than Sirolimus/Everolimus

• Potent immunosuppressant

BIOLIMUS A9

3

4040--OO--(2(2--ethoxyethyl) Modification, ethoxyethyl) Modification, Most preferred position for stentMost preferred position for stent--based applications,based applications,

as it doesn’t affect FKBP binding propertiesas it doesn’t affect FKBP binding properties

Mechanism of Action

• Anti-proliferative agent

• Binds to FKBP-12

• Inhibits mTOR activity

• Inhibits G1 phase of the cell cycle

� Nitinol self-expanding stent

platform

� 0.006 in. (0.15mm) strut

thickness

� Sizes

� 3.0 and 3.5mm in diameter

� 10 and 14 mm in length

1 Proximal Marker

AXXESS STENT

4

� Drug carrier: bioabsorbable

polymer matrix (PLA)

� Drug release rate: ~ 70% in 30

days, remaining ~ 30% released in

< 6 months

� Polymer absorption: ~ 6-9 months;

then, only the metal strut remains3 Distal Markers

• 4.8-Fr.• 7-Fr. or higher

catheter size compatible system

DELIVERY SYSTEM

Sheath actuator

Safety lock

Covered sheath Rapid Exchange (RX) delivery catheter

5

system

Handle

Flushing port

Catheter tip

Tip marker

Stent sheath markers

AXXESSStent markers

Existing techniques have several

drawbacks:

• T-stenting can leave a gap in coverage at

the SB ostium (1)

• If “crushed” to cover the ostium, 2 or 3

stent layers of stent are left to block side

branch flow (2)

Side BranchParent Vessel 1

2

RATIONALE

6

branch flow (2)

• The crushing action may pull the stent

away from the carina (3)

• The AXXESS approach leaves an

unobstructed side branch and completely

covers the SB ostium with DES (4)

3

4

GOAL: SPAN BOTH VESSELS

7

� Cover the proximal lesion segment

� Cover the ostium of the side branch and distal parent vessel without

compromising access to the side branch

� This is accomplished if 2 markers are in 1 branch and 1 is in the other

� Provide a convenient placement marker for additional distal stents

THERAPEUTIC CONCEPT

8

The AXEESS approach:

� Implant a stent with the appropriate shape to treat the

troublesome anatomy of the bifurcation, then

� Provisionally add subsequent stents to cover the lesion as

needed: stent “end to end”, rather than “through the side”

CASE EXAMPLE

� Location: LAD/diagonal

� Both branches

involved

� Calcification

9

AP CRANIAL VIEW LAO CAUDAL VIEW

� Calcification

� Distal angle <60o

� Lesions in distal

branches

DiagonalLAD

LAD

Diagonal

PROCEDURE I

Pre-dilatation

PVPV PV

SB

SB

PV predilatation 1 PV predilatation 2 PV predilatation 3

10

� Both parent vessel (PV) – LAD, and side

branch (SB) – diagonal, pre-dilated with high

pressure balloon inflations

� Pre-dilatation in the PV found “resistan-ce”

(yellow arrow) to fully dilate the lesion

PV

SB

SB SB

PV

SB single predilatation

PROCEDURE II

AXXESS ImplantationProximal and distal markers of the AXXESS

stent

Delivery system almost

completely withdrawn, self-

expanding mechanism to

Distal “flared” end

of the AXXESS

stent, covering the

SB angulation

PV angulationDistal markers

alignment not

11

RAO CRANIAL LAO CRANIAL

AXXESS inserted towards

the PV*

expanding mechanism to

“open” and deploy the stent origin of the SB

Alignment of distal markers is visualized in the most

orthogonal view of the SB origin, BEST for AXXESS

stent positioning

* Most angulated branch to the proximal vessel, recommended

alignment not

visualized:

foreshortening

view, SB origin

not well

visualized

PROCEDURE III

Additional Stents Distal markers of

the

AXXESS stentSES

proximal

marker

Overlap

Overlapping

segment

12

PV post-

dilatation

SESSimultaneous deployment of

PV and SB SES

PROCEDURE IV

Postdilatation

Overlapping

segment

13

Single SB post-

dilatation with high

pressure balloon

inflation

Final kissing-

balloon inflation

Single PV post-dilatation with high

pressure balloon inflation

View of the re-

constructed

bifurcation with

stents

FINAL RESULT

AXXESS STENT MSA

14

FINAL VIEW – RAO CRANIAL

SB OSTIUM MSA

SB DISTAL REFERENCE

CARINA – OVERLAPPING

SEGMENT (ARROWS)

AXXESS STENT MSA

MSA=minimum stent area

AXXESS Clinical Studies

AXXESS

N=43

AXXESS

PLUS

• Bare metal version of AXXESS Stent

• Safety and effectiveness study

• 6 month follow-up completed

• Evaluated drug-eluting AXXESS stent to BMS

• Safety and effectiveness studyPLUS

N=139

DIVERGE

N=302

• Safety and effectiveness study

• Follow-up through 3 years completed

• International safety and effectiveness study

• Evaluated best practices from AXXESS Plus

• 3 year follow-up will be presented at EuroPCR 2011

AXXESS PLUS TRIAL DESIGNAXXESS PLUS TRIAL DESIGNAXXESS PLUS TRIAL DESIGNAXXESS PLUS TRIAL DESIGN

� DESIGN Prospective, non-randomized, single-arm, multi-center

clinical evaluation of the AXXESSTM Plus Bifurcated

Coronary Stent System

� OBJECTIVE To evaluate the acute and long-term safety, tolerabi-

lity and performance of the AXXESS Plus stent

� PRINCIPAL INVESTIGATOR Eberhard Grube, MD

� DESIGN Prospective, non-randomized, single-arm, multi-center

clinical evaluation of the AXXESSTM Plus Bifurcated

Coronary Stent System

� OBJECTIVE To evaluate the acute and long-term safety, tolerabi-

lity and performance of the AXXESS Plus stent

� PRINCIPAL INVESTIGATOR Eberhard Grube, MD� PRINCIPAL INVESTIGATOR Eberhard Grube, MD

Helios Heart Center, Siegburg, Germany

� ANGIOGRAPHIC CORE LAB Alexandra J. Lansky, MD

Cardiovascular Research Foundation, New York, NY

� DATA MANAGEMENT CENTER Roxana Mehran, MD


� SPONSOR DEVAX, Inc., Irvine, CA

� PRINCIPAL INVESTIGATOR Eberhard Grube, MD

Helios Heart Center, Siegburg, Germany

� ANGIOGRAPHIC CORE LAB Alexandra J. Lansky, MD


� DATA MANAGEMENT CENTER Roxana Mehran, MD


� SPONSOR DEVAX, Inc., Irvine, CA

139 patients enrolled between July and December

2004 in 13 clinical sites in Europe, South America and

New Zealand

136 patients with AXXESS conical stent implanted

3 patients not stented

PATIENT FLOWCHARTPATIENT FLOWCHARTPATIENT FLOWCHARTPATIENT FLOWCHART

Clinical follow-up at 12 months

in 96.3% (N=131)

Angiographic follow-up at 6

months in 92.6% (N=126)

Clinical follow-up at 6 months

in 99.3% (N=135)

BASELINE DEMOGRAPHICSBASELINE DEMOGRAPHICSBASELINE DEMOGRAPHICSBASELINE DEMOGRAPHICS

Age, yearsAge, years 64.564.5

FemaleFemale 26.4%26.4%

DiabetesDiabetes 16.4%16.4%

HypertensionHypertension 72.9%72.9%

HyperlipidemiaHyperlipidemia 78.6%78.6%

Variable Variable N=139N=139

HyperlipidemiaHyperlipidemia 78.6%78.6%

SmokingSmoking 51.5%51.5%

Previous MIPrevious MI 31.4%31.4%

Previous PCIPrevious PCI 30%30%

Previous CABGPrevious CABG 4.3%4.3%

Congestive heart failureCongestive heart failure 1.4%1.4%

Left ventricule EF, %Left ventricule EF, % 65.565.5±±13.213.2

LESION LOCATIONLESION LOCATIONLESION LOCATIONLESION LOCATION

5.7%5.7%73.6%73.6%

16.4%16.4%

N=139N=139

4.3%4.3%

LESION SEVERITYLESION SEVERITYLESION SEVERITYLESION SEVERITY

Bifurcation lesion Duke classification


13.2%3.7%

2.9%


60.3% 0.7%18.4%

AXXESS Stent Only AXXESS Stent + Distal PV Stent

19.1%29.4%

TREATMENT CONFIGURATIONSTREATMENT CONFIGURATIONSTREATMENT CONFIGURATIONSTREATMENT CONFIGURATIONS

PV

PV

SB

SBPV

PV

AXXESS Stent Only AXXESS Stent + Distal PV Stent

AXXESS Stent + Distal PV and SB

StentsAXXESS Stent + SB Stent

9.6%

41.9%

PV

PV

SBSB

PV

PV

PREPRE-- AND FINAL QCAAND FINAL QCAPREPRE-- AND FINAL QCAAND FINAL QCA

BASELINEBASELINE

Lesion length, mmLesion length, mm 16.2816.28 7.437.43

RD, mmRD, mm 2.862.86 2.342.34

MLD, mmMLD, mm 0.780.78 0.880.88

VariableVariable PVPV SBSB

MLD, mmMLD, mm 0.780.78 0.880.88

% DS% DS 72.972.9 62.262.2

FINALFINAL††

MLD, mmMLD, mm 2.272.27 1.891.89

% DS% DS 23.823.8 22.322.3

Acute gain, mmAcute gain, mm 1.491.49 1.011.01*p<0.05 versus PV; †in-segment analysis

PARENT VESSEL QCA AT FOLLOWPARENT VESSEL QCA AT FOLLOW--UPUPPARENT VESSEL QCA AT FOLLOWPARENT VESSEL QCA AT FOLLOW--UPUP

LATE LUMEN LOSSLATE LUMEN LOSS

AXXESS conical stent, mmAXXESS conical stent, mm 0.090.09

InIn--stent, mmstent, mm 0.210.21

InIn--segment, mmsegment, mm 0.260.26

VariableVariable N=126N=126

InIn--segment, mmsegment, mm 0.260.26

RESTENOSISRESTENOSIS

AXXESS stent, mmAXXESS stent, mm 4%4%

InIn--stent, mmstent, mm 5.6%5.6%

InIn--segment, mmsegment, mm 10.5%10.5%

PRIMARY ENDPOINTPRIMARY ENDPOINT BA9 BMSBA9 BMS

AXXESS late loss, mmAXXESS late loss, mm 0.09 vs. 0.46 (0.09 vs. 0.46 (pp<0.001)<0.001)

SIDE BRANCH QCA BY TREATMENT SIDE BRANCH QCA BY TREATMENT MODALITYMODALITY

SIDE BRANCH QCA BY TREATMENT SIDE BRANCH QCA BY TREATMENT MODALITYMODALITY

BASELINEBASELINE

VariableVariable

No No treatmenttreatment

(N=26)(N=26)

PTCAPTCA

(N=40)(N=40)

StentStent

(N=70)(N=70)

BASELINEBASELINE

Lesion length, mmLesion length, mm 4.844.84 5.905.90 9.29*9.29*

RD, mmRD, mm 2.312.31 2.242.24 2.412.41††

MLD, mmMLD, mm 1.241.24 0.890.89 0.74*0.74*

% DS% DS 46.346.3 60.260.2 69.3*69.3**p<0.0001 vs. PTCA vs. NT; p=0.02 vs. PTCA vs. NT

InIn--segmentsegment

MLD, mmMLD, mm 1.831.83 1.641.64 2.05*2.05*

%DS %DS 22.422.4 28.128.1 19.019.0††

Acute gain, mmAcute gain, mm 0.590.59 0.750.75 1.311.31‡‡

FINALFINALNo treatmentNo treatment

(N=26)(N=26)

PTCAPTCA

(N=40)(N=40)

StentStent

(N=70)(N=70)

SB SUBSB SUB--SEGMENTAL QCA SEGMENTAL QCA -- IISB SUBSB SUB--SEGMENTAL QCA SEGMENTAL QCA -- II

*p=0.02 vs. NT, and p<0.0001 vs. PTCA; † p=0.002 vs. PTCA; ‡p<0.0001 vs. NT and vs. PTCA; §p=0.003 vs. Stent. Lesion success:

defined as attainment of <50% residual stenosis of the target lesion using any combination of percutaneous devices

Acute gain, mmAcute gain, mm 0.590.59 0.750.75 1.311.31

5mm ostium5mm ostium

MLD, mmMLD, mm 1.851.85 1.691.69 2.422.42‡‡

%DS %DS 21.621.6 26.026.0 3.93.9‡‡

Acute gain, mmAcute gain, mm 0.610.61 0.800.80 1.681.68‡‡

Lesion success, %Lesion success, % 96.296.2 77.577.5§§ 97.197.1

InIn--segmentsegment

MLD, mmMLD, mm 1.591.59 1.491.49 1.82*1.82*

%DS %DS 31.031.0 33.133.1 25.425.4††

Late lumen loss, mmLate lumen loss, mm 0.240.24 0.190.19 0.210.21

Restenosis, %Restenosis, % 12.012.0 25.025.0 7.97.9

FOLLOWFOLLOW--UPUPNo treatmentNo treatment

(N=26)(N=26)

PTCAPTCA

(N=40)(N=40)

StentStent

(N=70)(N=70)

SB SUBSB SUB--SEGMENTAL QCA SEGMENTAL QCA -- IIIISB SUBSB SUB--SEGMENTAL QCA SEGMENTAL QCA -- IIII

Restenosis, %Restenosis, % 12.012.0 25.025.0 7.97.9

5mm ostium5mm ostium

MLD, mmMLD, mm 1.651.65 1.541.54 2.152.15‡‡

%DS %DS 28.228.2 30.730.7 11.511.5§§

Late lumen loss, mmLate lumen loss, mm 0.200.20 0.180.18 0.280.28

Outcomes for SB with lesion success at index procedureOutcomes for SB with lesion success at index procedure

Restenosis, %Restenosis, % 8.38.3 13.813.8 8.28.2*p=0.04 vs. NT, and p=0.01 vs. PTCA; †p=0.05 vs. PTCA; ‡ p<0.0001 vs. NT and vs. PTCA; §p=0.0005 vs. NT, and p<0.0001 vs. PTCA

PREPRE--, FINAL AND FU ANGIOGRAPHY, FINAL AND FU ANGIOGRAPHYPREPRE--, FINAL AND FU ANGIOGRAPHY, FINAL AND FU ANGIOGRAPHY

Final Result Final Result 6 Months FU6 Months FU

ININ--HOSPITAL MAJOR EVENTSHOSPITAL MAJOR EVENTSININ--HOSPITAL MAJOR EVENTSHOSPITAL MAJOR EVENTS

MACE*MACE* 5% (7)5% (7)

Death Death 0% (0)0% (0)

MIMI 5% (7)5% (7)

Q waveQ wave 0.7% (1)0.7% (1)

Outcome Outcome

Q waveQ wave 0.7% (1)0.7% (1)

NonNon--Q waveQ wave 4.3% (6)4.3% (6)

TLRTLR 0% (0)0% (0)

Acute/subacute thrombosisAcute/subacute thrombosis 0% (0)0% (0)*Defined as death, MI and TLR

MI=myocardial infarction

TLR=target lesion revascularization

OUTOUT--OFOF--HOSPITAL OUTCOMESHOSPITAL OUTCOMESOUTOUT--OFOF--HOSPITAL OUTCOMESHOSPITAL OUTCOMES% of patients

% of patients

AXXESS PLUS TrialAXXESS PLUS TrialMACE CountMACE Count

AXXESS PLUS TRIALAXXESS PLUS TRIAL3 Year KM Curve3 Year KM Curve

MACE Free (%)

50

60

70

80

90

100MACE Free (%)

0

10

20

30

40

50

Time in Years

0 1 2 3

DIVERGE Trial DesignProspective, single-arm,

multi-center trial

1 mo 6 mo 9 mo 12 mo 2 yrs 3 yrs 4 yrs 5 yrs

Clinical FU

302 patients in 16 clinical sites in Europe, Australia and New Zealand

Lesion type:

Any bifurcation with:

• Significant SB’s > 2.25mm

• PV-SB angulation < 70°

Angio/IVUS FU

1° Endpoint: MACE* at 9 months

Key 2° Endpoints: MACE* at 30 days, 6, 9 and 12 months and 2, 3, 4 and 5 yrs

death, cardiac death, MI (Q-wave and non Q-Wave), id-TLR,

id-TVR and stent thrombosis at 30 days, 6, 9 and 12 months

and 2, 3, 4 and 5 yrs

Angiographic: In-stent restenosis and late loss at 9 months

*MACE = Composite of Death, MI and ischemia driven TLR

DAPT recommended: 12 months

Angio/IVUS FU

Lesion Inclusion Criteria

Parent Vessel

Side Branch

Any Type Bifurcation

SB > 2.25 mm

Up to 15 mm

Stents:

Proximal = 10 or 14 mm Axxess

Distal PV or SB = add Cypher to fit

Up to 10 mm

Up to 25 mmDistal

Parent Vessel

70°

Axxess Stent Procedure

Optimal Treatment Strategy

Pre Final

Axxess Stent Procedure

Optimal Treatment Strategy

Pre Final

Complex lesions were emphasized in this study.

Treatment was tailored to the disease with Axxess at the carina

followed by Cypher in the distal vessels.

DIVERGE Follow UpLead in Cases

< 3 per site

Enrollment

N=302

6 Months

Check up (N=302)

9 Months

N=301 (99.7% clin. FU)

Angiography

N=140 (94% FU)

IVUS Evaluation

N=68 (91% FU)

5 Year Annual

Follow Up

12 Months

N=300 (99.4% FU)

2 years

N=300 (99.4% FU)

3 years

N=294 (97.4% FU)

Agostoni P., oral presentation, EuroPCR 2011

DemographicsMean Age (years) 62.8 ± 10.6

Diabetic 18.2%

Insulin Dependent 5.6%

Current + History of Smoking 67.9%

Hypercholesterolemia 78.1%

Hypertension 56.6%

Verheye S. et al., J Am Coll Cardiol, 2009.

53(12): p. 1031-9

Prior MI 29.1%

Prior PCI/CABG 34.1%

Mean LVEF (%) 68.4 ± 11.1

Angina 92.1%

Stable 68.5%

Unstable 23.5%

Medina Class All Patients

1,1,1*1,1,1*1,1,1*1,1,1*

64.5%

6.6%6.3%

77.4%

True Bifurcation ****

1,1,01,1,01,1,01,1,0

12.0%

1,0,1*1,0,1*1,0,1*1,0,1*0,1,1*0,1,1*0,1,1*0,1,1*

1,0,01,0,01,0,01,0,0

6.6%

0,1,00,1,00,1,00,1,0

3.3%

0,0,10,0,10,0,10,0,1

0.7%


53(12): p. 1031-9

Procedure OutcomesAll Patients

(N=302)

AXXESS stent placed1 99.0%

Optimal placement1

(by core lab assessment) 93.0%

Branch vessel Cypher stents placed2500

1 Verheye S. et al., J Am Coll Cardiol, 2009.

53(12): p. 1031-92 Verheye S., oral presentation, TCT 2008

Branch vessel Cypher stents placed2

(210 in SB)

Angiographic success1

(Final DS < 50% by QCA)99.3%

Final mean diameter stenosis122.6% (PV)

18.8% (SB)

Procedure success1

(Angio success without in-hospital MACE)96.7%

Stent Distribution Patterns

AXXESS only:

12.3% AXXESS + PV:

17.7%

AXXESS + PV + SB: 64.7%

SB Stent: 68.7%

AXXESS + SB: 4.0%


53(12): p. 1031-9

9-month QCA Results

At Follow UpParent Vessel

(N=140)

Side Branch

(N=140)

Late Loss

(mm)

In-stent LL (AXXESS only) 0.18 ± 0.49 -

In-stent LL (all stents) 0.29 ± 0.50 0.29 ± 0.45

In-lesion LL 0.20 ± 0.41 0.17 ± 0.34

In-stent - AXXESS Only 0.7% -


53(12): p. 1031-9

Restenosis

Per Vessel

In-stent - AXXESS Only 0.7% -

In-stent - Cypher 2.3% 4.8%

In-lesion restenosis

(all stents + edges)3.6% 4.3%

Overall

Bifurcation

Restenosis

In-stent - PV + SB 5.0% (7/140)

In-stent or edges, within PV + SB 6.4% (9/140)

9 Month RestenosisAny In-segment bifurcation restenosis:

6.4% (9/140 at 9 months)

Side Branch RSSide Branch RSSide Branch RSSide Branch RS

3 pts2 pts

4 pts

Parent Vessel RSParent Vessel RSParent Vessel RSParent Vessel RS

BothBothBothBoth

Proximal edge:

2.8% SB stent:

4.8%(105 SB stents)

Location Analysis:

Verheye S. et al, J Am Coll Cardiol, 2009

3 pts 4 ptsBothBothBothBoth

Distal PV Cypher:

2.1%

AXXESS:

0.7%“Lowest restenosis rates ever reported in a

bifurcation study of any kind”

9-month Clinical Outcomes

*MACE: a composite of Death, MI and id-TLR

Verheye S. et al., J Am Coll Cardiol, 2009. 53(12): p. 1031-9

3-year Clinical OutcomesCumulative Rates

*MACE: a composite of Death, MI and id-TLR


MACE (Death, MI, id-TLR)

3-year Outcomes

9.3%

14.0%

16.0%

8

10

12

14

16

18

20%

Number at Risk 302 286 272 262 258 248 201

0

2

4

6

8

0 6 12 18 24 30 36

Month


MACE Components3-year Outcomes

8

12

16

20

%

6.0%7.4%

8

12

16

20

%6.0%

8.7%10.1%

8

12

16

20

%

Death MI id-TLR

0.7%2.3%

3.0%

0

4

8

0 12 24 36

Months

4.3%6.0%

0

4

8

0 12 24 36

Months

6.0%

0

4

8

0 12 24 36

Months


Antiplatelet Agent UtilizationCumulative incidence

(All patients N=302)

Aspirin

- At 6 months 95.3% (282/296)

- At 1 year 94.3% (280/297)

- At 2 years 93.2% (272/292)

- At 3 years 91.5% (260/284)

Clopidrogel/Thienopyridine

- At 6 months 85.1% (252/296)

- At 1 year 73.1% (217/297)

- At 2 years 43.2% (126/292)

- At 3 years 40.5% (115/284)

Definite Stent Thrombosis*

3-year outcomes

1.3%1.7%

2.4%

2

3

4

5

%

* Definite stent thrombosis defined by ARC

(Cutlip et al,. Circulation, 2007)


Number at Risk 302 299 292 288 288 280 224

0

1

0 6 12 18 24 30 36

Months

Stent Thrombosis up to 3 Years

Protocol ARC

Definite* Probable Definite* Probable Possible

Acute

(In-hospital)0 0 0 0 0

Subacute

(30 days)0.7% 0 0.7% 0 0

Late

(>30 days - 1 year)0.7% 0 0.3%§ 0 0

Very Late

(1 year - 3 years)1.0% 0.7% 1.0% 0.7% 2.4%

*All definite stent thrombosis in DIVERGE were confirmed

with angiography.

§One case of asymptomatic chronic total occlusion is

omitted in ARC classification but included in protocol

definition


Conclusions

� The safety and efficacy of the Axxess Biolimus A9-eluting stent was

confirmed up to 3 years

� The use of Axxess stent for the treatment of complex bifurcation lesions

resulted in low 3-year event rates:

– all-cause cumulative MACE rate 16.3%

– Ischemia-driven TLR rate 12.2%

– very late definite stent thrombosis 1.0%

– Very low definite VLST not resulting in any death

–Only one definite VLST attributed to the Axxess stent whereas

all events were present in the Cypher stent

axxess - European Bifurcation Club

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