Femoropopliteal Stenting with Nitinol Stentsmeetcongress.com/pdf/meet2007/MEET-june-15-07/Private lounges... · Femoropopliteal Stenting Cannes MEET 2007 with Nitinol Stents – ABSOLUTE

DEPARTMENT OF ANGIOLOGY – GENERAL HOSPITAL VIENNA

Femoropopliteal StentingFemoropopliteal Stenting

CannesCannesMEET 2007MEET 2007

with Nitinol Stents with Nitinol Stents ––ABSOLUTE 24 Months DataABSOLUTE 24 Months Data

in the Contextin the Context

M. SchillingerM. Schillinger


Treating the SFA in 2007

- Why should we stent the SFA?

- Do current data support the use of primary Nitinol stenting?- in all patients?- in selected patients?

- Which stents should we use?


SFA Treatment Options:Balloon Angioplasty


Subintimal PTA –The Way to Go?


• Bolia et al. – 1990• CLI• technical success

50% - 89%

Dorucci et al.J Cardiovasc Surg 2004

Subintimal PTA


Cryo, Cutting, Laser…

PVD Chill Registry

Excimer LaserDebulking – RekanalisationBiamino et al. EVT 2002

TASC A TASC A/BTechnically feasible…

…prevents restenosis???


PTA vs. Balloon Expanding Stents

noNitinolStents


Comparison of Self Expanding Stents: Nitinol vs. Wallstents

J Endovasc Ther 2005


Comparison of Self Expanding Stents: Nitinol vs. Wallstents

J Endovasc Ther 2005


Nitinol stents seem the best we currently have for the SFA…

…but randomized controlled trials are needed.


BLASTER Trial


BLASTER Trial

9 Months

12 Months

13 % - 22% restenosis at 9 monthsin a monitored randomized trial


ABSOLUTE Trial

A Randomized Controlled Trial

To compare morphological, hemodynamic and

clinical outcome after

PTA plus optional stenting

vs.

primary nitinol stenting

of superficial femoral artery (SFA) obstructions.N Engl J Med 2006


Study Endpoints

1° Endpointangiographic restenosis @ 6 mo(>50% by i.a. DSA or CTA)

2° Endpoints-) morphological Duplex restenosis @ 3,6,12&24mo

reocclusion rates @ 3,6,12&24modegree of restenosis @ 6 moTLR&TVR @ 3,6,12&24mostent fractures @ 6 & 12 mo

-) clinical Rutherford stage @ 3,6,12&24mowalking capacity @ 3,6,12&24mo

-) hemodynamic resting ABI @ 3,6,12&24mo


Trial Protocol

• Randomization after successful wire passage• PTA plus optional stenting vs. primary stenting

Residual stenosis >30%Flow limiting dissection

Elastic recoil

Restrictive predilationOverstent the entire lesion

1.Step: prolonged PTA

2.Step: optional StentN Engl J Med 2006


Selected Baseline Data

Stent PTA +/- Stent p-value(n=51) (n=53)

Diabetes 22 (43%) 17 (32%) 0.24Complete occlusion 19 (37%) 17 (32%) 0.58Length treated [mm] 132 (71) 117 (55) 0.24Primary success 51 (100%) 36 (68%) <0.01Stenting 51 (100%) 17 (32%) <0.01

Data are given as counts (percentages) or means (SD)


ABSOLUTE Trial:

6 Mo Angiographic Restenosis

0%

20%

40%

60%

80%

100%

Ang

iogr

aphi

c re

sten

sis

at 6

mon

ths

p=0.032

PTA +/- Stent Stent(primary)

Intention to Treat

23/53 12/51

43.4% 23.5%

p=0.010

PTA only Stent(prim. or second.)

Per Protocol(as treated)

18/36 17/68

50.0% 25.0%


ABSOLUTE Trial:

Restenosis Rates by DUS


NEJM 2006, Circulation 2007


ABSOLUTE Trial:

Restenosis Rates until 24 Mo


0 3 6 9 12 15 18 21 24

Follow-up Time (months)

20

40

60

80

100C

umul

ativ

e Fr

eedo

mfr

om R

este

nosi

s (%

)

Log Rank p=0.02

4652

39 (7)40 (12)

33 (13)28 (24)

33 (13)28 (24)

29 (17)19 (33)

27 (19)19 (33)

27 (19)17 (35)

27 (19)17 (35)

25 (21)16 (36)

StentPTA

45.7%

69.2%



ABSOLUTE Trial:

Clinically Driven TVR

DEPARTMENT OF ANGIOLOGY – GENERAL HOSPITAL VIENNA NEJM 2006, Circulation 2007

37.0%

53.8%

0 3 6 9 12 15 18 21 24

Follow-up Time (months)

20

40

60

80

100

Cum

ulat

ive

Free

dom

from

TVR

(%)

Log Rank p=0.12

4652

46 (0)51 (1)

41 (5)44 (8)

38 (8)38 (14)

33 (13)37 (15)

32 (14)27 (25)

31 (15)25 (27)

31 (15)24 (28)

29 (17)24 (28)

StentPTA


ABSOLUTE Trial:Clinical Outcome: Walking Capacity




ABSOLUTE Trial:

Hemodynamic Outcome



POBA Stent

Physical ComponentSummary

p=0.072

POBA Stent0

20

40

60

80

100

PhysicalFunctioning

p=0.051

POBA Stent

Role-PhysicalFunctioning

p=0.031

POBA Stent

BodilyPain

p=0.080

POBA Stent

Vitality

p=0.015

SF-3

6 Q

oL S

core

POBA Stent

Mental ComponentSummary

p=0.14

POBA Stent0

20

40

60

80

100

SocialFunctioning

p=0.49

POBA Stent

RoleEmotional

p=0.026

POBA Stent

GeneralHealthp=0.21

POBA Stent

MentalHealth

p=0.040

SF-3

6 Q

oL S

core

Better quality of life (SF-36) in patients

after primary stent implantation.


Clinical Implications –ABSOLUTE Trial

Primary Stenting with the Absolute nitinol stent improved primary patency rates and clinical outcomes until 24 months compared to balloon angioplasty with optional stenting in lesions with a median length of 12cm.


Mean lesion length 8cm

Restenosis at 2 years:DES 22.9%BMS 21.1%

SIROCCO – 2 Year Data

0

10

20

30

40

6 Months 9 Months 18 Months 24 Months

Duda et. al JEVT 2006

… everthing looks really great for SFA stenting…









Conclusions –FAST

In patients with a mean lesion length around 4.5 cm, primary stenting using the Luminexx Stent did not improve morphological outcome.


Primary Stenting in patients…

… with long / complex lesionsABSOLUTE vs. FAST

… with restenosis after prior PTAeven Wallstents were better than repeat PTA

… when an optimal primary result is crucial (CLI)because ulcer healing rather than long term patency counts


Which Stents should we use?

Biamino et al TCT 2004

Allie et al Endovasc Today 2004


Fracture Rates in the Context –Data from RCTs

SIROCCO I SIROCCO II ABSOLUTE FAST RESILIENT

6-mo 19% 9% 1.5% - 2.2%

12-mo 31% 11% 1.5% 12% -

Length 85 mm 82 mm 124 mm 45mm 65mm

Factors which determine fracture rates:- length of the lesion- type of the stent


Unresolved Problems of SFA Stenting

• How to avoid and treat restenosis

• How to handle stent-occlusion / thrombosis


Treating the SFA in 2007

- Do current data support the use of primary Nitinol stenting?currently liberal „stenting on indication“

- Which stents should we use?stents with approved low restenosis and low fracture rates from randomized trials

- Why should we stent the SFA?symptomatic SFA disease is usually long&complex:best results in this indication are obtained with stents


Don´tJust Stent It!

Endovascular Treatment of Long & Complex SFA Lesions:

Documents

Femoropopliteal Stenting with Nitinol Stentsmeetcongress.com/pdf/meet2007/MEET-june-15-07/Private lounges... · Femoropopliteal Stenting Cannes MEET 2007 with Nitinol Stents – ABSOLUTE