1. Heavily calcified SFA lesions do not avoid the use of 4 F systems
Maria Schoder
Division of Cardiovascular and Interventional Radiology
Medical University of Vienna
Bulgarian Endovascular Course 2011

2. CTA 90-year old lady History of CABP x3 chronic heart insufficiency
chronic renal insufficiency
hyperlipidemia
femoropopliteal PTA (rigth side) 12 years ago
Symptoms Intermittend claudication on both sides
Fontaine stage IIb

3.  Subintimal recanalization
 Antegrade access
 Subintimal recanalization
pushability

5. severe
calcifications
Identical findings on the left side

6. ABI
improved
from below of 0.4 to
right 0.85
left 0.79
Worsening of the
walking distance
after 6 month

7. 6 F device (Absolute)
Pulsar-18

8. after re-PTA

9. Dick P et al. Catheter Cardiovasc Interv 2009;74:1090-5
ASTRON Trial
 Prospektive, randomized, multicenter trial
 Astron Pulsar vs PTA and optional stenting
 Study entry
 intermittend claudication and CLI (Rutherford class 3-5)
 lesion length mm
 at least one tibioperoneal run-off vessel
SES- Sirolimus eluting stent
 Primary endpoint
 occurrence of restenosis within 6 month (> 50% lumen diameter reduction)
 Secondary endpoints (at 3, 6 and 12 months)
 Binary restenosis, walking distance, amputation and death, ABI

10. ASTRON Trial Lesion-characteristics- ITT Astron Pulsar n=34 PTA n=39 P
Length of target lesion, mm 82 65
0.022
Occlusions, % 38 39
0.98
Procedural data
Astron Pulsar
PTA P
Cross-over access, % 88 92
0.55
Stents used, %
100
26 (bail-out)
<0.001
Length of treated segment, mm 98 71
0.011

11. ASTRON Trial – Results
Conclusion: primary stenting using the Astron Nitinol stent improved morphological and clinical outcome compared to PTA with optional stenting

12. Patency and lesion length for randomized stent studies
Level I Evidence
FAST
RESILIENT
ASTRON Trial
ABSOLUTE
Design
Stent vs PTA
Mean lesion length (cm)
4.5
6.2
8,4
10.1
12-month primary patency (%)
67 vs 62
81,3 vs 36,7
66 vs 39
63 vs 36 P
p=0.38
p<0.0001
p<0.05
p=0.01
Primary stenting vs PTA; Astron prim stenting vs PTA+optional stenting Astron results intention to treat
TASC II A and B lesions
Stent fracture rates were reported in 2% to 12%

13. ASTRON PULSAR Nitinol stent in the femoropopliteal sector
AcÍn F et al. Técnicas Endovasculares 2010;13:
ASTRON PULSAR Nitinol stent in the
femoropopliteal sector
 prospective, non-randomized registry
 bail-out procedure after failed PTA
 intermittend claudication and CLI (69%)
 total mean lesion length 52 mm
− mean stenosis length 31 mm
− mean occlusion length 67 mm
Bail-out:> 30% reststenosis, dissection
 Primary endpoints
 primary patency (< 50% ISR, PSVR < 2.5 ) and fracture rate

14.  Target lesion revascularization 14%  Clinical success 61%
AcÍn F et al. Técnicas Endovasculares 2010;13:
77.5%
Freedom from binary restenosis
68%
Primary patency
Bail-out:> 30% reststenosis, dissection. Kaplan Meyer analysis revealed a 24months…..
 No stent fracture
 Target lesion revascularization 14%
 Clinical success %
 Limb salvage at 24 months 73.7%

15. Performance characteristics of self-expanding Nitinol stents
Schmidt W et al. Fortschr Rröntgenstr 2011;183:818-25
7/80 mm stent systems
Bending stiffness of stents in crimped and expanded conditions
 highest flexibility
Trackability of stent system
(mean track force F)
 best trackability

16. The radial force of the expanded stent
Schmidt W et al. Fortschr Rröntgenstr 2011;183:818-25
Radial force during stent expansion as a
function of stent diameter (5 and 6 mm)
The radial force of the expanded stent
is essential for holding the lesion
widely open
It is not finally clear wether a high,
moderate or low radial force will
result in higher patency rates

17. Conclusion Primary patency rates after stenting in long SFA lesion
are significantly better compared to PTA alone
Astron-Trial shows comparable results to 6F systems
Radial force of the Astron stent family seems to be high enough even for treatment of heavily calcified lesions
4F systems  lower crossing profile
 lower access site complications
 cost effectiveness - no closure device
- earlier ambulation

18. Active investigational study
 4-EVER Trial; M. Bosiers, Belgium
 enrollment of 120 pts completet
 Rutherford-category 2-4
 De novo, re-stenotic and re-occluded lesions
 length up to 200 mm; treatable with 1 stent
 at least one-vessel-runoff
Acute and interim results will be presented at LINC 2012
Safety and efficacy studies on the way. Bioflex estimated enrollement 396 Pts.
ClinicalTrials.gov

19. MERRY CHRISTMAS
AND
ALL THE BEST FOR 2012