1. The 4EVER Trial Final 24 month results:
BEC 2014, София
The 4EVER Trial
Final 24 month results:
A.Z. Sint-Blasius, Dendermonde
Marc Bosiers
Koen Deloose
Joren Callaert
Imelda Hospital, Bonheiden
Patrick Peeters
Jürgen Verbist
OLV Hospital, Aalst
Lieven Maene
R.Z. Heilig Hart, Tienen
Koen Deloose, MD
Koen Keirse

2. Point to make…..
“Less invasive 4F devices, with sufficient chronic outward forces & high crush resistance and radial resistive forces, show equal technical success, primary patency and freedom from TLR rates as 6F devices, also on the longer term, and without the need for expensive closure devices”

3. 4EVER Trial outline
Physician-Initiated, prospective, non-randomized, multi-center Trial Investigating the Safety of the Full 4F EndoVascular TrEatement AppRoach of Infra-Inguinal Arterial Stenotic Disease

4. Less invasive 4F devices…
Fortress 4F 45/100cm Biotronik
Cruiser 18 Biotronik
CXI support catheter (Cook)
Pulsar 18 Biotronik
Passeo 18 Biotronik

5. Less invasive 4F devices…
Low Profile Delivery Systems
Puncture hole size mm
4.52 mm²
44.44 %
7.07 mm²
69.44 %
10.18 mm² % 2
1.8
1.5
1.2 1 6F 5F 4F

6. …with sufficient chronic outward force…
Outward force exerted on vessel by self expanding stents
to achieve preset diameter
Stent Preset Diameter
Vessel Wall
Zhao HQ, Nikanorov A, Virmani R, Jones R, Pacheco E, Schwartz LB. Late stent expansion and neointimal proliferation of oversized Nitinol stents in peripheral arteries. Cardiovasc Intervent Radiol Jul;32(4):720-6.
Stent Placement
COF
Stent COF

7. …with sufficient chronic outward force…
TOO LOW…
4EVER : calcified lesions = 31%
4EVER : Technical success rate = 100%
“the ability to cross and stent the lesion in order to achieve residual angiographic stenosis no greater than 30% and residual stenosis less than 50% by duplex imaging”
Impossible to open the lesion
Residual stenosis

8. …with sufficient chronic outward force…
TOO HIGH…
chronic stent-vessel irritation
intimal hyperplasia

9. …with sufficient chronic outward force…
Average reference vessel diameter of SFA is 5 mm
Most commonly used stent diameter in SFA is 7 mm 1
1- Garcia L. Superb Trial 12 Month Results. Presented at TCT Miami, FL.

10. …with sufficient chronic outward force…

11. …with sufficient chronic outward force…
Even when oversizing low rates of COF, due to the flat expansion curve

12. …with sufficient chronic outward force…
Bent Leg:vessel diameter range: mm : 6mm stent A implant
100N
Expansion force increases with decreasing diameter
60N
40N
5,02
Flat expansion force
2,98
5,02
Illustration is artist’s rendition.

13. …with sufficient chronic outward force…
Bent Leg:vessel diameter range: mm : 6mm stent B implant
Flat expansion force curves induce lower COF & offer less concern for precise vessel sizing
Expansion force increases with decreasing diameter
40N
5,02
30N
20N
Flat expansion force
2,98
5,02
Illustration is artist’s rendition.

14. …with high radial resistive force…
Resistive force exerted by self expanding stents to resist
CONCENTRIC squeezing by the artery (concentric
restenosis) or other external factors
Vessel Wall
Stent RRF
Stent Placement
Zhao HQ, Nikanorov A, Virmani R, Jones R, Pacheco E, Schwartz LB. Late stent expansion and neointimal proliferation of oversized Nitinol stents in peripheral arteries. Cardiovasc Intervent Radiol Jul;32(4):720-6.
Stent RRF

15. …with high radial resistive force…

16. …with high radial resistive force…

17. …with high radial resistive force…
Flat RRF curve with low variations according to diameter changes

18. …with high crush resistance…
Crush resistance exerted by self expanding stents to resist ECCENTRIC, focal compression of the artery (external finger pinching or eccentric restenosis)
circular
ovalized
Unloaded
Loaded

19. …with high crush resistance…
At 10, 25 and 50% radial compression, the pulsar stent has similar RRF to other devices
50%
25%
10%

20. …show in equal circumstances as 6F device-studies…
Patient demographics (N=120)
Male (%) (68.34)
Age (min – max; SD) (47 – 90; 9.70)
Nicotine abuse (%) (41.67)
Hypertension (%) (65.83)
Diabetes mellitus (%) 43 (35.84)
Renal insufficiency (%) 13 (10.83)
Hypercholesterolemia (%) 66 (55.00)
Obesity (%) (32.50)
Rutherford category (35.83%)
Rutherford category (47.50%)
Rutherford category (16.67%)

21. …show in equal circumstances as 6F device-studies…
Lesion characteristics (N=120)
Left/Right limb (%) (59.17%) /49 (40.83%)
Lesion length in mm (min – max) (10 – 200)
Popliteal involvement (%) (4.17%)
Occlusions (%) (20.83%)
Ulcerated lesion (%) 3 (2.50%)
Calcified lesion (%) (30.83%)
Presence of trombus (%) 2 (1.67%)

22. …show in equal circumstances as 6F device-studies…
Study name
Device
Mean Lesion Length
Resilient
Lifestent
6.2 cm
Zilver Flex arm
Zilver Flex
6.3 cm
Zilver PTX arm
Zilver PTX
6.6 cm
Durability II
Everflex
8.9 cm
Supera
9.0 cm
Durability
9.6 cm
Absolute Vienna
Absolute
10.1 cm
4EVER
Pulsar 18
7.2 cm

23. …equal clinical success as 6F devices…

24. …equal primary patency rates as 6F devices…
At 2 years…
81.4%
72.3 %
time
baseline
at risk
120 %
100%
24MFU 63
72.3%

25. …equal primary patency rates as 6F devices…
At 2 years…
82.0%
80.2%
76.7 %
P=0.485
66.8%
time
baseline
Calcification 37
No calcification 83
24MFU 27 62

26. …equal freedom from TLR rates as 6F devices…
At 2 years…
89.3%
82.7 %
time
baseline
at risk
120 %
100%
24MFU 71
82.7%

27. …equal freedom from TLR rates as 6F devices…
At 2 years…
91.1%
85,1%
P =
85.2%
82,3%
baseline
1MFU
6MFU
12MFU
24MFU # 70 69 67 61 46 %
100
98,6
94,1
82,3 43 38 33 23
92,7
87,8
85,1

28. Loss of primary patency in combination with stent fracture:
Fracture rate at 12-months
Stent fracture rate: 4.17% (5/120) #
Loss PP
Class 0
No strut fractures
115
Class I
Single tine fracture 1
Class II
Multiple tine fractures
Class III
Stent fracture(s) with preserved alignment of the components 3
Class IV
Stent fracture(s) with mal-alignment of the components
Class V
Stent fracture(s) in a trans-axial spiral configuration
Loss of primary patency in combination with stent fracture:
1.67% (2/120)

29. …without the use of expensive closure devices.
No closure devices were used
Decreased manual compression time : 8.2 min
BOGART, Am J Crit Care, 1995 – 6F – 22 min
SIMON, Am J Crit Care, 1998 – 6F – 14.9 min
UPPONI, Eur J Radiol – 6F – 10.6 min

30. …without the use of expensive closure devices.
Number of puncture site complications (secondary endpoint)
= 3.33 % major hematomas
No surgical repair – 3 transfusions
17.65% in Coumarin patients
0.97% in non Coumarin patients
p =

31. Point made…..
“Less invasive 4F devices, with the right chronic outward force, radial resistive force and crush resistance, show equal technical success, primary patency and freedom from TLR rates as 6F devices, also on the longer term, and without the need for expensive closure devices”