MEET, 2014, Nice
A.Z. Sint-Blasius, Dendermonde
Marc Bosiers
Koen Deloose
Joren Callaert
Imelda Hospital, Bonheiden
Patrick Peeters
Jürgen Verbist
OLV Hospital, Aalst
Evidence for endovascular
treatment for TASC C and D
femoral lesions
Lieven Maene
R.Z. Heilig Hart, Tienen
Koen Keirse
Bart Joos
Koen Deloose, MD
FMRP 2014 | 1
MCQ: How to treat?
SFA TASC A lesion
FMRP 2014 | 2
MCQ: How to treat?
SFA TASC B lesion
FMRP 2014 | 3
MCQ: How to treat?
SFA TASC C lesion
FMRP 2014 | 4
MCQ: How to treat?
SFA TASC D lesion
FMRP 2014 | 5
TASC A & B – evidence for BMS
100
12-month Primary Patency (%)
90
80
2
1
70
4
3
5
60
6
Stent
7
1.
2.
3.
4.
5.
6.
7.
50
40
PP@12M
± 75%
30
20
FAST
FACT
RESILIENT
4EVER
DURABILITY
ASTRON
VIENNA
10
0
0
5
10
Lesion Length (cm)
15
FMRP 2014 | 6
TASC A & B – evidence for DCB
100
12-month Primary Patency (%)
90
80
2
70
1
3
60
DCB
50
1.
2.
3.
40
PP@12M
± 78%
30
20
THUNDER
FEMPAC
LEVANT I
10
0
0
5
10
Lesion Length (cm)
15
FMRP 2014 | 7
TASC A & B – evidence for DES
100
12-month Primary Patency (%)
90
1
80
70
2
60
DES
50
40
1.
2.
PP@12M
± 85%
30
20
ZILVER PTX
STRIDES
10
0
0
5
10
Lesion Length (cm)
15
FMRP 2014 | 8
Reality  TASC C & D
FMRP 2014 | 9
Reality  TASC C & D
chemical action
2. DES
scaffolding
3. DCB
1. BMS
4. Covered
Stent
mechanical barrier
FMRP 2014 | 10
1. BMS
• DURABILITY 200
– prospective, multi-center, non randomized trial
– lesion length ≥ 150 mm (mean lesion length: 24,2 cm)
– 100 subjects
FMRP 2014 | 11
1. BMS
• VIASTAR
– prospective, randomized, multi-center trial
– subjects: 69 BMS (72 Viabahn)
– mean lesion length for BMS: 17.3 ± 6.6 cm
BMS
p value
Primary patency
53.5%
0.009
Freedom from TLR
77.0%
0.37
Lammer et al. J Am Coll Cardiol; 2013, 62(15), 1320-1327
FMRP 2014 | 12
TASC C & D – evidence for BMS
100
12-month Primary Patency (%)
90
80
70
Stent
1. DURABILITY 200
2. VIASTAR: BMS
1
60
2
50
40
PP@12M
± 65%
30
20
10
0
0
5
10
15
20
Lesion Length (cm)
25
30
FMRP 2014 | 13
2. DES
• Zilver PTX trial: long lesions
FMRP 2014 | 14
TASC C & D – evidence for DES
100
12-month Primary Patency (%)
90
1
80
2
70
60
DES
50
1.
2.
40
PP@12M
± 82%
30
20
10
ZILVER PTX registry
ZILVER PTX single arm
study
0
0
5
10
15
20
Lesion Length (cm)
25
30
FMRP 2014 | 15
3. DCB
• Leipzig registry
– Single center registry of fem-pop lesions
– 288 treated limbs, Rutherford 2-6
– Lesion length: 24.0 ± 10.1 cm
–
–
–
–
stenosis / occlusion
de novo
restenosis
in-stent restenosis
Schmidt et al. LINC 2013
34.7 % / 65.3 %
51.7 %
11.1 %
37.2 %
FMRP 2014 | 16
3. DCB
Schmidt et al. LINC 2013
FMRP 2014 | 17
3. DCB
• Zeller registry
– multi-center, retrospective analysis
– IN.PACT DCB vs. DES
– Lesions ≈ 19 cm
FMRP 2014 | 18
TASC C & D – evidence for DCB
100
12-month Primary Patency (%)
90
2
80
1
70
60
DCB
50
1.
2.
40
Leipzig registry
Zeller registry
PP@12M
± 77%
30
20
10
0
0
5
10
15
20
Lesion Length (cm)
25
30
FMRP 2014 | 19
4. Covered Stent
• VIABAHN 25CM
– multi-center, non-randomized, prospective trial
– 71 subjects, mean lesion length: 26,5 cm
FMRP 2014 | 20
4. Covered Stent
• VIASTAR
– prospective, randomized, multi-center trial
– subjects: 72 Viabahn (69 BMS)
– mean lesion length for Viabahn: 19.0 ± 6.3 cm
Viabahn
BMS
p value
Primary patency
78.1%
53.5%
0.009
Freedom from TLR
84.6%
77.0%
0.37
Lammer et al. J Am Coll Cardiol; 2013, 62(15), 1320-1327
FMRP 2014 | 21
TASC C & D – evidence for Covered Stent
100
12-month Primary Patency (%)
90
80
2
70
Covered Stent
1. VIABAHN 25CM
2. VIASTAR: Viabahn
1
60
50
40
PP@12M
± 73%
30
20
10
0
0
5
10
15
20
Lesion Length (cm)
25
30
FMRP 2014 | 22
TASC C & D – evidence
100
DCB
12-month Primary Patency (%)
90
1
2 2 2
80
70
1
2
50
40
DES
30
1.
2.
20
10
0
0
5
10
15
20
Lesion Length (cm)
25
Leipzig registry
Zeller registry
BMS
1. DURABILITY 200
2. VIASTAR: BMS
1
1
60
1.
2.
30
ZILVER PTX registry
ZILVER PTX single arm
study
Covered Stent
1. VIABAHN 25CM
2. VIASTAR: Viabahn
FMRP 2014 | 23
Conclusion
• Scaffolding BMS are insufficient for long SFA lesions
• Scaffolding and chemical active DCB look very
promising although we wait for more, upcoming
scientific data
• Chemical active, scaffolding DES and scaffolding
mechanical barriers as Covered stents are reaching
high patency levels in these challenging lesions
FMRP 2014 | 24