2. Disclosure
Speaker name:
.................................................................................
I have the following potential conflicts of interest to report:
Consulting
Employment in industr
Stockholder of a healthcare company
Owner of a healthcare company
Other(s)
I do not have any potential conflict of interest
3. Interventional Therapy BTK
for CLI-Patients
• First Goal (for tissue loss):
–To achieve a straight line flow to the
foot
• Long term patency of the treated vessel:
- Of secondary importance ??
4. Angioplasty with
Uncoated Balloons (POBA)
Occlusion ATA, Stenosis PA After POBA both arteries 3-mo re-occlusion
5. 3-Months Angiographical FU
after POBA of long BTK-Lesions
- 58 CLI-pts. / 62 limbs
- Mean length of BTK-lesions: 183 mm
- Treatment with non-coated balloons
- Restenosis > 50 % after 3 months: 68.8 %
- Mean length of restenosis: 155 mm
A. Schmidt et al., Catheter Cardiovasc Intervent 2010
12. Leipzig Experience with DEB BTK
POB BTK DEB BTK
Lesion-length 183 mm 173 mm
Restenosis >50 % @ 3 Mo 69 % 27 %
61% restenosis reduction
Length of restenosis 155 mm 64 mm
13. DEB in BTK Lesions
DEBATE BTK
First published randomized trial
complex CLI–Diabetic population
• Single Center Randomized (1:1)
• CLI, Diabetic patients
• IN.PACT Amphirion vs. std PTA
• Primary Endpoint: 12-month
(>50%) Angiographic RR
to assess DEB vs. PTA in a
with 12-month angiographic
endpoint
CLI + Diabetes
150 (Tibial) Lesions
random
(1:1)
Aspirin + Clopidogrel (1 month)
F.Liistro et al. Circulation 2013
DEB
(75 lesions)
Std PTA
(75 lesions)
12m Angio / Clinical FU
24 m Duplex / Clinical FU
14. DEBATE BTK – 1-year Results
Restenosis and Occlusion Rates TLR
12-month TLR
DEB vs. PTA:
18.5% vs. 43.3%
(p=0.003)
Complete Wound Healing
Major Adverse Events
F.Liistro et al. Circulation 2013
15. DEB vs. PTA in BTK (RCT)
• DEBATE BTK [1] randomized Trial - IN.PACT vs. PTA
– Lesion length 12.8 cm (DEB) / 13.0 cm (PTA)
– 12-m TLR = 18.5% (DEB) vs. 43.3% (PTA) (p=0.003)
– 12-m Wound Heal. Rate (WHR) 86% (DEB) vs. 67% (PTA)
(p=0.01)
59% TLR
p=0.003
28% WHR
p=0.01
F.Liistro et al. Circulation 2013
16. DEB vs. PTA in BTK (RCT)
Inpact deep - Medtronic Press Release
• No biological efficacy (identical LLL)
• Trend towards more major amputations in the
DEB cohort
What to do now in long lesions?
Continue with new studies using alternative
coating technologies
Th.Zeller
17. DEB in BTK Interventions
Conclusion
1. Recent CLI studies using In.PACT Amphirion DEBs resulted
in inconclusive outcomes
2. Further studies investigating the performance of DEB in
BTK lesions are mandatory
1. Due to potential safety concerns in patients with PAOD
Rutherford 2 to 4
2. Proof of concept studies with an angiographic endpoint prior to
lager scale CLI trials
3. It can be expected that biological effective DEB coatings
will achieve comparable clinical outcomes as DES.
Th.Zeller
19. YUKON, DESTINY & ACHILLES Trials
Primary Patency
P < 0.05
For all trials
Rastan et al. EHJ 2011
Scheinert et al. JACC 2012
Bosiers et al. JVS 2012
20. DES vs. PTA in BTK (RCT)
• ACHILLES [1-2] randomized Trial – Cypher Select vs. PTA
– Lesion length 2.7 cm (DES) / 2.7 cm (PTA)
– 12-m TLR = 10.0% (DES) vs. 16.5% (PTA) (p=0.257)
– 12-m Wound Heal. Rate (WHR): 61.7% (DES) vs. 41.3%
(PTA) (p=0.0628)
1. D.Scheinert et al. A Prospective Randomized Multicenter Comparison of Balloon Angioplasty and
Infrapopliteal Stenting With the Sirolimus-Eluting Stent in Patients With Ischemic Peripheral Arterial
Disease. (J Am Coll Cardiol 2012;60:2290–5
2. Konstantinos Katsanos CIRSE 2012 Oral Presentation
39% TLR
p=0.257
49% WHR
p=0.0628
21. MAE and TVRat 2-year FU in patients with Claudication
DES vs. BMS
(YUKON Trial, Rastan A. et al. JACC 2012)
Intermittent
claudication
Sirolimus Stent
(N=38)
Bare Metal Stent
(N=44)
P
Death 7 (18.4%) 8 (18.2%) 1.0
Major-/Minor Amputation 0/0 (0%) 0/2 (4.7%) 0.19
TVR 3 (7.9%) 11 (25%) 0.04
Myocardial infraction 1 (2.6%) 2 (4.5%) 0.50
Limb salvage 31 (100%) 36 (100%) 1.0
Rutherford-Becker class
Median change (IQR) -1 (-2 to -1) -1 (-1 to 0) 0.03
22. DES in BTK Lesion Trials
Conclusions
• In lesions up to 10cm DES are the
treatment of choice in BTK lesions
extending to the ankle
• They are superior to BMS and POBA
• Longest lesions enrolled in ACHILLES
(up to 10cm)
• Uncertainty about the performance of DES
in long lesions
• Improved patency after DES results in
– Reduced TLR rates
– Preserved clinical benefit
– Increased limb preservation
Rastan et al. EHJ 2011; Scheinert et al. JACC 2012; Bosiers et al. JVS 2012
