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Current Status of DCB Experience with Non-
Femoropopliteal Applications (Dialysis, Tibial, Venous)
Saher Sabri, MD
University of Virginia Health System
Charlottesville, Virginia
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Dialysis vascular access
dysfunction
• Less than 15% of dialysis fistulae remain
patent and can function without problems
during the entire period of a subject's
dependence on hemodialysis.
• Problem-free patency for AVF is about 3
years, and for AVG 1-2 years
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Dialysis vascular access
dysfunction
• The primary patency rate after PTA at 6
months in AVF Document is approximately
50% while the primary patency observed in
AVG is approximately 40% (23% - 63%).
• Cutting balloons and BMS have had limited
impact in patency
• Stent grafts in AVG showed superiority
to PTA
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RCT PTA vs DCB
Katsanos et al • RCT comparing DCB dilation (N=20) with
standard PTA (N=20) to treat stenosed AVF
and AVG venous outflow lesions.
• At 6 months, cumulative target lesion primary
patency was significantly higher after DCB
application (70% in DCB group vs 25% in
PTA group, p=0.001; HR 0.30)
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Target Lesion Primary PatencyDCB group 35% Vs 5% PBA group p<0.001
respective HR (95%CI) = 0.27 (0.13-0.58)
TLPP @ 1 year
P.M. Kitrou et al. / European Journal of Radiology 84 (2015) 418–423
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TLPP @ 1 year
Group PCB 308 days vs. 161 days Group HPB p=0.0398
Kitrou P et al. Paclitaxel-Coated versus Plain Balloon Angioplasty for Dysfunctional Arterio-Venous Fistulae.One-year Results of a Prospective Randomized Controlled Trial, JVIR, DOI: 10.1016/j.jvir.2014.11.003
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Circuit @ 1 year
Group PCB 270 days vs. Group HPB 161days p=0.04
Kitrou P et al. Paclitaxel-Coated versus Plain Balloon Angioplasty for Dysfunctional Arterio-Venous Fistulae.
One-year Results of a Prospective Randomized Controlled Trial, JVIR, DOI: 10.1016/j.jvir.2014.11.003
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Summary of DCB in dialysisAuthor Katsanos [1,2] Kitrou [3] Patanè [4] Swinnen [5]
Study device IN.PACT IN.PACT IN.PACT IN.PACT
Design Prospective RCT Prospective RCT Prospective Single Arm Prospective Single Arm
Single/Multicenter single center single center single center single center
# patients 40 40 25 37
Anastomosis AVF (14) and AVG(26) AVF AVFAVF ISR
Lesion location Mid-arm Mid-arm Fore-armFore-arm (54%)Mid-arm (46%)
Radiocephalic 5% 2.5% 100% 100%
Primary EP Primary Patency TLR free survival Primary Patency Freedom from TLR:
Results
12-month PP 35% (DCB)vs 5% (PTA) p<0.001
Median Survival234 (DEB) vs. 131 (PTA) days p<0.05
12-month PP 30% (DEB)vs 10% (PTA) p<0.05
Median Survival308 (DEB) vs. 161 (PTA) days p<0.05
12-months patency: 81.8%24-months patency : 57.8%
Freedom from TLR: 69% (DCB) vs 19% (PTA- historical cohort)
1. Katsanos et al. Paclitaxel-Coated Balloon Angioplasty vs. Plain Balloon Dilation for the Treatment of Failing Dialysis Access: 6-Month Interim Results From a
Prospective Randomized Controlled Trial J ENDOVASC THER 2012;19:263–2722. Kitrou et al. Drug-eluting versus plain balloon angioplasty for the treatment offailing dialysis access: Final results and cost-effectiveness analysis from a prospective
randomized controlled trial (NCT01174472) European Journal of Radiology3. Kitrou et al. Paclitaxel-Coated versus PlainBalloon Angioplasty for Dysfunctional Arteriovenous Fistulae: One-Year Results of a Prospective Randomized Controlled
Trial J VascIntervRadiol2015 4. Patanè et al. Drug-eluting balloon for the treatment of failing hemodialytic radiocephalic arteriovenous fistulas: our experience in the treatment of juxta-anastomotic
stenoses, J Vasc Access 2014;5. Swinnen, et al., Paclitaxel drug-eluting balloons to recurrent in-stent stenoses in autogenous dialysis fistulas: a retrospective study, J Vasc Access 2015;
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Summary of DCB in dialysis
Results
12-month PP 35% (DCB)vs 5% (PTA) p<0.001
Median Survival234 (DEB) vs. 131 (PTA) days p<0.05
12-month PP 30% (DEB)vs 10% (PTA) p<0.05
Median Survival308 (DEB) vs. 161 (PTA) days p<0.05
12-months patency: 81.8%24-months patency : 57.8%
Freedom from TLR: 69% (DCB) vs19% (PTA-historical cohort)
1. Katsanos et al. Paclitaxel-Coated Balloon Angioplasty vs. Plain Balloon Dilation for the Treatment of Failing Dialysis Access: 6-Month Interim Results From a
Prospective Randomized Controlled Trial J ENDOVASC THER 2012;19:263–2722. Kitrou et al. Drug-eluting versus plain balloon angioplasty for the treatment offailing dialysis access: Final results and cost-effectiveness analysis from a prospective
randomized controlled trial (NCT01174472) European Journal of Radiology3. Kitrou et al. Paclitaxel-Coated versus PlainBalloon Angioplasty for Dysfunctional Arteriovenous Fistulae: One-Year Results of a Prospective Randomized Controlled
Trial J VascIntervRadiol2015 4. Patanè et al. Drug-eluting balloon for the treatment of failing hemodialytic radiocephalic arteriovenous fistulas: our experience in the treatment of juxta-anastomotic
stenoses, J Vasc Access 2014;5. Swinnen, et al., Paclitaxel drug-eluting balloons to recurrent in-stent stenoses in autogenous dialysis fistulas: a retrospective study, J Vasc Access 2015;
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LUTONIX® 035 AV IDE
Clinical Trial• Prospective, Global,
Multicenter, Randomized,
Safety and Effectiveness
• Objective: to assess the
safety and effectiveness of
the LUTONIX® 035 AV Drug
Coated Balloon PTA
Catheter in the treatment of
dysfunctional AV fistulae
• 284 randomized subjects at
up to 35 clinical sites
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2 ongoing physician- led AVF
RCT using IN.PACT DCB
Study Anatomy Design Patient #
IN.PACT Shunt AVF Multicenter RCT
(DCB v PTA)
150
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9 months
follow up
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6 months
follow up
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AV access ISR
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Patent at 9
months
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DCB BTK• Three single-center, non-core lab
adjudicated trials showed encouraging data
which suggests that DCB in
BTK arteries effectively inhibit the risk of early
restenosis
• The RCT multicenter, core lab adjudicated
trials failed to match with these result.
• Results in the femorheopopliteal region
cannot be transferred to BTK arteries.
• Potential refinement of the technology can
result in improved results in BTK CLI
applications
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DCB BTK
Langhoff et al Promising role of drug-coated balloons in the tibial vessels?
J Cardiovasc surg ( Torino) 2016 Oct;57(5):667-76.
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DES vs DCB in BTK
• Siablis et al.
• 50 pts DES vs DCB
• Lesion length in the DCB group (148±56.7 mm
vs. 127±46.5 mm in the DES group; P=0.14)
• Binary (>50%) angiographic restenosis rate was
significantly lower in the DES arm (7/25 [28%]
vs. 11/19 [57.9%] in DCB arm (P=0.0457)
• TLR did not differ between the groups (2/26
[7.7%] in DES vs. 3/22 [13.6%] in DCB; P=0.65)
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LUTONIX® 014 BTK
Clinical Trial• Active BTK trial in the U.S.
• Prospective, Multicenter, Single Blind,
Randomized– Same as LEVANT 2: both follow-up physician
and core lab blinded
• Study device: LUTONIX® 014 DCB
• Primary Endpoints:– Safety at 30 days
– Limb salvage and primary patency at 6
months
Diameter (mm) Lengths (mm)
2-4 Up to 120
Study Device Offering in
BPV/LTNX/1216/0100
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IN.PACT BTK trial
• IN.PACT 014 is the IN.PACT Admiral platform on the 0.014” GW compatible catheter.
• Different than the previous generation 0.014” platfrom, IN.PACT Amphirion,
• Same coating FreePac coating matrix, (i.e. Urea as the excipient and 3.5ug/mm^2 paclitaxel dose)
• Different balloon bladder polymer and coating process
Study Anatomy Design Patient # Est.
Completion
IN.PACT BTK
RCT
[IN.PACT 014]1
Infrapopliteal
arteries
Multicenter RCT
(DCB v PTA)
60 2020
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ISR
• IN.PACT Global registry in fempop
included 18 % ISR
• Results were superior to PTA, similar to
Denovo lesions
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Trials for Expanded
Indications
• Objective: to demonstrate efficacy and safety
of the LUTONIX® catheter for the treatment
of SFA ISR
• Study device: LUTONIX® 035
LUTONIX®
SFA ISR Trial
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Renal A ISR
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SMA ISR
Two PTA
with DCB 9
months apart
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Two ISR PTA
with DCB 9
months apart
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LSCA ISR
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Benign biliary stricture post OLTCourtesy of Shep Morano VCU
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Future of DCB
• Promising results for DCB in AV access.
Awaiting results of RCT
• Additional RCT for BTK with new
balloon design
• Need to study application in ISR
( visceral , renal , SCA…etc)
• Potential expansion in nonvascular
applications
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Current Status of DCB Experience with Non-
Femoropopliteal Applications (Dialysis, Tibial, Venous)
Saher Sabri, MD
University of Virginia Health System
Charlottesville, Virginia