Current Status of DCB Experience with Non-

Femoropopliteal Applications (Dialysis, Tibial, Venous)

Saher Sabri, MD

University of Virginia Health System

Charlottesville, Virginia

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

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

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)

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

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

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

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;

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;

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

2 ongoing physician- led AVF

RCT using IN.PACT DCB

Study Anatomy Design Patient #

IN.PACT Shunt AVF Multicenter RCT

(DCB v PTA)

150

9 months

follow up

6 months

follow up

AV access ISR

Patent at 9

months

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

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.

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)

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

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

ISR

• IN.PACT Global registry in fempop

included 18 % ISR

• Results were superior to PTA, similar to

Denovo lesions

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

Renal A ISR

SMA ISR

Two PTA

with DCB 9

months apart

Two ISR PTA

with DCB 9

months apart

LSCA ISR

Benign biliary stricture post OLTCourtesy of Shep Morano VCU

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

Attend the conference live

from your computer!

The latest vascular monthly

news in your inbox!

September 11 – 14, 2017at Wynn Las Vegas, Nevada, U.S.A.

@VIVAPhysicians

Visit Table top #6 for more information.

Current Status of DCB Experience with Non-

Femoropopliteal Applications (Dialysis, Tibial, Venous)

Saher Sabri, MD

University of Virginia Health System

Charlottesville, Virginia