Current Status of DCB Experience with Non- Femoropopliteal Applications (Dialysis, Tibial, Venous)

Transcription

1 Current Status of DCB Experience with Non- Femoropopliteal Applications (Dialysis, Tibial, Venous) Saher Sabri, MD University of Virginia Health System Charlottesville, Virginia

2 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

3 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

4 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)

5 1 year Target Lesion Primary Patency DCB group 35% Vs 5% PBA group p<0.001 respective HR (95%CI) = 0.27 ( ) P.M. Kitrou et al. / European Journal of Radiology 84 (2015)

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7 1 year Group PCB 308 days vs. 161 days Group HPB p= 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: /j.jvir

8 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: /j.jvir year Group PCB 270 days vs. Group HPB 161days p=0.04

9 Summary of DCB in dialysis Author 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 Anastomosis AVF (14) and AVG(26) AVF AVF Lesion location Mid-arm Mid-arm Fore-arm AVF ISR Fore-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 Survival 234 (DEB) vs. 131 (PTA) days p< month PP 30% (DEB) vs 10% (PTA) p<0.05 Median Survival 308 (DEB) vs. 161 (PTA) days p< 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: 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 (NCT ) European Journal of Radiology 3. Kitrou et al. Paclitaxel-Coated versus PlainBalloon Angioplasty for Dysfunctional Arteriovenous Fistulae: One-Year Results of a Prospective Randomized Controlled Trial J VascIntervRadiol 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;

10 Summary of DCB in dialysis Results 12-month PP 35% (DCB) vs 5% (PTA) p<0.001 Median Survival 234 (DEB) vs. 131 (PTA) days p< month PP 30% (DEB) vs 10% (PTA) p<0.05 Median Survival 308 (DEB) vs. 161 (PTA) days p< months patency: 81.8% 24-months patency : 57.8% Freedom from TLR: 69% (DCB) vs 19% (PTAhistorical 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: 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 (NCT ) European Journal of Radiology 3. Kitrou et al. Paclitaxel-Coated versus PlainBalloon Angioplasty for Dysfunctional Arteriovenous Fistulae: One-Year Results of a Prospective Randomized Controlled Trial J VascIntervRadiol 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;

11 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

12 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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16 9 months follow up

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19 6 months follow up

20 AV access ISR

21 Patent at 9 months

22 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

23 DCB BTK Langhoff et al Promising role of drug-coated balloons in the tibial vessels? J Cardiovasc surg ( Torino) 2016 Oct;57(5):

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25 Siablis et al. DES vs DCB in BTK 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)

26 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 Study Device Offering in Diameter (mm) Lengths (mm) 2-4 Up to 120 BPV/LTNX/1216/0100

27 IN.PACT BTK trial IN.PACT 014 is the IN.PACT Admiral platform on the GW compatible catheter. Different than the previous generation 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)

28 ISR IN.PACT Global registry in fempop included 18 % ISR Results were superior to PTA, similar to Denovo lesions

29 Trials for Expanded Indications LUTONIX SFA ISR Trial Objective: to demonstrate efficacy and safety of the LUTONIX catheter for the treatment of SFA ISR Study device: LUTONIX 035

30 Renal A ISR

31 SMA ISR Two PTA with DCB 9 months apart

32 Two ISR PTA with DCB 9 months apart

33 LSCA ISR

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35 Benign biliary stricture post OLT Courtesy of Shep Morano VCU

36 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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38 Current Status of DCB Experience with Non- Femoropopliteal Applications (Dialysis, Tibial, Venous) Saher Sabri, MD University of Virginia Health System Charlottesville, Virginia