Disclosures. Consultant/Independent Contractor: B Braun, Teleflex, MedComp, Cook, Bard, WL Gore Royalty: Cook, Teleflex
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1 Disclosures Consultant/Independent Contractor: B Braun, Teleflex, MedComp, Cook, Bard, WL Gore Royalty: Cook, Teleflex
2 DCB in Hemodialysis Access Scott Trerotola, MD
3 2016: 50 th birthday of the AVF
4 History of Therapeutic Interventions for Hemodialysis Access 51 Years
5 Restenosis Acute gain: PTA elastic recoil Late loss: Intimal hyperplasia Stent devices can maximize acute gain Drug coating can minimize late loss Drug coated stent does both Graphic c/o Lutonix
6 PTA in Dialysis Circuits Some elastic recoil Manageable with prolonged PTA Exuberant restenosis Stent graft uses barrier approach DCB uses chemical approach Inhibit SMC migration UoAWoVChMI7q7Wq4idyAIVCVQ-Ch2dDAmg#tbm=isch&q=smooth+muscle+cell+migration+restenosis&imgrc=5z5IVp0SPMAPuM%3A
7 Will DCB Work? DCB will not help elastic recoil DCB will help with restenosis, theoretically without candy-wrapper effect DCB avoids leaving metal/plastic behind Image courtesy of Lutonix
8 Downsides to Metallic Devices Fracture Embolization Skin erosion Restenosis Infection in cannulation zones Jailing of viable future access sites Cost
9 Good place for a stent? Or worse, a stent graft? LIJ patent and usable. POBA
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12 16.3% infection leading to excision Intragraft stent infection higher than elsewhere 26.9% vs 6.9%, P>0.001
13
14 Evidence in DCB-refreshing RCT Cohort studies Case-control studies Case series Single case reports Ideas, opinions Animal research In vitro research
15 Author Type Results Paclitaxel drug-eluting balloons to recurrent in-stent stenosis in autogenous dialysis fistulas: a retrospective study Swinnen et al. Journal Vascular Access (2015) epub Paclitaxel-Coated Balloon Angioplasty for Symptomatic Central Vein Restenosis in Patients with Hemodialysis Fistulas Massmann et al. Journal of Endovascular Therapy 2015; 22: Drug-Eluting Balloon for the Treatment of Failing Hemodynamic Radiocephalic Arteriovenous Fistulas: Our Experience in the Treatment of Juxta-Anastomotic Stenoses Patanè D et al. J Vasc Access 2014 epub Retrospective n=37 Retrospective n=27 Retrospective n=26 12 Month 0% Reintervention 19% with POBA 69% with DCB Restenosis Intervals 4 Months POBA 9 Months DCB 96% 6 Month TLPP 91% 12 Month TLPP
16 Author Type Results Percutaneous Angioplasty Using a Paclitaxel-Coated Balloon Improves Target Lesion Restenosis on Inflow Lesions of Autogenous Radiocephalic Fistulas: A Pilot Study Lai et al. JVIR 2014: 25: Paclitaxel-Coated vs. Plain Balloon Angioplasty for Dysfunctional Arteriovenous Fistulae: One-Year Results of a Prospective Randomized Controlled Trial Kitrou et al. JVIR 2015;26: 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 Katsanos et al. J Endovasc Ther 2012;19: RCT N=10 (20 lesions) AVF RCT n=40 AVF RCT n=40 Grafts+AVF TLR 251 days DCB 103 days POBA TLPP at 6 (p<0.01) and 12 months (P=NS) 70%, 20% DCB 0%, 0% POBA TLR-free survival 308 days DCB vs 161 days POBA (p=0.03) ACPP 270 days DCB vs 161 (p=0.04) 70% TLPP at 6 months DCB 25% TLPP at 6 Months POBA (P<0.001)
17 Author Type Results Drug-eluting versus plain balloon angioplasty for the treatment of failing dialysis access: Final results and cost-effectiveness analysis from a prospective randomized controlled trial Kitrou et al, Eur J Radiol 2015;84: Paclitaxel-coated balloons for the treatment of symptomatic central venous stenosis in dialysis access: Results from a randomized controlled trial Kitrou et al, JVIR 2017;28: RCT n=40 Grafts+AVF RCT n=40 19 AVF/21 G 35% TLPP at 12 months DCB 5% TLPP at 12 months POBA (P<0.001) Median intervention free patency better for DCB 179 vs 125 days P=0.026
18 More to come! PAVE (RCT-UK, M. Robson) DCB in cephalic arch restenosis (RCT-Israel, A. Verstandig, NCT ) APERTO (RCT-Netherlands, P. Pattynama, NCT ) DEBEFF (RCT-Saudi Arabia, N. Haq, NCT ) FISBAL (RCT-Spain, M. Vargas, NCT ) ABISS (RCT-France, R. Coscas, NCT ) FAVABED (RCT-France, J-F Heautot, NCT ) DEB (RCT-Canada, E. Therasse, NCT ) IN.Pact AV access trial (RCT, A Holden, R Lookstein) Lutonix AV (RCT-US, S. Trerotola, NCT ) DEBAPTA (RCT-Singapore, F. Irani, NCT )
19 Lutonix AV Clinical Trial A Prospective, Global, Multicenter, Randomized, Controlled Study Comparing LUTONIX 035 AV Drug Coated Balloon PTA Catheter vs. Standard Balloon PTA Catheter for the Treatment of Dysfunctional AV Fistulae
20 Lutonix AV Clinical Trial Study Design Study Design Objective Number of Patients/Sites Primary Effectiveness Endpoint Primary Safety Endpoint Follow Up Status Prospective, Global, Multicenter, Randomized, Core lab Blinded, Safety and Effectiveness To assess the safety and effectiveness of the LUTONIX 035 AV Drug Coated Balloon PTA Catheter in the treatment of dysfunctional AV fistulae 285 randomized subjects at 23 clinical sites Target Lesion Primary Patency (TLPP) - 6 months Freedom from any serious adverse event(s) involving the AV access circuit through 30 days 1, 3, 6, 9, 12, 18, 24 month visits First Subject: June 2015 Enrollment Completion: March 2016
21 Lutonix AV Clinical Trial Study Design
22 Lutonix AV Clinical Trial Primary Safety 18 Months Interim LTX DCB (N=141) Standard PTA (N=144) Difference % (95% CI) P-value 545 Day Event Free Rate (SE) 34.3% (4.7%) 22.6% (4.4%) 11.6% (6.4%) 95% CI (25.3%, 43.5%) (14.7%, 31.6%) (-0.9%, 24.2) *one-sided p-value 95% CI of the rate and the rate difference at each time point were calculated based on normal approximation and one-sided p-value is from test for non-inferiority, with 10% as non-inferiority margin..
23 Lutonix AV Clinical Trial Target Lesion Primary Patency 6 Months P=0.024* LTX DCB (N=141) Standard PTA (N=144) Difference % (95% CI) P-value 180 Day Event Free Rate (SE) 71.4% (4.0%) 63.0% (4.1%) 8.4% (5.7%) 95% CI (62.7%, 78.4%) (54.4%, 70.4%) (-2.8%, 19.6%) 210 Day Event Free Rate (SE) 64.1% (4.3%) 52.5% (4.3%) 11.6% (60%) 95% CI (55.1%, 71.8%) (43.9%, 60.5%) (-0.2%, 23.4%) *one-sided p-value *one-sided p-value
24 Lutonix AV Clinical Trial Summary First and only approved drug coated balloon for AV fistulae in US Safety outcomes are non-inferior to PTA 71.4% target lesion primary patency (TLPP) at 6 months 32.6% fewer number of interventions required to maintain TLP at 6 months Sustained effectiveness benefit 36.8% improvement in primary patency over PTA at 18 months
25 Some new things to learn Geographic miss Longer is better Contact time Longer is better Transit time Shorter is better Compliant balloons (old new) Goldilocks inflation
26 DCB in HD-Here to stay New approach to restenosis in HD Evidence mounting More yet to come Immature fistulae Candy-wrapper lesions Clotted fistulae CVS
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