The (Potential) Role of Drug Eluting Balloons in BTK Interventions

Slides:



Advertisements
Similar presentations
Infrapopliteal Sirolimus-Eluting Versus Bare Metal Stents for Critical Limb Ischemia: Long-Term Angiographic and Clinical Outcome in >100 Patients Dimitris.
Advertisements

Drug Coated Balloons From Bench to Bedside Service de Radiodiagnostic et Radiologie Interventionnelle Université de Lausanne Salah D. Qanadli, MD, PhD,
Single Center Experience with Drug Eluting Stents for Infrapopliteal Occlusive Disease in Patients with Critical Limb Ischemia: Mid-term follow up Robert.
Management of distal peripheral vascular disease Cheuk Kwan Yee, Queenie Tuen Mun Hospital.
Superficial Femoral Artery Stents - Bare, Covered, or Drug-Coated – “The Data and The HYPE” Dennis F. Bandyk, MD Division of Vascular & Endovascular Surgery.
Wires, balloons, drug-eluting devices, ect.
Treatment of In-Stent Restenosis by Paclitaxel Coated PTCA Balloons Presented at The American Heart Association Scientific Session 2006 Presented by Dr.
Upendra Kaul, MD for the TUXEDO INDIA Investigators Paclitaxel Eluting Versus Everolimus Eluting Stents in Patients with Diabetes Mellitus and Coronary.
Angelo Cioppa, MD  I have the following potential conflicts of interest to report:  Research contracts  Consulting  Employment in industry  Stockholder.
Slow-rate release polymer-based paclitaxel- eluting stent compared with bare stent in patients with single complex coronary lesions TAXUS V Presented at.
A Prospective, Randomized Trial Evaluating a Paclitaxel-Eluting Balloon in Patients TReated with Endothelial Progenitor Cell CapTuring Stents for De Novo.
Endovascular Treatment of Atherosclerotic Popliteal Artery Lesions – Balloon Angioplasty versus primary Stenting: A prospective, multi-centre, randomised.
Endeavor 4: A Randomized Comparison of a Zotarolimus- Eluting Stent and a Paclitaxel- Eluting Stent in Patients with Coronary Artery Disease Martin B.
A Comparison of the Moxy™ Drug Coated Balloon Catheter vs. Standard PTA for Femoropopliteal Disease NCT# MONTH RESULTS OF THE LEVANT I TRIAL.
The new consensus document on peripheral DCB PTA Bernardo Cortese Intv’ Cardiology, A.O. Fatebenefratelli bernardocortese.com B. Cortese,
UpdateDEB Lesions Learned from the Trials and Daily Clinical Practice Ralf Langhoff, MD Center for Vascular Medicine Berlin-Wilmersdorf St. Gertrauden.
University of Modena and Reggio Emilia Vascular Surgery – Director: prof. Coppi Silingardi R. Veronesi J. Gennai S.
FMRP 2014 | 1 Marc Bosiers Koen Deloose Joren Callaert A.Z. Sint-Blasius, Dendermonde Imelda Hospital, Bonheiden Patrick Peeters Jürgen Verbist OLV Hospital,
D.DELEANU, M.CROITORU BUCHAREST, ROMANIA. BTK Interventions ? BTK disease = claudication and CLI BTK interventions = CLI Main goal of CLI therapy = functional.
Superficial Femoral Artery – Where Does the Data Stand? Director, Endovascular Services Mehdi H. Shishehbor, DO, MPH, PhD Cleveland Clinic.
From: Sustained Safety and Effectiveness of Paclitaxel-Eluting Stents for Femoropopliteal Lesions: 2-Year Follow-Up From the Zilver PTX Randomized and Single-Arm.
Date of download: 9/19/2016 Copyright © The American College of Cardiology. All rights reserved. From: Paclitaxel-Coated Balloon Angioplasty Versus Drug-Eluting.
The angiosome theory to guide revascularization for CLI
November 9, 2015 February 20, 2017 Using real world evidence – industry perspective Pma indication expansion Melissa hasenbank, phd Sr. Clinical Research.
Global Experience with Peripheral DCBs/Stent Studies: C.R. Bard
Clinical Trials and Outcomes with DES in CTO Revascularization
Can Drug-Coated Balloons Work in Synergy with Stent Grafts?
The Invatec Program Features and Clinical Trials
INFRATIBIAL INTERVENTIONS Current Results with DES
Lutonix® Paclitaxel-Coated Balloon to Treat Obstructive Lesions in the Superficial Femoral and Popliteal Arteries Preliminary Six-Month Results from.
DCB for In-Stent Restenosis: Is It Superior to DES?
Heavily calcified SFA lesions do not avoid the use of 4 F systems
Stent Graft for the Treatment of ISR:
Paclitaxel Drug-Coated Balloons for De Novo Lesions
What is the Data for DCB in BTK & What Next?
University-Heart Center Freiburg - Bad Krozingen
Prof. Thomas Zeller Department Angiology
Current Results of Drug Coated Balloons for Infrapopliteal Disease
Harmonized Assessment by Randomized Multicenter Study of OrbusNEich’s COMBO StEnt Japan-USA HARMONEE: Primary Report of A Randomized Trial of a Bioabsorbable.
The Tryton Bifurcation Trial:
Eric J Dippel, MD FACC Davenport, Iowa, USA February 19, 2017
LONG-DES II Trial Randomized Comparison of the Efficacy of Sirolimus-Eluting Stent Versus Paclitaxel-Eluting Stent in the Treatment of Long Native Coronary.
Drug Eluting Balloons Bodo Cremers, MD
TAXUS IV Trial Slow-rate release polymer-based paclitaxel-eluting stent compared with bare stent in patients with single de novo coronary lesions Presented.
DES Should be Used as the Default Stent in ACS!
Instent Restenosis and Occlusion: Time for Surgical Revision?
Insights from the IMPERIAL and MAJESTIC SFA Studies
Drug-Coated Balloons in Peripheral Artery Disease
Regulatory Considerations for Coronary Drug Coated Balloons – FDA View
Are we using fewer Covered Stents for SFA Occlusive Disease?
Stenting of Coronary Arteries in Non Stress/Benestent Disease
Andrew J. Klein, MD, FSCAI Piedmont Heart Institute, Atlanta, GA
AcoArt I Trial design: Patients with femoropopliteal artery disease were randomized to paclitaxel-coated balloon angioplasty (n = 100) vs. standard peripheral.
Giuseppe Biondi Zoccai
American College of Cardiology Presented by Dr. Stephan Windecker
FAIR Trial design: Patients with SFA in-stent restenosis (ISR) were randomized to either a paclitaxel-coated balloon (DCB) (dose 3.5 μg/mm2) or routine.
Drug-Coated Balloons:
REALITY: 8 month results
How and why this study may change my practice ?
3-Year Clinical Outcomes From the RESOLUTE US Study
ILLUMENATE Trial design: Patients with superficial femoral artery (SFA) and/or popliteal arterial stenoses were randomized in a 2:1 fashion to either balloon.
Presented at ACC 2003 Late Breaking Clinical Trials
Randomized comparison of everolimus-eluting versus bare-metal stents in patients with critical limb ischemia and infrapopliteal arterial occlusive disease 
The American College of Cardiology Presented by Dr. Raimund Erbel
Paclitaxel-coated balloon reduces target lesion revascularization compared with standard balloon angioplasty  Nicholas Candy, MBBS, Eugene Ng, MBBS, Ramesh.
ENDEAVOR II Five-Year Clinical Follow-up
The United States StuDy for EvalUating EndovasculaR TreAtments of Lesions in the Superficial Femoral Artery and Proximal Popliteal By usIng the Protégé.
American College of Cardiology Presented by Dr. Adnan Kastrati
The American College of Cardiology Presented by Dr. A. Abazid
TYPHOON Trial Trial to Assess the Use of the Cypher Stent in Acute Myocardial Infarction Treated with Balloon Angioplasty (TYPHOON) Trial Presented at.
Presentation transcript:

The (Potential) Role of Drug Eluting Balloons in BTK Interventions Thomas Zeller, MD

Faculty Disclosure Thomas Zeller, MD For the 12 months preceding this presentation, I disclose the following types of financial relationships: Honoraria received from: Abbott Vascular, Bard Peripheral Vascular, Veryan, Biotronik, Boston Scientific Corp., Cook Medical, Cordis Corp., Covidien, Gore & Associates, Medtronic, Spectranetics, Straub Medical, TriReme, VIVA Physicians Consulted for: Abbott Vascular, Bard Peripheral Vascular, Boston Scientific Corp., Cook Medical, Gore & Associates, Medtronic, Spectranetics Research, clinical trial, or drug study funds received from: 480 biomedical, Bard Peripheral Vascular, Veryan, Biotronik, Cook Medical, Cordis Corp., Covidien, Gore & Associates, Abbott Vascular, Medtronic, Spectranetics, Terumo, TriReme, Volcano

DEB are not yet indicated in clinical routine Further Research needed! Why?

Conflicting Evidence DEBATE BTK vs. IN.PACT Deep Journal of the American College of Cardiology 2014. 64;15:1568-76 Drug-Eluting Balloon Versus Standard Balloon Angioplasty for Infrapopliteal Arterial Revascularization in Critical Limb Ischemia 12 Month Results From the IN.PACT DEEP Randomized Trial Thomas Zeller, Iris Baumgartner, Dierk Scheinert, Marianne Brodmann, Marc Bosiers, Antonio Micari, Patrick Peeters, Frank Vermassen, Mario Landini, David B. Snead, K. Craig Kent, Krishna J. Rocha-Singh, IN.PACT DEEP Trial Investigators Circulation Drug-Eluting Balloon in peripherAl inTErvention for Below The Knee Angioplasty Evaluation (DEBATE-BTK): A Randomized Trial in Diabetic Patients with Critical Limb Ischemia Single-Center Randomized Trial 132 Patients CLI: 100%, Diabetes: 100% Average lesion length: 13 cm CTO: 80% IN.PACT™ Amphirion™ vs. PTA ™ Liistro F et al. Drug-eluting balloon in peripheral intervention for below the knee angioplasty evaluation (DEBATE-BTK): a randomized trial in diabetic patients with critical limb ischemia. Circulation. 2013 Aug 6;128(6):615-21 T. Zeller LINC 2014 & Zeller et al. JACC 2014

Binary Restenosis (BR) and Clinically Driven TLR (CD-TLR) IN.PACT Deep 12-month Freedom from Major Amputation, Binary Restenosis Rate, TLR Rate & LLL 12-month Binary Restenosis (BR) and Clinically Driven TLR (CD-TLR) 12-month Late Lumen Loss 0.605 ± 0.775 0.616 ± 0.781 Zeller T. et al. JACC 2014

IN.PACT DEEP vs. CLI literature Lowest Restenosis, TLR and Major Amputation in both arms IN.PACT DEEP [1] Rocha-Singh KJ et al. Catheter Cardiovasc Interv. 2012 Nov 15;80(6):1042-51; [2] Bosiers M LINC 2011; [3] Zeller T. LINC 2011; [4] Scheinert LINC 2011 «amputations» [1] Lejay A et al. Acta Chir Belg. 2009; [2] Romiti M et al. J Vasc Surg. 2008; [3] Adam DJ et al. Lancet. 2005; [4] Rocha-Singh KJ et al. Catheter Cardiovasc Interv. 2012; [5] Scheinert D et al. JACC 2012; [6] Iida et al. EJVEVS 2012

DCB-BTK Evidence: DCB vs. DES 50-patients (CLI + IC) RCT of IN.PACT Amphirion vs. DES Lesion length: 14.8 (DCB) vs. 12.7 (DES) (p=0.330) Key findings (DCB vs. DES) at 6-month: Binary restenosis: 58% vs. 28% (p=0.0457) LLL: 1.35±0.2 vs. 1.15±0.3 (p=0.62) >50% restenosis length (cm): 4.3±1.6 vs. 3.6±1.5 (p=0.16) TLR: 14.3% vs. 7.4 (p=0.21) (P.M. Kitrou, MD, PhD – CIRSE 2013, LINC 2014)

DEB-BTK - Negative Evidence: BIOLUX P II 72-patients (CLI + IC) RCT of Passeo-18 Lux vs. PTA 12-month CD-TLR Rates: 30.1% (DCB) vs. 30.6% (PTA) (p=0.805) 12-month Loss of Primary Patency 49.2% (DCB) vs. 45.6% (PTA) (p=0.908) Event Rate: TLR Lesions 0.0% 20% 40% 60% 80% 100% Time to Event (days) 365 uncoated DRB Event Rate: Patency loss 0.0% 20% 40% 60% 80% 100% Time to Event (days) 365 uncoated DCB Amputation target extremity Major 8/ 23.7 [12.6,42.0] 1/ 3.3[0.5,21.4] 9/ 25.8 [ 14.3, 43.9] 2/ 5.6 [1.4,20.7] 0.975 0.631 Zeller T et al., JACC CCI 2015

Why do we need deb in btk interventions?

In CLI most BTK lesions are longer than 10cm Bare metal stents did fail to show a benefit over PTA

Ferraresi R, LINC 2016

In CLI most BTK lesions are longer than 10cm Bare metal stents did fail to show a benefit over PTA No dedicated DES for BTK use are yet commercially available and clinically tested Appropriate length, at least 8cm for balloon expandable stents Drug eluting nitinol stents not yet tested below the knee Are stents the right choice for long distant BTK lesions extending to the foot? DEB are the optimal treatment tool for long BTK lesions an din particular foot arteries

Why do we need deb in btk interventions? Because Patency matters!

Ferraresi R, LINC 2016

Liistro F et al. Drug-eluting balloon in peripheral intervention for below the knee angioplasty evaluation (DEBATE-BTK): a randomized trial in diabetic patients with critical limb ischemia. Circulation. 2013 Aug 6;128(6):615-21

Ulcer Healing & Ambulation and Vessel Patency

Vermassen F, LINC 2016

Vermassen F, LINC 2016

Background of Pedal Artery Interventions Due to the small vessel diameters and extensive external forces exposed to the distal tibial and pedal arteries stents in particular DES are no option for improving durability of the procedure. Thus, DEB is an interesting choice.

Wound Healing & Preserved Pedal Arch

NO DCB Class Effect?! results awaited IN.PACT DEEP failure applies to IN.PACT Amphirion only. Each DCB stands on the merits of its own data 480-patient RCT of Lutonix DCB vs. PTA in BTK-CLI results awaited Marianne Brodmann LINC 2014

DEB in BTK Interventions Summary I Early DCB-BTK evidence showed high promise for IN.PACT Amphirion to reduce restenosis and reintervention rates at 3 and 12 months vs. PTA Significantly higher restenosis rates reported for IN.PACT Amphirion vs. DES vs. in BTK lesions with length 1315 cm Inpact Deep is the largest BTK-CLI Trial completed to date Failed to demonstrate superior treatment effect of IN.PACT Amphirion vs. PTA Met primary safety endpoint; safety signal detected with a trend toward higher major amputation rate in the DCB arm No significant difference primary patency with Passeo 18 Lux DEB vs. PTA at 12-month FU underpowered study No difference in amputation rates No major differences in hard clinical outcomes across all studies between any DCB and control

DEB in BTK Interventions Summary II Further research on the efficacy of DEB in tibial arteries is mandatory 1. step: Due to potential safety concerns regarding the cytotoxic drug paclitaxel efficacy studies should include claudicants only, no wounds Angiographic primary endpoint, e.g. LLL, binary restenosis 2. step: clinical endpoint driven CLI study after confirmation of biological efficacy of paclitaxel eluting DEB in tibial arteries Alternative exipients resulting in higher drug uptake of paclitaxel Reduction of overall drug dose (paclitaxel) Alternative antiproliferative, non-toxic drugs in CLI patients “Limus” drugs

DEB in BTK Interventions Summary III For foot arteries and distal tibial arteries DEB need a coronary balloon like profile DEB coating must be hydrophilic High friction of the drug coating in small & calcified arteries The combination of atherectomy and DEB should be considered in calcified BTK lesions To reduce friction To reduce recoil To potentially improve drug uptake / wall persistance