Real PTX RCT: 3 year data from a randomized comparison of DCB vs. DES in femoropopliteal lesions
|
|
|
- Solomon Booker
- 6 years ago
- Views:
Transcription
1 Real PTX RCT: 3 year data from a randomized comparison of DCB vs. DES in femoropopliteal lesions Dierk Scheinert, MD Department of Angiology University of Leipzig, Germany
2 Disclosure Dierk Scheinert, MD Advisory Board /Consultant: Abbott, Biotronik, Boston Scientific, Cook Medical, Cordis, CR Bard, Gardia Medical/Allium, Medtronic, TriReme Medical, Trivascular, Upstream Peripheral Technologies
3 Study Design Prospective, multicenter (5 centers in Europe), randomized, controlled trial Zilver PTX drug eluting stent vs drug coated ballon (1:1) in native femoropopliteal disease Investigator initiated: PI Prof. D. Scheinert, Germany N= 150 patients, 75 in each group Stratification for lesion length for both groups (1:1:1) short: 10 cm middle: > 10 and 20 cm long: > 20 and 30 cm Mean lesion length: ± 88.2 mm Independend core-lab assessment for angio and duplex
4 Study Design Follow up: Endpoints 3 Years Primary: Primary 12 Month (Duplex) Secondary: Procedural sucess Mayor Adverse Event (Mayor Amputation; Death or TLR within 30 days) Primary 24, 36 Month Clinically driven target lesion revascularisation (TLR) ABI, Improvement in Rutherford Categories, Assessment of walking capacity (WIQ) Mortality
5 Patient Flow Chart DEB (n=75) Randomized and stratified (n=150) DES (n=75) Short (n=25) Mid (n=26) Long (n=24) Short (n=25) Mid (n=24) Long (n=26) death = 5, withdrawal = 2, missed visit = 1 6 MFU (n=132) death = 2, withdrawal = 6, lost = 1, missed visit = 1 withdrawal =2, missed visit= 4 12 MFU (n=122) withdrawal = 5, missed visit = 1 death = 3, withdrawal = 6, lost = 1 24 MFU(n=113) withdrawal =4 Withdrawal = MFU(n=94) Death =1; withdrawal=7; Follow up too late=1
6 Patient Characteristics DCB (n=75) ZilverPTX (n=75) p-value Age in years (± SD) 68.2 ± ± Gender (male %) BMI, mean (± SD) 26.5 ± ± Myocardial Infarction, n (%) 11 (14.7) 9 (12) 0.6 Heart Failure, n (%) 6 (8.0) 1 (1.3) 0.1 Cerebral Vascular Disease, n (%) 12 (16.0) 9 (12.0) 0.6 Hyperlipidemia, n (%) 51 (68.0) 56 (74.7) 0.3 Hypertension, n (%) 59 (78.7) 61 (81.3) 0.9 Renal Insufficiency, n (%) 16 (21.3) 14 (18.6) 0.8 Smoking, n (%) 0.5 Current, n (%) 32 (42.7) 29 (38.7) Previous, n (%) 22 (29.3) 29 (38.7) Diabetes, n (%) 25 (34.7) 23 (30.7) 0.7 Type 1, n (%) 1 (1.3) 1 (1.3) Type 2, n (%) 24 (32.0) 22 (29.3) Claudication (RC 2-3), n (%) 67 (89.3) 63 (84.0) 0.5 Critical limb ischemia (RC 4-5), n (%) 8 (10.7) 12 (16.0) Data are given as mean±std or number (%).
7 Lesion Characteristics DEB (n=75) ZilverPTX (n=75) p-value Target lesion length, mm ± ± Diameter stenosis 87.4 ± ± Chronic total occlusions 40 (53.3) 39 (52.0) 0.9 Popliteal involvement 15 (20.0) 12 (16.0) 0.5 Lesion calcification 0.5 None/mild 41 (54.7) 28 (37.3) Moderate/Mod. Severe/Severe 34 (45.3) 47 (62.7) Procedural Outcome DEB (n=75) ZilverPTX (n=75) p-value Bailout Stenting CoreLab 19 (25.3) NA Dissection 54 (72.0) 29 (38.7) < Type A/B 19 (25.3) 11 (14.7) Type C-F 35 (46.7) 18 (24.0) Complication Embolic event 4 (5.3) 1 (1.3) AV-Fistel (local) 6 (8.0) 2 (2.7) Target Vessel Perforation 1 (1.3) 0 Data are given as mean±std or number (%).
8 Primary 36 months months ITT ZilverPTX Follow 1 year 2 years 3 years DCB KM estimates ±SE ZilverPTX 0.79± ± ±0.07 DCB 0.80± ± ±0.07 Days Days No@Risk ZilverPTX DCB
9 Primary 36 months ZilverPTX vs DCB only vs DCB plus Stent ZilverPTX Follow 1 year 2 years 3 years KM estimates ±SE ZilverPTX 0.79± ± ±0.07 DCB only 0.82± ± ±0.08 DCB/Stent 0.74± ± ±0.12 DCB only DCB/Stent Days Days No@Risk ZilverPTX DCB only DCB/Stent
10 Primary 36 months Stratification for lesion length - ITT Short lesions Middle lesions Long lesions Follow KM estimates ±SE Follow KM estimates ±SE Follow KM estimates ±SE 1 years ZilverPTX 0.90±0.07 DCB 0.91± years ZilverPTX 0.84±0.09 DCB 0.81± years ZilverPTX 0.77±0.09 DCB 0.64± years ZilverPTX 0.85±0.08 DCB 0.80± years ZilverPTX 0.66±0.12 DCB 0.49± years ZilverPTX 0.45±0.13 DCB 0.19± years ZilverPTX 0.64±0.10 DCB 0.79± years ZilverPTX 0.48±0.10 DCB 0.70± years ZilverPTX 0.43±0.10 DCB 0.33±0.11
11 Primary 36 months - ITT in middle and long lesions >10cm ZilverPTX Follow 1 year 2 years 3 years KM estimates ±SE ZilverPTX 0.74± ± ±0.08 DCB 0.74± ± ±0.07 DCB Days Days No@Risk ZilverPTX DCB
12 Primary 36 months PP ZilverPTX vs DCB only in middle and long lesions >10cm ZilverPTX Follow 1 year 2 years 3 years KM estimates ±SE ZilverPTX 0.74± ± ±0.08 DCB only 0.75± ± ±0.09 DCB only Days Days No@Risk ZilverPTX DCB only
13 Conclusion No significant difference between DCB and DES in Primary 1 year Long-term trend showing better durability of DES treatment at 2 and 3 years Equal performance of DCB and DES in short lesions up to 10 cm Increased benefit of DES in lesions >10cm in comparison to DCB treatment Vessel preparation is mandatory for both DCB and DES particularly in complex lesions! Pilot trial not powered to show statistical significance
14 Real PTX RCT: 3 year data from a randomized comparison of DCB vs. DES in femoropopliteal lesions Dierk Scheinert, MD Department of Angiology University of Leipzig, Germany
COMPARE-Pilot RCT: 1-year results of a randomised comparison of RANGER DCB vs. IN.PACT DCB in complex SFA lesions. Dierk Scheinert
COMPARE-Pilot RCT: 1-year results of a randomised comparison of RANGER DCB vs. IN.PACT DCB in complex SFA lesions Dierk Scheinert Department of Angiology University Hospital Leipzig, Germany Disclosure
Dierk Scheinert, MD. Department of Angiology University Hospital Leipzig, Germany
The RANGER clinical trial programme: 12-month results from the RANGER RCT and first look at the COMARE I study of RANGER vs. IN.PACT for femoropopliteal lesions Dierk Scheinert, MD Department of Angiology
Latest Insights from the LEVANT II study and sub-group analysis
Latest Insights from the LEVANT II study and sub-group analysis Prof. Dr. med. Dierk Scheinert Division of Interventional Angiology University-Hospital Leipzig, Germany Conflicts of Interest Advisory Board
Long-term results with interwoven nitinol stents vs. BMS vs. DCB
Long-term results with interwoven nitinol stents vs. BMS vs. DCB Dierk Scheinert, MD Division of Interventional Angiology University Hospital Leipzig, Germany Disclosure Advisory Board /Consultant: Abbott,
The Illumina FIH study with a next generation DES 12-months results
The Illumina FIH study with a next generation DES 12-months results Dierk Scheinert, MD Head of Medical Department V - Angiology University of Leipzig Medical Center, Germany Disclosure Dierk Scheinert,
Rotarex mechanical thrombectomythe first line option for thrombotic occlusions?
Rotarex mechanical thrombectomythe first line option for thrombotic occlusions? Dierk Scheinert, MD Division of Interventional Angiology University Hospital Leipzig, Germany Disclosure Advisory Board /Consultant:
Update on the Levant 2 Clinical Trial Programme. Dierk Scheinert, MD University Hospital Leipzig Leipzig, Germany
Update on the Levant 2 Clinical Trial Programme Dierk Scheinert, MD University Hospital Leipzig Leipzig, Germany Disclosure Speaker name: Dierk Scheinert I have the following potential conflicts of interest
Rotarex mechanical debulking: The Leipzig experience in patients
Rotarex mechanical debulking: The Leipzig experience in 1.200+ patients Dierk Scheinert, MD Division of Interventional Angiology University-Hospital Leipzig, Germany Disclosure Speaker name: Dierk Scheinert
Lutonix DCB in BTK Update on the BTK real world registry and RCT
Lutonix DCB in BTK Update on the BTK real world registry and RCT Prof. Dr. med. Dierk Scheinert Department of Interventional Angiology University Hospital Leipzig Disclosures Speaker: Prof. Dr. med. Dierk
Update on the Ranger clinical trial programme
Update on the Ranger clinical trial programme Dierk Scheinert, MD Universitätsklinikum Leipzig, Leipzig, Germany on behalf of the RANGER SFA investigators Disclosure Speaker s name: Dierk Scheinert I have
Alternative concepts for drug delivery in BTK arteries the LIMBO project
Alternative concepts for drug delivery in BTK arteries the LIMBO project Dierk Scheinert, MD Division of Interventional Angiology University Hospital Leipzig, Germany 1 Disclosure Speaker s name: Dierk
Do we really need a stent in long SFA lesions? No: DEB is the answer
Do we really need a stent in long SFA lesions? No: DEB is the answer Thomas Zeller, MD University Heart-Center Freiburg-Bad Krozingen Bad Krozingen Germany My Disclosures: Advisory Board: Medtronic-Invatec,
Michael K. W. Lichtenberg, MD, FESC Westfälische Wilhelms-Universität Münster. Dierk Scheinert, M.D. Universitätsklinikum Leipzig AöR
Michael K. W. Lichtenberg, MD, FESC Westfälische Wilhelms-Universität Münster Dierk Scheinert, M.D. Universitätsklinikum Leipzig AöR Disclosure Dierk Scheinert, MD Advisory Board /Consultant: Abbott, Biotronik,
EffPac - Trial: Assessment of the Effectiveness of DCB versus POBA in the SFA Ulf Teichgräber, MD, MBA
EffPac - Trial: Assessment of the Effectiveness of DCB versus POBA in the SFA Ulf Teichgräber, MD, MBA Leipzig, 24.01.2017 Prof. Dr. Ulf Teichgräber - LINC 2017 2 Disclosure of conflict of interest Speaker
Novel concept for drug delivery in infrapopliteal arteries The LIMBO trial
Novel concept for drug delivery in infrapopliteal arteries The LIMBO trial Prof. Dr. med. Dierk Scheinert Division of Interventional Angiology University Hospital Leipzig, Germany 1 Disclosure Advisory
Drug-Coated Balloon Treatment for Patients with Intermittent Claudication: Insights from the IN.PACT Global Full Clinical Cohort
Drug-Coated Balloon Treatment for Patients with Intermittent Claudication: Insights from the IN.PACT Global Full Clinical Cohort a.o. Univ. Prof. Dr. Marianne Brodmann Medical University of Graz Graz,
Outcomes Of DCB Use In Real World Registries: 2 Year Results From The INPACT Global Registry
Outcomes Of DCB Use In Real World Registries: 2 Year Results From The INPACT Global Registry Marianne Brodmann, MD Head of the Clinical Division of Angiology Department of Internal Medicine Medical University
Promise and limitations of DCB in long lesions What Have we Learned from Clinical Trials? Ramon L. Varcoe, MBBS, MS, FRACS, PhD
Promise and limitations of DCB in long lesions What Have we Learned from Clinical Trials? Ramon L. Varcoe, MBBS, MS, FRACS, PhD Associate Professor of Vascular Surgery University of New South Wales Sydney,
The ZILVERPASS study a randomized study comparing ZILVER PTX stenting with Bypass in femoropopliteal lesions
The ZILVERPASS study a randomized study comparing ZILVER PTX stenting with Bypass in femoropopliteal lesions Dr. Sven Bräunlich Department of Angiology University-Hospital Leipzig, Germany Disclosure Speaker
Final Results of the Feasibility Study for the Drug-coated Chocolate Touch PTA balloon. (The ENDURE Trial)
Final results of the feasibility study for the drug-coated Chocolate Touch PTA balloon of of femoropopliteal Femoropopliteal lesions lesions: (The ENDURE Trial) Final Results of the Feasibility Study for
The Lutonix BTK Clinical Trial Programme: Status Update and Real World Clinical Experience
The Lutonix BTK Clinical Trial Programme: Status Update and Real World Clinical Experience Dierk Scheinert, MD University Hospital Leipzig Leipzig, Germany Disclosure Speaker name: Dierk Scheinert I have
Is a Stent or Scaffold Necessary in The SFA?
1 2 3 Is a Stent or Scaffold Necessary in The SFA? Stents were developed to optimize acute results after angioplasty Specifically, stents are universally accepted to manage flow limiting dissections and
12-month Outcomes of Post Dilatation in the IN.PACT Global CTO Cohort. Gunnar Tepe, MD RodMed Clinic Rosenheim Rosenheim, Germany
12-month Outcomes of Post Dilatation in the IN.PACT Global CTO Cohort Gunnar Tepe, MD RodMed Clinic Rosenheim Rosenheim, Germany Disclosure Speaker name: Gunnar Tepe I have the following potential conflicts
The drug-eluting balloon superficial femoral artery-long study THE DEB SFA-LONG STUDY
The drug-eluting balloon superficial femoral artery-long study THE DEB SFA-LONG STUDY Safety and efficacy of the Drug Eluting Balloon (DEB) for the treatment of the Superficial Femoral Artery (SFA) ischemic
6-month 0utcomes of a Novel Sirolimus Coated DCB Technology Evaluated in SFA Thomas Zeller, MD University Heart Center Freiburg-Bad Krozingen
First Report of the SELUTION Trial: 6-month 0utcomes of a Novel Sirolimus Coated DCB Technology Evaluated in SFA Thomas Zeller, MD University Heart Center Freiburg-Bad Krozingen On behalf of the SELUTION
The latest generation DEB
The latest generation DEB V. Riambau, MD. PhD Prof. and Chief of Vascular Surgery Division, Cardiovascular Institute, Hospital Clínic of Barcelona University of Barcelona Consultant: Bolton Medical/ Medtronic/
The ZILVERPASS study a randomized study comparing ZILVER PTX stenting with Bypass in femoropopliteal lesions Preliminary report
The ZILVERPASS study a randomized study comparing ZILVER PTX stenting with Bypass in femoropopliteal lesions Preliminary report G. Biro, M. Bosiers on behalf of ZILVERPASS Study Group Disclosure Speaker
The drug-eluting balloon superficial femoral artery-long study THE DEB SFA-LONG STUDY
The drug-eluting balloon superficial femoral artery-long study THE DEB SFA-LONG STUDY Safety and efficacy of the Drug Eluting Balloon (DEB) for the treatment of the Superficial Femoral Artery (SFA) ischemic
Contemporary use of DCBs, Ranger clinical trial and investigator sponsored research
Contemporary use of DCBs, Ranger clinical trial and investigator sponsored research Dierk Scheinert, MD Division of Interventional Angiology University-Hospital, Leipzig, Germany IMPORTANT INFORMATION:
Could a combination of DCB + stent be the answer in complex SFA lesions
Could a combination of DCB + stent be the answer in complex SFA lesions Sven Bräunlich, MD Division of Interventional Angiology University-Hospital Leipzig, Germany Disclosure Speaker name: Sven Bräunlich
Final Results of the Feasibility Study for the Drug-coated Chocolate Touch PTA balloon. (The ENDURE Trial)
Final results of the feasibility study for the drug-coated Chocolate Touch PTA balloon of of femoropopliteal Femoropopliteal lesions lesions: (The ENDURE Trial) Final Results of the Feasibility Study for
Endovascular Therapy vs. Open Femoral Endarterectomy Rationale and Design of the Randomized PESTO Trial
Endovascular Therapy vs. Open Femoral Endarterectomy Rationale and Design of the Randomized PESTO Trial Prof. Thomas Zeller, MD Department Angiology Clinic for Cardiology and Angiology II University Heart-Center
LUTONIX DCB in BTK Update on the BTK clinical program & single center experience
LUTONIX DCB in BTK Update on the BTK clinical program & single center experience Prof. Dr. med. Dierk Scheinert Department of Interventional Angiology University Hospital Leipzig Disclaimer 1. The information
TOBA Trial 12 months Results
Tack Optimized Balloon Angioplasty: TOBA Trial 12 months Results New Paradigm for Managing Post PTA Dissections Marc Bosiers, MD A.Z. St. Blasius Hospital, Belgium Disclosure Speaker name: Dr. Marc Bosiers
New approaches for drug delivery in BTK arteries
New approaches for drug delivery in BTK arteries Dierk Scheinert, MD Department of Angiology University of Leipzig, Germany Disclosure Dierk Scheinert, MD Advisory Board /Consultant: Abbott, Bayer, Boston
DCB level 1 evidence review
DCB level 1 evidence review Raphaël COSCAS Vascular Surgery Department Ambroise Paré Hospital, AP-HP and Paris-Ouest University Boulogne-Billancourt, France Disclosure Speaker name: Raphael COSCAS I have
RANGER SFA REGISTRY Interim Analysis. Bernd Gehringhoff, MD On behalf the Ranger SFA Registry Investigators
RANGER SFA REGISTRY Interim Analysis Bernd Gehringhoff, MD On behalf the Ranger SFA Registry Investigators Conflict of Interest - Disclosure Within the past 12 months, I or my spouse/partner have had a
Making BTK Interventions more Durable: Are DES and DCB the answer? Thomas Zeller, MD
Making BTK Interventions more Durable: Are DES and DCB the answer? Thomas Zeller, MD Faculty Disclosure Thomas Zeller, MD For the 12 months preceding this presentation, I disclose the following types of
Michael K.W. Lichtenberg, MD
Ranger All-Comer Registry Treatment of femoropopliteal atherosclerotic lesions using the Drug eluting Balloon Ranger: An All Comers Registry Michael K.W. Lichtenberg, MD Klinikum Arnsberg Arnsberg, Germany
Surgical Bypass vs. Zilver PTX stent for long SFA lesions : Interim results of the ZilverPass Trial
Surgical Bypass vs. Zilver PTX stent for long SFA lesions : Interim results of the ZilverPass Trial Dr. Koen Deloose Head of Vascular Surgery AZ Sint-Blasius Dendermonde Belgium Disclosure slide Speaker
MICHAEL R. JAFF, DO MASSACHUSETTS, UNITED STATES. Medtronic Further. Together
DRUG-COATED BALL0ON TREATMENT FOR PATIENTS WITH INTERMITTENT CLAUDICATION: INSIGHTS FROM THE IN.PACT GLOBAL FULL CLINICAL COHORT MICHAEL R. JAFF, DO MASSACHUSETTS, UNITED STATES Medtronic Further. Together
14F OD Ovation Abdominal Stent Graft System
14F OD Ovation Abdominal Stent Graft System 2 Year Results from the European Study Dierk Scheinert, MD Center for Vascular Medicine Angiology and Vascular Surgery Park Hospital Leipzig, Germany Disclosure
Update from Korea on the Lutonix SFA registry 12 month data
Update from Korea on the Lutonix SFA registry 12 month data Prospective, Multicenter, Post-Market Registy Assessing the Clinical Use and Safety of the Lutonix Drug Coated Balloon in Femoropopliteal Arteries
Luminor DCB in femoropopliteal lesions
Luminor DCB in femoropopliteal lesions EffPac trial results and solo DCB study design Marcus Thieme, MD Department of Angiology/ Cardiology/ Diabetology Regiomed Vascular Center Sonneberg Clinic for Internal
LIFESTREAM TM First look at the BOLSTER 2-year follow up data
LIFESTREAM TM First look at the BOLSTER 2-year follow up data Dierk Scheinert, MD, on behalf of the Investigators Department of Angiology University Hospital Leipzig, Germany Disclosure Dierk Scheinert,
TOBA II 12-Month Results Tack Optimized Balloon Angioplasty
TOBA II 12-Month Results Tack Optimized Balloon Angioplasty William Gray, MD System Chief, Cardiovascular Division Main Line Health, Philadelphia, PA Dissection: The Primary Mechanism of Angioplasty Lesions
Christian Wissgott MD, PhD Assistant Director, Radiology Westküstenkliniken Heide
2-Year Results Of The Tack Optimized Balloon Angioplasty (TOBA) Trial For Fem- Pop Lesions Demonstrates Safety and Efficacy Of The Tack Endovascular System In Repairing Focal Post-PTA Dissections Christian
Long Lesions: Primary stenting or DCB first? John Laird MD Adventist Heart and Vascular Institute, St. Helena, CA
Long Lesions: Primary stenting or DCB first? John Laird MD Adventist Heart and Vascular Institute, St. Helena, CA Disclosures John R. Laird Within the past 12 months, I or my spouse/partner have had a
NCT Teichgräber et al. Trials (2016) DOI /s x
NCT02540018 Teichgräber et al. Trials (2016) DOI 10.1186/s13063-016-1657-x EffPac-Trial: Effectiveness of Luminor DCB vs. POBA in the SFA: primary endpoint and 12- months results Ulf Teichgräber, MD, MBA
ISR-treatment The Leipzig experience with purely mechanical debulking. Sven Bräunlich Department for Angiology University-Hospital Leipzig, Germany
ISR-treatment The Leipzig experience with purely mechanical debulking Sven Bräunlich Department for Angiology University-Hospital Leipzig, Germany Disclosure Speaker name: Sven Bräunlich I have the following
Potential Conflicts of Interest
DES-BTK: A Prospective, Double-Blind Randomized Trial of Polymer-Free Sirolimus-Eluting Stents Compared to Bare Metal Stents in Patients with Infrapopliteal Disease Aljoscha Rastan, MD, Gunnar Tepe, MD,
BioMimics 3D in my Clinical Practice
BioMimics 3D in my Clinical Practice M Lichtenberg M.D. Vascular Centre Arnsberg / German Venous Centre Arnsberg CAUTION: Investigational Device. Limited by Federal (or United States) Law to Investigational
Disclosures. Rational Selection of Endovascular Options for the SFA and Popliteal: What Works Where and for How Long?
Rational Selection of Endovascular Options for the SFA and Popliteal: What Works Where and for How Long? UCSF Vascular Symposium 2017 April 6-8, 2017 San Francisco, CA Disclosures Consulting, Speakers
Department of Radiology. EffPac - Trial:
Department of Radiology EffPac - Trial: Effectiveness of LUMINOR DCB versus POBA in the SFA: primary endpoint and 6 months results Ulf Teichgräber on behalf of the Investigators NCT02540018 Teichgräber
Surgical Bypass or. Zilver PTX. 12 months preliminary data. LINC 2016, Leipzig. Marc Bosiers, MD. Marc Bosiers Koen Deloose Joren Callaert
LINC 2016, Leipzig Surgical Bypass or A.Z. Sint-Blasius, Dendermonde Marc Bosiers Koen Deloose Joren Callaert Imelda Hospital, Bonheiden Patrick Peeters Jürgen Verbist Wouter Van den Eynde OLV Hospital,
DCB use in fem-pop lesions of patients with CLI (RCC 4-5): subgroup analysis of IN.PACT Global 12-month outcomes
DCB use in fem-pop lesions of patients with CLI (RCC 4-5): subgroup analysis of IN.PACT Global 12-month outcomes Carlos Mena, MD FACC FSCAI Associate Professor of Medicine - Cardiology Director Cardiac
Atherectomy is Still Live and Effective. John R. Laird, MD Professor of Medicine Medical Director of the Vascular Center UC Davis Health System
Atherectomy is Still Live and Effective John R. Laird, MD Professor of Medicine Medical Director of the Vascular Center UC Davis Health System Why is Atherectomy Still Alive? Improved devices Better data
DISRUPT PAD. (( Data Summary )) DISRUPT PAD Data Summary SPL Rev. B 2016 Shockwave Medical Inc. All rights reserved.
DISRUPT PAD (( Data Summary )) DISRUPT PAD Data Summary SPL 60971 Rev. B 1 Summary of the key findings from the DISRUPT PAD Study 99% of femoropopliteal lesions treated were moderately or severely calcified.
XPEDITE Clinical Study PaclitaXel-coated Peripheral StEnts used In the Treatment of FemoropoplitEal Stenoses
XPEDITE Clinical Study PaclitaXel-coated Peripheral StEnts used In the Treatment of FemoropoplitEal Stenoses Thomas Zeller, M.D. Universitäts-Herzzentrum Freiburg-Bad Krozingen, Germany Disclosure Speaker
Zilver PTX Post-Market Surveillance Study of Paclitaxel-Eluting Stents for Treating Femoropopliteal Artery Disease in Japan: 24-Month Results
Post-Market Surveillance Study of Paclitaxel-Eluting Stents for Treating Femoropopliteal Artery Disease in Japan: 24-Month Results Hiroyoshi Yokoi, MD, Fukuoka Sannou Hospital Fukuoka, Japan On behalf
BIOLUX P-III Passeo-18 Lux All-comers Registry: 12-month Results for the All-Comers Cohort
BIOLUX P-III Passeo-18 Lux All-comers Registry: 12-month Results for the All-Comers Cohort Prof. Dr. Gunnar TEPE, Klinikum Rosenheim, Germany CCI on behalf of the BIOLUX P-III Investigators Disclosure
Which Stent Is Best for Various Femoropopliteal Anatomy? 2018 Pacific Northwest Endovascular Conference June 15-26, 2018 Seattle, WA
Which Stent Is Best for Various Femoropopliteal Anatomy? 2018 Pacific Northwest Endovascular Conference June 15-26, 2018 Seattle, WA Brian DeRubertis, MD, FACS Associate Professor of Surgery UCLA Division
The Crack and Pave technique for highly resistant calcified lesions. Manuela Matschuck MD University Hospital Leipzig Department Angiology
The Crack and Pave technique for highly resistant calcified lesions Manuela Matschuck MD University Hospital Leipzig Department Angiology Disclosure Speaker name: Dr. med. Manuela Matschuck I have the
BIOLUX 4EVER : Combining Passeo-18 Lux DCB and Pulsar-18 BMS : 12 month results of full cohort
BIOLUX 4EVER : Combining Passeo-18 Lux DCB and Pulsar-18 BMS : 12 month results of full cohort Koen Deloose, MD Head Dept Vascular Surgery AZ Sint-Blasius Dendermonde, Belgium Disclosure slide Speaker
MEET M. Bosiers K. Deloose P. Peeters. SFA stenting in 2009 : The good and the ugly What factors influence patency?
MEET 2009 SFA stenting in 2009 : The good and the ugly What factors influence patency? M. Bosiers K. Deloose P. Peeters 1 TASC II 2007 vs TASC 2000 Type A Type B Type C Type D 2000 < 3 cm 3-5 cm < 3 cm
First time data release: Initial experience with the temporary Spur Stent System: DEEPER Trial first-in-man results Jihad A. Mustapha, MD, FACC,
First time data release: Initial experience with the temporary Spur Stent System: DEEPER Trial first-in-man results Jihad A. Mustapha, MD, FACC, FSCAI Associate Professor of Medicine Michigan State University,
Michael K. W. Lichtenberg MD, FESC on behalf of KANSHAS 1 investigators; Tepe G, Müller-Hülsbeck S, Deloose K, Verbist J, Goverde P, Zeller T
Interim 30-day analysis from the KANSHAS 1 study of the novel KANSHAS drug coated balloon for treatment of femoropopliteal occlusive disease; a latest first-in-human study Michael K. W. Lichtenberg MD,
Comparison Of Primary Long Stenting Versus Primary Short Stenting For Long Femoropopliteal Artery Disease (PARADE)
Comparison Of Primary Long Stenting Versus Primary Short Stenting For Long Femoropopliteal Artery Disease (PARADE) Young-Guk Ko, M.D. Severance Cardiovascular Hospital, Yonsei University Health System,
2-YEAR DATA SUPERA POPLITEAL REAL WORLD
2-YEAR DATA SUPERA POPLITEAL REAL WORLD Enrique M. San Norberto. Angiology and Vascular Surgery. Valladolid University Hospital. Valladolid. Spain. Disclosure Speaker name: ENRIQUE M. SAN NORBERTO I have
One Year after In.Pact Deep: Lessons learned from a failed trial. Prof. Dr. Thomas Zeller
One Year after In.Pact Deep: Lessons learned from a failed trial Prof. Dr. Thomas Zeller Disclosure Speaker name: Thomas Zeller... I have the following potential conflicts of interest to report: x Consulting:
Fabrizio Fanelli, MD, EBIR Director Vascular and Interventional Radiology Department "Careggi " University Hospital Florence - Italy
Don t Use Risky and Embolizing Drug Coated Balloons Below The Knee! Fabrizio Fanelli, MD, EBIR Director Vascular and Interventional Radiology Department "Careggi " University Hospital Florence - Italy
Specificities for infrapopliteal stents
Specificities for infrapopliteal stents Nicolas Diehm, M.D. Swiss Cardiovascular Center Clinical and Interventional Angiology University Hospital Bern, Switzerland Disclosures Speaker`s Bureau: MEDRAD,
The importance of scientific evidence. Prof. I. Baumgartner Head Clinical & Interventional Angiology University Hospital Bern
The importance of scientific evidence Prof. I. Baumgartner Head Clinical & Interventional Angiology University Hospital Bern Disclosure Speaker name:...i. Baumgartner... I have the following potential
Mechanical thrombectomy in peripheral interventions: A multitask and effective tool in a widening scenario. Current evidence and technical tips.
Mechanical thrombectomy in peripheral interventions: A multitask and effective tool in a widening scenario. Current evidence and technical tips. Dr. Bruno Freitas, Prof., MD Department of Interventional
The latest treatment approach and current developments in SFA
The latest treatment approach and current developments in SFA Dierk Scheinert, MD Department for Interventional Angiology University-Hospital Leipzig, Germany Disclosure Statement of Financial Interest
Maximizing Outcomes in a complex population with Drug-coated balloon
Maximizing Outcomes in a complex population with Drug-coated balloon March 13, 2018 Chumpol Wongwanit, MD Siriraj Hospital, Mahidol University, Bangkok, Thailand LINC Asia-Pacific 2018, Hong Kong Disclosure
The latest evidences from the DES trials in peripheral arterial disease
The latest evidences from the DES trials in peripheral arterial disease Michael D. Dake, MD Thelma and Henry Doelger Professor Stanford University School of Medicine Disclosure Speaker name: Michael D.
DCB in my practice: How the evidence influences my strategy. Yang-Jin Park
DCB in my practice: How the evidence influences my strategy Yang-Jin Park Associate Professor Division of Vascular Surgery, Department of Surgery Samsung Medical Center Sungkyunkwan University School of
12-Month and preliminary 24-month outcomes of combining a DCB with a modern generation of nitinol stent in fem-pop lesions. BIOLUX 4EVER study
12-Month and preliminary 24-month outcomes of combining a DCB with a modern generation of nitinol stent in fem-pop lesions BIOLUX 4EVER study Dr. Lieven Maene OLV Aalst, Belgium Disclosure slide Speaker
Cutting/scoring balloon Cryoplasty Drug-eluting balloon Brachytherapy Debulking Restent (BMS or DES) John R. Laird, MD
Current Treatment of Femoropopliteal Instent Restenosis Professor of Medicine Medical Director of the Vascular Center UC Davis Medical Center SFA In-stent Restenosis Common: 18%- 40% at 12 months in recent
SFA CTO Lesion Management laser or directional atherectomy?
SFA CTO Lesion Management laser or directional atherectomy? Kevin, Chung-Ho Hsu, M.D. Setion of Peripheral Vascular Disease, Division of Cardiology, China Medical University Hospital, Taichung, Taiwan
EffPac RCT: final 6-month results with the Luminor DCB
EffPac RCT: final 6-month results with the Luminor DCB Ulf Teichgräber, MD, MBA on behalf of the investigators Aschenbach R, Scheinert D, Zeller T, Brechtel K, Thieme M, Blessing E, Lichtenberg M, von
Future Algorithm for Lower Extremity Revascularization: Where Does Vessel Prep Fit?
Future Algorithm for Lower Extremity Revascularization: Where Does Vessel Prep Fit? John R. Laird Adventist Heart and Vascular Institute St. Helena, CA Disclosure Speaker name: John R. Laird... I have
The BATTLE Trial Comparing Bare Metal to Drug Eluting Stents for Intermediate Length Lesions of the SFA
The BATTLE Trial Comparing Bare Metal to Drug Eluting Stents for Intermediate Length Lesions of the SFA BATTLE RCT investigators: Y. Gouëffic, A. Sauguet, P. Desgranges, P. Feugier, E. Rosset, E. Ducasse,
Clinical Data Update for Drug Coated Balloons (DCB) Seung-Whan Lee, MD, PhD
Clinical Data Update for Drug Coated Balloons (DCB) Seung-Whan Lee, MD, PhD Asan Medical Center, Heart Institute, University of Ulsan College of Medicine, Werk et al. Circulation Cardiovasc Intervent 2012
Outcome of DCB and PTA post stenting in occluded versus stenotic lesions subgroup analysis of the randomized Freeway Stent Study
Outcome of DCB and PTA post stenting in occluded versus stenotic lesions subgroup analysis of the randomized Freeway Stent Study J. Tacke, K.A. Hausegger, H. Schröder, J. Dambach, S. Stahnke, S.Müller-Hülsbeck,
Vessel preparation with scoring balloons prior to DCB or stenting
Vessel preparation with scoring balloons prior to DCB or stenting Deep dive session: lower limb interventions Erwin Blessing, MD, FESC SRH Klinikum Karlsbad- Langensteinbach, Germany Disclosure Speaker
BIOFLEX PEACE Registry
BIOFLEX PEACE Registry Pulsar Efficacy: an All Comers Registry INTERIM ANALYSIS Michael K. W. Lichtenberg On behalf of the BIOFLEX-PEACE study group Definition and understanding of various radial forces
William A. Gray MD System Chief of Cardiovascular Services, Main Line Health President, Lankenau Heart Institute Wynnewood, PA USA
William A. Gray MD System Chief of Cardiovascular Services, President, Wynnewood, PA USA Why atherectomy? Calcification is the norm not the exception Most trials do not include heavy calcification There
Best DCB outcomes in SFA TASC A&B lesions: EFFPAC-RCT 12-months follow-up
NCT02540018 Teichgräber et al. Trials (2016) DOI 10.1186/s13063-016-1657-x Best DCB outcomes in SFA TASC A&B lesions: EFFPAC-RCT 12-months follow-up Ulf Teichgräber, MD, MBA on behalf of the investigators
The Freeway Stent Study: the 12 Months results highly favor the use of DEB in combination with stenting
The Freeway Stent Study: the 12 Months results highly favor the use of DEB in combination with stenting J. Tacke, K.A. Hausegger, H. Schröder, J. Dambach, S. Stahnke, S.Müller-Hülsbeck, MD, EBIR, FCIRSE,
Are DES and DEB worth the cost in BTK interventions?
Are DES and DEB worth the cost in BTK interventions? Thomas Zeller, MD University Heart-Center Freiburg-Bad Krozingen Bad Krozingen, Germany -1- My Disclosures: Advisory Board: Medtronic-Invatec, Gore,
Clinical use and safety of the Lutonix DCB for the treatment of BTK: interim data from a prospective registry
Clinical use and safety of the Lutonix DCB for the treatment of BTK: interim data from a prospective registry Alexander Zimmermann Department of Vascular and Endovascular Surgery Klinikum rechts der Isar
ILLUMENATE FIH Direct DCB Cohort 12-Month Results
ILLUMENATE FIH Direct DCB Cohort 12-Month Results Stephan Duda Berlin Study Investigators: H. Schröder (PI), B. Lux, F. Rücker, M. Martorana, D. Meyer, H. Hartmann, S. Duda Disclosure Speaker name: S.
Efficacy of DEB in Calcification and Subintimal Angioplasty
Efficacy of DEB in Calcification and Subintimal Angioplasty Seung-Woon Rha, MD, PhD, FACC, FAHA, FSCAI, FESC, FAPSIC Div of Cardiovascular Intervention and Research Cardiovascular Center, Korea University
Long-term Zilver PTX Data from Japan: 5-year Results in the Real World
Long-term Data from Japan: 5-year Results in the Real World Hiroyoshi Yokoi, MD Department of Cardiovascular Medicine Fukuoka Sanno Hospital Fukuoka, Japan On behalf of the Investigators Disclosure Speaker
LIBERTY 360 Study. 15-Jun-2018 Data 1. Olinic Dm, et al. Int Angiol. 2018;37:
LIBERTY 360 Study LIBERTY is a prospective, observational, multi-center study to evaluate procedural and long-term clinical and economic outcomes of endovascular device interventions in patients with symptomatic
Treatment Strategies for Long Lesions of greater than 20 cm
Treatment Strategies for Long Lesions of greater than 20 cm Donald L. Jacobs, MD C. Rollins Hanlon Professor and Chair Chair of the Department of Surgery Saint Louis University Disclosure Speaker name: