Michael K.W. Lichtenberg, MD

Transcription

1 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

2 Conflict of Interest - Disclosure Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Affiliation/Financial Relationship Company 1. Honoraria for lectures: CR Bard, Veniti, AB Medica, Volcano, Optimed GmbH, Straub Medical, Terumo, Biotronik, Veryan 2. Honoraria for advisory board activities: Veniti, Optimed GmbH, Straub Medical, Biotronik, Veryan, Boston Scientific 3. Participation in clinical trials: Biotronik, CR Bard, Veryan, Straub Medical, Veniti, TVA Medical, Boston Scientific, LimFlow, Terumo 4. Research funding: Biotronik, Boston Scientific, Veryan, Veniti, AB medica

3 Next Generation DCB: Boston Scientific Ranger Sterling balloon platform TransPax TM coating technology Paclitaxel 2 µg/mm 2 Ranger TM DCB Loading Tool Designed to protect the drug coating Size matrix: SFA: 4-8 mm; * mm BTK: 2-4 mm; up to 150 mm *Up to 100 mm lengths available for use in the study.

4 Ranger SFA Registry Clinical Study Overview: RANGER SFA registry Title Primary Investigator / Sponsor Centres Study Design Subjects Key Inclusion Criteria Primary Safety Endpoint Primary Efficacy Endpoint Ranger All-Comer Registry Treatment of femoro-popliteal atherosclerotic lesions using the Drug eluting Balloon Ranger: An All Comers Registry Michael Lichtenberg, MD Germany Klinikum Arnsberg - Germany Germany (Dr. von Bilderling (Munich), Dr. Ranft, Dr. Niemöller (Bottrop), Dr. Grell (Trier) and Switzerland (Dr. Saucy, Lausanne) Multicentre, all comer registry 172 patients PAOD SFA PIII, Rutherford II - V Major Adverse Events (MAE): composite of device or procedure related mortality and major target limb amputation at 6 months Primary patency at 12 and 24 months, defined as freedom from 50% restenosis as indicated by duplex ultrasound peak systolic velocity ratio (PSVR) 2.4 in the target lesion with no re-intervention

5 Ranger SFA Registry Patient Demographics Ranger DCB N 172 Mean Age (years) 71 Male 62 % ABI 0.69 ( ) General Medical History Diabetes mellitus 35 % Hyperlipidemia 94 % Hypertension 92 % Smoking Current 34 % Previous 43 % Renal History Renal disease 19 % Rutherford stage I 2 % II 18 % III 64 % IV 8 % V 5 % VI 1 %

6 Ranger SFA Registry Lesion Characteristics Ranger DCB Lesion (N) 226 SFA Prox 76 (34%) SFA Mid 112 (50%) SFA Distal 106 (47%) POP Prox 62 (27%) POP Mid 43 (19%) POP Distal 12 (5%) Lesion length (mm) 129 mm (5-400 mm) Calcification None/low 74% Moderate 23% Severe 3% Percent diameter stenosis 91 % ± 10 % TASCII A 24 % B 21 % C 18 % D 30 % unclassified 7 %

7 Ranger SFA Registry Procedure Characteristics Procedure Number of lesion segments per patient 1 69% 2 20% 3 6% 4 2.5% 5 0.5% Pre-dilatation before DCB 76.1% Ranger DCB avg. inflation time (sec) 115 Bail out stent rate 22% Procedure Outcomes Technical success for DCB only (no flow limiting dissection) 73% Procedural success DCB plus adjunctive therapy (stent) 100% Residual angiographic stenosis 12%

8 Stents used in DCB Studies Longer mean lesion length in DCB studies correlates with higher provisional stenting rate Ranger SFA Registry Fempac RANGER SFA PACIFIER ILLUMENATE FIH ILLUMENATE EU RCT THUNDER IT Registry ILLUMENATE US RCT In.Pact SFA Lutonix Registry In.Pact Global Registry CONSEQUENT Bad Krozingen Lutonix Registry LL Leipzig Registry In.Pact Global LL Provisional Stenting in Randomized Controlled Trials may not be representative of actual stenting in studies due to study design Results from different trials are not directly comparable. Information provided for educational purposes. FEMPAC- Werk M et al. Circulation 2008; RANGER SFA-Bausback et al. J Endovasc Ther 2017; PACIFIER- Werk et al. Circ Cardiovasc Interv 2012 THUNDER- Tepe G et al. N Engl J Med 2008 IT Registry- Micari A Et al. J Am Coll Cardiol Intv 2012; IN.PACT SFA- Tepe et al. Circulation 2015; ILLUMENATE FIH- Schroeder H et al. Catheter Cardiovasc Interv Lutonix Registry- Thieme M, et al. JACC Cardiovasc Interv. 2017; 2015; CONSEQUENT- Tepe et al. Cardiovasc Intervent Radiol 2017; ILLUMENATE EU RCT- Schroeder et al, Circulation 2017; Bad Krozingen- Zeller T et al. J Endovasc Therapy 2014; ILLUMENATE US RCT- Krishnan et al, Circulation 2017; Leipzig Registry- Schmidt A, et al. JACC Cardiovasc Interv. 2016; In.PACT Global Registry- Ansel G. TCT 2015.

9 Ranger SFA Registry Preliminary Primary Patency Analysis - 24 Months 84% 70.1% 0 months 6 months 12 months 24 months Patients at risk Events Censored Kaplan-Meier Estimate 24-month follow-up complete for 70 patients

10 Ranger SFA Registry Preliminary Freedom from TLR - 24 Months 89% 74.8% 0 months 6 months 12 months 24 months Patients at risk Events Censored Kaplan-Meier Estimate

11 Patient Outcomes 84 % of patients moved up at least 1 Rutherford category at 12M 68 % of patients moved up 2 Rutherford categories at 12M 81 % of patients at least maintained Rutherford category between 12-24M (preliminary)

12 Patient Outcomes Statistically significant difference for the affected limb from baseline to 12M P < 0.01 Affected limb Contralateral limb

13 Patient Outcomes Statistically significant difference for the affected limb from baseline to 24M (preliminary) P < 0.01 Affected limb Contralateral limb

14 Ranger DCB case SFA / APOP occlusion POBA plus Ranger DCB 11 months FU contralateral Results from case studies are not necessarily predictive of results in other cases. Results in other cases may vary.

15 Conclusions Consistent results between the Ranger DCB Registry and FIM RCT at 12 months Results from the Ranger SFA All-Comer Registry showed: Baseline mean lesion length 129mm & 48% TASCII C/D 84% primary patency at 12 months Encouraging preliminary 24-month results awaiting full cohort follow up

16 PI AA PI AA Jan2018 SEP2017 THANK YOU FOR YOUR ATTENTION

17 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