DCB From a Pre-Clinical Perspective: The Relevance of Paclitaxel Dose and Coating Integrity
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1 DCB From a Pre-Clinical Perspective: The Relevance of Paclitaxel Dose and Coating Integrity Juan Granada, MD President and CEO Cardiovascular Research Foundation Columbia University Medical Center, New York
2 Disclosure Statement of Financial Interest Within the past 12 months, the Skirball Center for Innovation have received grants and research support with the organization(s) listed below: Grant/Research Support: Abbott Vascular, Amaranth Medical, Amber Medical, Amgen, Baylis, BIO2 Medical, Bristol-Myers, Boston Scientific, Cagent Vascular, Caliber Therapeutics, Cephea, Columbia Medical, Corindus Vascular, Celyad, Freudenberg Medical, Intact Vascular, JenaValve, Keystone Heart, LimFlow Medical, LoneStar Heart, Marvel Medical, Medtronic, Meril Life Sciences, MicroVention, Motus GI, Navigate Cardiac Structures, New York University, OrbusNeich Medical, SoundBite Medical, Spectranetics, Toray Industries, Vetex Medical, Volcano (Philips), Zimmer Biomet
3 Coating Morphology Determines Particle Adhesion and Tissue Pharmacokinetics
4 Cumulative PTx Release (µg) % D r u g D i s s o l u t i o n * Paclitaxel Particle Microstructure Affects Drug Tissue Residence Particle Micro-Structure and In Vitro Dissolution Rates Amorphous Transpax Crystalline Transpax I N. P A C T L u t o n i x Crystalline Time (min) H o u r s * D e r i v e d p e r c e n t a g e v a l u e s c o n s t r a i n e d b y 0 a n d Particle Micro-Structure and Paclitaxel Tissue Levels Amorphous Granada JF, et al. Open Heart 2014 Gongora CA. JACC Cardiovasc Interv. 2015
5 Paclitaxel Levels (ng/mg) Paclitaxel Levels (ng/mg) Tissue Levels Paclitaxel Tissue Levels Variations in Drug Coated Balloon Technologies Ranger DCB In.Pact Admiral DCB Lutonix DCB Ranger DCB In.Pact Admiral DCB Lutonix DCB hours 1 Day 7 Day 21 Day 30 Day 45 Day 60 Day 0 4 hours 1 Day 7 Day 21 Day 30 Day 45 Day 60 Day Gongora CA. JACC Cardiov. Interv Jul;8(8):
6 Impact of Paclitaxel Balloon Dose in Neointimal Proliferation and Restenosis COTAVANCE-MEDRAD Dose Response Study Reduction in %AS SFA, ISR-model High-cholesterol swine 1-µg/mm 2 : 13.2% (p=0.5) vs. PTA 3-µg/mm 2 : 26% (p<0.04) vs. PTA 50% Granada JF. JACC Cardiovascular Interventions Oct 2012 Biological efficacy of DCB depends on both Paclitaxel concentration and particle solubility profile!
7 Comparative Impact of Dosing on Neointimal Proliferation and Restenosis SHORT TERM Effect (28-Days) 2.0 μg/mm μg/mm μg/mm 2 Gongora CA et al. J Am Coll Cardiol Intv. 2015;8:
8 IN.PACT Passeo-Lux Lutonix Stellarex PTA SHORT TERM (28-Days) Restenosis Rates of Different Clinically Available DCB ISR Model in the Familial Hypercholesterolemic Swine 4,00 Inflammation Score 100% % Area Stenosis 3,00 2,00 P=0.01 P= NS 80% 60% 40% 73% P<0.001 P= NS 1,00 20% 36% 34% 29% 28% 0,00 PTA Stellarex Lutonix Passeo IN.PACT 0% PTA Stellarex Lutonix Passeo IN.PACT 4,00 Injury Score 4,00 Fibrin Score P< ,00 3,00 2,00 2,00 2,20 2,23 2,34 2,50 1,00 1,00 0,00 PTA Stellarex Lutonix Passeo IN.PACT 0,00 0,54 PTA Stellarex Lutonix Passeo IN.PACT Data Courtesy of Cheng YP. Skirball Center for Innovation 2017 During the first year, the anti-restenotic effect of most DCB technologies is expected to be comparable
9 Impact of Dose in Long-Term Paclitaxel Tissue Levels (Sustained Drug Availability) Healthy Porcine Arterial Model 1 In-Stent Restenosis Porcine Arterial Model 2 Higher input drug concentration facilitates higher long-term tissue concentrations 1,2 Data on file with Medtronic; Study PS767
10 Stellarex Stellarex IN.PACT IN.PACT 90-Days Restenosis Prevention Following DCB Treatment in Swine Model of SFA-ISR Area (mm²) Pre-DCB 60 Days 90 Days Pre-DCB Post-DCB 60 Days Post-DCB 90 Days Lumen Area by OCT Δ= 1.59 (12%) 12,84 14,82 8,03 11,25 13,85 8,40 Stellarex Δ = 0.97 (7%) IN.PACT 100% Area Stenosis by OCT P= % 60% Δ +5% Δ +4% 40% 20% 61% 51% 56% 58% 42% 46% 0% Stellarex IN.PACT Data Courtesy TCT October of Cheng 2017 The YP. Science Skirball Behind the Outcomes Center DC for Innovation 2017
11 DCB Coating Integrity and Particulate Acute Drug Transfer Coating Stability Particulate Formation Acute Drug Transfer Ranger 6X40 (2μg/mm²) Lutonix Moxy 6X40 (2μg/mm²) In.Pact Pacific 6X40 (3μg/mm²) DCBs were delivered in a peripheral track model with fluid recirculation. Particulates lost downstream were collected with a 5µm polycarbonate filter and are shown as green dots. Fluid recirculation ~320 ml/min; Fluid temp 37 C Gongora CA, et al. JACC Cardiovasc Intv. July 2015.
12 Major Adverse Clinical Events In FDA-Approved DCBs 12-Month Reported Thrombosis and Major Amputation Rates LEVANT II 1 Global 2 IN.PACT SFA 3 Global Clinical Cohort 4 EU RCT 5 US Pivotal 6 Global 7 PTA Lutonix 035 PTA IN.PACT Admiral PTA Stellarex PTA Stellarex Stellarex Subjects All Thrombosis 3.7% (4/107) 1.4% (3/207) Revasc. due to Thrombosis 0.7% (1/140) Major Amputation 0.0% (0/140) 0.4% (1/285) 0.3% (1/286) 1.3% (8/634) 0.5% (3/635) 0.0% (0/107) 0.0% (0/207) 2.9% (38/1311) 0.2% (3/1311) 0.0% (0/60) 0.0% (0/204) 0.0% (0/95) 0.0% (0/95) 1.1% (2/189) 0.0% (0/189) Rosenfield K, et al. N Engl J Med 2015;373: Presented by Laurich C, SVS, Chicago, USA Tepe G, et al. Circ 2015;131: Presented by Jaff MR, VIVA, Las Vegas, USA Presented by Brodmann M, AMP, Chicago, USA Stellarex Instructions for Use; IFU No. P C Rev 07/ Presented by Zeller T, LINC, Leipzig, Germany One major amputation reported, but total number of subjects evaluated at 12 months for this endpoint is unavailable. Distal downstream particle embolization does not seem to impact thrombosis or amputation rates in RCT
13 Conclusions RCTs have proven the clinical performance and the mechanisms of action (and failure) of DCBs in the SFA territory Not only paclitaxel dosing but also particle solubility are important technological drivers to achieve long-term suppression of restenosis In lower-dose DCBs, paclitaxel particle solubility is particularly key to achieve long term-clinical success Particulate embolization does not seem to affect thrombosis or amputation rates in RCT The ability to maintain a sustained biological response over time (restenosis prevention) will be the main driver of clinical success in the field of DCBs
14 DCB From a Pre-Clinical Perspective: The Relevance of Paclitaxel Dose and Coating Integrity Juan Granada, MD President and CEO Cardiovascular Research Foundation Columbia University Medical Center, New York
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