DESIGN GOALS AND PRE- CLINICAL EVIDENCE OF NEXT GENERATION DCB
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1 DESIGN GOALS AND PRE- CLINICAL EVIDENCE OF NEXT GENERATION DCB Juan F. Granada, MD Executive Director and Chief Scientific Officer CRF-Skirball Center for Innovation Columbia University Medical Center, New York
2 DISCLOSURE STATEMENT OF FINANCIAL INTEREST Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below: Grant/Research Support: Abbott Vascular, Amaranth Medical, Angiometrix, AstraZeneca, Bioventrix, Boston Scientific, Caliber Therapeutics, Cardia, Cardiac Implants, Cagent, Cardiovascular Systems Inc., Cardiosolutions, Celladon, Cephea, Circulite/Heartware, ControlRad, Corindus Vascular Robotics, CR Bard/Lutonix, DC Devices, Direct Flow Medical, Draper, Edwards LifeSciences, Fulgur Medical, Guided Delivery Systems, Intact Vascular, Lutonix, Marvel Medical, Medtronic, Mercator, MedAlliance, Meril Life Sciences, Microvention, MicroInterventional Systems, Mitralign, Neovasc, Nitiloop, Nitinotes, Orbus Neich Medical, REVA Medical, Siemens, Sonivie, Spectranetics, Svelte, Stentys, Surmodics, Thoratec, UniQure, Volcano, WL Gore, Zenvalve
3 SUSTAINABILITY OF BIOLOGICAL EFFICACY OVER TIME: A NEED FOR HEAD TO HEAD RCT DCB Dose (µg/mm 2 ) Excipient RCT Data Lutonix 035 (Bard) 2.0 Polysorbate & Sorbitol 1- and 2-year IN.PACT (Medtronic) 3.5 Urea 1-, 2-, and 3-year Blinded Core Labadjudicated primary patency 1-Year LEVANT II Trial 1-2 IN.PACT SFA Trial 3-5 Δ16.7% P<0.001 Δ31.7% P< Year Δ5.6% P=0.05 Δ28.8% P< Year Not available Δ24.4% P<0.001 Primary patency definitions: LEVANT II defined primary patency as PSVR 2.5 and freedom from TLR 1-2 ; IN.PACT SFA defined primary patency as PSVR 2.4 and freedom from CD-TLR Rosenfield K, et al. NEJM:373: (2015). 2. Presented by Laurich C, SVS Chicago Tepe G, et al. Circ 131: (2015). 4. Laird J, et al. JACC 66: (2015). 5. Krishnan P, presented at VIVA, Las Vegas 2016.
4 % D r u g D i s s o l u t i o n * DCB: PROPOSED MECHANISM OF ACTION (1) Paclitaxel Particle Adhesion (2) Paclitaxel Particle Surface Retention Granada JF. TCT Min 1 Day 3 Days 7 Days 14 Days Picture courtesy of BSCI (3) Paclitaxel Particle Solubility (4) Paclitaxel Tissue PK I N. P A C T 5 0 L u t o n i x 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 Picture courtesy of Medtronic Picture courtesy of Spectranetics
5 IMPACT OF PACLITAXEL COATING TYPE ON DOWNSTREAM PARTICLE EMBOLIZATION Kolodgie FD, J Vasc Interv Radiol 2016;27:
6 DCBx3 DCBx1 PTA EXPERIMENTAL EVALUATION OF DCB USE IN THE SFA TERRITORY IN PRESENCE OF DISTAL WOUNDS DAY 0 DAY 14 ARROWS INDICATE WOUND MARGIN DAY 28 Wound Creation; Bilateral Treatment PTA or DCB x1 vs. DCB x3 (5-6 mm x 80 mm) Hollander Scoring-Margin Separation Pictures courtesy of Bob Melder, Medtronic
7 % D r u g D i s s o l u t i o n * PACLITAXEL PARTICLE SOLUBILITY DETERMINES LONG TERM PACLITAXEL TISSUE LEVELS I N. P A C T 5 0 L u t o n i x H o u r s Figure courtesy of Medtronic * 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 Gongora CA. JACC Cardiovasc Interv. 2015;8: NEXT GENERATION DCB FEATURES Controlled crystallinity Reproducible drug content Predictable tissue levels Long residency time Low particulate content Granada JF. Interventional Cardiology (2E). Chapter 32
8 Acute Drug Transfer IN VITRO PARTICULATE FORMATION Coating Stability Particulate Formation Acute Drug Transfer Gongora CA. JACC Cardiovasc Interv Jul;8(8): COATING TYPE IMPACTS PARTICULATE FORMATION, ACUTE DRUG TRANSFER AND TISSUE RESIDENCY 1 ST GENERATION DCB COATING NEWER GENERATION DCB COATINGS Highly Crystalline Drug Content Variability Inconsistent Tissue Levels High Residency Time High Particulate Content Decreased Paclitaxel Particle Solubility Controlling Paclitaxel Particle Crystallinity Encapsulating Paclitaxel Particles REDUCTION IN BALLOON PACLITAXEL CONTENT
9 IMPACT OF PACLITAXEL BALLOON DOSE IN NEOINTIMAL PROLIFERATION (RESTENOSIS) Cotavance DCB 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 Granada JF. JACC Cardiovasc Interv, Oct 2012
10 IMPACT OF LOWER DOSE PACLITAXEL CONCENTRATION ON NEOINTIMAL PROLIFERATION QVA % DIAMETER STENOSIS AT 42 DAYS IN THE FAMILIAL HYPERCHOLESTEROLEMIA MODEL OF SFA RESTENOSIS Termination 42 Days Histology 2-mcg/mm mcg/mm 2 Data on File, Skirball Center for Innovation
11 CONCLUSIONS A strong clinical foundation support the use of DCB technologies in the SFA territory (when clinically indicated) The mechanism of action of DCB appears to be clearer; particle coating solubility clearly impact clinical outcomes One-year efficacy data is promising for all DCB; however, sustainability of the clinical effect will drive clinical adoption In the SFA territory, the safety profile of DCB has been proven; then, new generation DCB technologies must focus in matching or exceeding current clinical DCB performance Lower-dose DCBs have the potential to reduce downstream particle embolization without compromising biological efficacy allowing the potential use in other vascular applications
12 DESIGN GOALS AND PRE- CLINICAL EVIDENCE OF NEXT GENERATION DCB Juan F. Granada, MD Executive Director and Chief Scientific Officer CRF-Skirball Center for Innovation Columbia University Medical Center, New York
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