How DCB drug dose effects vessel healing. Aloke Finn, MD CVPath Institute Inc. Gaithersburg, MD. USA
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1 How DCB drug dose effects vessel healing Aloke Finn, MD CVPath Institute Inc. Gaithersburg, MD. USA
2 Disclosure Statement of Financial Interest Speaker's name : Aloke, Finn, Gaithersburg I have the following potential conflicts of interest to report: Institutional Receipt of grants / research supports: Abbott, Biosensors, Biotronik, Boston Scientific, Celonova, Edwards Lifesciences, Medtronic, MicroPort, Mitralign, OrbusNeich, Sinomed Receipt of honoraria or consultation fees: Abbott, Boston Scientific, Celonova, Sinomed, Cook, Bard, Amgen
3 Biologic changes secondary to DCB (paclitaxel) and Healing in Porcine Peripheral arteries. Biologic changes induced by Paclitaxel (in the first few weeks): Loss of endothelial cells and fibrin deposition: intima and media Smooth muscle cell death in the media - transmural and circumferential Healing following use of DCB (paclitaxel) (weeks to months) Endothelialization, smooth muscle cell proliferation and intimal thickening with proteoglycan deposition, persistent fibrin, with time will resolve Proteoglycan deposition in the medial wall and adventitia transmural and circumferential, followed by collagen deposition in media and adventitia Duration of healing is dependent on the persistence of paclitaxel within the arterial wall (loading and efficiency of drug transfer) - pk related
4 Lutonix 035 vs. In.Pact Differences Lutonix 035 In.Pact Paclitaxel Dose 2 μg/mm μg/mm 2 Carrier Polysorbate & Sorbitol Urea Systemic Downstream Effects in a Pre-Clinical Model SFA/BTK Product Line None SFA= 1 st with FDA Approval / BTK Ongoing Trial Present SFA FDA Approval / BTK Product Recall 2014 Lutonix 035 In.Pact Distal Tip Medial
5 Histologic Parameters for Evaluation of DCB Efficacy Key parameters include: Endothelial loss Fibrin / Platelets Inflammation Injury Medial smooth muscle cell loss Matrix replacement Proteoglycan Collagen Adventitial fibrosis Fibrin SMC loss Proeoglycan
6 Vascular Pharmacokinetic Responses to Treatment with a Lutonix 035 in a Swine Femoral Artery Yazdani SK, et al. Catheter Cardiovasc Interv. 2014;83(1):132-40
7 Vascular Changes Following Lutonix DCB Treatment in Porcine Iliac Arteries
8 Beyond Drug Dose: Drug- Bioavailabilty Paclitaxel is a lipophilic, poorly water soluble compound The activity of the drug is dependent upon solubilization by plasma matrix components and transport into the tissue Both urea and sorbitol are hydrophilic substances but there may be differences in their ability to facilitate dissolution of paclitaxel
9 Granada JF Journal of Drug Delivery Volume 2019, Article ID
10 Granada JF Journal of Drug Delivery Volume 2019, Article ID
11 Lutonix DCB vs. In.Pact DCB Comparison Study Study device LUTONIX DCB IN.PACT DCB Device size 4.0 / 5.0 / 6.0 x 80 mm 4.0 / 5.0 / 6.0 x 80 mm Coating dose 2 ug/mm ug/mm 2 Treated sites SFA, 1x (single); 3x (3 DCB OL) SFA, 1x (single); 3x (3 DCB OL) Organ / Tissues assessed for histopathology and PK Skeletal muscles, Gastrocnemius Muscle, Gluteus Maximus Muscle, Gracilis Muscle, Rectus Femoris Muscle, Semimembranosus Muscle, and Semitendinosus Muscle and coronary band Same 28 d treated SFA N 1x =5; 3x=5, 1 x =5; 3x =5 90 d treated SFA N 3x=5 3x =5 Plasma PK Plasma ptx level tested in selected pigs in which only one kind of DCB used
12 Left or Right SFA Randomly Treated by LUTONIX, In.Pact or POBA Histo only Treatment Scheme: A total of 2 DCB treated sites (1/vessel) in the external femoral arteries of one leg (left or right). PK and histo Treatment Scheme: A total of 2 treated sites in the external femoral arteries of one leg (left or right). IN.PACT 1x or 3x Tx site LUTONIX1x or 3x Tx site 1x or 3x LUTONIX or IN.PACT Tx site POBA 1x or 3x Tx site REF 1x or 3x OL RIF LEF 1x or 3x OL LIF RIF REF LEF:1x or LEF 3x POBA 1x or
13 Histologic Vascular Changes following Lutonix 035 vs. IN.PACT DCB Treatment (1x) at 28 days Lutonix 035: n=5, In.Pact DCB: n=5, POBA: n=4 SMC loss score (Depth) SMC loss score (Circumference) 4 3 P= P= Lutonix 035 IN.PACT POBA 0 Lutonix 035 IN.PACT POBA Medial proteoglycan score Fibrin/thrombus score 4 3 P= P= Lutonix 035 IN.PACT POBA 0 Lutonix 035 IN.PACT POBA
14 Histologic Vascular Changes following Lutonix 035 vs. IN.PACT DCB Treatment (3x) at 28 and 90 days Lutonix 035: n=5, In.Pact DCB: n=5, POBA: n=4 SMC loss score (Depth) SMC loss score (Circumference) 4 3 P=0.004 P= P=0.01 P= Lutonix 035 IN.PACT POBA Lutonix 035 IN.PACT POBA 0 Lutonix 035 IN.PACT POBA Lutonix 035 IN.PACT POBA 28 days 90 days 28 days 90 days 4 3 Medial proteoglycan score Fibrin/thrombus score 4 P=0.01 P=0.007 P=0.41 P= Lutonix 035 IN.PACT POBA Lutonix 035 IN.PACT POBA 0 Lutonix 035 IN.PACT POBA Lutonix 035 IN.PACT POBA 28 days 90 days 28 days 90 days
15 Vascular Changes in Porcine Skeletal Muscle (at 28-Day) Lutonix (1x) In.Pact (3x) High (20x and 40x) power images of vascular changes in skeletal muscle at 28 days. Vascular changes include pyknotic nuclei embedded in homogenous pink material (yellow arrow), representing fibrinoid necrosis (black arrows), with surrounding inflammatory cells (blue arrows). In.Pact (1x) In.Pact (3x)
16 Distal Embolization (%) A Downstream Incidence of Distal Embolization (%) 28-Day Survival 90-Day Survival Single Balloon (1x) Overlapping Balloons (3x) Overlapping Balloons (3x) P= P= P= Lutonix % (0-11.5) n=5 IN.PACT 15.4% ( ) n=5 0 Lutonix % (0-15.4) n=5 IN.PACT 38.5% ( ) n=5 0 Lutonix 035 0% (0-11.5) N=5 IN.PACT 46.2% ( ) N=5 B Number of micro-vessels with paclitaxelassociated findings Survival Treatment & Arteries Lutonix 035 IN.PACT P-value 28-day (1x, n=5) 1 (0-2) 4 (2-12) day (3x, n=5) 1 (0-12) 26 (11-34) day (3x, n=4) 0 (0-3) 11 (5-15) 0.02 C Survival Treatment & Arteries Lutonix 035 IN.PACT P-value Paclitaxel concentration in downstream tissues (ng/g) 28-day (1x, n=5) 28-day (3x, n=5) 90-day (3x, n=4) Skeletal muscle 1.3 ( ) 3.7 ( ) 0.6 ( ) Coronary band 1.5 ( ) 31.5 ( ) 2.7 ( ) Skeletal muscle 60.8 ( ) ( ) 16.1 ( ) Coronary band ( ) ( ) ( ) Skeletal muscle Coronary band
17 Efficacy DCB Design: All About Balancing Safety, Efficacy, and Biologic Response Not all balloons are created equal. More Less Less neointima Absence of restenosis No early or late thrombosis Biologic changes, but no emboli Rapid vascular healing Good re-endothelialization No distal emboli Safety Less Drug Load Use of Carrier / Excipient Drug Retention Repeat Inflations More
18 Funding CVPath Institute Inc. Acknowledgments CVPath Institute Hiroyuki Jinnouchi, MD Sho Torii, MD Atsushi Sakamoto, MD Anne Cornelissen, MD Maria Romero, MD Abebe Atiso, HT Jinky Beyer Lila Adams, HT Frank D Kolodgie, PhD Liang Guo, PhD Renu Virmani, MD Washington DC
19
20 28 Days Vascular Changes in Downstream Porcine Skeletal Muscle (NONE of physiological significance observed for Lutonix at any time) 90 Days 1x Dose (None observed for 1x dose at 180 days) 28 Days 4x Dose 90 Days 180 Days
21 Histological Findings of Emboli / Vascular Changes, Skeletal Muscle Arteries Lutonix 035 x3 (2µg/mm 2 paclitaxel) at 90-days Inflammatory cells Fibrinoid necrosis of the arterial wall Loss of medial SMCs with fibrinoid necrosis and replacement by proteoglycan/collagen No. No. of sections (Downstream muscle/coronary band) Vascular Changes Skeletal Muscle Necrosis/Fibrosis Crystalline material 1 14 (12/2) (12/2) (12/2) (12/2) Total /56 = 8.9 % from DCB treatment showed findings of vascular change associated with paclitaxel and/or excipient (drug carrier). Skeletal Muscle: Gastrocnemius Muscle, Gluteus Maximus Muscle, Gracilis Muscle, Rectus Femoris Muscle, Semimembranosus Muscle, and Semitendinosus Muscle
22 Skeletal Muscle: Gastrocnemius Muscle, Gluteus Maximus Muscle, Gracilis Muscle, Rectus Femoris Muscle, Semimembranosus Muscle, and Semitendinosus Muscle Histological Findings of Emboli / Vascular Changes, Skeletal Muscle Arteries In.Pact DCB x3 (3.5µg/mm 2 paclitaxel) at 90-days Crystalline material Fibrinoid Necrosis No. No. of sections (Downstream muscle/coronary band) Vascular Changes Skeletal Muscle Necrosis/Fibrosis Crystalline material 1 13 (12/1) (12/1) (12/1) (12/1) (12/1) (12/1) Total Skeletal Muscle 38/78 = 48.7 % from DCB treatment showed findings of vascular changes 9/78 = 11.5% from DCB showed findings of skeletal muscle fibrinoid necrosis
23 Histologic Vascular Changes following Lutonix vs. In.Pact DCB Treatment (3x) Lutonix 3x-28d In.Pact 3X-28d POBA-28d Luminal Stenosis, % P=0.02 P= Lutonix 035 IN.PACT POBA Lutonix 035 IN.PACT POBA 28 days 90 days Lutonix 3x-90d In.Pact 3x-90d POBA-90d Neointimal Area, mm 2 P=0.02 P= Lutonix 035 IN.PACT POBA Lutonix 035 IN.PACT POBA 28 days 90 days
24 Crystalline Material in Porcine Skeletal Muscle at 28 Days: In.Pact (1x / 3x) In.Pact (1x) High (40x) power images of crystalline material (red arrows) at 28d In.Pact (3x)
25 Vascular Changes in Porcine Skeletal Muscle at 90-Day In.Pact (3x) Fibrinoid necrosis In.Pact (3x) Inflammatory cells Fibrinoid necrosis Lutonix (3x) POBA (3x) Fibrinoid necrosis Inflammatory cells
26 Histologic Vascular Changes following Lutonix vs. In.Pact DCB Treatment (1x) Pre-clinical results demonstrate no significant difference in neointimal hyperplasia. Lutonix 1x-28d In.Pact 1x-28d POBA-28d Luminal Stenosis, % P= Lutonix 035 IN.PACT POBA Neointimal Area, mm 2 P= Lutonix 035 IN.PACT POBA
27 Elements of an Effective DCB Formulation Must deliver large quantities of the drug within seconds Distribute within the media in the first few days Therapeutic drug levels must be maintained for at least several weeks Must allow rapid healing as compared to DES No need for long-term anti-platelet therapy Biologic effects at 28-days at least
28 Paclitaxel Uptake in the Animal Arterial Wall Lutonix 035 offers similar to In.Pact concentration levels at 24 hours and 60 days. In.Pact has 75% more Paclitaxel per dose per balloon. Similar efficacy concentration levels with significantly less drug * Data obtained from two data sets. Lutonix data from Virmani Pre-clinical animal data GLP study. Medtronic data from Medtronic own reported data, Dr. Melder, LINC presentation 2012.
29 Paclitaxel Adherence to the Balloon Polysorbate & Sorbitol vs. Urea Significantly less drug loss than In.Pact during simulated shake test Drug Lost During Shake Test Lutonix 035 vs. In.Pact Balance of 2.0 μg/mm 2 paclitaxel and carriers polysorbate and sorbitol, minimizes unwanted drug loss in the lab *Bench test data on file. Bench results may not be indicative of clinical performance. Different test methods may yield different results.
30 How DCB drug dose effects vessel healing Aloke Finn, MD CVPath Institute Inc. Gaithersburg, MD. USA
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