Update on the Levant 2 Clinical Trial Programme. Dierk Scheinert, MD University Hospital Leipzig Leipzig, Germany
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1 Update on the Levant 2 Clinical Trial Programme Dierk Scheinert, MD University Hospital Leipzig Leipzig, Germany
2 Disclosure Speaker name: Dierk Scheinert I have the following potential conflicts of interest to report: Consulting: Abbott, Angioslide, Atheromed, Biotronik, Boston Scientific, Cook Medical, Cordis, Covidien, CR Bard, Gardia Medical, Hemoteq,Intact Vascular Inc., Medtronic, Ostial Inc, TriReme Medical, Trivascular, Upstream Peripheral Technologies Stockholder: IDEV Technologies
3 Anatomy of DCB Balloon Drug Carrier COATING All DCBs use Paclitaxel Paclitaxel differs from DCB to DCB: Crystalline Amorphous Important to bind paclitaxel to the balloon Differs from manufacturer to manufacturer KEY REQUIREMENTS: Drug Uniformity Drug Retention Drug Release
4 Lutonix DCB Formulation Result of extensive development and rigorous testing 45 pre-clinical studies >11,000 histology samples Resulted in an optimized formulation with a therapeutic dose of 2 µg/mm 2 4
5 Lutonix Coating: Drug Uniformity Coating Uniformity Analysis* Segment-to-Segment Variability ± 4.0% Longitudinal Segment Variability ± 2.7% *Consistent variance across all Lutonix balloons *Bench test data on file. Bench results may not be indicative of clinical performance. Different test methods may yield different results.
6 Lutonix Coating: Drug Delivery In Vivo Administration of Fluorescent-Labeled PTX to Excised Porcine Artery 10% Oregon green labeled paclitaxel incorporated into Lutonix DCB coating Uniform Delivery in vivo at 1 hour (Animal vessel cross section after 30 sec. inflation) Lutonix coating uniformity allows uniform drug delivery
7 Lutonix Coating Durability Dry Inflate Shake Test Residual Drug on DCB Balloon After Inflation/Shake Drug Loss After DCB Inflation/Shake LTX DCB (n=5) 99.4% ± 1.1% <0.1%* * Below limits of detection Methods of Kelsch et al., Invest Radiol 2011; 46(4): Evidence of Durability. *Bench test data on file. Bench results may not be indicative of clinical performance. Different test methods may yield different results.
8 Lutonix Coating: Drug Retention 100% 80% 60% 40% 20% 0% 0.08% 0.03% 0.07% 0.07% (n=10) (n=10) (n=10) (n=10) 6F Sheath 6F Tuohy 7F Sheath *Terumo Pinnacle 7F Destination Tuohy Residual on balloon after Passage through Sheath/Tuohy Drug on Hemostatic Adapter* after Balloon Passage Drug load preserved on balloon post-insertion through sheath valve or tuohy Durability of coating preserved through insertion *Bench test data on file. Bench results may not be indicative of clinical performance. Different test methods may yield different results.
9 New Insights from Levant 2 Randomized Data Sub Group and Post Hoc Analysis
10 Free from Primary Patency Event (%) Primary Patency Kaplan-Meier Lutonix DCB = 16.7% (~ 30% Improvement over PTA) Standard PTA = 16.7% p< Survival % Time Lutonix DCB Standard PTA P-value 365 days 73.5% 56.8% Months from Randomization Date
11 Full Wall Apposition Facilitated Drug Delivery and Showed Increased Primary Patency * Correct DCB Sizing is required to Realize Treatment Effect A post-hoc subgroup analysis suggests the full wall apposition of the Lutonix 035 Drug Coated Balloon (minimum 1.04:1 balloon-toartery ratio of the treatment device) showed increased primary patency of 79.9% (Kaplan Meier, not pre-specified). Primary patency is defined as absence of binary restenosis defined by DUS PSVR 2.5 and freedom from Target Lesion Revascularization (TLR). Primary safety by treatment balloon / artery ratio <1 was 85.8% (DCB) and 82.1% (PTA). Primary safety by treatment balloon / artery ratio >1 was 79.3% (DCB) and 75.5% (PTA). Warning: Do not exceed Rated Burst Pressure.
12 Lutonix DCB Effective in Calcified Lesions Survival % Time Lutonix DCB Standard PTA P-value 365 days 75.4% 55.7% Kaplan Meier analysis, 38 events 67 at risk Sub Group analysis. Study endpoint not powered for statistical significance, not adjusted for mulitplicity
13 Lutonix DCB Effective in Diabetic Patients Survival % Time Lutonix DCB Standard PTA P-value 365 days 68.8% 54.0% Kaplan Meier analysis, 42 events 107 at risk Sub Group analysis. Study endpoint not powered for statistical significance
14 Stent Like TLR Lutonix DCB freedom from TLR rate of 89.7% is consistent with current stent freedom from TLR rates mo Freedom from TLR Levant 2 (n =316) for Lutonix =89,7% Zilver PTX Resilient (Lifestent) Durability II (Everflex) Complete SE Stroll (SMART) Kaplan-Meier Analysis from public data results as reported in different studies, with different protocols and different patient population. Not intended for head to head comparisons. Viastar (Viabahn w/ propaten) Superb (Supera)
15 Walking Distance Score Reported Patient Benefits WIQ Walking Distance Lutonix DCB Standard PTA = 31.5 = Baseline 12 Months Lutonix DCB Baseline 12 Months Standard PTA Sub Group analysis. Study endpoint not powered for statistical significance
16 Free from Same/Increase Rutherford (%) Reported Patient Benefits Improvement in Rutherford Class Lutonix DCB Standard PTA Survival % Time Lutonix DCB Standard PTA 365 days 82.7% 73.4% Months from Randomization Date Sub Group analysis. Study endpoint not powered for statistical significance
17 Free from Primary Safety Event (%) Freedom from Primary Safety Event Lutonix DCB Standard PTA Survival % Time Lutonix DCB Standard PTA P-value 365 days 86.7% 81.5% Months from Randomization Date
18 Other Secondary Safety Endpoints Outcome Composite Safety Events Lutonix DCB n/n (%) Standard PTA n/n (%) 240/286 (83.9%) 113/143 (79.0%) Difference % [95% CI] 4.9% [-3.0, 12.8] Death 7/290 (2.4%) 4/144 (2.8%) -0.4% [-3.6, 2.8] Major Amputation 1/286 (0.3%) 0/140 (0.0%) 0.3% [-0.3, 1.0] Rate of embolism 1/316 (0.3%) 1/160 (0.3%) Reintervention for Thrombosis 1/285 (0.4%) 1/140 (0.7%) -0.4% [-1.9, 1.2]
19 Demonstrated Safety of Lutonix DCB Low rate of embolic events, similar to PTA Low rates of re-intervention due to thrombosis, similar to PTA Every adverse event (including serious and nonserious) was adjudicated in Levant 2 by an independent panel of medical experts.
20 Insights from the Global Real World SFA Registry (interim Update)
21 Baseline DCB Demographics Levant 2 vs Global SFA Registry * Levant2 DCB (316) Global SFA Registry (691) * Interim Results N = 289 Age, Mean ± SD (n) 67.8 ± 10.0 (316) 68.3 ± 9.8 (691) Male gender, % (n/n) 61.1% (193/316) 67.6% (467/691) Obesity 34.8% (110/316) Current Smoker 35.1% (111/316) 36.5% (252/690) Dyslipidemia 89.6% (283/316) 69.9% (483/691) Diabetes 43.4% (137/316) 39.5% (273/691) Hypertension 89.2% (282/316) 85.2% (589/691) Rutherford Grade % (93/316) 17.6% % (198/316) 62.5% 4 7.9% (25/316) 7.3% 5 and 6 0.0% (0/316) 1.6%
22 DCB Angiographic Demographics Levant 2 vs Global SFA Registry * Levant2 DCB (316) Global SFA Registry (691) Two lesions treated 1.9% (6/316) 14.2% (98/688) Total Lesion Length (mm) 62.7 ± 41.4 (315) ± 84.2 (684) Treated Length (mm) ± 47.0 (316) ± (202) Calcification 59.2% (187/316) 34.2% (235/687) Total Occlusion 20.6% (65/316) 30.9% (212/686) Lesion Locations SFA 90% (285/316) 70% (477/678) Proximal Popliteal 4.7% (15/316) 16.8% (114/678) Mid & Distal Popliteal 5.0% (16/316) 12.8% (87/678) %DS post-treatment 23.4 ± 12.3 (316) 14.3 ± 18.3 (680) Bail-out Stenting 2.5% (8/316) 27.6% (191/691) Dissection 63.7% (200/314) 38.1% (263/691) * Interim Results N =
23 Primary Patency Levant 2 and Global SFA Registry * 12 Month Primary Patency 81.7% 73,5% Levant 2 Trial SFA Global Registry * Interim Results N = 289 ** Kaplan Meier analysis, 77 events 179 at risk *** Site reported primary patency 25
24 Freedom from TLR Levant 2 and Global SFA Registry * 12 Month Freedom from TLR 89,7% 88.5% Levant 2 Trial SFA Global Registry * Interim Results N =
25 Secondary Safety Endpoints Levant 2 and Global SFA Registry * Outcome Levant2 Global SFA Registry Composite Safety Events 240/286 (83.9%) Death 7/290 (2.4%) 5/267 (1.9%) Major Amputation 1/286 (0.3%) 0/262 (0.0%) Rate of embolism 1/316 (0.3%) 2/264 (0.8%) Reintervention for Thrombosis 1/285 (0.4%) 0/262 (0.0%) * Interim Results N = 289
26 Effectiveness Without Compromising Safety Levant 2 demonstrated superior patency for Lutonix DCB against PTA 29.4% Improved patency over PTA Lutonix DCB effective in challenging patient population TLR rates of 89% consistent in both Clinical Trial and Real-World Registry Levant 2 demonstrated safety of Lutonix DCB Low rates of re-intervention for thrombosis and embolism No unanticipated safety events in over 1000 patients * Patients who received Lutonix DCB reported Clinical Benefits in Levant 2 Sustained improvement in Rutherford Class Improvement in self-reported Walking Distance scores * Levant 2 roll-ins, Levant 2 randomized trials and Levant 2 Continued Access Registry
27 Effectiveness Without Compromising Safety Levant 2 demonstrated superior patency for Lutonix DCB against PTA 29.4% Improved patency over PTA Lutonix DCB effective in challenging patient population TLR rates of 89% consistent in both Clinical Trial and Real-World Registry Levant 2 demonstrated safety of Lutonix DCB Low rates of re-intervention for thrombosis and embolism No unanticipated safety events in over 1000 patients * Patients who received Lutonix DCB reported Clinical Benefits in Levant 2 Sustained improvement in Rutherford Class Improvement in self-reported Walking Distance scores * Levant 2 roll-ins, Levant 2 randomized trials and Levant 2 Continued Access Registry
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