TOBA II 12-Month Results Tack Optimized Balloon Angioplasty

Transcription

1 TOBA II 12-Month Results Tack Optimized Balloon Angioplasty William Gray, MD System Chief, Cardiovascular Division Main Line Health, Philadelphia, PA

2 Dissection: The Primary Mechanism of Angioplasty Lesions with dissections have a TLR rate 3.5 times higher than lesions without dissection 1 Current tools for dissection repair have limitations 1 Kokkinidis, Intervent Cardiol Clin 2017 Images 2018 Intact Vascular, Inc.

3 Tack Endovascular System Addresses stent drawbacks with novel design: ATK Tack Implant for post-pta dissection repair Six pre-loaded implants on a single delivery system 6mm deployed length Self-sizing Nitinol fits vessel diameters mm CAUTION: Investigational device. Tack Endovascular System is limited by Federal (United States) law to investigational use. Not approved for sale in the United States. Tack Endovascular System is CE Mark authorized under EC Directive 93/42/EEC. Tack Endovascular System and Tack are registered trademarks of Intact Vascular, Inc.

4 TOBA II Study Design Prospective, multi-center, single-arm, non-blinded study in US, Europe 213 subjects, all with post-pta dissection following POBA (n=90) or Lutonix angioplasty (n=123) Primary Safety Endpoint: Primary Efficacy Endpoint: Key Observational Endpoints: Tack Optimized Balloon Angioplasty Study for Post-Dissection Repair of the Superficial Femoral and Proximal Popliteal Arteries (TOBA II) Freedom from the occurrence of any new-onset MAE(s) at 30 days: Index limb amputation (above the ankle) CEC adjudicated CD-TLR All-cause death at 30 days Primary patency at 12 months: Freedom from CEC adjudicated CD-TLR and Freedom from core lab adjudicated DUS-derived binary restenosis (PSVR 2.5) Freedom from CEC adjudicated CD-TLR Tack Performance: Dissection Resolution, Migration and Fracture Changes in Rutherford, ABI and Quality of Life measures Angiographic Core Laboratory: Yale Cardiovascular Research Group (New Haven, CT) Vascular Ultrasound Core Laboratory: VasCore (Boston, MA) Clinical Events Committee: Yale Cardiovascular Research Group (New Haven, CT)

5 TOBA II Key Eligibility Criteria Inclusion Criteria RVD mm, inclusive De novo or non-stented restenotic lesion in SFA and/or P1: 70 99% stenosis: length mm 100% occlusion: length 100mm Presence of 1 patent (DS% <50) infrapopliteal vessel Post-PTA residual DS 30% AND Presence of at least one dissection Grade A to F Exclusion Criteria Previous bypass in target limb Acute/sub-acute thrombosis and/or occlusion Post-PTA residual DS >30% Severe calcium

6 Key Baseline Patient and Lesion Characteristics (Intent to Treat Population) Patient Characteristics Mean ± SD (N) or n/n (%) Age (y) 68.2 ± 9.1 (213) Male gender 151/213 (70.9%) BMI 29.3 ± 6.1 (212) ABI in treated leg 0.76 ± 0.21 (200) Rutherford /213 (31.9%) 136/213 (63.8%) 9/213 (4.2%) Diabetes mellitus 92/213 (43.2%) Coronary disease 128/211 (60.7%) Renal insufficiency 19/213 (8.9%) Hypertension 191/213 (89.7%) Hyperlipidemia 184/211 (87.2%) Lesion Characteristics Target vessel: SFA P1 SFA and P1 Mean ± SD (N) or n/n (%) 184/211 (87.2%) 12/211 (5.7%) 15/211 (7.1%) Target lesion length (mm) 74.3 ± 40.6 (210) PTA treated length (mm) 96.7 Calcification: Proximal RVD (mm) Distal RVD (mm) 5.3 ± 0.7 (211) 5.5 ± 0.7 (211) Total Occlusion 49/211 (23.2%) Moderate Severe Patent Run-Off Vessels: /211 (53.6%) 12/211 (5.7%) 6/207 (2.9%) 72/207 (34.8%) 86/207 (41.5%) 43/207 (20.8%)

7 TOBA II Primary Endpoints Met 213 subjects with post-pta dissection following POBA (n=90) or Lutonix angioplasty (n=123) Safety 1 Population Met/Not Met p-value* 30-Day Freedom from MAE: Index limb amputation CD-TLR All-cause death Intent to Treat (n=212) MET < Efficacy 2 Population Met/Not Met p-value* Primary Patency at 12 Months: Freedom from CEC adjudicated CD-TLR and Freedom from core lab adjudicated DUS-derived binary restenosis (PSVR 2.5) Intent to Treat (n=183) MET Per Protocol (n=176) MET *Fisher s exact test for one proportion, p-values and 95% CI are one-sided 1 Objective PG derived from VIVA PG: Rocha-Singh, Catheter Cardiovasc Interv Objective PG derived from LEVANT 2: Rosenfield, N Engl J Med 2015

8 12 Month Kaplan-Meier Estimates (Core lab adjudicated) Primary Patency 79.3% Freedom from Clinically Driven Target Lesion Revascularization (CD-TLR) (%) % Dissected Vessel Population Dissections are site-reported (visual estimate during index procedure); 99.5% core-lab adjudicated dissection rate Freedom from CD-TLR 86.5% Days since Index Procedure Database Date: 17Jun2018

9 % of Subjects (N=209) Pre-Tack: Dissection Severity (Core lab adjudicated) 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Number of dissections per subject 44.5% 1.8 ± 0.9 (209) Mean dissection length (mm) 20.7 ± 21.4 (368) 20.1% 24.4% 10.0% 0.5% 0.5% No dissection A B C D E F Pre-Tack Worst Dissection Grade Mean ±SD (N) or n/n (%) Total number of dissections % of subjects had a dissection Grade C before using Tack

10 % of Dissections (N=369) Post-Tack: Dissections Resolved (Core lab adjudicated) 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 92.1% 92.1% of all dissections were completely resolved with Tack Post PTA 2 Post Tack Grade C 69.4% Tacks (core lab) of subjects (core had lab) a dissection Grade C before using Tack No dissection 0% No dissection Post-Tack Dissection Grade Images courtesy of Prof. Marianne Brodmann, MD

11 Tack Stability and Durability Mean ±SD (N) or % (n/n) Total number of Tack implants deployed 871 Number of dissections per subject 1.8 ± 0.9 (209) Number of Tack implants per subject 4.1 ± 2.5 (213) Bailout stent rate 0.5% (1/213) Freedom from Tack fracture at 12 months 100% Freedom from Tack migration at 12 months 99.9% (870/871*) *2.6mm per core lab at 12-month X-ray

12 % of Patients Significant, Sustained Clinical Improvement Rutherford Clinical Category ABI WIQ PAQ 70% p< p< p< % % 63% improved 2 classes % 30% 20% 10% p< M Baseline % Rutherford Clinical Category All p-values calculated using Wilcoxon Signed Rank Test These analyses were not included in the overall Type I error control for the study

13 Patency Observations: DCB Group Longer lesions More total occlusions More severe dissections Sustained DCB patency rate when using Tack in a more complicated patient population Lesion Length (mm) % Total Occlusion % Dissection C K-M Patency 1 Rosenfield, N Engl J Med 2015 TOBA II DCB LEVANT II DCB Observational data only Patient populations and study methodologies differed Not powered for statistical significance

14 Patency Observations: POBA Group Comparable length Fewer total occlusions More severe dissections Notably higher patency rate using Tack with POBA Lesion Length (mm) % Total Occlusion % Dissection C K-M Patency 1 Rosenfield, N Engl J Med 2015 TOBA II POBA LEVANT II POBA Observational data only Patient populations and study methodologies differed Not powered for statistical significance

15 Tack: A New Therapy for Dissection Repair TOBA II: Unique trial: first IDE to enroll 100% dissected vessels Successfully met primary safety and efficacy endpoints Demonstrated that Tack effectively repairs dissections after POBA/DCB with: Minimal metal footprint Stable and durable design Preserved future treatment options Bailout stent rate 0.5% High patency rate (79.3%) and high freedom from CD-TLR (86.5%) position Tack to be a clinically important treatment option for focal dissection repair after balloon angioplasty