OCT Guided Atherectomy: Initial Results of the VISION Trial Using the Pantheris Catheter. Patrick Muck, MD

Transcription

1 OCT Guided Atherectomy: Initial Results of the VISION Trial Using the Pantheris Catheter Patrick Muck, MD Chief, Division of Vascular Surgery Good Samaritan Hospital Cincinna<, OH, USA Program Director, Vascular Surgery Residency Good Samaritan Hospital Cincinna<, OH, USA

2 Disclosures Speaker s Bureau: WL Gore Abbott Stockholder: Avinger Hansen Medical/Scientific Boards: Abbott

3 My Background Vascular Surgeon 12 th year of Practice Little Atherectomy >120 Endarterectomies/year Carotid/Femoral

4 EEL MEDIA DISEASE Inves&gator Device. Limited by Federal (U.S.) law for inves&ga&onal use only. Not available for sale un&l CE marked.

5 CUTTING & REVIEWING TROUGHS CUTTING TROUGH USING OCT GUIDANCE REVIEWING TROUGHS MEDIA MEDIA POST-CUT TROUGH EEL EEL POST-CUT TROUGH ECCENTRIC DISEASE Inves&gator Device. Limited by Federal (U.S.) law for inves&ga&onal use only. Not available for sale un&l CE marked.

6 PANTHERIS TISSUE SPECIMENS PRE OCT POST PANTHERIS PANTHERIS TISSUE SPECIMEN

7 Iden%fy Eccentric Disease

8 Visualize Debulking

9 PANTHERIS TISSUE HISTOLOGY INTIMAL PLAQUE 94.43% MEDIAL TISSUE 5.57% ADVENTITIAL TISSUE 0%

10 MAJOR INCLUSION CRITERIA Patient is 18 years old Patient is candidate for percutaneous intervention for PAD Rutherford Classification 2-5 RVD 3.0 mm and 7.0 mm by visual estimation De novo target lesion(s) with stenosis 70%. No more than 2 lesions may be treated. Target lesion length 15 cm (may be two tandem lesions that do not exceed 15 cm in length) At least one patent tibial run-off MAJOR EXCLUSION CRITERIA Moderate to severe calcification Target lesion stenosis < 70% Target lesion within graft or target lesion in the iliac artery In-stent restenosis within the target lesion Acute ischemia and/or acute thrombosis Significant ( 70%) lesions proximal to the TL not successfully treated during the index procedure (i.e., iliac lesion treated prior to target lesion treatment on same day) Lesion in the contralateral limb requiring intervention during the index procedure or within 30 days from index procedure

11 TREATED COHORT (PER PROTOCOL) Patients (n=130) Lesions (n=164) NO FOLLOW-UP AVAILABLE AT 30 DAYS Patients (n=2) FOLLOW-UP AVAILABLE AT 30 DAYS Patients (n=128)

12 SAFETY & EFFICACY ENDPOINTS ENDPOINTS BASELINE 30 DAYS 6 MONTHS PRIMARY 50% Residual Stenosis post Pantheris* EFFICACY SECONDARY 30% Post Pantheris* +/- adjunctive treatment Change from baseline: Ankle-brachial Index Rutherford Quality of Life Change from baseline: Ankle-brachial Index Rutherford Quality of Life SAFETY PRIMARY Device related events (Acute) Clinically significant perforation Clinically significant dissection Clinically significant embolus Pseudoaneurysm Freedom from MAEs thru 6M (Data collection ongoing) Cardiovascular Related Death Unplanned, major index limb amputation Clinically driven target lesion revascularization (TLR) Myocardial infarction SECONDARY Freedom from procedural emboli Freedom from MAEs Freedom from clinically driven TVR

13 EFFICACY ENDPOINTS PRIMARY EFFICACY ENDPOINT (LESIONS) POST PANTHERIS STENOSIS 50% Performance Goal: Lower bound 1-sided confidence interval >87% Adjudicated Efficacy: 96% (157/164) PASSED* (1-sided 95% CI = 92.3%) PASSED* SECONDARY EFFICACY ENDPOINT POST PANTHERIS +/- ADJUNCTIVE THERAPY STENOSIS 30% LESIONS TREATED POST (164) PRE-STENOSIS (162) ± 9.6% 78.7 ±15.2% % ARTERIAL STENOSIS * Analyzed by imaging core lab 1 % Arterial stenosis for N=2 lesions could not be analyzed at baseline.

14 CO-MORBIDITIES & DEMOGRAPHICS CO-MORBIDITIES DEMOGRAPHICS CO-MORBIDITIES PER PROTOCOL COHORT (N=130) DEMOGRAPHICS PER PROTOCOL COHORT (N=130) Smoking 83.1% (108/130) Diabetes Requiring Therapy 43.1% (56/130) Average Age (yrs) Mean ± Stdev (N) Gender, % (m/n) Female 67.4 ± 10.6 (130) 44.6% (58/130) Hypertension Requiring Intervension 93.1% (121/130) Gender, % (m/n) Female 55.4% (72/130) Coronary Artery Disease 60.0% (78/130) Other Vascular Disease 83.8% (109/130) Average BMI Mean ± Stdev (N) 28.2 ± 5.9 (130)

15 BASELINE LESION CHARACTERISTICS LESION LOCATION A, % (M/N) SFA 82.9% (136/164) Proximal 18.9% (31/164) Mid 40.2% (66/164) Distal 23.8% (39/164) SFA / POPLITEAL 6.1% (10/164) Popliteal 11.0% (18/164) TASC A, % (M/N) A % (125/162) B 19.8% (32/162) C 2.5% (5/162) CALCIFICATION B, % (M/N) None 23.8% (39/164) Mild 75.6% (124/164) Moderate 0.6% (1/164) LESION TYPE B, % (M/N) De Novo 100.0% (164/164) LESION LENGTH A, % (M/N) Mean ± Stdev (N) 5.5 ± 4.1 (162) CTO Subset Mean ± Stdev (N) 8.2 ± 3.9 (33) 1 REFERENCE VESSEL DIAMETER A, (MM) Mean ± Stdev (N) 4.7 ± 0.8 (162) PRE-PROCEDURE STENOSIS A, % (M/N) Mean ± Stdev (N) /- 15.2% (164) PER PROTOCOL COHORT / NUMBER OF LESIONS TREATED (N=164) A. Analyzed by imaging core lab B. Site reported data

16 STANDALONE & ADJUNCTIVE THERAPY TOTAL COHORT BY LESION LENGTH THERAPY (N=164) % LESION TREATED (PRIMARY COHORT) 60 Pantheris (Standalone) 55.5% (91/164) Pantheris + PTA 40.2% (66/164) Pantheris + PTA + Stent 4.3% (7/164) LESIONS TREATED <5cm (n=98)* 5-10cm (n=40)* >10-15cm (n=24)* * Excludes 2 subjects where baseline lesion length could not be assessed by Core Lab. Pantheris (Standalone) Pantheris + PTA Pantheris + PTA + Stent

17 CTO SUB-GROUP ANALYSIS (N=33) PRIMARY COHORT ALL CTO LESIONS (N=33) a LESION LENGTH <5CM (N=98) b LESION LENGTH 5-10CM (N=40) b LESION LENGTH >10-15CM (N=24) b 20.4% (33/162) 8.2% (8/98) 37.5% (15/40) 41.7% (10/24) a Determination of CTO based on imaging Core Lab (CL) assessment. b Excludes 2 subjects where lesion length could not be assessed by CL TREATMENT Pantheris (standalone): 39.4% (13/33) Pantheris + PTA: 57.6% (19/33) Pantheris + PTA + Stent: 3.0% (1/33)

18 ANKLE BRACHIAL INDEX (ABI) (P<0.0001) RUTHERFORD CATEGORY (P<0.0001) N=112 N= ± ± 0.16 (n=128) 1 (n=112) 2 Baseline (n=130) 30 Day (n=124) Baseline (n=130) 30 Day (n=124) 3 1 Two patients at baseline did not receive ABI 2 12 patients at 30 days did not receive ABI 3 Six patients did not have Rutherford assessed at 30 days

19 MAJOR ADVERSE EVENTS (MAES) THROUGH 30 DAYS a 30 DAY MAE PER PROTOCOL COHORT (N = 130 PATIENTS b ) Overall MAE Rate 7% (9/128) MAEs Cardiovascular Related Death 3.1% (4/128) Unplanned, major index limb amputation 0% (0/128) Target lesion revascularization (TLR) 0% (0/128) Myocardial infarction (MI) 0% (0/128) DEVICE RELATED EVENTS 3.9% (5/128) Pantheris Related Occlusion Sheath Related Perforation 0% (0/128) 0% (0/128) Dissection 0% (0/128) 0.8% (1/128) Embolus 2.3% (3/128) 0% (0/128) Pseudoaneurysm 0% (0/128) 0.8% (1/128) a Adjudicated by Clinical Events Committee ab Excludes 2 patients who did not return for 30 day follow-up visit

20 % ADVENTITIA IN ATHERECTOMY TISSUE HISTOLOGIC ANALYSIS FOLLOWING RETRIEVAL OF PANTHERIS ATHERECTOMY SPECIMENS KEY TISSUE CHARACTERISTICS BY LESION (N=164) N=10 N=10 N=10 % Adventitia Area all Lesions 1.02% ± 3.4 (162) 1 0% Adventitia 61.7% (101/162) 1 5% Adventitia 94% (152/162) 1 N=31 N=101 0% (No Adventitia) 0-1% 1-2% 2-5% >5% 1 Tissue not analyzed on two lesions

21 % ADVENTITIA BY AREA 1.19% ± 4.15 PER LESION LENGTH 1 (N=96) % ± % ± 1.84 (N=40) 3 (N=24) % STENOSIS Pre % Stenosis 4 Post Pantheris +/- Adjunctive % Stenosis <5cm (n=98) 5-10cm (n=40) >10-15cm (n=24) 1 Sponsor reported 2 Excludes two lesions where % adventitia not available 3 Excludes two lesions where baseline length not determined 4 Assessed by imaging core lab 5 Post procedure stenosis includes entire treatment zone as determined by core lab

22 Single Center Experience (Good Sam Cincinna% (GSC)) vs. Primary Cohort(PC) Standalone Pantheris: GSC: 100% (n=7) PC: 55.5% (n= 91) Stent Usage: GSC: 0% (n=7) PC: 4% (n=164) %Adven%%a by area 0.12% 1.02% 75% 50% 25% CTOs Treated: GSC: 14% (n=1) PC: 20.4% (n=33) 0% N=7 N=7 N=162 N=164 GSC PC %Pre Stenosis %Post Stenosis

23 VISION primary cohort 6-month follow-up currently underway.

24 CONCLUSIONS VISION TRIAL Primary efficacy endpoint achieved 55% standalone OCT guided atherectomy (n=164) 4% stent rate in Primary Cohort; 3% stent rate in CTO subset Statistically significant ABI and Rutherford improvement at 30 days 6 month safety + efficacy data collection ongoing ATHERECTOMY TISSUE ANALYSIS 1.02% adventitia by area across all lesions treated (n=162)* 94% of lesions treated with 5% adventitia by area (n=152)* *2 lesions without histology assessment

25 Thank You

26 OCT Guided Atherectomy: Initial Results of the VISION Trial Using the Pantheris Catheter Patrick Muck, MD Chief, Division of Vascular Surgery Good Samaritan Hospital Cincinna<, OH, USA Program Director, Vascular Surgery Residency Good Samaritan Hospital Cincinna<, OH, USA