Update from Korea on the Lutonix SFA registry 12 month data

Transcription

1 Update from Korea on the Lutonix SFA registry 12 month data Prospective, Multicenter, Post-Market Registy Assessing the Clinical Use and Safety of the Lutonix Drug Coated Balloon in Femoropopliteal Arteries Je Hwan Won, MD Division of Interventional Radiology, Radiology Department Ajou University Hospital, S. Korea

2 Disclosure Speaker name: Je Hwan Won... I have the following potential conflicts of interest to report: Consulting Employment in industry Stockholder of a healthcare company Owner of a healthcare company Other(s) v I do not have any potential conflict of interest

3 DCB reimbursement in Korea 2 DCBs for SFA 1 DCB for Popliteal Reimbursement of DCBs for Femoropopliteal artery 70% stenosis in De novo 50% stenosis in ISR 2 for SFA, 1 for Popliteal 1 bail-out stent can be reimbursed for the 50% residual stenosis or dissection On-going discussions for the expansion of DCB reimbursement indication (BTK, AV)

4 Not All DCBs are created Equal Lutonix 035 DCB Other DCB Carrier: Polysorbate & Sorbitol (IV approved carriers) PTX Dose: 2µg/mm 2 Plasma Half-Life: 6.9 hours Carrier: Urea PTX Dose: 3.0µg/mm 2 Plasma Half-Life: 72.5 hours

5 Other DCB Other DCB ng /g ng /g Downstream Safety in a Porcine Model Downstream Paclitaxel Concentration: Lutonix (2µg/mm 2 ) vs. Other DCB (3.0µg/mm 2 ) Skeletal Muscle Lutonix 1,3 60,8 47x More 28 day (1x dose) Other DCB Coronary Band LUTONIX LUTONIX Lutonix 1, x More 28 day (1x dose) Other DCB Kolodgie et al, JVIR D R1. Preclinical results may not be indicative of clinical performance. Different test methods may yield different results. Lutonix showed significantly lower downstream paclitaxel levels Coronary band BPV/LTNX/0816/0086c

6 LUTONIX Korean Registry Prospective, Multicenter, Post-Market Registry Assessing the Clinical Use and Safety of the LUTONIX 035 Drug Coated Balloon in Femoropopliteal Arteries

7 Study Design Study Design A Prospective, Multicenter, Single Arm, Post-Market Registry Objective Number of Patients/Sites Inclusion Criteria Exclusion Criteria Selected Endpoint To assess the clinical use and safety of the Lutonix Drug Coated Balloon Catheter in a heterogeneous patient population in real world clinical practice. Approximately 250 subjects at up to 16 sites in Korea Rutherford Clinical Category 4, Stenotic or obstructive vascular lesions Inadequate distal outflow Primary Effectiveness: Freedom from target lesion revascularization(tlr) at 12 months Primary Safety: Freedom at 30 days from the *composite endpoint *: target vessel revascularization (TVR) and target lesion revascularization (TLR), major amputation and major reintervention (new bypass graft, jump/interposition graft revision, or thrombectomy/thrombolysis) of index limb and device- and procedure-related death.

8 Subject Disposition Lutonix Korea registry (N=249) Enrolled 249 (100.0%) Completed 6 month (180 days) 241 (96.8%) Completed 12 month (365 days) 232 (93.2%) Discontinued prematurely 16 (6.4%) Withdrawal of consent 1 (0.4%) Death 11 (4.4%) Lost to follow-up 2 (0.8%)

9 Baseline DCB Demographics Class. Description Korean registry (N=249) Age(Years) Mean (SD) 69.1±10.46 Gender Male 212 (85.1%) Female 37 (14.9%) DM 149 (59.8%) Risk Factor Dyslipidemia 49 (19.7%) Hypertension 176 (70.7%) Cigarette smoking 106 (42.6%) Class 1~2 45.5% Rutherford Grade Class % Class % Class 5~6 -

10 DCB Angiographic Demographics Classification Korean registry (N=249) Number of Lesions=338 Target Lesion Length (mm) (79.42) Calcification 256 / 338 (75.7%) Chronic Total Occlusion 143 / 338 (42.3%) Lesion Locations SFA 248 / 338 (73.3%) Proximal Popliteal 53 / 338 (15.6%) Mid & Distal Popliteal 37 / 338 (10.9%) Bail-out Stenting 22 / 249 (8.8%)

11 Pretreatment and bailout stenting Variables N=249 Comment Pretreatment Balloon angioplasty 225 / 249 (90.4%) Atherectomy 15 / 249 (6.0%) Others 1 / 249 (0.4%) Cutting balloon Post-DCB treatment Balloon angioplasty 20 / 249 (8.0%) Bail-out stenting 22 / 249 (8.8%) 20 BMS/ 2 Covered stent Device Success: 100.0% Procedural Success*: 96.3% *: residual stenosis > 30% and AE(death, stroke, MI, emergent surgical revascularization, significant distal embolization in the target limb, and thrombosis of the target vessel)

12 Primary Safety Endpoint Free from * composite events through 30 days N 247 / DAYS % [95% CI] 99.2% [96.8%, 99.8%] *: target vessel revascularization (TVR) and target lesion revascularization (TLR), major amputation and major reintervention (new bypass graft, jump/interposition graft revision, or thrombectomy / thrombolysis) of index limb and device- and procedure-related death.

13 Primary safety endpoint at 1 month Variables N=249 Comment TVR 1 TLR 1 LT SECOND TOE WOUND and 100% Stenosis Occlusion of LT. POPLITEAL ARTERY Major reintervention - Death - Procedure-related - Device-related - Major index limb amputation - * Minor index limb amputation *: was not in the list of primary safety endpoint 1 LT 4th toe ray amputation

14 2 composite events within 30 days EVENT 1 Primary treatment: Pre-dilatation + DCB only + Post-dilatation Over 50% residual stenosis 17 days Reason for Re-Intervention: LT SECOND TOE WOUND and 100% Stenosis Location: Target vessel and non-target lesion Treatment: PTA, Stenting EVENT 2 Primary treatment: Pre-dilatation + DCB only 20% residual stenosis 25 days Reason for Re-Intervention: Occlusion of LT POPLITEAL ARTERY Location: Target lesion Treatment: PTA, Stenting

15 Primary Efficacy Endpoint at 1 year Subjects Free from TLR Number of Subjects with TLR 180 DAYS DAYS 12 Estimates of Subjects Free from TLR [95% CI] 98.4% [95.7%, 99.4%] 95.0% [91.3%, 97.1%]

16 LUTONIX Global SFA Registry Prospective, Multicenter, Post-Market Registry Assessing safety, clinical benefit, and outcomes of the Lutonix 035 drug-coated balloon (DCB) in a heterogeneous, real-world patient population at 12 and 24 months in Femoropopliteal Arteries

17 Baseline DCB Demographics Global registry (N=691) Korean registry (N=249) Age, Mean ± SD (n) 68.2 ± 9.8 (691) 69.1±10.46 Male gender, % (n/n) 67.9% (469/691) 85.1% Obesity 24.7% (164/665) Current Smoker 36.9% (254/689) 42.6% Dyslipidemia 70.0% (484/691) 19.7% Diabetes 39.5% (273/691) 59.8% Hypertension 84.9% (587/691) 70.7% Rutherford Glade Class 1~2 20.6% (142/689) 45.5% Rutherford Glade Class % (461/689) 41.3% Rutherford Glade Class 4 7.4% (51/689) 13.2% Rutherford Glade Class 5~6 1.6% (11/689) -

18 DCB Angiographic Demographics Classification Global registry (N=691) Korean registry (N=249) > Two lesions treated 15.6% (108/691) Total Lesion Length (mm) ± 84.2 (685) Treated Length (mm) ± 89.7 (689) Calcification 50.2% (238/474) 75.7% Chronic Total Occlusion 31.2% (214/686) 42.3% Lesion Locations SFA 70.0% (483/690) 73.3% Proximal Popliteal 16.8% (116/690) 15.6% Mid & Distal Popliteal 13.1% (91/690) 10.9% Final %Diameter Stenosis 14.6 ± 18.6 (680) Bail-out Stenting 25.2% (174/690) 8.8% Dissection 18.4% (127/690) 2.8%

19 Lutonix Global SFA Real-World Registry 12 months results MEASURE % (n / N) Korean Registry 30-day Safety % (681/685) 99.2% Free from TLR 93.4% (605/648) 95.0% 1 Freedom at 30 days from TVR, major index limb amputation, and device-and procedure-related death ALL SAEs adjudicated. Study monitored.

20 Lutonix Global SFA Real-World Registry 24 months results MEASURE % (n / N) Free from TLR 89.3% (526/589) 1 Secondary endpoint. Clinical primary patency of the target lesion was reported by the investigator based on presenting symptoms and clinical exam.

21 Conclusions Lutonix DCB Korean registry data shows acceptable safety at 1 month and shows 98.4% at 6 months and further 95.0% at 1 year of freedom from TLR, respectively The results of Lutonix Korean registry are correspond to the results of the global registry. This study have great significance since it shows the efficacy and safety of Lutonix DCB for the large Asian population. Adequate vessel preparation seems to be a critical success factor for the drug delivery and the long-term result of DCB procedure Downstream effect should be considered when you re using multiple DCBs

22 Update from Korea on the Lutonix SFA registry 12 month data Prospective, Multicenter, Post-Market Registy Assessing the Clinical Use and Safety of the Lutonix Drug Coated Balloon in Femoropopliteal Arteries Je Hwan Won, MD Division of Interventional Radiology, Radiology Department Ajou University Hospital, S. Korea