Maximizing Outcomes in a complex population with Drug-coated balloon

Transcription

1 Maximizing Outcomes in a complex population with Drug-coated balloon March 13, 2018 Chumpol Wongwanit, MD Siriraj Hospital, Mahidol University, Bangkok, Thailand LINC Asia-Pacific 2018, Hong Kong

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3 Disclosure Speaker name: Chumpol Wongwanit, MD 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) I do not have any potential conflict of interest

4 Background Global registries are evaluating performance of DCBs in a realworld population Most studies have strict exclusion criteria on patients with RC5 & RC6, allowing for enrollment of claudicants with a small number of CLI patients More data in complex patients is needed Which DCB performs well in severely diseased population?

5 Drug Coated Balloons are proven in different global registries (all-comers 12 months) STUDY DEVICE Av. Lesion Length. PP FTLR Bailout stent BIOLUX P-III (n=700) 1 Passeo-18 Lux 8.5 cm 85.2% 94.8% 16.7% Illumenate Global (n=371) 2 Stellarex 7.5 cm 81.45% 94.0% 17.3% Lutonix Global (n=691) 3 Lutonix 10.1 cm 85.4% 94.13% 25.2% In.Pact Global (n=1406) 4 In.Pact Admiral 11.1 cm N/A % Ranger SFA Registry (n=172) 5 Ranger 12.9 cm 84.0% N/A 22% Are all DCBs created equal? BIOLUX P-III all-comers: LINC 2018 Illumenate Global : Schroë H. et al, Catheter Cardiovasc Interv 2017 Lutonix Global: Thieme M. et al, JACC: Cardiovascular Interventions 2017 In.Pact Global: Jaff MR, VIVA 2016 Current Data and Performance of Drug Eluting Technology in SFA: M. LINC 2018

6 BIOTRONIK Passeo-18 Lux DCB Passeo-18 Lux Specifications Passeo-18 balloon Platform Controlled compliance Low profile Highly deliverable 2 Paclitaxel : 3 mg/mm Excipient: BTHC (Butyryl-tri-hexyl citrate) Hydrophobic Sizes available : mm diameter mm length SafeGuard Insertion Aid Lux Coating Technology Clinically Proven

7 % of total drug load Passeo-18 Lux Key Elements for Success Protect SafeGuard insertion aid minimizes losses in sheath Distal End Raised Portion Crimped End (1.49% drug loss) 94% Passeo-18 Lux Drug Loss in Introducer Sheath Valve 1 Deliver The hydrophobic nature of the BTHC excipient improves coating adhesion to the balloon surface and maximizes drug availability at the lesion site Coating Integrity 2 After submerging and deployment of a 5x40mm balloon in physiological solution at 37ºC 100,0% Transfer / Retain The Lux coating formulation results in a micro-crystalline Paclitaxel structure which assures an optimal tissue absorption and retention upon vessel contact 75,0% 50,0% Passeo-18 Lux In.Pact Admiral Lutonix Passeo-18 Lux 4/120/130 with Cordis Avanti Plus 4F 11 cm, w & w/o SafeGuard insertion aid 2 In water Data on file at BIOTRONIK (IIB Test)

8 Passeo-18 Lux Clinical Program RCT Passeo-18 Lux vs PTA, femoro-popliteal artery (N= 60 pts) RCT Passeo-18 Lux vs PTA, infra-popliteal artery (N= 72 pts ) Prospective, single arm study, femoro-popliteal artery (N= 158 pts) Global Prospective Registry, infra-inguinal artery (N= 882 pts) BENELUX SPAIN Prospective Registry, focus on isolated Popliteal Lesions (N= 100 pts) Prospective Registry, focus on Long Lesions (N= 150 pts)

9 BIOLUX P-III Study Prospective, global, multi-centre, Real-World All-Comers registry to further investigate Passeo-18 Lux DCB Efficacy and Safety in Infra-inguinal arteries in a Real-World Environment PRIMARY ENDPOINTS: Freedom from MAE 1 at 6 months Freedom from CD-TLR 2 at 12 months Inclusion Criteria Lesion(s) in the infra-inguinal arteries suitable for endovascular intervention, treated with or scheduled to be treated with the Passeo-18 Lux drug coated balloon Exclusion Criteria Failure to successfully cross the target lesion with a guide wire BIOLUX P-III is the only Real -World Registry in Infra-inguinal arteries : No patient characteristic limitations No lesion characteristic limitations Use of additional devices allowed 47 sites, 16 countries (EU, Australia, Asia)

10 BIOLUX P-III Cohorts and Subgroups TASC C n = 114 N = years n = 517 N = 634 Occlusion n = 189 N = 244 n = # subjects from the subgroup in the All-Comers population N = # subjects from the subgroup in the Full Cohort population Heavily calc. n = 75 N = 141 CLI n = 237 N = 332 Diabetes n = 328 N = 420 All-Comers Cohort n=700 Full Cohort N=882 RC 3 n = 489 N = 649 Popliteal lesions n = 150 N = 225 Renal Insuf. n = 258 N = 327 BTK n = 75 N = 150 Not pre defined subgroup ISR n = 81 N = 94 TASC D n = 69 N = 132

11 Baseline Characteristics All-Comers # Subjects N = 700 Age, yrs (mean ± SD) 70.0 ± 10.2 Male (n, %) 439 (62.7%) Hypertension (n, %) 595 (85.0%) Hyperlipidemia (n, %) 472 (67.4%) Smoking (n, %) 483 (69.0%) Current Smokers 191 (39.5%) History of PAOD (n, %) 411 (58.7%) Previous PVI /Surgeries (n, %) 373 (53.3%) Diabetes (n, %) 330 (47.1%) Coronary Artery Disease (n, %) 295 (42.1%) Cerebrovascular Disease (n, %) 145 (20.7%) Renal Disease (n, %) 255 (36.4%) ABI target limb (mean± SD) 0.7 ± % 40% 35% 30% 25% 20% 15% 10% 5% 0% Rutherford Classification 43,5% 21,2% 16,3% 10,5% 6,6% 0,6% 1,3% % CLI Subjects

12 Lesion Characteristics All-Comers Lesion Characteristics N=864 Lesion Length, mm (mean ± SD) 84.6+/-73.3 Reference Vessel Diameter, mm (mean ± SD) 4.8+/-1.0 Diameter Stenosis (%) 86.4+/-12.9 De novo Lesion (n, %) 466 (53.9%) Occlusion (n, %) 205 (23.7%) In Stent Restenosis (n, %) 97 (11.2%) Re-Stenosis (n, %) 96 (11.1%) Calcification (n,%) None Mild Moderate Heavy TASC Classification (n,%) A B C D 216 (25.1%) 283 (32.8%) 260 (30.2%) 103 (11.9%) 361 (42.2%) 269 (31.4%) 143 (16.7%) 83 (9.7%) Lesion Location N (%) Common femoral 9 (1.0%) SFA 492 (56.9%) Popliteal artery 194 (22.5%) ATA 37 (4.3%) PTA 20 (2.3%) Tibioperoneal trunc 28 (3.2%) Peroneal artery 19 (2.2%) Dorsalis Pedis 1 (0.1%) Other 64 (7.4%) 74.9% of lesions calcified 42.1% moderate to heavy calcified lesions 26.4% lesions are TASC C/D 12.2% BTK lesions

13 BIOLUX P-III All-Comers Consistent Results Through Subgroups 12-month Kaplan Meier Estimates BIOLUX P-III Freedom from cd TLR Primary Patency Freedom from Major target limb amputation Change in Rutherford Classification All-comers 94.0% [ ] 85.2% [ ] 98.4% [ ] 82.2% SFA 94.4% [ ] 85.3% [ ] 98.5% [ ] 81.7% Diabetics 92.9% [ ] 83.6% [ ] 96.9% [ ] 81.6% CLI 91.2% [ ] 84.7% [ ] 95.9% [ ] 87.4% Illumenate Global : Schroë H. et al, Catheter Cardiovasc Interv 2017 Lutonix Global: Thieme M. et al, JACC: Cardiovascular Interventions 2017 In.Pact Global: Jaff MR, VIVA 2016

14 Baseline Characteristics CLI (N= 237 subjects) Age, yrs (mean ± SD) 71.3+/-10.0 Male (n, %) 141 (59.5%) Hypertension (n, %) 204 (86.1%) Hyperlipidemia (n, %) 140 (59.1%) Smoking (n, %) 133 (56.1%) Current Smokers 57 (42.9%) History of PAOD (n, %) 129 (54.4%) Previous PVI /Surgeries (n, %) 120 (50.6%) Diabetes (n, %) 150 (63.3%) Coronary Artery Disease (n, %) 111 (46.8%) Cerebrovascular Disease (n, %) 61 (25.7%) Renal Disease (n, %) 110 (46.4%) ABI target limb (mean± SD) 0.6+/-0.3 Rutherford Classification 17.3% 27.4% 55.3% 4 5 6

15 Lesion Characteristics CLI Lesion Characteristics N=301 Lesion Length, mm (mean ± SD) 77.2+/-60.9 Reference Vessel Diameter, mm (mean ± SD) 4.4+/-1.1 Diameter Stenosis (%) 87.4+/-12.5 De novo Lesion (n, %) Occlusion (n, %) In Stent Restenosis (n, %) Re-Stenosis (n, %) Calcification (n,%) None Mild Moderate Heavy TASC Classification (n,%) A B C D Lesion Location N % Common femoral SFA Popliteal artery ATA PTA Tibioperoneal trunc Peroneal artery Dorsalis Pedis Other % of lesions calcified 41.2% moderate to heavy calcified lesions 28.6% lesions are TASC C/D 21.3 % BTK lesions

16 CLI Population through global DCB registries STUDY Device RCC4 RCC5 RCC6 Data available BIOLUX P-III (n=700) 1 Passeo-18 Lux 10.5% 21.2% 6.6% Illumenate Global (n=371) 2 Stellarex 6.2% 2.4% 0 Lutonix Global (n=691) 3 Lutonix 7.4% 1.5% 0.1% In.Pact Global (n=1406) 4 In.Pact Admiral 8% 3% 0 Ranger SFA Registry (n=172) 5 Ranger 8% 5% 1% LuminorRegistry (n=207) 6 Luminor 10.6% 60% 0 BIOLUX P-III all-comers: LINC 2018 Illumenate Global : Schroë H. et al, Catheter Cardiovasc Interv 2017 Lutonix Global: Thieme M. et al, JACC: Cardiovascular Interventions 2017 In.Pact Global: Jaff MR, VIVA 2016 Current Data and Performance of Drug Eluting Technology in SFA: M. LINC 2018 Lumionor Registry, 12-m data: V. LINC 2018

17 CLI 12-m outcomes comparison STUDY BIOLUX P-III CLI 12-m IN.PACT Global CLI 12-m LUMINOR CLI 12-m Patient (n) BTK (%) Calcification (%) Diabetics (%) Rutherford Classification BIOLUX P-III is the only registry with RCC RCC 6 patients (17.3%) RCC RCC 4 (%) RCC 5 (%) RCC 6 (%) BIOLUX P-III all-comers: LINC 2018 In.Pact Global: Jaff MR, VIVA 2016 Lumionor Registry, 12-m data: V. LINC 2018

18 CLI 12-m outcomes comparison Passeo-18 Lux shows excellent outcomes despite more diseased population BIOLUX P-III all-comers: LINC 2018 In.Pact Global: Jaff MR, VIVA 2016 Lumionor Registry, 12-m data: V. LINC 2018

19 Conclusions BIOLUX P-III is the 2nd largest real world all-comers DCB registry with no exclusion criteria BIOLUX P-III is the only global DCB registry that enrolled RCC6 patients (6.6% of 882 patients) BIOLUX P-III 12-month outcomes further confirm Passeo-18 Lux DCB safety and effectiveness and show clinical benefit in a high risk population such as CLI: 84.7% Primary Patency 91.2% Freedom from Clinically-Driven TLR 95.9% Freedom from Major target limb amputation Passeo-18 Lux demonstrates excellent CLI results despite heavily diseased population

20 Maximizing Outcomes in a complex population with Drug-coated balloon March 13, 2018 Chumpol Wongwanit, MD Siriraj Hospital, Mahidol University, Bangkok, Thailand LINC Asia-Pacific 2018, Hong Kong