Six Month Results of the Global BIOLUX P-III All-Comers Registry using Drug Coated Balloon in Infra-Inguinal Artery Disease

Transcription

1 Six Month Results of the Global BIOLUX P-III All-Comers Registry using Drug Coated Balloon in Infra-Inguinal Artery Disease Dr. Shaiful Azmi Yahaya, FNHAM, FAPSIC Institut Jantung Negara, Kuala Lumpur, Malaysia CCI on behalf of the BIOLUX P-III Investigators

2 Disclosure Speaker name: Dr. Shaiful Azmi Yahaya 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) X I do not have any potential conflict of interest

3 Passeo-18 Lux combines proven technologies for treating lower limb arteries Coating Drug: Paclitaxel Excipient: Butyryl- Trihexyl Citrate (BTHC) Balloon Platform SafeGuard Insertion Aid Improves ease of handling Protects the user and balloon from contact and damage Passeo-18 Balloon Catheter

4 Paclitaxel blocks the cell cycle directly Mode of action for Paclitaxel and Limus drugs Paclitaxel inhibits the cell cycle directly vs. Limus drugs which act indirectly DCB s aim for a high-dose effect of Paclitaxel, causing cell s mitotic arrest A low-dose effect is expected to sustain antiproliferation long term

5 BTHC fulfills the requirements of an ideal excipient for DCB applications BTHC in the Lux formulation allows to balance good coating adhesion to the balloon surface and rapid drug delivery upon vessel contact BTHC assures micro-crystalline Paclitaxel structure in Lux formulation for optimal tissue absorption and retention Lux formulation with BTHC is safe and biocompatible

6 Passeo-18 Lux Clinical Trial Program Study Device(s) Indication Design Primary Endpoint PI(s) Passeo-18 Lux vs. Passeo-18 SFA EU Multicenter FIM RCT (60 pts/5 sites) D. Scheinert Passeo-18 Lux vs. Passeo-18 BTK EU Multicenter FIM RCT (72 pts/6 sites) T. Zeller * Passeo-18 Lux Passeo-18 Lux + Pulsar-18 Infrainguinal Arteries SFA Global Multicenter Allcomers Registry (min. 700 pts/55 sites) EU Multicenter Single-arm trial (120 pts/5 sites) MAE@6m FTLR@12m PP@12m G. Tepe M. Bosiers * Passeo-18 Lux vs. PTA AV Fistula Access Canadian Multicenter RCT (120 pts/4 sites) LLL@6m E. Terasse * Passeo-18 Lux + Pulsar-18 SFA Australian Single-arm trial (100 pts) PP@12m PP@24m P. Mwipatayi * Passeo-18 Lux In-stent restenosis Australian Retrospective registries (35* pts / 29 pts) PP, FTLR, P. Myers* D. Robertson *Investigator-Initiated Trials 6 GAP 2015

7 BIOLUX P-I 6 month Late Lumen Loss Comparison of Peripheral DEB RCTs 7 References: BIOLUX P-I. Scheinert et al. Presented at EuroPCR 2012 THUNDER Tepe et al: N Engl J Med Feb 14;358(7): FEMPAC Werk et al: Circulation. 2008;118: PACIFIER Werk et al: Circ Cardiovasc Interv Dec;5(6): LEVANT-I: Scheinert et al.: JACC: Cardiovasc Interv. 2014; 7(1): GAP 2015

8 Major Adverse Events at 30 days Adjudicated by an Independent Clinical Events Committee 50% 40% 30% MAE (%) 20% 10% p-value : (Fisher s exact) POBA 8.3% [ ] DCB 0.0% [ ] 0% Time to Event (days) 0 30 p-value : (Fisher s Exact) Death Major Amputation TLR TVR TL Thrombosis DCB (%) 0.0% 0.0% 0.0% 0.0% 0.0% POBA (%) [CI] 0.0% 2.8% [ ] 5.6% [ ] 5.6% [ ] p-value % p* < 0.05 significant 8 GAP 2015 BIOLUX P-II: Brodmann M Presented at LINC 2014

9 TL Primary Patency at 6 months Evaluated by an Independent Core Laboratory 100% 80% DEB 82.4% [ ] POBA 75.9% [ ] 60% p-value : (Log Rank) 40% 20% 0.0% Time to Event (days) p* < 0.05 significant 9 BIOLUX P-II: Brodmann M Presented at LINC 2014 GAP 2015

10 Six Month Results of the Global BIOLUX P-III All-Comers Registry using Drug Coated Balloon in Infra-Inguinal Artery Disease

11 Participating Sites 204 Subjects Reached 6 Month FUP # Subject enrolled #Subjects enrolled up to 25 th Jan 2016 Pr G. Tepe (CCI) RoMed Klinikum Rosenheim Germany 3 36 Pr M. Brodmann Medical University Graz Austria Pr T. Zeller Universitäts-Herzzentrum Freiburg - Bad Krozingen Germany Dr J. K. Christensen Kolding Hospital Denmark Dr L. Spak VUSCH East Slovak Cardiology Institute Slovakia Pr C. Binkert Kantonspital Winterthur Switzerland Dr H. Schröder Jüdischen Krankenhaus Berlin Germany Pr G. Nano, Policlinico San Donato Italy 8 15 Dr M. Araujo Hospital Universitaro Severo Ochoa Spain 7 16 Dr L. Yo Catharina Ziekenhuis Eindhoven Hospital Netherlands 6 13 Dr J. Dahm Herz-und Gefässzentrum Göttingen Germany 5 18 Pr F. Hammer Cliniques Universitaires Saint-Luc Belgium 5 6 Dr S. Houthoofd UZ Leuven Belgium 5 10 Dr M. Lichtenberg Klinikum Arnsberg Germany 3 10 Dr S. Kum Changi General Hospital Singapore 2 4 Pr J.L. Magne Centre Hospitalier Universitaire de Grenoble France 2 7 Dr J.M. Romero Hospital Universitari Santa Creu i Sant Pau Spain 3 8 Dr D. Kretzschmar Universitätsklinikum Jena Germany 2 6 Dr E. Alejandre-Lafont Universitätsklinikum Giessen und Marburg Germany 2 14 Dr D. Henroteaux CHR de la Citadelle de Liège Belgium 1 13 Later initiated sites

12 All-Comers Design DESIGN: Prospective, international, multi-centre, All- Comers registry, with pre-defined subgroups 700+ subjects PRIMARY ENDPOINTS: Clinical: Freedom from MAE 1 at 6 months Performance: Freedom from CD-TLR 2 at 12 months First 204 subjects enrolled with de novo or restenotic lesions in the infra-inguinal arteries 6 month Follow-up N= month clinical assessments N = 193 Death N= 10 Withdrawals N= 1 12 month Follow-up (1) Major Adverse Event : Composite of freedom from device and procedure related mortality through 30 days, major target limb amputation and clinically driven target lesion revascularization (TLR). MAE are adjudicated by an independent Clinical Events Committee (2) Clinically driven TLR/TVR is any re-intervention performed for 50% diameter stenosis (visual estimate) at the target lesion/vessel after documentation of recurrent clinical symptoms of the patient 24 month Follow-up

13 Baseline Characteristics Age, yrs (mean ± SD), [Min; Max] 70.2 ± 10.4 [44.0 ; 94.0] Male (n, %) 123 (60.3%) Medical History N= 204 % Hypertension % Hyperlipidemia % Smoking Current Smokers % 38.1% History of PAOD % Previous PVI /Surgeries % Diabetes % Coronary Artery Disease % Cerebrovascular Disease %

14 Lesion Characteristics Lesion Characteristics N= 259 Lesion Length, mm (mean ± SD) 74.3 ± 69.9 Reference Vessel Diameter, mm (mean ± SD) 4.7 ± 1.0 Diameter Stenosis (%) 85.8 ± 13.8 De Novo Lesion (n, %) % Re-Stenosis (n, %) % In Stent Restenosis (n, %) % Occlusion (n, %) % 10.4% 32.8% 0.8% Calcification 23.6% 32.4% None Mild Moderate Heavy Unknown Lesion Locations N = 259 % Common Femoral Superficial Femoral Artery Femoro-Popliteal Popliteal Artery Anterior Tibial Artery Posterior Tibial Artery Tibioperoneal Trunc Peroneal Artery Combination of Infrapopliteal Arteries Other (Bypass, Illiac) TASC Classification TASC A TASC B TASC C TASC D Unknown 44.0% 33.2% 12.4% 7.3% 3.1%

15 Procedure Details N= 259 % Lesion treated with DCB only Combination therapy % DCB + Stent DCB + Scoring / Cutting /Rotational Devices DCB + Scoring / Cutting /Rotational Devices + Stent (1) Only planned stenting - not bailout stenting

16 Freedom Survival Estimate: from MAE MAE Freedom From MAE (adjudicated by an independent CEC) 100% 94.4% SE CI95% [ 90.2, 96.9] 80% 60% 40% 20% 0.0% Time Time to Event to events (days) (days) N= 143 MAE (composite of procedure or device related death within 30 days post index procedure, CD-TLR, Target Limb Major amputation) % Death % Clinically Driven Target Lesion Revascularization % Target Limb Major Amputation %

17 Freedom Survival Estimate: from Clinically Driven driven TLR TLR Freedom From Clinically Driven Target Lesion Revascularization 1 100% 80% 96.8% SE CI95%[ 93.7, 98.4] 60% 40% 20% 0.0% Time to to events Event (days) (days) (1) Any re-intervention performed for 50% diameter stenosis (visual estimate) at the target lesion after documentation of recurrent clinical symptoms of the patient N= 186

18 No. of Subjects Change in Rutherford Classification p*< Baseline vs 6 Month - Paired Data p*< * P<0.05 significant Baseline 6 Month Follow-Up p*= p*< p*<0.001 p*= p*= Rutherford Class 80.0% of all subjects improved significantly in Rutherford Class at 6 months compared to baseline

19 No. of Subjects Change in Pain Scale 1 Baseline vs 6 Month - Paired Data P*< P*<0.05 significant P* < P*< Baseline 6 Month Follow-Up P*= P*= P*= No hurt Hurts little bit Hurts little more Hurts even more Hurts whole lot Hurts worst 80.4% of all subjects improved significantly in Pain Scale at 6 months compared to baseline (1) Wong-Baker FACES Pain Rating Scale

20 Conclusion BIOLUX P-III is a real All-Comers Registry evaluating the performance of DCB in daily practice in respect to patient and lesion characteristics and combination therapy 6 Months results of the first 200 subjects present comparable safety and performance results: 96.8 % Freedom from Clinically Driven Target Lesion Revascularization 80.0 % of subjects improved significantly in Rutherford classification (p<0.001) 80.4% subjects experienced significantly less pain at 6 months compared to baseline (p<0.001) Further subgroup analysis will reveal even more insight in daily routine practice specifically DCB in combination therapy

21 Thank You

22 Six Month Results of the Global BIOLUX P-III All-Comers Registry using Drug Coated Balloon in Infra-Inguinal Artery Disease Dr. Shaiful Azmi Yahaya, FNHAM, FAPSIC Institut Jantung Negara, Kuala Lumpur, Malaysia CCI on behalf of the BIOLUX P-III Investigators