BIOLUX 4EVER : Combining Passeo-18 Lux DCB and Pulsar-18 BMS : 12 month results of full cohort
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1 BIOLUX 4EVER : Combining Passeo-18 Lux DCB and Pulsar-18 BMS : 12 month results of full cohort Koen Deloose, MD Head Dept Vascular Surgery AZ Sint-Blasius Dendermonde, Belgium
2 Disclosure slide Speaker name: Koen Deloose, MD I have the following potential conflicts of interest to report: Consulting: Medtronic, Spectranetics, Biotronik, Abbott, Bard, ivascular, Bentley, Cook, GE Healthcare, Terumo, Contego Medical, Boston Scientific, B Braun Employment in industry Stockholder of a healthcare company Owner of a healthcare company Other(s) I do not have any potential conflict of interest
3 The reality of BMS anno 2018 By introducing PTX 1. Bosiers M. J Endovasc Ther. 2013; 20: Mwapatayi P. DEBAS-I 12-m. presented LINC Scheinert D. J. Endovasc. Ther 2015; 22: Deloose K. Presented LINC PMA P100022: FDA Summary of Safety and Effectiveness Data 8. Vries J-P. Presented VEITH Mueller-Huellbeck.S. Presented CIRSE Blessing E. EVT May 2015: Vol. 3, No.4 5. PMA P140028: FDA Summary of Safety and Effectiveness Data; 10. Listro F. JACC ; 6; *Zilver Flex is platform for Zilver PTX **Innova is platform for Eluvia PP = Primary Patency FTLR = freedom from Target Lesion Revascularisation DCB = Drug Coated Balloon PTX = Paclitaxel Source: graphic courtesy of Paul Ransom, Biotronik AG
4 PTX effect by DES Without Polymer ZILVER PTX 3 12m Zilver FLEX* arm Zilver PTX* arm N Av.Lesion Length (cm) ABI Diabetic (%) CLI (%) Occlusion (%) Calcification (%) Primary Patency (%) ftlr (%) With Polymer supernova/majestic 12m supernova (Innova**) MAJESTIC² (Eluvia**) N Av.Lesion Length (cm) ABI >1.02 Diabetic (%) CLI (%) Occlusion (%) Calcification (%) Primary Patency (%) ftlr (%) PTX effect + 30% 1 year PTX effect + 1 year PTX effect + 10% 1 year 1. COOK Zilver PTX clinical data guide Mueller-Huellbeck.S. Presented CIRSE
5 Primary Patency PTX effect by DCB Evidence supports use in simple & complex lesions Performance of DCBs seems to be lesion complexity INDEPENDENT With the courtesy of Azah Tabah, Medtronic Lesion Length [cm]
6 , PTX effect by DCB Evidence also shows increasing use of scaffolds in more complex lesions : Bail-out stenting is lesion complexity DEPENDENT 1. Rosenfield K, et al. New Engl J Med 373: (2015). 2. Presented by Brodmann M, AMP Chicago, USA Presented by Zeller T, LINC Leipzig, Germany Presented by Lyden S, TCT Washington DC, USA Tepe G, et al. Circ 131: (2015). 6. Laird J, et al. J Am Coll Cardiol 66: (2015). 7. Presented by Brodmann M, VIVA Las Vegas, USA Bard Lutonix Instructions for Use, BAW r3. 9. Presented by Tepe G, Charing Cross London, UK Presented by Scheinert D, EuroPCR Paris, France Lesion length (cm) DCB rate Bail-out stent rate
7 Evidence is reflecting the reality of daily angiosuite experiences Stent >1/3 + DCB Patients N = 151 Stent only 78 (52%) Stent plus DCB 55 (36%) Stent plus rotational thrombectomy 2 (1%) Stent plus atherectomy 7 (5%) Stent plus scoring balloon 5 (3%) DCB >1/7 + Stent Stent plus cutting balloon 4 (3%)
8 Let s evaluate this daily practice in a prospective multicentric way First Stent, then DCB First DCB, then Stent DEBAS STUDY BIOLUX 4EVER Direct scaffolding No DCB only possibility Loosing PTX-wall contact Single center, single arm prospective study 65 lesions Pulsar 18 + Passeo-18 Lux (Biotronik) Mean lesion length : 18.7 cm Maximum contact PTX DCB only possibility Distal embolization? Multicenter, single arm prospective study 120 lesions Passeo-18 Lux + Pulsar 18 (Biotronik) Mean lesion length : 8.3 cm
9 DEBAS STUDY 6m PP = 98.0 % 12m PP = 94.1 % 24m PP = 88.2 % Time 1MFU 6MFU 12MFU 18MFU 24MFU At risk % Mwipatayi P. Veith 2015, NYC, US
10 Is there a PTX effect if we postdilate the BMS with a DCB??? 4EVER/DEBAS 12m 4EVER 1 (Pulsar) DEBAS² (Pulsar+ Passeo Lux) N Av.Lesion Length (cm) Diabetic (%) CLI (%) Occlusion (%) Calcification (%) Primary Patency (%) ftlr (%) EVER/DEBAS 24m 4EVER 1 (Pulsar) DEBAS² (Pulsar+ Passeo Lux) N Av.Lesion Length (cm) Diabetic (%) CLI (%) Occlusion (%) Calcification (%) Primary Patency (%) ftlr (%) 88.2 PTX effect + 13% 1 year PTX effect + 16% 2 year 1. Bosiers M. J Endovasc Ther. 2013; 20: Mwipatayi P. Veith 2015, NYC, US
11 Is there a PTX effect if we prepare the vessel with a DCB & scaffold with a stent afterwards??? BIOLUX 4EVER 5 PARTICIPATING CENTERS Sint-Blasius Hospital, Dendermonde (K. Deloose, M. Bosiers,J. Callaert) Imelda Hospital, Bonheiden (P. Peeters, J. Verbist, W. Van den Eynde) OLV Hospital, Aalst (L. Maene, R. Beelen) RZ Heilig Hart, Tienen (K. Keirse, B. Joos) University Hospital Antwerp (J. Hendriks, P. Lauwers)
12 Patient demographics N = 120 out of 120 Male (%) 79 (65.83%) Age (min max; ±SD) years ( ; ±10.52) Nicotine abuse (%)* 73 (60.83%) Hypertension (%)* 76 (63.33%) Diabetes mellitus (%)* 23 (19.17%) Renal insufficiency (%)* 15 (12.50%) Hypercholesterolemia (%)* 66 (55.00%) Obesity (%)* 28 (23.33%) *missing data for 1 patient
13 Indications & Procedural characteristics Lesion length (min max; ±SD) mm ( ; ±49.49) Reference Vessel Diameter 5.26 mm ( ; ±0.59) DCB STENT N = 151 N = 131 Minimal oversizing for lowest possible COF (ca. 0.5mm) Mean DCB diameter (min max; ±SD) 5.15 mm ( ; ±0.57) Mean STENT diameter (min max; ±SD) 5.78 mm ( ; ±0.53) Occlusion (%) 40 (33.33%) Calcified lesion (%) 60 (50.00%)
14 12 Month Primary Patency (120pts) 89.9 % time baseline 1MFU 6MFU 12MFU (D365) 12MFU (D395) %
15 12 Month freedom from TLR(120 pts) 93.6 % time baseline 1MFU 6MFU 12MFU (D365) 12MFU (D395) %
16 24 month primary patency (105/120 pts) 83,3 %
17 24 month freedom from TLR (105/120 pts) 86,2 %
18 24 month survival rate (105/120 pts) 90,5 %
19 Is there a PTX effect if we prepare the vessel with a DCB & scaffold with a stent afterwards??? BIOLUX 4EVER 12m (Passeo-18 Lux + Pulsar-18) 4EVER1 (Pulsar) N LL(cm) Diabet (%) CLI (%) Occl (%) Calcium (%) PP (%) ftlr (%) m preliminary (105/120) 4EVER 1 (Pulsar) BIOLUX 4EVER (Passeo-18 Lux + Pulsar-18) N LL(cm) Diabet (%) CLI (%) Occl (%) Calcium (%) PP (%) ftlr (%) PTX effect + 8% 1 year 1. Bosiers M. J Endovasc Ther. 2013; 20: PTX effect + 11% 2 year
20 Is it comparable to DES data? Benchmarking in the DES 1yr MAJESTIC Zilver PTX RCT Zilver PTX Japanese PMS BIOLUX 4EVER DEBAS PPR 1yr f TLR LL (cm) 7,0 5,5 14,7 8,3 18,7 PSVR (<) 2,5 2,0 2,4 2,5 2,
21 Is it comparable to DES data? Benchmarking in the DES 2 yr ,3 86, MAJESTIC (1) Zilver PTX RCT (2) BIOLUX 4EVER (60(105/120 out of 120 pts) pts) DEBAS (3) PPR 2yr f TLR LL (cm) 7,0 5,5 8,3 18,7 PSVR (<) 2,5 2,0 2,5 2,5 Mueller-Huelsbuck S. Presented at CIRSE 2016, Barcelona - COOK Zilver PTX clinical data guide Mwipatayi P. Veith 2015, NYC, US
22 Conclusion Adding Paclitaxel to BMS is definitely improving patency & TLR Implanting Pulsar-18 stent, postdilated with Passeo-18 Lux creates a win-win situation as shown in the full 12 months & 24 months data of DEBAS Prepping with Passeo-18 Lux & scaffolding afterwards with Pulsar-18 stent creates a win-win situation as shown in the full 12 months & preliminary 24 months data of BIOLUX 4EVER The combination of Passeo-18 Lux & Pulsar-18 offers similar efficacy outcomes compared to DES data
23 BIOLUX 4EVER : Combining Passeo-18 Lux DCB and Pulsar-18 BMS : 12 month results of full cohort Koen Deloose, MD Head Dept Vascular Surgery AZ Sint-Blasius Dendermonde, Belgium
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