My most promising perspective for DCB

Transcription

1 My most promising perspective for DCB Raphaël COSCAS, Auréline BOITET, Stanislas GRASSIN-DELYLE, Marc COGGIA, Ziad MASSY, Jean-Baptiste MICHEL Vascular Surgery Department Ambroise Paré University Hospital, AP-HP Boulogne-Billancourt, France

2 Disclosure of Interest Speaker name: Raphael COSCAS I have the following potential conflicts of interest to report: Consulting: Medtronic, Spectranetics, Bard Employment in industry Shareholder in a healthcare company Owner of a healthcare company Other(s) I do not have any potential conflict of interest

3 AV access Scant and conflicting data My best perspectives BTK Level I evidence No perspective De novo SFA Current DCB uses ISR No stent DCB Nothing to declare «No stent» zone Ongoing studies +/- debulking Wait and see

4 DCBs in BTK

5 8.8% vs 3.6%; p=0.080 Embolization of PTX particles? Zeller et al. IN.PACT DEEP Trial, JACC 2014

6 Do PTX embolize distally? Lutonix Bard IN.Pact Medtronic Ranger Boston Stellarex Spectranetics Dosage PTX 2 3, Passeo-18 Lux Biotronik Excipient Forme du PTX Technique de dépôt du PTX Etat du ballon lors du dépôt Polysorbate Sorbitol Hybride Crystallin + amorphe Urée Citrate ester Polyethylene glycol Crystallin Microcrystallin Hybride Microcrystallin + amorphe BTHC Microcrystallin Pulvérisation Micro-pipetage Pulvérisation Pulverisation Micro-pipetage Inflaté Inflaté Déflaté Inflaté Déflaté

7 Experimental approach 5 different DBCs x 5 specimens each = 25 rabbits

8 Experimental approach Sacrifice H2 Samples Aorta Plasma DCB Muscles Thigh: TFL, Vastus lateralis Leg: Tibialis cranialis Blinded dosage PTX by high pressure liquid chromatography

9 PTX in the 3 muscles 0,7 0,6 0,5 0,45 0,4 0,35 0,3 0,4 0,25 0,3 0,2 0,1 0,2 0,15 0,1 0,05 0 Vaste externe (ng/mg) 0 Tenseur du Fascia Lata (ng/mg) 0,4 0,35 0,3 0,25 0,2 0,15 0,1 0,05 0 * * Tibial antérieur (ng/mg) Lutonix In.Pact Ranger Stellarex Passeo-18-Lux

10 PTX in the muscles (global) 2,5 2 1,5 1 0,5 Lutonix In.Pact Ranger Stellarex Passeo-18-Lux 0 Total muscles (ng/mg)

11 PTX in the aortic wall * Lutonix In.Pact Ranger Stellarex Passeo-18-Lux 0 Aorte (ng/mg)

12 PTX in the Plasma * Lutonix In.Pact Ranger Stellarex Passeo-18-Lux 1 0 Plasma (ng/ml)

13 Remnant PTX on the DCB 4000 * Lutonix In.Pact Ranger Stellarex Passeo-18-Lux Ballon actif (μg)

14 Some DCBs embolize more than others Amount of embolized PTX is low compared to the whole PTX contained in the DCB Stellarex and Ranger DCBs may be more appropriate in BTK lesions whereas In.Pact and Lutonix may be less appropriate Clinical implications of such results remain to be demonstrated

15 DCBs in AV

16 Baek et al. J Vasc Surg 2015

17 Katsanos et al. J Endovasc Ther 2012

18 DCB in AV Juxta-anastomotic Radiocephalic AVF Inflow lesions of Radiocephalic AVF Central Vein Stenosis

19 ABISS Trial Angioplastie au Ballon Imprégné de paclitaxel versus angioplastie Standard pour le traitement des Sténoses sur fistule artério-veineuse Prospective Randomized Multicenter Double Blind N = 150 Primary Objective Primary Patency at 6 months PP = Reintervention or back to initial AVF flow PHRC IR 2015

20 ABISS Trial Angioplastie au Ballon Imprégné de paclitaxel versus angioplastie Standard pour le traitement des Sténoses sur fistule artério-veineuse Inclusion Native AVF AVF already punctured Preop fistula flow Hemodynamic stenosis Unique stenosis Length < 120 mm Diameter < 12 mm Non inclusion Multiple stenoses Arterial stenosis Central stenosis Stent in AVF AVF lower limb

21 Sélection + Consent + Randomization Standard angioplasty Failure = simple FU Angioplasty Placebo ClearPAC Omega Angioplasty DCB Lutonix FU 3, 6, 12 months clinical + duplex

22 Center Investigators Clinique Ambroise Paré IMM Clinique de l Europe Clinique les Fontaines Hôpital Foch Hôpital Ambroise Paré Hôpital Bichat Hôpital Tenon Hôpital Henri Mondor CHU Nîmes CHU Nantes Luc TURMEL, Gilles HUFNAGEL Alessandro COSTANZO, Alexandros MALLIOS Rabih HOUBBALLAH, Maxime RAUX Angel FERRARIO, Karim BELATTAR Philippe GOY, Gaelle PELLE Raphaël COSCAS, Ziad MASSY Quentin PELLENC, Yves CASTIER, Quentin RAIMBOURG Mihaela GIOL, Marielle LE ROUX Joseph TOUMA, Vania TACHER Eric PICARD, Isabelle AICHOUN Yann GOUEFFIC

23

24 Other Ongoing Studies

25 Questions about DCB Studies Is the study industry-funded? Is this an AVF/AVG, stenosis/restenosis mix? How is it made «Double Blind»? How is the stenosis degree evaluated? Are indications well defined? What are the criterias of success? How is follow-up performed?

26 Conclusion BTK and AV are the two current sites where the need to decrease restenosis is paramount where DCBs may change the practice More physician sponsored studies are needed All DCBs are not the same Some DCBs may be efficient in one location but not in another When one DCB is efficient in one location, other DCBs may provide different results

27