Future of stenting in the. Koen Deloose, MD Head Dept Vascular Surgery AZ Sint Blasius Dendermonde, Belgium

Transcription

1 Future of stenting in the current DCB world 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, BD/Bard ivascular, Bentley, Cook, GE Healthcare, Contego medical, Boston Scientific, Cardionovum, B Braun, Terumo Employment in industry Stockholder of a healthcare company Owner of a healthcare company Other(s) I do not have any potential conflict of interest 2

3 Primary Patency The reality of DCB anno 2019 Evidence supports use in simple & complex lesions Performance of DCBs seems to be lesion complexity INDEPENDENT Lesion Length [cm] 3

4 Can DCB alone fit it all? 90 Provisional stenting rate in DCB trial up to 40% in real-world studies bailout calcium LL (cm) 0 Levant 2 In.Pact SFA Illumenate IDE BIOLUX P-I Illumenate Global Illumenate Global : Schroë H. et al, Catheter Cardiovasc Interv 2017 BIOLUX P-III all comers: Tepe G, CIRSE 2017 Lutonix Global: Thieme M. et al, JACC: Cardiovascular Interventions 2017 Lutonix Global Long lesions 6 : Thieme M. et al, JACC: Cardiovascular Interventions 2017 In.Pact Global: Jaff MR, VIVA 2016 In.Pact Global Long Lesions: Ansel G. TCT 2015 BIOLUX P-III all-comers Lutonix Global In.Pact Global Lutonix In.Pact Global Long Global Long Lesions Lesions Levant II : Rosenfield K. et al, N Engl J Med n. 2, 373, pp In.Pact SFA: 2, Tepe G. et al, Circulation n. 5, 131, pp Illumenate IDE : 3, Krishnan P. et al, Circulation. 2017;136: Biolux P-I: 4, Scheinert D. et al, J. Endovasc. Ther. 2015;22:

5 Is DCB + BMS as good as DES? Combining Passeo-18 Lux And Pulsar Shows Good 12-month Outcomes In SFA Compared To DES LL (cm) mth PP 12 mth fcdtlr PSVR BIOLUX 4 EVER DEBAS ZILVER PTX RCT ZILVER PTX Japanese PMS Passeo-18 Lux+ Pulsar Pulsar + Passeo-18 Lux BIOLUX 4 EVER : Deloose K., Presented at CX 2017, 12-month data (365 days) DEBAS: Mwipatayi P. et al. First-in-man experience of self-expanding nitinol stents combined with drug-coated balloon for the treatment of femoropopliteal occlusive disease. Vascular, Jan 2017 [Epub ahead of print]. The use of Passeo-18 Lux for post-dilatation is not within the indication for the product. MAJESTIC ELUVIA FIM IMPERIAL RCT ELUVIA IMPERIAL RCT ZILVER PTX ZILVER PTX RCT : Dake M, Circ Cardiovasc Interv. 2011;4: ZILVER PTX Japan : Hiroyoshi Yokoi, JACC, Volume 9, Issue 3, February 2016 MAJESTIC : Mueller-Huellbeck. Journal of Endovascular Therapy 2016, Vol. 23(5) IMPERIAL RCT : Gray WA. Lancet 2018 (Published online Sept 22, 2018) 5 0

6 The problem of DCB + BMS Full lesion stenting : full metal jacket Chronic 86.4 physical irritation Long length vessel caging Fractures Intimal Hyperplasia In-stent restenosis mth PP 12 mth fcdtlr BIOLUX 4 EVER DEBAS ZILVER PTX RCT ZILVER PTX Japanese PMS Passeo-18 Lux+ Pulsar Pulsar + Passeo-18 Lux BIOLUX 4 EVER : Deloose K., Presented at CX 2017, 12-month data (365 days) DEBAS: Mwipatayi P. et al. First-in-man experience of self-expanding nitinol stents combined with drug-coated balloon for the treatment of femoropopliteal occlusive disease. Vascular, Jan 2017 [Epub ahead of print]. The use of Passeo-18 Lux for post-dilatation is not within the indication for the product. MAJESTIC ELUVIA FIM IMPERIAL RCT ELUVIA IMPERIAL RCT ZILVER PTX LEAVING NOTHING/LESS BEHIND 6

7 Therefore, a REACT treatment algorithm No Consensus on stent requirement to treat elastic recoil and flow limiting dissection No clear definition for flow limiting dissection in peripheral artery Should a dissection be treated or observed? How to improve procedural hemodynamic assessment and related stenting approach? POBA Prolonged Predilation Proven DCB Prolonged inflation 3 BMS As Less as Reasonably Achievable + post dilatation Acceptable Satisfactory Unsatisfactory Mission accomplished 7

8 BIO REACT PILOT STUDY Design Global Multicenter Prospective, Pilot Diagnostic Study Evaluation of adjunctive procedural assessments to diagnose post drug-coated balloon flow-limiting dissection/residual stenosis additional to angiography Objective *intra-operative DUS (core lab controlled) *intra-arterial pressure gradient measurement (IAP) +/- IVUS Estimation Biotronik REACT algorithm clinical performance Assessment health care resources 8

9 Participating centers Country Belgium Sites A.Z. Sint-Blasius, Dendermonde (Dr K. Deloose) Onze-Lieve-Vrouwziekenhuis, Aalst (Dr L. Maene) ZOL Genk (Dr W. Lansink) France University Hospital of Nantes (Pr Y. Gouëffic) Austria Germany Medical University, Graz (Pr M. Brodmann) Medical University Vienna (Pr C. Loewe) Arnsberg Clinic, Arnsberg (Dr M. Lichtenberg) Universität Herzzentrum, Freiburg-Bad Krozingen (Pr T. Zeller) University Hospital Leipzig Heart Center, Leipzig (Pr D. Scheinert) FPI : September subjects enrolled Australia Royal Perth Hospital, Perth (Pr P.B. Mwipatayi) Spain University Hospital, Guadalajara (Dra M. Guerra) 9

10 Study endpoints Primary Endpoints evaluate the diagnostic performance of (core lab controlled) intraprocedural DUS added to angiography compared to angiography alone: Specificity/Sensitivity will be calculated for various peak systolic velocity ratio (PSVR) values Determination of optimal cut-off via ROC curve Secondary Endpoints (selected) Diagnostic performance of IAP+/-IVUS Stenting rate, Nb of stents/lesion, stented length (full, spot) Primary Patency, cdtlr, MAE Health care costs 10

11 Inclusion/Exclusion criteria Inclusion Criteria Exclusion Criteria Subgroups Sample size De novo, restenotic or (re)occluded lesion(s) post PTA in the native superficial femoral artery and or the proximal popliteal arteries RC 2-4 RVD 4 and 7 mm ISR Use of debulking devices during the index procedure Outcomes will be analyzed by different pre-defined subgroups : lesion length <15 cm vs >=15 cm; TASC A/B vs C/D; CLI vs non CLI 150 subjects Study duration Enrollment : 12 months / FUP : 1, 6 and 12 months 11

12 Procedural flow chart operator Passeo-18 balloon Platform Paclitaxel : 3 g/mm2 Excipient : BTHC Safe guard insertion aid Catheter type, GW Struts dimensions Stent coating OTW, Thickness : 140 m ; Width : 85 m probio (Amorphous Silicon Carbide) Predilatation Passeo-18 Passeo-18 Lux 2 planes angiography DUS (or IAP +/-IVUS)* Independent Review Committee : Dissection grade (A-F)? FLD or not FLD? stent needed? full, spot stenting? Stent markers Proximal Shaft 6 gold markers at each end 3.6F, hydrophobic coated Pulsar-18 Where needed No stent Final treatment with or without stent based on angiography & adjunctive evaluation findings * IAP+/-IVUS will be conducted exclusively at pre-specified trained centers 12

13 Diagnostic performance Adjunctive DUS + Angiography vs Angiography alone Sensitivity : rate of true positive, based on the subjects with a clear FLD diagnosed by angiography = TP /(TP +FN) Specificity : rate of true negative, based on the subjects with no FLD diagnosed by angiography = TN/ (FP + TN) Angiography (independent Committee) FLD (+) FLD (-) Angio+adjunctive DUS or IAP+/-IVUS* FLD (+) True positive (TP) False positive (FP) FLD (-) False negative (FN) True negative (TN) * IAP+/-IVUS will be conducted exclusively at pre-specified trained centers 13

14 BIO REACT case 14

15 BIO REACT case Independent Review Committee : Dissection grade (A-F)? FLD or not FLD? stent needed? full, spot stenting? Intra-operative DUS by operator 15

16 BIO REACT case Stenting middle portion SFA 16

17 BIO REACT case 17

18 BIO REACT case 18

19 Summary DCB alone for complex lesions doesn t work leaving nothing behind is a dream Combination DCB + BMS seems to work good and can be benchmarked with DES Defining evaluating deciding on recoil & flow limiting dissections on angiography alone is extremely difficult and subjective BIO REACT pilot study evaluates the extra value of intra-operative DUS, IAP & IVUS to angiography alone, following the REACT strategy 19

20 Future of stenting in the current DCB world Koen Deloose, MD Head Dept Vascular Surgery AZ Sint Blasius Dendermonde, Belgium