Drug eluting therapies: Just do it! Y. Gouëffic, MD, PhD Department of vascular surgery, University hospital of Nantes, France
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1 Drug eluting therapies: Just do it! Y. Gouëffic, MD, PhD Department of vascular surgery, University hospital of Nantes, France
2 Disclosure Speaker name: Yann Gouëffic X I have the following potential conflicts of interest to report: X Receipt of grants/research support Details: Abbott; Bard; Medtronic; Terumo; WL Gore X Receipt of honoraria and travel support Details: Abbott; Bard; Boston Sc; Cook; WL Gore; Medtronic; Perouse; Spectranetics Employment in industry Details: / Shareholder in a healthcare company Details: / Owner of a healthcare company Details: / I do not have any potential conflicts of interest to report
3 What is the best strategy for femoropopliteal lesions? POBA Bare metal stent Drug eluting stent Drug eluting balloon Covered stent Bioresorbable stent
4 Algorythm
5 5 levels of evidence
6 Becquemin, J Vasc Surg, 2003 Krankenberg, Circulation, 2007
7 Dake, Circ Cardiovasc Interv Müller-Hülsbeck, J Endovasc, Ther, 2016
8 Tepe, Circulation, 2014; Rosenfield, NEJM, 2015; Schroeder, Circulation, 2017
9 Mean lesion length: 82.2±68.4 mm Complete occlusion: 28.6% Prospective registry (In Pact Admiral,Medtronic) 53 patients 90.8% versus 1 y 18 mo Krankenberg, Circulation, 2015 Bague, Eur J Vasc Endovasc Surg, 2016
10 IN-PACT SFA (DEB arm) LEVANT 2 (DEB arm) ILLUMINATE RCT (DEB arm) RANGER SFA (DEB arm) Patients (n) 220/ / /72 71/34 Mean age 67.5± ± ±9 68±8 Intermittent claudication (%) Mean length (cm) Severe calcifications (%) / 8.94± ± ± ± Occlusions Tepe, Circulation, 2014; Rosenfield, NEJM, 2015 ; Schroeder, Circulation, 2017; Bausback, J Endovasc Ther,2017
11 IN-PACT SFA LEVANT 2 ILLUMINATE RCT RANGER SFA Provisionnal stenting (%) Iy patency rates at 12 months (%) (proportional rate) 82.2 vs p < vs p < vs p < vs 56 P<0.001 Iy patency rates at 24 months (%) 78.9 vs p < vs p= vs 65 p <0.001 NA Tepe, Circulation, 2014; Rosenfield, NEJM, 2015 ; Schroeder, Circulation, 2017; Bausback, J Endovasc Ther,2017
12 In/Ex critieria? - Long lesions - Failure of vessel prep - Severe calicification
13 BMS DES?
14 Zilver PTX RCT Zilver PTX vs POBA for TASC A/B femoropopliteal lesions At 5 years, sustained clinical, morphological and hemodynamic outcomes Dake, Circ Cardiovasc Interv Dake, Circulation, 2016
15 Samples size calculation of Zilver-PTX RCT First arm of randomization Primary end point 12-month rates of event-free survival and patency in the prim ary DES and PTA groups 479 patients to include Second arm of randomization - Sub groups - Secondary endpoints Dake, Circ Cardiovasc Interv. 2011
16 Prospective, multicentre, singlearm, open label (n= 57) Mean age 69±9 years Diabetes 35% Restenotic lesions - Mean lesion length 70.8±28.1 mm Occlusions 46% TASC A/B 90% Iy patency 96% Freedom from TLR 96% Müller-Hülsbeck, J Endovasc ther, 2016
17 Cumulative TLR-Free Rate Overall Efficacy & Safety Majestic at 36 months 36-Month Freedom from TLR Kaplan-Meier Estimate 85.3% freedom from TLR rate (K-M estimate) No target limb major amputations At risk: Time Post-procedure (months) 2 deaths at >365 days postprocedure, unrelated to study device or procedure No stent fractures 12 Months 24 Months TLR 96.4% 92.8% Primary Patency b 96.4% 83.5% Assisted Primary Patency 98.2% 88.9% Müller-Hülsbeck S. CIRSE Müller-Hülsbeck S. et al, Cardiovasc Interv Radiol 2017, doi: /s TLR, target lesion revascularization.
18 Few head to head comparison between devices for FP lesions treatment Katsanos, J Vasc Surg, 2014
19 POBA the weakest competitor
20 No high level evidence support an algorythm to treat femoropopliteal lesions > 4-cm
21
22 * * * * BATTLE trial (ClinicalTrials.gov number, NCT ) French multicentric randomized clinical trial comparing MISAGO vs. ZILVER PTX for the treatment of intermediate femoropopliteal lesions * * * * * 10 centers: Clinique d'antony (Jean-Marc PERNES); CHU de Besançon (Simon RINCKENBACH); CHU de Bordeaux (Eric DUCASSE) ; CHU de Clermont Ferrand (Eugenio ROSSET) ; AP-HP, Hôpital Henri Mondor (Pascal DESGRANGES) ; CH de Lyon (Patrick FEUGIER) ; CH de Bourgouin (Patrick LERMUSIAUX); Clinique Ollioules (Philippe COMMEAU) ; CHU de Rennes (Alain CARDON) ; Clinique Pasteur (Antoine SAUGUET); CHU de Nantes (Yann GOUËFFIC) 12-months outcomes with 186 patients will be released in 2018 Principal investigator: Pr Gouëffic Sponsor: Nantes University Hospital Granted from the French ministry of health (PHRC 2010 DGOS 20-03)
23 IMPERIAL trial Clinical Study Overview: IMPERIAL Enrollment completed Title A randomized trial comparing the ELUVIA drug-eluting stent versus Zilver PTX stent for treatment of superficial femoral and/or proximal popliteal arteries Primary Investigators Objective Global: William A. Gray, MD European: Prof. Dr. med Stefan Müller-Hülsbeck To evaluate the safety and effectiveness of the ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions up to 140 mm in length. Study Design The trial consists of the following: A prospective, multicenter, 2:1 randomized (ELUVIA vs Zilver PTX), controlled, single-blind, non-inferiority trial (RCT) A concurrent, non-blinded, non-randomized, single-arm, pharmacokinetic (PK) substudy A subject may be enrolled in the RCT or the substudy; but not in both The Eluvia Stent system is an investigational device, not available for sale in the European Economic Area (EEA).
24 EMINENT Clinical Study Clinical Study Overview: EMINENT Ongoing Title A Randomized Trial Comparing the ELUVIA Drug-Eluting Stent versus Bare Metal Self- Expanding Nitinol Stents in the Treatment of Superficial Femoral and/or Proximal Popliteal Arteries Coordinating Principal Investigators Objective Study Design Prof. Yann Goueffic, Nantes, France Prof. Giovanni Torsello, Münster, Germany To confirm superior effectiveness of the ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions up to 140 mm in length when compared against bare metal stents, and collect additional data including health economics data. Prospective, multi-centre, single-blind, superiority trial (RCT) Randomized 2:1 (Eluvia : Self Expanding BMS) Subjects 750 subjects to receive treatment Test Device Eluvia Drug Eluting Vascular Stent System N=500 subjects Control device N=250 Self Expanding Bare Nitinol Stents with US approval and CE marking Caution: Eluvia is an investigational device limited under US law for investigational use only. Not available for sale in the U.S.
25 EMINENT enrollment by country Country Enrollment Sites Activated to Enroll AT 21 3 BE 25 7 CH 8 4 DE ES 13 1 FR IE 1 1 IT 12 3 NL 6 3 UK 10 8 Total Enrollment as of 23Jan2018
26 Activated centers to enroll in France City Center Investigator Enrollment Nantes CHU NANTES Goueffic 11 Lille CHU Lille Sobocinski 5 Clermont-Ferrand CHU CLERMONT-FERRAND Rosset 5 Toulouse CL SARRUS TEINTURIERS Sauguet 4 Paris Hôpital Européen Georges-Pompidou Del Guidice 4 Saint Nazaire CHU de Saint-Nazaire Guillemot 3 Lyon HEH (CHU - HCL) Feugier 2 Strasbourg CHU STRASBOURG Thaveau 2 Nancy CHU Nancy Settembre 2 Valenciennes CHU Valenciennes Bianchini 2 Dijon CHU DIJON Steinmetz 1 Champigny Hôpital Privé Paul d'egine Becquemin 1 Créteil CHU MONDOR (CHU - APHP) Desgranges 0 Marseille SCAPP TIMONE (CHU - APHM) Bartoli 0 Enrollment as of 23Jan2018
27 Take home message - Lesions de novo < 4-cm: POBA - Restenosis: DCB - Lesions de novo > 4-cm: BMS, DES, DCB BUT POBA
28
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30 Drug eluting stent trials for TASC C/D femoropopliteal lesions Davaine, Eur J Vasc Endovasc Surg, 2015 Bosiers, J Cardiovasc Surg, 2013 Ishihara, J Endovasc Ther, 2016
31 Prospective,multicenter,single-arm study Age 68±9 years; Limbs: 105 IC/CLI: 89.5/10.5 Diabetes: 57.2% De novo lesions: 91.4% Lesion length (mm)251.71±78.9mm Total occlusions: 49.5% Bailout stenting rate was 10.9%. Micari, J Am Coll Cardiol Intv 2017
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