Drug delivery devices for BTK treatment
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- Darrell Murphy
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1 LINC AP 2016, Hong Kong A.Z. Sint-Blasius, Dendermonde Marc Bosiers Koen Deloose Joren Callaert Imelda Hospital, Bonheiden Drug delivery devices for BTK treatment Patrick Peeters Jürgen Verbist W. Van den Eynde OLV Hospital, Aalst Lieven Maene Roel Beelen R.Z. Heilig Hart, Tienen Koen Keirse Bart Joos Koen Deloose, MD FMRP
2 Disclosure slide 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) I do not have any potential conflict of interest FMRP
3 BTK vessels for restenotic cascade FMRP
4 Antiproliferative Agents Drug elution is the only solution Crush plaque Stretch artery De-endothelialization Platelet/fibrin deposition Signaling cascades SMC migration & division ECM production Reendotheliazation RESTENOSIS FMRP
5 Drug elution is the only solution Cook Medical Taxol Family Paclitaxel DES Boston Scientific Stentys DCB Medtronic Bard Biotronik Spectranetics Ivascular Cardionovum EuroCor Boston Scientific Cook Medical Limus Family Cordis Abbott Medtronic Sirolimus Everolimus Zotarolimus Tacrolimus Sorin Biomedica FMRP
6 DES BTK in literature 100 Primary Patency DES-registry DES-RCT mm 10 21mm 27mm Time (months) Rastan A. et al (2011). European Heart Journal, 32, ; Bosiers M. et al (2012). Journal of Vascular Surgery, 55, Scheinert D. et al (2012). Journal of the American College of Cardiology, 60, 2290 FMRP
7 DES BTK in literature PREVENT study Prospective, non-randomized, multi-center study (3 Belgian, 2 German centers) : 70 patients Study objective: To evaluate the immediate and long-term (up to 12 months) outcome of the PROMUS ELEMENT (PLUS) Everolimus-Eluting Coronary Stent System (Boston Scientific) in a corelab controlled prospective way for BTK lesions of max 40mm FMRP
8 DES BTK in literature FMRP
9 DES BTK in literature 96.8 % 95.4 % % Baseline 1MFU 6MFU Freedom from TLR (%) Patients at risk Baseline 1MFU 6MFU Primary Patency (%) Patients at risk Baseline 1MFU 6MFU Freedom amputation (%) Patients at risk FMRP
10 DES BTK in literature DESTINY 2 study Prospective, non-randomized, multi-center study (4 Belgian, 3 German, 1 Australian center) Study objective: To evaluate the immediate and long-term (up to 12 months) outcome of the XIENCE PRIME BX Everolimus- Eluting Coronary Stent System (Abbott Vascular) in a corelab controlled prospective way for BTK lesions between 30mm and 100mm FMRP
11 DES BTK in literature FMRP
12 DES BTK in literature 84.9 % 75.4 % 96.6 % time baseline 1MFU 6MFU 12MFU at risk % time baseline 1MFU 6MFU 12MFU at risk % time baseline 1MFU 6MFU 12MFU at risk % FMRP
13 DES BTK in literature PES BTK-70 study Prospective, non-randomized, multi-center study ( 5 belgian centers) To evaluate the immediate and long-term (up to 12 months) outcome of the dedicated BTK SX Paclitaxel- Eluting Stentys Stent System (Stentys) in a corelab controlled prospective way for BTK lesions of max 50 mm FMRP
14 DES BTK in literature FMRP
15 DES BTK in literature 79.1 % 72.6% 98.5 % time baseline 6MFU 12MFU at risk % time baseline 6MFU 12MFU at risk % time baseline 6MFU 12MFU at risk % FMRP
16 DES BTK in literature Fusaro M, JACC 2013;6: FMRP
17 DES BTK in literature Fusaro M, JACC 2013;6: FMRP
18 DES BTK in literature Fusaro M, JACC 2013;6: FMRP
19 FMRP
20 Coronary DES trials showed increased risk for restenosis if full index lesion is not completely covered by DES Sakurai et al. Am J Cardiol 2005;96: FMRP
21 DCB-BTK Evidence: The LEIPZIG Registry Single Center Registry 104 Patients (CLI 82.6%) Diabetes 73% Mean lesion length 17 cm CTO s 62% IN.PACT Amphirion* vs. matched PTA historical cohort** * Schmidt A et al. J Am Coll Cardiol Sep 6;58(11): ** Schmidt A et al. Catheter Cardiovasc Interv Dec 1;76(7): FMRP 2016
22 DCB-BTK Evidence: The LEIPZIG Registry Single Center Registry 132 Patients (CLI 100%) Diabetes 100% Mean lesion length 13 cm CTO s 80% IN.PACT Amphirion vs. PTA in CLI DM patients Liistro F et al. Ciculation Aug 6;128(6): FMRP 2016
23 DCB-BTK Evidence: small RCT DCB-DES Single Center RCT 50 Patients (CLI + CI) Mean lesion length : 14,8 cm (DCB) vs 12,7 cm (DES) ; p=0,33) IN.PACT Amphirion vs. DES : 6 m results Binary restenosis: 58% vs. 28% (p=0.045) LLL: 1.35±0.2 vs. 1.15±0.3 (p=0.62) TLR: 14.3% vs. 7.4 (p=0.21) Late Lumen Loss (mm) Group DES: 1.35 ± 0.2 Group PCB: 1.15 ± 0.3 P=0.62 P.M. Kitrou, MD, PhD LINC 2014 >50% Restenosis Length (cm) Group DES: 3.6 ± 1.5 Group PCB: 4.3 ± 1.6 p=0.16 FMRP 2016
24 DCB-BTK Evidence : BIOLUX P-II prospective, multi-center 1:1 RCT: DEB vs. POBA primary endpoints: clinical: 30-day Major Adverse Events (MAE) efficacy: 6-month target lesion primary patency 72 subjects enrolled (Rutherford 2-5) DEB (N=36) Passeo-18 Lux POBA (N=36) Passeo day FU (N=35) 30-day FU (N=35) 6-month FU (N=33) 6-month FU (N=30) 12-month FU M. Brodmann, MD LINC 2014 FMRP
25 DCB vs. PTA in C IN.PACT DEEP IN.PACT DEEP : prospective, multi-center 2:1 RCT: DEB vs. POBA 358 subjects enrolled (Rutherford 4-6) DEB (N=239) In.Pact Amphirion POBA (N=119) standard PTA Angio eligible = 168 DEB = 113 PTA = 54 Angio excluded = 191 DEB = 126 PTA = 65 Angiographic outcomes Clinical outcomes Zeller et al. JACC 2014, 64 ; 15 FMRP
26 DCB-BTK Evidence overall FMRP
27 DEVICE RELATED? STUDY DESIGN RELATED? BTK/CLI RELATED? FMRP
28 DEVICE RELATED? DCB PTA p 12-month LLL (mm) 0.61± ± Lack of drug effect? Coating method Old IN.PACT Amphirion Manually-coated on folded balloon New (Next Gen) IN.PACT Pacific Admiral Automaticallycoated on semiinflated balloon Animal studies confirmed balloon material can impact drug delivery: - New design delivered more drug to vessel Folds protect the drug - New design had less residual drug on balloon Better drug release With the courtesy of T. Zeller, LINC 2015 FMRP 2016
29 STUDY DESIGN RELATED? No standardized wound care protocols? No standardized major amputation protocols? Zeller T, JACC 2014;64: Liistro F, Circulation 2013;128(6): FMRP
30 BTK/CLI RELATED? Is there an essential fysiological difference between SFA and BTK? (IN.PACT SFA vs IN.PACT DEEP) Is there an essential difference between CLI and CI patients in PTX response/risk? FMRP
31 Lutonix BTK FMRP
32 Lutonix BTK Steiner S., 2016, Leipzig,Germany FMRP
33 New horizons. Direct drug delivery in the vessel wall Bullfrog micro-infusion device (Mercator Medsystems) FMRP
34 CONCLUSION DES are effective for short BTK lesions in terms of primary patency, ftlr & amputation free survival but randomized trials miss superiority in hard clinical outcome of RB-classification shift & woundhealing. There is no proven clinical advantage across all studies between ANY DCB & control groups. The lack of wound treatment-/amputation protocols are partially responsable for these issues Further research with new technologies is mandatory in the challenging DCB-BTK field FMRP
35 LINC AP 2016, Hong Kong A.Z. Sint-Blasius, Dendermonde Marc Bosiers Koen Deloose Joren Callaert Imelda Hospital, Bonheiden Drug delivery devices for BTK treatment Patrick Peeters Jürgen Verbist W. Van den Eynde OLV Hospital, Aalst Lieven Maene Roel Beelen R.Z. Heilig Hart, Tienen Koen Keirse Bart Joos Koen Deloose, MD FMRP
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