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Drug Eluting Platforms for Below-The-Knee lesions: What We Know So Far? Dr Cheng SC, MMed(Surg) FRCSEdin(Gen) FAMS Consultant Vascular and Endovascular Surgeon Adj Assistant Prof , National University Singapore NOTHING MUCH CHANGED SINCE 2012 Why INTEREST in BTK Lesions “Real-World” lesions in SEA “Real-World” impact for SEA patients 60-70% of PVD work is BTK 20-30% at At Ankle 1st Presentation is Tissue Loss Long healing time is required A Schmidt et al Catheter Cardiovas Intervent 2010 58 CLI patients 62 limbs Mean lesion length 183mm Re-stenosis > 50% after months 68.8% Fernandez et al J Vas Surg 2010:52 834-42 111 CLI patients year follow up Duplex patency 33% 50% stenosis at months BTK DEB 27% Medtronic, Inc 8200 Coral Sea Street NE Mounds View, MN 55112 www.medtronic.com Urgent Field Safety Notice IN.PACT® Amphirion DrugEluting Balloon (DEB) November, 2013 Medtronic reference # FA597 Dear Healthcare Professional (Hospital Administrator, OR Manager, and Risk Manager), Based on data from the IN.PACT® DEEP clinical study, Medtronic has decided to voluntarily recall and stop selling the IN.PACT Amphirion drug-eluting balloon (DEB) Only the IN.PACT Amphirion DEB is subject to this recall Other products in the IN.PACT DEB product family are not subject to this recall IN.PACT DEEP Randomized Trial Zeller et al J Am Coll Cardio 2014 Oct Multicenter Prospective 2:1 DEB : POBA 358 CLI patients End-points CD-TLR LLL CD-TLR DEB 9.2% POBA 13.1% p=0.291 LLL DEB 0.61 +/- 0.78mm POBA 0.62 +/- 0.78mm p=0.950 A safety signal driven by major amputations through 12 months was observed in the IA-DEB arm versus the PTA arm (8.8% vs 3.6%; p = 0.080) MEANWHILE IN SINGAPORE 2010-2012 Tan Tock Seng Hospital Registry 2010 Loong TH etal 24 patients agreed to the use of DEB DEB use after predilatation with uncoated balloon Patients that need DES or BMS stent salvage not included in analysis All started on double antiplatelets for at least months At ankle and below ankle cases included as well Safety– Acute Re-Thrombosis Limb Salvage Month Month Month Patency by Duplex DEB Use in BTK Lesions Age Range 45-94 Mean 67.6 Males 12 ( 57%) Females (43%) DM 19 (90%) HPT 16 (76%) Hyperlipidaemia 13 (62%) IHD (38%) Smoking (10%) patients passed away > 30 days after intervention from unrelated causes 19 patients BKA- ascending infection, vessel patent Mean lesion length 140mm Percentage of > 50% restenosis on duplex Months 0% Months 10% Months 20% DEBATE-BTK Liistro et al Circulation 2013 Single Center DM CLI patient 1:1 Randomisation DEB:POBA 132 patients Primary End-point Binary Stenosis on treated segment 12 months on US or Angiography Secondary End Points CD TLR, Amputations and Occlusion Binary restenosis 27% DEB vs 74% POBA p