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Why INTEREST in BTK Lesions “Real-World” lesions in SEA “Real-World” impact for SEA patients... Stents answer a structural problem Medications answer a re-stenosis problem... Stents add

Drug Eluting Platforms for Below-The-Knee lesions:

What do 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

1 st 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 3 months 68.8%

Fernandez et al J Vas Surg 2010:52 834-42

111 CLI patients

1 year follow up

Duplex patency 33% <50% re-stenosis

Re-intervention rate 50%

Longevity is the main Issue

Stents answer a structural problem Medications answer a re-stenosis problem

Stents address a structural issue

Role of BMS in BTK post CTO Angioplasty Salvage

situation

Xu G, Tang ZH, Cheng SC ASVS Kyoto 2010

1 year period 12 Limbs (10 patients) out of 130 Limbs Restenosis >50% on duplex/ DSA/CTA

Restenosis rate 91.2% by one month follow up

Re-occlusion rate 100% by 4 months

• Short lesions < 3cm

• Feasibility across joints/Movement points

• Feasibility of “full metal jacket”

• Stent still remains

YUKON, ACHILLES, DESTINY Trials

Deal with long length lesions

No residual inflammatory reaction inciting stents

No concerns across joints and areas of movement

5-10% may still need stents (?DES) for salvage reasons

TIMELINE OF EVENTS

2009 0.014 MonoRx Platform

2010 OTW 0.014 Platform Available 2010-2012 DCB Era started withInvatec 2013-Present Lutonix / Ranger

• Leipzig BTK Registry Schmidt A et al 2011

• 107 patients treated Amphiron DCB

• 60.5% total occlusion Rutherford class V 63.2%

Drug-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 3

months

At ankle and below ankle cases included as well

Safety– Acute Re-Thrombosis

Limb Salvage

1 Month 3 Month 6 Month Patency by Duplex

DEB Use in BTK Lesions

2 patients passed away > 30 days after intervention from unrelated causes

19 patients 1 BKA- ascending infection, vessel patent

Mean lesion length 140mm

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<0.001 TLR 18% DEB vs 43% POBA p=0.002

Occlusion 17% DEB vs 55% POBA p<0.001

Only 1 major amputation occurred, in the PTA group

(P=0.9)

DCB Default

DES/Self Expanding TPT Salvage

REGION SPECIFIC STUDIES

-PRE-EMPTIVE TREATMENT NEW PARADIGM

THANK YOU