DEB will be the Future for BTK Lesions

GB Danzi, MDGB Danzi, MDGB Danzi, MDGB Danzi, MDMilan - Italy

BTK Intervention: Drug-Eluting Balloon

1. Pattern of disease in CLI patients

l2. Targets in CLI revascularization

3. Lesion length in BTK‐CLI‐PTAg

4. Restenosis in BTK vessel PTA

5% ATGOur last 1000 CLI patients• 84% DM2%

1%

5% ATG • 84% DM• 17% ESRD-HD• Mean age 72 yy

2%• Mean age 72 yy

55% FEM-POP29%

42%

TPT 29%

0 BTK vessel 4%32%

1 BTK vessel 14%

2 BTK vessels 42%29%

96% BTK

2 BTK vessels

3 BTK vessels 40%

26%

80%

49%87% 96% BTK 0 FOOT  vessel 26%1 FOOT  vessel 23%

l 33%

49%87%

2 FOOT  vessels 33%3 FOOT  vessels 18%

57%

51%36%

5% ATG2%

1%

5% ATG2%

In our society we are facing

55% 42%

y gan epidemic of OLD-DM-ESRD-CLI patients

32%

ESRD CLI patientscharcterized by mutileveldisease & extensive

29%

disease & extensiveinvolvement of BTK & FOOT

l

96% BTK

80%

49%87%

vessels

96% BTK49%87%

57%51%

36%

BTK Intervention: Drug-Eluting Balloon

1. Pattern of disease in CLI patients

l2. Targets in CLI revascularization

3. Lesion length in BTK‐CLI‐PTAg

4. Restenosis in BTK vessel PTA

Targets in BTK-CLI revascularization

1 Complete revascularization1 Complete revascularization1. Complete revascularization1. Complete revascularization

• 1 vessel better than 0

• 2-3 vessels better than 1

• Tibials better than peroneal

Case 1Case 1Case 1Case 1

Operators need to be familiarOperators need to be familiar with all the available techniques

Pedal-Plantar Loop Technique Case 1Case 1Case 1Case 1

Case 1Case 1Case 1Case 1

Targets in BTK-CLI revascularization

1. Complete revascularization1. Complete revascularization

Failure!

2. Wound related artery PTA2. Wound related artery PTA

Direct revascularization,

bypass or PTA better than

indirect revascularization

Case Case 22Case Case 22

“complete” or… complete or WRA are the targets

f BTK CLIof BTK-CLI-revascularizationrevascularization

BTK Intervention: Drug-Eluting Balloon

1. Pattern of disease in CLI patients

l2. Targets in CLI revascularization

3. Lesion length in BTK‐CLI‐PTAg

4. Restenosis in BTK vessel PTA

Mean length of treated lesions

Our last 1000 CLI patients• 84% DM84% DM• 17% ESRD-HD• Mean age 72 yyMean age 72 yy

29%

96% BTK

80%

49%87% 96% BTK49%87% 185185±±121 121 mmmm

57%51%

36%

Length of BTK treated lesion

Balloon expandable stent (BMS/DES/AMS): 36 mm (11-97)

mm

Length of BTK treated lesion

Balloon expandable stent (BMS/DES/AMS): 36 mm (11-97)

Self expandable stent (Xpert): 51mm (33-75)

mm

Length of BTK treated lesion

Balloon expandable stent (BMS/DES/AMS): 36 mm (11-97)

Self expandable stent (Xpert): 51mm (33-75)

POBA (UB): 179 mm (140-213)

mm

BTK Intervention: Drug-Eluting Balloon

1. Pattern of disease in CLI patients

l2. Targets in CLI revascularization

3. Lesion length in BTK‐CLI‐PTAg

4. Restenosis in BTK vessel PTA

Restenosis in extensive BTK PTA with UB

3030% t% t≈30≈30% patency% patency

≈ 70≈ 70% % restenosisrestenosis

Restenosis in extensive BTK-FOOT-PTA is precocious and aggressive: p gg70% at 3 months

Restenosis delays healing of tissue lesions!Restenosis delays healing of tissue lesions!

Lida O, European J Vasc Endovasc Surg 2012;44;425

Restenosis in extensiveRestenosis in extensive BTK-FOOT-CLI-PTA with UB is precocious and aggressive and delaysaggressive and delays healing of tissue lesions: i 3 th 70% fin 3 months 70% of our work has gone awayg y

3 months!3 months!

DEB in BTK-CLI

DEB BTK Registry104 patients (CLI = 82.6%; Diabetics = 73%) treated with IN.PACT Amphirion for long BTK stenosis and occlusions (avg length 173±87 mm)Primary EP: 3m Angiographic Rest Rate

Remarkably low Restenosis rate at 3m vs. historical PTA cohort

Primary EP: 3m Angiographic Rest. Rate

Angiographic FU 3-month 3-month

DEB PTA*

Restenosis (>50%) 27.4% 69%

Full-segment Resten. 10% 56%

Restenosis Length 64 mm 155 mm

Clinical FU 12-month 15-monthDeaths 16.3% 10.5%

Limb Salvage 95.6% 100%Limb Salvage 95.6% 100%

Clinic. Improvem. 91.2% 76.5%

Compl. wound healing 74.2% 78.6%

TLR 17 3% 50%

Schmidt A, JACC 2011

TLR 17.3% 50%

* PTA historical cohort (A.Schmidt et al. CCI 2010)

DEB in BTK-CLI: randomized studies

DEBATE BTK RCTSignificant reduction in LLL and  Restenosis  

120 patients with CLI and Diabetes randomized to IN PACT Amphirion vs PTA

(DEBATE BTK RCTat 6‐m and TLR reduction at 12‐m vs. PTA

to IN.PACT Amphirion vs. PTA

Primary EP: 12m Angiographic Rest. Rate

Significant reduction of 12m Rest.Significant reduction of 12m Rest. Rate vs. PTA in BTK / CLI / Diabetics

6-month LLL 12-month TLR12 month TLR

(F.Liistro LINC 2012)Fanelli F. CIRSE 2012

Length of BTK treated lesion

Balloon expandable stent (BMS/DES/AMS): 36 mm (11-97)

Self expandable stent (Xpert): 51mm (33-75)

POBA (UB): 198 mm (184-213)

mm POBA (DEB) 147 mm (121-173)

Only POBA (UB & DEB) can treatthe long lesions typical ofthe long lesions typical ofBTK&FOOT vessel disease

93%72%72%

Micari A, JACC Intv 2013;2:282

DEB Technolog O er ieDEB Technology Overview

Dose Manufacturer DEB Drug (µgr/mm2) Excipient

MEDRAD PACCOCATH Paclitaxel 3 Ultravist

MEDTRONIC IN.PACT Paclitaxel 3 Urea

BARD Lutonix Paclitaxel 2 Polysorbate & Sorbitol

EUROCOR Freeway Paclitaxel 3 Shellac

BIOTRONIK Passeo 18 Lux Paclitaxel 3 BTHC

COOK Advance PTX Paclitaxel 3 none

COVIDIEN CVI Paclitaxel ? ?COVIDIEN CVI Paclitaxel ? ?

CONCLUSIONSCONCLUSIONSCONCLUSIONSCONCLUSIONS

DEB are the Present for BTK L iBTK Lesions

DEBs are the only devices able to guarantee:DEBs are the only devices able to guarantee:1. Extensive BTK&FOOT vessel treatment2. Long term vessel patency1. Extensive BTK&FOOT vessel treatment2. Long term vessel patency3. Reduced TLR4 And probably reduced healing time3. Reduced TLR4 And probably reduced healing time4. And probably reduced healing time4. And probably reduced healing time