NEW PERSPECTIVES IN CRITICAL LIMB ISCHEMIA:

DEB vs. DES

G. Biamino

Disclosure

Speaker name:

.................................................................................

I have the following potential conflicts of interest to report:

Consulting

Employment in industr

Stockholder of a healthcare company

Owner of a healthcare company

Other(s)

I do not have any potential conflict of interest

Interventional Therapy BTKfor CLI-Patients

• First Goal (for tissue loss):

–To achieve a straight line flow to the foot

• Long term patency of the treated vessel:- Of secondary importance ??

Angioplasty with Uncoated Balloons (POBA)

Occlusion ATA, Stenosis PA 3-mo re-occlusionAfter POBA both arteries

3-Months Angiographical FUafter POBA of long BTK-Lesions

- 58 CLI-pts. / 62 limbs

- Mean length of BTK-lesions: 183 mm

- Treatment with non-coated balloons

- Restenosis > 50 % after 3 months: 68.8 %

A. Schmidt et al., Catheter Cardiovasc Intervent 2010

- Mean length of restenosis: 155 mm

BTK Restenosis and TLR rates post-PTAInsufficient Durability

101 Patients

12m Angio

PTA arm PTA arm

60 Patients

10m Angio

33 Patients

6m Angio

11 Patients

12m Angio

67 Patients

12m Angio

58 Patients

3m Angio

PTA arm

1. D.Scheinert, J Am Coll Cardiol 2012;60:2290–5)

2. H.K.Soder, J Vasc Interv Radiol 2000; 11:1021–1031

3. F. Baumann, J Vasc Interv Radiol 2011; 22:1665–1673

4. F.Fanelli, J Endovasc Ther. 2012;19:571–580

5. F.Liistro, TCT 2012 oral presentation

6. A.Schmidt, Catheter Cardiovasc Interv. 2010 Dec 1;76(7):1047-54

BTK-Lesions Treated with the PTX-Coated In.Pact Amphirion Deep

- 104 patients included (Jan 2009 – Feb 2010)

- 109 limbs treated with In.Pact Amphirion

- Clinical limb status

- Ruth 3 19 (17.4 %)

- Ruth 4 19 (17.4 %)

- Ruth 5 70 (64.2 %)

- Ruth 6 1 (0.9 %)CLI 82.6 %

Leipzig Experience with DEB BTK

Leipzig Experience with DEB BTK

Leipzig Experience with DEB BTK

Leipzig Experience with DEB BTK

3-months follow-up angiography3 mo FU

Leipzig Experience with DEB BTK

61% restenosis reduction

POB BTK DEB BTK

Lesion-length 183 mm 173 mm

Restenosis >50 % @ 3 Mo 69 % 27 %

Length of restenosis 155 mm 64 mm

DEB in BTK LesionsDEBATE BTK

• Single Center Randomized (1:1)

• CLI, Diabetic patients

• IN.PACT Amphirion vs. std PTA

• Primary Endpoint: 12-month (>50%) Angiographic RR

F.Liistro et al. Circulation 2013

CLI + Diabetes

150 (Tibial) Lesions

DEB

(75 lesions)

Std PTA

(75 lesions)

12m Angio / Clinical FU

Aspirin + Clopidogrel (1 month)

24 m Duplex / Clinical FU

random (1:1)

First published randomized trial

to assess DEB vs. PTA in a

complex CLI–Diabetic population

with 12-month angiographic

endpoint

DEBATE BTK – 1-year Results

Restenosis and Occlusion Rates TLR

Complete Wound Healing

12-month TLR

DEB vs. PTA:

18.5% vs. 43.3%

(p=0.003)

Major Adverse Events

F.Liistro et al. Circulation 2013

DEB vs. PTA in BTK (RCT)

• DEBATE BTK [1] randomized Trial - IN.PACT vs. PTA

– Lesion length 12.8 cm (DEB) / 13.0 cm (PTA)

– 12-m TLR = 18.5% (DEB) vs. 43.3% (PTA) (p=0.003)

– 12-m Wound Heal. Rate (WHR) 86% (DEB) vs. 67% (PTA) (p=0.01)

59% TLRp=0.003

28% WHRp=0.01

F.Liistro et al. Circulation 2013

DEB vs. PTA in BTK (RCT)Inpact deep - Medtronic Press Release

• No biological efficacy (identical LLL)

• Trend towards more major amputations in the DEB cohort

What to do now in long lesions?

Continue with new studies using alternative coating technologies

Th.Zeller

DEB in BTK InterventionsConclusion

1. Recent CLI studies using In.PACT Amphirion DEBs resulted in inconclusive outcomes

2. Further studies investigating the performance of DEB in BTK lesions are mandatory

1. Due to potential safety concerns in patients with PAOD Rutherford 2 to 4

2. Proof of concept studies with an angiographic endpoint prior to lager scale CLI trials

3. It can be expected that biological effective DEB coatings will achieve comparable clinical outcomes as DES.

Th.Zeller

DES in Tibial Interventions

YUKON, DESTINY & ACHILLES TrialsPrimary Patency

P < 0.05

For all trials

Rastan et al. EHJ 2011

Scheinert et al. JACC 2012

Bosiers et al. JVS 2012

DES vs. PTA in BTK (RCT)

• ACHILLES [1-2] randomized Trial – Cypher Select vs. PTA

– Lesion length 2.7 cm (DES) / 2.7 cm (PTA)

– 12-m TLR = 10.0% (DES) vs. 16.5% (PTA) (p=0.257)

– 12-m Wound Heal. Rate (WHR): 61.7% (DES) vs. 41.3% (PTA) (p=0.0628)

1. D.Scheinert et al. A Prospective Randomized Multicenter Comparison of Balloon Angioplasty and

Infrapopliteal Stenting With the Sirolimus-Eluting Stent in Patients With Ischemic Peripheral Arterial

Disease. (J Am Coll Cardiol 2012;60:2290–5

2. Konstantinos Katsanos CIRSE 2012 Oral Presentation

39% TLRp=0.257

49% WHRp=0.0628

MAE and TVRat 2-year FU in patients with Claudication DES vs. BMS

(YUKON Trial, Rastan A. et al. JACC 2012)

Intermittent

claudication

Sirolimus Stent

(N=38)

Bare Metal Stent

(N=44)

P

Death 7 (18.4%) 8 (18.2%) 1.0

Major-/Minor Amputation 0/0 (0%) 0/2 (4.7%) 0.19

TVR 3 (7.9%) 11 (25%) 0.04

Myocardial infraction 1 (2.6%) 2 (4.5%) 0.50

Limb salvage 31 (100%) 36 (100%) 1.0

Rutherford-Becker class

Median change (IQR) -1 (-2 to -1) -1 (-1 to 0) 0.03

DES in BTK Lesion TrialsConclusions

• In lesions up to 10cm DES are the

treatment of choice in BTK lesions

extending to the ankle

• They are superior to BMS and POBA

• Longest lesions enrolled in ACHILLES

(up to 10cm)

• Uncertainty about the performance of DES

in long lesions

• Improved patency after DES results in

– Reduced TLR rates

– Preserved clinical benefit

– Increased limb preservation

Rastan et al. EHJ 2011; Scheinert et al. JACC 2012; Bosiers et al. JVS 2012

Focal Restenosis after DCB BTK

Occlusion left anterior tibial artery

Focal Restenosis after DCB BTK

Retrograde recanalization, 3 x 2.5/120 In.Pact Amphirion

Focal Restenosis after DCB BTK

3-months angiogram