“Is 2018 the right moment to try to harmonize BTK

intervention approaches? ”

Pr. E. Ducasse MD PhD FEVBSBordeaux- France -

Disclosure

Speaker name:

Pr. E. Ducasse

I have the following potential conflicts of interest to report:

X Consulting: Alvimedica

Employment in industry

Stockholder of a healthcare company

Owner of a healthcare company

Other(s)

I do not have any potential conflict of interest

Trends in PAD Therapy

Goodney et al. J Vasc Surg 2009:50:54-60

Evolutions in PAD Therapy

Ferraresi et al. Linc 2017

Endoluminal

Sub-intimal

1/ Antegrade Approach

2/ Retrograde Approach

3/ Trans-collateral Approach

Evolutions in PAD Therapy

Ferraresi et al. Linc 2017

Endoluminal

Sub-intimal

1/ Antegrade Approach

2/ Retrograde Approach

3/ Trans-collateral Approach

So after crossing the lesionWe have too choose again …

Viva 2011 survey

POBA/PTA

Drug Coated Balloon

Drug Eluting Stent (BX)

Others

Actual Results 1/ POBA/PTA

• Remains the first step and option in BTK treatment strategy

• 1er RCT

• Clinically driven TLR : 11.9% (DCB) vs 13.5% (PTA)

• BUT MAJOR AMPUTATION RATES : 8.8% (DCB) vs 3.6% (PTA)

• Acts on negative remodelling issues

2/ DCBs

IN.PACT DEEP

Explanation N°1: exceptionnaly low amputation rates

in the PTA group @ 12 months

Actual Results

Explanation N°2: distal embolization of drug particles

• 5-10% of histologic sections of the skeletal muscles exhibit pathologic changes in small arteries

• either from embolization of coating

• or from toxic effects of PTX released from DCB

Micro embolization

and capillary bed

blockages

A lot of remaining issues

Find the best combination drug/excipient/coating and balloon

NO DCB CLASS EFFECT

Drug penetration and action in calcified lesions?

Moderate to Highly calcified lesions in up to 45% of the cases*

Geographic miss

Still needs scaffolding in case of elastic recoil or flow limiting dissection

Distal embolization

2/ DCBsActual Results

*

3/ Stents / DESActual Results

TLR

Primary Patency

Limb Salvage

RC improvement

Mortality

We are already trying to harmonizeBTK treatment strategies in CLI

patients all over the world

European Society Guidelines on Diabetic foot

European Society Guidelines on PAD

Italian concensus document on PAD Treatment in Diabetics

Carlo Setacci @ LINC 2017

Update of TASC II Committeeto include BTK lesions

We need pertinent endpoints• Endpoints of trials that include claudicants with femoropopliteal artery disease can be

analyzed objectively

• Conditions for BTK trials are much more challenging

• objective determination of technical endpoints can only be done using angiography

• high dropout rates due to death, concomitant diseases, and unwillingness to participate in FU angiography

• The main indication for BTK revascularization is limb preservation and pain relief

• But most BTK trials include “pseudo-CLI”patients

• High proportion of patients with DM

• important covariables affecting the outcome

• rest pain and neuropathy?

• wound healing and glycemic control/infection control/quality of wound care

• the correlation of technical efficacy and clinical improvement is not as close as in a claudicantpopulation

Take Home Message

We Do need some harmonization

• For all technical aspects…..maybe !

• Standardized wound assessment and wound care protocols

• Standardized “interdisciplinary CLI specialist” care protocols

Especially if we want to be able to draw any conclusions from clinical

trials

As Of Today Data is still lacking to draw any kind of definitive

guidelines

Future research should focus on (very) specific cohorts of patients

CONCLUSION

• For indication, techniques and FU

a strong intuition is much more powerfullthan a weak test !!!

Siddhartha Mukherjee

Thank you for your attention

“Is 2018 the right moment to try to harmonize BTK

intervention approaches? ”

Pr. E. Ducasse MD PhD FEVBSBordeaux- France -