“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 -
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