Post on 24-Jan-2020
San Raffaele Scientific Institute
Focus on SFA:When should we use DESs?
Why?
Andrea KahlbergVascular Surgery, “Vita-Salute” University
Scientific Institute San Raffaele – Milan, Italy
Latest advancements in diabetic patients:May drug elution technologies improve clinical outcome?
San Raffaele Scientific Institute
• Investigator for trials sponsored by Alvimedica, Boston Scientific, Cook Medical, Medtronic, Cordis, W.L. Gore, Bolton Medical
• Lecturer at courses/symposia hosted by Alvimedica, Boston Scientific, Cook Medical, Medtronic, W.L. Gore, Terumo, Biovascular, Abbott
• Proctorship for W.L. Gore
Disclosure statement
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BMS vs DES: the role of the drug
COOK* Zilver Flex Zilver PTX
Diabetic 42.0 49.6
Occlusion (%) 25.0 30.0
Calcification (%) 57.0 72.6
Primary Patency (%) 73.0 83.1
Results @ 1 year
* COOK Zilver PTX clinical data guide 2010-2011
+14%
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BMS vs DES: the role of the drug
Results @ 1 year
+45%
BOSTON** superNOVA Majestic
Diabetic 40.5 35.1
Occlusion (%) … 46.0
Calcification (%) 70.2 78.9
Primary Patency (%) 66.4 96.1
* * Mueller-Huelsbeck @ CIRSE 2016
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BMS vs DES: the role of the drug
Results @ 5 years
41% reductionin restenosis rate
Dake et al, Circulation 2016
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The role of the drug on balloons
5. Scheinert, D. Charing Cross 2017. Ranger-SFA Study
DCB,86.0%
DCB,56.0%
Δ 30.0%P < 0.001
[5]
5. Scheinert, D. Charing Cross 2017. Ranger-SFA Study
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The role of the drug on balloons
5. Scheinert, D. Charing Cross 2017. Ranger-SFA Study
DCB,91.0%
PTA,70.0%
Δ 21.0%P = 0.010
[5]
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DCB: what about bail-out stenting?
Complex lesions: Increasing use of DCBs
AND increasing use of bail-out stents
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Drug Coated Balloons
• No permanent implants (leave no metal behind)
• Reduced requirement for DAPT
• Procedural effectiveness similar to simple PTA (recoil, calcium dissection)
• Increased provisional stent placement with increasing lesion length
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The role of DESs in the daily practice
When and why?
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1) Bail-out after PTA
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1) Bail-out after PTA
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1) Bail-out after PTA
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2) Restenosis/occlusion after DCB
3 months after DCB
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3) Complex lesions(> 20 cm occlusions and/or heavily calcified)
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3) Complex lesions(> 20 cm occlusions and/or heavily calcified)
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Marketed DES drug release approachesCurrently 2 different approaches
in the release of a drug from a stent:
1) “Simple” Polymer-free release-controller (e.g. Cook Zilver PTX)
Dake MD - J Vasc Interv Radiol. 2011;22(5):603-610.
No
rmal
po
rcin
e ar
tery
mo
del
Relative paclitaxel levels remaining on the stent
Pro safety: no-inflammatory trigger
Con efficacy: fast elution
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2) Polymer-based drug delivery (e.g. Boston Sc. Eluvia)
Pro efficacy: sustain elution
Con safety: possible negative (inflammatory) long-term effect of the polymer
The Münster all-comers registry of Eluvia – T. Bisdas @Linc2018
Marketed DES drug release approachesCurrently 2 different approaches
in the release of a drug from a stent:
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Other new solutions for DES
Polymer-free
but
controlled and sustained elution
“maximize the efficacy avoiding polymer’s drawbacks “
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NiTiDES (Alvimedica)
patented technology of abluminal reservoir
sustained release but polymer-free platform
Other new solutions for DES
Drug/formulationwithout polymersReservoir section
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Amphilimus™ formulation (NiTiDES)
Drug formulation = Sirolimus + permeation enhancer (fatty acid)
DICLOFENAC
Drug+
Permeation Enhancer
Fatty Acids are used to improve delivery of many
different drugs.*
* Drug Delivery, 15:373-379, 2008
Fatty Acid uptake is double in diabetic mice model.**
** Cardiac fatty acid uptake and metabolism in db/+ and db/db mice.Curr Cardiol Rev. 2008 February; 4(1): 12-21
Increased drug concentration
(diabetes)
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ILLUMINA study
FIH study of NiTiDES stent100 patients enrolled in 10 European centers(Germany, Italy, France) - Coord. P.I. Dierk Scheinert
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1 year results• Excellent Safety (3% MAE)
• Excellent Efficacy (Primary Patency -87%; TLR – 2%)
Data firstly presented @ CIRSE 2018
Free
do
m f
rom
TLR
Pri
mar
y P
ate
ncy
ILLUMINA study
Freedom from TLR98% @1y
Primary patency97% @1y
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Conclusions
Drug elution has proved to increase patency rates of both balloons and stents up to 5 years
Stenting with DES has elective indications in complexlesions, bail-out situations, restenosis and occlusions
after DCB
It’s time to investigate the role od DES in subgroups of patients considered at high-risk
San Raffaele Scientific Institute
Focus on SFA:When should we use DESs?
Why?
Andrea KahlbergVascular Surgery, “Vita-Salute” University
Scientific Institute San Raffaele – Milan, Italy
Latest advancements in diabetic patients:May drug elution technologies improve clinical outcome?