Current Status of DRUG ELUTING BALLOONS FOR SFA (Dr Khan)

Report
BY
M. AKRAM KHAN MD FACC FSCAI
None
PTA
High rate of restenosis (40 – 60%)
DEBULKING
DEVICE
High rate of restenosis / high rate of stent deployment
BMS
ISR – 30-50% (RESILIENT TRIAL)
COVERED
STENTS
Same Issue, 1 year patency 40 -80%
DES
Same Issue, not like coronary DES (SIROCCO II TRIAL),
(ZIVER PTX), (Everolimus)
Long lesions, complex morphology, frequent multi level
Low flow rates
Calcification
Uneven delivery of local drug
Stent fracture
Polymer induced inflammation
Constant bio-mechanical pressure due to body movement
Professor Ulrich
Speck
(scientist)
INVENTORS
1979 – Professor Speck invented contrast
agent Ultravist (iopromide)
2001 – Both Prof. Speck and Prof. Scheller
introduced Ultravist / Paclitaxel Paccocath
balloon
Paclitaxel with Spacer
which was iopromide
Paccocath Balloon
B. Braun
Cotavance Balloon
MEDRAD
Dr. Bruno
Scheller
(Interventional
Cardiologist)
How does it work
Local Dose: 300 – 600 µg (100 – 200 µg in DES) which is 300 times
less compare to systemic administration.
Immediate Release
Short acting exposure
No Polymers
Cytotoxic which inhibits G2 phase of Mitosis
Spacer / Excipient which facilitates local delivery
Paclitaxel+
Hydrophilic
Spacer
(iopromide)
FIRST
GENERATION
BALLOON
Current Drug Coated Balloons on the Market
Peripheral and coronary DCBs with CE Mark
Company
Device Name
Balloon Drug
Load
Carrier
Lutonix
Moxy DCB
2 µg/mm²
Non- plymeric
Medrad-Possis
Coatavance
3 µg/mm²
Lopromide
Medtronic/Invatec
In.Pact
3.5 µg/mm²
Urea
Biotronik
Pantera Lux,
Passeo 18
3 µg/mm²
BTHC
B. Braun
Sequent Please
3 µg/mm²
Lopromide
Eurocor
DIOR II, Freeway
3 µg/mm²
Shellac
Aachen Resonance
Elutax
3 µg/mm²
Unknown
Blue Medical
Protege
3 µg/mm²
Unknown
THUNDER TRIAL
FEMPAC TRIAL
No. of patients
FEMPAC TRIAL
THUNDER TRIAL
Uncoated
42
54
Coated
45
48
Uncoated
1.0±1.1
1.7±1.8
Coated
0.5±1.1
0.4±1.2
Uncoated
47
44
Coated
19
17
Uncoated
33
37
Coated
9
4
Uncoated
48
52
Coated
20
15
Uncoated
2
0
Coated
0
2
6-mo late lumen loss, mm
6-mo angiographic restenosis, %
6-mo % TLR
18–24 mo % TLR
6-mo major amputations
Freedom from TLR: Kaplan-Meier
PAC Balloon Vs. Control
Follow up 18 and / or 24 Months
LEVANT-I
Lutonix Paclitaxel-Coated
Balloon for the Prevention of
Femoro popliteal Restenosis
Trial for Femoro popliteal
Revascularization
PACIFIER
A Randomized Multicenter Trial
Evaluating Prevention of
Restenosis with PaclitaxelCoated PTA Balloon Catheters in
Stenosis or Occlusion of Femoro
popliteal Arteries
DEB
Control
P value
% Diameter Stenosis %
28.6%
40.4%
0.01
Min. Lumen Diameter mm
3.6 mm
3.0 mm
0.03
Binary Restenosis n/N (%)
4/40 (10%)
12/39 (31%)
0.03
Late Lumen Loss mm
-0.05 mm
0.61 mm
0.003
Conclusion: Consistent with statistically significant lower
rate of restenosis in DEB Trials.
ITT Analysis at 1 Year
DEB (n=220)
Angioplasty (n=111) P Value
Primary Patency
82.2%
52.4%
<0.001
Clinically Driven TLR
2.4%
20.6%
<0.001
Primary Sustained
Clinical Improvement
85.2%
68.9%
Primary Safety
Endpoint
95.7%
76.6%
MACE
6.3%
24.3%
The primary safety composite (freedom from 30-day device- and
procedure-related death and from target limb major amputation and
clinically driven TVR through 12 months) was higher in the DEB arm.
Conclusion: The IN.PACT Admiral DEB achieves
substantially better primary patency at 1 year
compared with angioplasty.
LEVANT-II
IN.PACT SFA II
DEFINITIVE - AR
(ENROLLMENTS EITHER COMPLETE OR NEAR COMPLETION)
12-month Restenosis and TLR (per lesion)
Restenosis per lesion length
12-month Major Adverse Event
Restenosis per Revasc Technique
p
Adjusted p
21.5% (21/79)
0.705
0.550
15.6% (17/109)
19.0% (15/79)
0.543
0.572
23.9% (26/109)
30.4% (24/79)
0.319
0.372
Major Adverse Event
DEB
DES
N
131
97
Any TLR
19.3% (21/109)
Clinical Driven TLR
Loss of Patency
DEB provisional Stent rate = 18.3%
1.
Single Center
2.
Retrospective with
Propensity Score analysis
3.
IN.PACT DEB vs Zilver PTX
4.
228 Patients
5.
Mean lesion length = 19 cm
DEB IN ISR
DEB IN ISR
(DIABETICS)
DEB FOLLOWING
ATHERECTOMY
DEB FOLLOWING
LASER ATHERECTOMY
DEB VS. DES IN
ISR
• FAIR TRIAL
• DEBATE ISR TRIAL
• DEFINITIVE-AR TRIAL
• PHOTOPAC TRIAL
• RIBS-V
1.
2.
3.
4.
5.
6.
7.
ROLE OF DEB IN SFA/POP INTERVENTION IS
PROMISING.
DEB IS SUPEIOR TO PTA IN ALL CLINCAL TRIALS.
RESULTS OF DEB ANGIOPLASTY ARE COMPARABLE
OR BETTER THAN DES.
DEB ARE EASIER TO USE.
IT IS COST EFFECTIVE MODALITY FOR DE-NOVO
AND RESTENOSIS LESIONS.
COMPARE TO STENTS, NO ANATOMICAL
LIMITATION.
DEB PRESERVE FUTURE PERCUTAEOUS AND OPEN
SURGERY OPTIONS.

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