current status of drug eluting balloons for sfa/pop intervention
DESCRIPTION
Current Status of DRUG ELUTING BALLOONS FOR SFA/POP INTERVENTION. BY M. AKRAM KHAN MD FACC FSCAI. None. Financial Disclosure. WHY DRUG ELUTING BALLOON FOR SFA/POP DISEASE. ISSUES WITH SFA/POP RESTENOSIS. INVENTORS 1979 – Professor Speck invented contrast agent Ultravist (iopromide ) - PowerPoint PPT PresentationTRANSCRIPT
CURRENT STATUS OF
DRUG ELUTING
BALLOONS FOR
SFA/POP INTERVENTI
ONBY
M. AKRAM KHAN MD FACC FSCAI
FINANCIAL DISCLOSURE
None
WHY DRUG ELUTING BALLOON FOR SFA/POP DISEASE
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)
ISSUES WITH SFA/POP RESTENOSIS
Long lesions, complex morphology, frequent multi levelLow flow ratesCalcificationUneven delivery of local drug Stent fracturePolymer induced inflammationConstant bio-mechanical pressure due to body movement
HISTORY OF DEBINVENTORS
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 BalloonMEDRAD
Dr. Bruno Scheller
(Interventional Cardiologist)
Professor Ulrich Speck
(scientist)
PACLITAXEL IN DEBHow 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
PACCOCATH TECHNOLOGY DESCRIPTION
Paclitaxel+Hydrophilic Spacer (iopromid
e)
FIRST GENERATI
ON BALLOON
Current Drug Coated Balloons on the Market
Peripheral and coronary DCBs with CE MarkCompany Device Name Balloon
Drug LoadCarrier
Lutonix Moxy DCB 2 µg/mm² Non- plymericMedrad-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
FIRST GENERATION LANDMARK TRIALS
THUNDER TRIAL
FEMPAC TRIAL
THUNDER & FEMPAC TRIAL 6 MONTHS RESULTS
No. of patients FEMPAC TRIAL THUNDER TRIAL
Uncoated 42 54
Coated 45 48
6-mo late lumen loss, mm
Uncoated 1.0±1.1 1.7±1.8
Coated 0.5±1.1 0.4±1.2
6-mo angiographic restenosis, %
Uncoated 47 44
Coated 19 17
6-mo % TLR
Uncoated 33 37
Coated 9 4
18–24 mo % TLR
Uncoated 48 52
Coated 20 15
6-mo major amputations
Uncoated 2 0
Coated 0 2
THUNDER FIVE YEAR OUTCOMEFreedom from TLR: Kaplan-Meier
FEMPAC 2 YEAR OUTCOMEPAC Balloon Vs. Control
Follow up 18 and / or 24 Months
NEXT GENERATION TRIALS
Lutonix Paclitaxel-Coated Balloon for the
Prevention of Femoro popliteal Restenosis Trial
for Femoro popliteal Revascularization
A Randomized Multicenter Trial Evaluating Prevention
of Restenosis with Paclitaxel-
Coated PTA Balloon Catheters in
Stenosis or Occlusion of Femoro popliteal Arteries
LEVANT-I PACIFIER
LEVANT-I 6 MONTHS RESULTS
PACIFIER – 6 MONTHS ANGIOGRAPHIC FOLLOW UP
DEB Control P value% Diameter Stenosis % 28.6% 40.4% 0.01Min. Lumen Diameter
mm3.6 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
METANALYSIS OF DEB RANDOMIZED TRIALS
Conclusion: Consistent with statistically significant lower rate of restenosis in DEB Trials.
FIRST DEB VS PTA TRIAL IN USA(APRIL 2014)
IN.PACT SFA TRIAL- ONE YEAR DATA331 PATIENTS FROM EUROPE AND THE US RECEIVED A DRUG-ELUTING BALLOON (DEB;
N=220) OR ANGIOPLASTY (N=111)
Conclusion: The IN.PACT Admiral DEB achieves substantially better primary patency at 1 year
compared with angioplasty.
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.
CURRENTLY ONGOING USA TRIALS ON DEB
LEVANT-IIIN.PACT SFA IIDEFINITIVE - AR
(ENROLLMENTS EITHER COMPLETE OR NEAR COMPLETION)
DEB VS PTA FOLLOWED BY STENTING- DEBATE SFA TRIAL
12-month Restenosis and TLR (per lesion)
12-month Major Adverse Event
Restenosis per lesion length Restenosis per Revasc Technique
DEB VS DESINPACT VS ZILVER PTX
1. Single Center2. Retrospective with
Propensity Score analysis
3. IN.PACT DEB vs Zilver PTX
4. 228 Patients 5. Mean lesion length =
19 cm
DEB provisional Stent rate = 18.3%
Major Adverse Event
DEB DES p Adjusted p
N 131 97Any TLR 19.3% (21/109) 21.5% (21/79) 0.705 0.550
Clinical Driven TLR 15.6% (17/109) 19.0% (15/79) 0.543 0.572Loss of Patency 23.9% (26/109) 30.4% (24/79) 0.319 0.372
DEB IN COMPLEX SFA DISEASE
•FAIR TRIALDEB IN ISR
•DEBATE ISR TRIALDEB IN ISR (DIABETICS)
•DEFINITIVE-AR TRIALDEB FOLLOWING ATHERECTOMY
•PHOTOPAC TRIALDEB FOLLOWING LASER
ATHERECTOMY
•RIBS-VDEB VS. DES IN ISR
CONCLUSION:1. ROLE OF DEB IN SFA/POP INTERVENTION IS
PROMISING.2. DEB IS SUPEIOR TO PTA IN ALL CLINCAL
TRIALS.3. RESULTS OF DEB ANGIOPLASTY ARE
COMPARABLE OR BETTER THAN DES.4. DEB ARE EASIER TO USE. 5. IT IS COST EFFECTIVE MODALITY FOR DE-
NOVO AND RESTENOSIS LESIONS.6. COMPARE TO STENTS, NO ANATOMICAL
LIMITATION.7. DEB PRESERVE FUTURE PERCUTAEOUS AND
OPEN SURGERY OPTIONS.
THANK YOU!!!