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.