Update on the role of drug eluting balloons William A. Gray MD William A. Gray MD Director of Endovascular Services Director of Endovascular Services f fC f fC Columbia University Medical Center Columbia University Medical Center Th C di l R hF d ti Th C di l R hF d ti Associate Professor of Clinical Medicine Associate Professor of Clinical Medicine The Cardiovascular Research Foundation The Cardiovascular Research Foundation
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Uppggdate on the role of drug eluting balloonsUppggdate on the role of drug eluting balloons William A. Gray MD Director of Endovascular Services ffC Columbia University Medical Center
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Update on the role of drug eluting p g gballoons
William A. Gray MDWilliam A. Gray MDDirector of Endovascular ServicesDirector of Endovascular Services
f f Cf f CColumbia University Medical CenterColumbia University Medical Center
Th C di l R h F d tiTh C di l R h F d ti
Associate Professor of Clinical MedicineAssociate Professor of Clinical Medicine
The Cardiovascular Research FoundationThe Cardiovascular Research Foundation
PCB Trials in the SFA TerritoryPCB Trials in the SFA TerritoryAngiographic Late Loss at 6 MonthsAngiographic Late Loss at 6 MonthsAngiographic Late Loss at 6 MonthsAngiographic Late Loss at 6 Months
RCT of PCB for the Treatment of De Novo SFA Disease RCT of PCB for the Treatment of De Novo SFA Disease
0.61-0.05
PACIFIER(Medtronic)(Medtronic)
N=45“Still less than “Still less than
(ITT= PTA Only)(ITT= PTA Only)
0.461.09LEVANT I
POBAN=35N=39(Lutonix)(Lutonix)
(Medtronic)(Medtronic)several several hundred hundred
0.30.8Fem-PAC PCBN=34
N=31
( )( )
(Medrad)(Medrad)patients having patients having 6 month 6 month
0.41.7Thunder N=48
N=41(Medrad)(Medrad)angiographic angiographic data and long data and long
Drug Eluting Balloon Evaluation for Lower Limb mUltilevel treatMent
Single center RCT of IN.PACT vs. PTA in MULTILEVEL lower limbdisease(Fabrizio Fanelli MD Roma Italy)
IN.PACT shows reduction of restenosis vs. PTA in multilevel (SFA + BTK) disease
with and without Stent(Fabrizio Fanelli MD - Roma, Italy)• Prim. Endpoint: 6m LLL• 50 patientsp• Fempop / BTK = 76% / 24%• LLC / CLI = 62% / 38%
F.Fanelli LINC 2012
Opportunities for ImprovementOpportunities for ImprovementAll available DCBs use PaclitaxelAll available DCBs use Paclitaxel
DrugDrug•• All available DCBs use PaclitaxelAll available DCBs use Paclitaxel•• Change in Paclitaxel form, size or chemical featuresChange in Paclitaxel form, size or chemical features•• Drug micro encapsulation or advanced drug systemsDrug micro encapsulation or advanced drug systems
Al i d (liAl i d (li b d h )b d h )•• Alternative drugs (limusAlternative drugs (limus--based or others)based or others)
•• Alternative carriers aiming to improve coatings:Alternative carriers aiming to improve coatings:•• Reduce total drug concentrationReduce total drug concentrationCarrierCarrier •• Reduce total drug concentrationReduce total drug concentration•• Enhance tissue transferEnhance tissue transfer•• Increasing tissue drug retentionIncreasing tissue drug retention
•• Bifurcations AMI calcified lesions etcBifurcations AMI calcified lesions etc•• Bifurcations, AMI, calcified lesions, etc…Bifurcations, AMI, calcified lesions, etc…
Paclitaxel DCB TypesPaclitaxel DCB TypesImpact on Biological PerformanceImpact on Biological PerformanceImpact on Biological PerformanceImpact on Biological Performance
Particles Released +++ ++Uniform Coating ++ +++Drug Transfer to Vessel +++ ++Drug Transfer to Vessel +++ ++Drug Retention vs. Time +++ +Biological Effectiveness +++ ?g
Separate Variables to be OptimizedSeparate Variables to be OptimizedCrystalline vs Amorphous; Tissue Uptake vs RetentionCrystalline vs Amorphous; Tissue Uptake vs RetentionCrystalline vs Amorphous; Tissue Uptake vs. RetentionCrystalline vs Amorphous; Tissue Uptake vs. Retention
Tissue Drug Concentration (%)Tissue Drug Concentration (%)
Angiographic Outcomes: PCB Trials Angiographic Outcomes: PCB Trials for “De Novo” Applicationsfor “De Novo” Applicationsfor De Novo Applicationsfor De Novo Applications
• PEPCAD III: BMS Crimped on PCB (3 µg/mm2) versus Cypher Stent• Lutonix De Novo Registry: Pre or Post Dilatation Using PCB (2 µg/mm2)