Presentation on theme: "Drug Coated Balloons From Bench to Bedside Service de Radiodiagnostic et Radiologie Interventionnelle Université de Lausanne Salah D. Qanadli, MD, PhD,"— Presentation transcript:
Drug Coated Balloons From Bench to Bedside Service de Radiodiagnostic et Radiologie Interventionnelle Université de Lausanne Salah D. Qanadli, MD, PhD, FCIRSE Cardio-Thoracic and Vascular Unit, QMI Lab Department of Radiology CHUV-University of Lausanne
Potential Conflict of Interest Educational grants – Cordis, Boston Scientific, Medtronic, Invatec, Bard Research grants – Abbott Vascular, Biotronik, Cordis, St Jude Medical Consultancy –Mediar Ltd. –University of Kingston London –Cook, Optimed, Cordis, Bard, Abbott, Terumo –Bioclinica
Dotter’s Predictions in World’s First PTA* – Balloon angioplasty – Recanalization devices – Outpatient PTA – Cost saving relative to surgery – Endovascular “splints” (stents) that “reintimalize” (endothelialize) Dotter et al., Circulation, 1964
PTA in 2013 for PAD Critical issues –Immediate technical results - Immediate out-come -Flow limiting dissection -Elastic Recoil -Immediate technical success -CTO recanalization –Re-stenosis (mid and long-term patency) DCB Technology
DCB Mechanism of Action 1.30-second minimum inflation transfers drug to endoluminal surface 2.PTX diffuses into the arterial wall from an endoluminal reservoir 3.Over time, therapeutic drug levels are sustained in deep cell layers after endothelial drug levels become sub-therapeutic 4.Drug continues to inhibit restenosis in arterial wall while allowing the lumen to restore and re-endothelialize
Coating uniformity European Product, Data on file. 6x60 mm Lutonix Drug Coated Balloon – N=5 6x60 mm In.Pact Admiral-Paclitaxel-eluting PTA balloon catheter – N=5
Defining Indications for DCB Clinical needs Device availability Proof of concept Clinical evaluation Strategy for use/Cost-effectiveness
Defining Indications for DCB Clinical needs –Clinically driven concept -High risk of re-stenosis -Femoro-popliteal lesions -up to 60 % at 12 mo* -Small vessels BTK -up to 69%** -AV Dialysis access -Re-stenosis/occlusion up 62 % at 12 mo*** *Muradin GS et al., Radiology, 2001. **Krokidis M et al., Cardiovasc Intervent Radiol, 2012. ***Bittl JA, JACC Cardiovascular Interv, 2010.
Defining Indications for DCB Clinical needs -Clinically driven concept -Limitations of existing alternatives (Stents, including DES) -BTK ? -BTA -AV shunts -FP -ISR -Complex anatomy (bifurcations, trans-collateral approaches,…) -Over dependence of double anti-agregants
Defining Indications for DCB Technology safety/efficacy –Proof of concept -Paclitaxel coated balloon (PCB) -DCB in routine practice in 2013 is PCB ! Clinical evaluation –Level of Evidence Cost-effectiveness –Strategy for use
De-Novo Femoro-popliteal Lesions N=433 ptsUncoated BPaclitaxel CBp TLR (n=350)27.7 %12.2 %<0.00001 RR (n=233)45.5 %18.7 %<0.0001 LLL (n=307)0.61-1.7 mm-.05-.05 mm<0.00001 Mortality (n=358)4.8 %2.1 %0.95 Adjunctive Stents (cross over) 14 to 34 %4 to 21 % THUNDER FemPac LEVANT I PACIFIER Control arm: UB ! Median FU: 10.3 mo Exclusion: Severely impaired arterial out flow
BTK Lesions BTK RCTTarget segmentArmsPE/FUNb PtsEstimated completion PICCOLOBTKPCB vs UB6 mo-18 mo114April 2011 IN.PACT DEEP NCT00941733 BTKPCB vs (UB+pStent) 12 mo357December 2015 DEBATE BTKBTKPCB vs UB12 mo150 DEBELLUMSFA/BTKPCB vs UB6 mo50 EURO CANAL NCT01260870 BTKPCB vs UB6 mo120December 2017
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