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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 )

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current status of drug eluting balloons for sfa pop intervention

Current Status of DRUG ELUTING BALLOONS FOR SFA/POP INTERVENTION

BY

M. AKRAM KHAN MD FACC FSCAI

history of deb

INVENTORS

1979 – Professor Speck invented contrast agent Ultravist (iopromide)

2001 – Both Prof. Speck and Prof. Scheller introduced Ultravist / Paclitaxel Paccocath balloon

Professor Ulrich Speck

(scientist)

Dr. Bruno Scheller

(Interventional Cardiologist)

History of DEB
paccocath technology description

FIRST GENERATION BALLOON

Paclitaxel+Hydrophilic Spacer (iopromide)

Paccocath Technology Description
fempac 2 year outcome
PAC Balloon Vs. Control

Follow up 18 and / or 24 Months

Fempac 2 year outcome
next generation trials
Next generation trials

LEVANT-I

PACIFIER

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

metanalysis of deb randomized trials
Metanalysis of deb randomized trials

Conclusion: Consistent with statistically significant lower rate of restenosis in DEB Trials.

slide18
Conclusion: The IN.PACT Admiral DEB achieves substantially better primary patency at 1 year compared with angioplasty.

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)

currently ongoing usa trials on deb
CURRENTLY ONGOING USA TRIALS ON DEB

(ENROLLMENTS EITHER COMPLETE OR NEAR COMPLETION)

deb vs pta followed by stenting debate sfa trial
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 des inpact vs zilver ptx
Single Center

Retrospective with Propensity Score analysis

IN.PACT DEB vs Zilver PTX

228 Patients

Mean lesion length = 19 cm

DEB provisional Stent rate = 18.3%

DEB VS DESINPACT VS ZILVER PTX
conclusion
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.

Conclusion: