drug eluting devices: facts or concerns€¦ · pi-566410-18 12 month primary patency 100% 100%...
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Carlos Mena, MD FACC FSCAIAssociate Professor of Medicine - CardiologyDirector Cardiac Catheterization LaboratoriesDirector Vascular Medicine & Endovascular FellowshipYale New Haven HospitalYale UniversityNew Haven CT USA
Drug Eluting Devices: Facts or Concerns
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Meta-analyses have shown improved patency and TLR rates for DES and DCB treatment, compared with bare-metal stents and PTA, in the femoropopliteal segment1,2
1. Simpson EL, et al. Health Technol Assess 2014;18(10). 2. Katsanos K, et al. J Vasc Surg. 2014;59(4):1123-1133 e1128.
Drug Elution for Peripheral Applications: Intended Clinical Benefit of DES & DCB
Anti-proliferative drugs (e.g., paclitaxel) counteract neointimal response to intervention1
Prolong vessel patency
Reduce need for reintervention
DCB, drug-coated balloon; DES, drug-eluting stent; PTA, percutaneous transluminal angioplasty; TLR, target lesion revascularization.
DCB
• Inhibit restenotic cascade
• Prevent lumen loss
DES
• Inhibit restenotic cascade
• Scaffolding prevents vessel shrinkage (recoil)
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Results from different clinical investigations are not directly comparable. Information provided for educational purposes only.
The Ranger Drug Coated balloon is an investigational device, not available for sale in the United States
* = Pure Patency
89.0% 88.5% 87.5% 86.4%83.1% 82.3%
73.5%67.0%65.0%
79.5%
52.4%56.5%
32.8%
70.9%
56.8% 55.0%
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DCB ControlEluvia
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DES and DCB RCT 12M Primary Patency
/Zilver PTX
• In general, DES and DCB have shown similar results in SFA RCTs
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Limits of DCB
Treatment Durability:
Long Lesion
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Limits of DCB Treatment Durability Lesion Length
Results from different clinical investigations are not directly comparable. Information provided for educational purposes only.
• 1 year: no association between increasing mean lesion length and worsening primary patency or TLR rates
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Limits of DCB Treatment Durability Lesion Length
Results from different clinical investigations are not directly comparable. Information provided for educational purposes only.
.
• 2 years: patency and reintervention rates appear to be worse for cohorts with longer lesions
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• Longer mean lesion length correlates with higher provisional stenting rate
In Studies Assessing DCB Outcomes: Primary Therapy Stents Were Commonly used
Provisional Stenting in Randomized Controlled Trials may not be representative of actual stenting in studies due to study design
Results from different clinical investigations are not directly comparable. Information provided for educational purposes only.
0%
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0 5 10 15 20 25 30
Pro
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Mean Lesion Length (cm)
FIH or RCT
Registry
RegistrySubgroupTrend Line
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• Pilot study results suggest increased benefit of DES (vs DCB) in lesions >10cm in length (greater separation between patency curves)
Lesion Length & Treatment DurabilityREAL PTX- RCT DCB vs DES
Scheinert D, LINC 2018Intent-to-treat; DCB group includes patients who received bailout stents.
Primary Patency @ 36 months
Lesion Length
DCB ZILVER PTX P
>10 cm 0.26±0.07 0.45±0.08 0.1892
<10 cm 0.64±0.11 0.77±0.09 0.4524
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Limits of DCB
Treatment Durability:
Calcium
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12 Month Primary Patency
100% 100% 100%90% 90% 88%
50% 50%
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1a 1b 2a 2b 3a 3b 4a 4b
Minimal Calcificationa High Calcification
• 60 patients with SFA stenosis or occlusion treated with DCB
• 50% primary patency rates in heavily calcified SFA lesions, regardless of lesion length
• Greater calcification was associated with poorer outcomes at 1 year:
o Greater TLR rate
o Lower ankle-brachial index
o Greater late lumen loss
Lesion Calcification May Affect Drug-Coated Balloon Efficacy
DCB, drug-coated balloon; SFA, superficial femoral artery; TLR, target
lesion revascularization.
Fanelli F, et al. Cardiovasc Intervent Radiol. 2014 ;37(4):898-907.
aCalcium burden quantified with computed tomography
angiography (CTA), digital subtraction angiography
(DSA), and intravascular ultrasound (IVUS).
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Severe Calcification Is More Prevalent In Stenting Studies
Results from different clinical investigations are not directly comparable. Information provided for educational purposes only.
IMPERIAL
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Limits of DCB
Treatment Durability:
Occlusions
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Limits of DCB Treatment Durability Occlusions
Results from different clinical investigations are not directly comparable. Information provided for educational purposes only.
• 1 year: no association between occlusions and worsening primary patency or TLR rates
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Limits of DCB Treatment Durability Occlusions
• 2 years: patency and reintervention rates appear to be worse for cohorts with greater proportions of patients with occlusions
Results from different clinical investigations are not directly comparable. Information provided for educational purposes only.
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Limitations of
Stent Technology on
the Market
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9% 9%
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BMS Zilver PTX
SFA Stenting Clinical Trials at 12M
• Historically, stenting studies show TLR rates near double digits and higher
Results from different clinical investigations are not directly comparable. Information provided for educational purposes only.
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9% 9%
4.5%4% 4% 4%
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BMS Eluvia Coronary and Iliac benchmarksZilver PTX Covered Stent SFA
SFA Stenting Clinical Trials at 12M• What vessel beds are we most comfortable stenting in? • What is an acceptable SFA TLR rate?
Results from different clinical investigations are not directly comparable. Information provided for educational purposes only.
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Mortality Rates from Literature
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No Increased Long-term Mortality with DES
Secemsky E, et al. J Am Coll Cardiol. E-pub ahead of print 01March2019. doi https://doi.org/10.1016/j.jacc.2019.02.020
• Medicare CMS population
• 51,456 patients– 47,351 BMS
– 4,105 DES (Zilver PTX)
• Similar mortality for BMS and
DES through 4.1 years– Overall adjusted p=0.53
– Without CLI adjusted p=0.95
– With CLI adjusted p=0.32
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Conclusions
• Data show lesion complexity and characteristics (lesion length, calcium and occlusions) may negatively impact DCB treatment durability from year one to year two
• Data suggests provisional stenting becomes more prevalent as mean lesion length increase, exceeding 30% in some DCB trials
• SFA stenting clinical trials continue to achieve lower TLR rates as next generation technology become available
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Carlos Mena, MD FACC FSCAIAssociate Professor of Medicine - CardiologyDirector Cardiac Catheterization LaboratoriesDirector Vascular Medicine & Endovascular FellowshipYale New Haven HospitalYale UniversityNew Haven CT USA
Drug Eluting Devices: Facts or Concerns