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%

0

1

2

3

4

5

6

7

8

9

10

0%

20%

40%

60%

80%

100%

Me

an L

esi

on

Le

ngt

h (

cm)

Pri

mar

y P

ate

ncy

(K

M)

DCB ControlEluvia

*

**

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


• 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


.

• 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


0%

10%

20%

30%

40%

50%

0 5 10 15 20 25 30

Pro

visi

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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


Calcium

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12 Month Primary Patency

100% 100% 100%90% 90% 88%

50% 50%

0%

20%

40%

60%

80%

100%

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


IMPERIAL

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Limits of DCB


Occlusions

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Limits of DCB Treatment Durability Occlusions


• 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


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Limitations of

Stent Technology on

the Market

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9% 9%

0%

10%

20%

30%

Targ

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evas

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12%

21%

10%

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BMS Zilver PTX

SFA Stenting Clinical Trials at 12M

• Historically, stenting studies show TLR rates near double digits and higher


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9% 9%

4.5%4% 4% 4%

7%

0%

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30%

Targ

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Rev

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12%

21%

10%

14%

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?


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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

drug eluting devices: facts or concerns€¦ · pi-566410-18 12 month primary patency 100% 100%...

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