cas · randomized yet, show very promising results in terms of sdrs, in the first 30 days post...

ID3 Medical – 2020

Koen Deloose, MD

Head Dept Vascular Surgery

AZ Sint Blasius

Dendermonde, Belgium

CAS:

Time to revisit the guidelines?

Disclosure slide

❑ I have the following potential conflicts of interest to report:

❑ Consulting: Abbott, BD, Biotronik, Boston Scientific, Cook, CTI vascular,

iVascular, Medtronic, Philips, Terumo, CyndRX, Profusa

❑ Employment in industry

❑ Stockholder of a healthcare company

❑ Owner of a healthcare company

❑ Other(s)

❑ I do not have any potential conflict of interest

Speaker name: Koen Deloose, MD

Long term CREST results…

4iD3 Medical – 2019 |

Post procedural

• Scaffolding Stent

Per-procedural• Technique improvement

• Operator experience

• Patient selection

• Lesion selection

• EPD improvements

• Scaffolding Stent

Room for periprocedural improvementD0-> D31

We need better protection againstSMALL & LATE embolisation


…We need a better & sustained “embolicprotection device”….

Adapted from Stephan Muller Hulsbeck, presented @LINC 2017, Leipzig, Germany

21,383110,447

196,350

865,904

2,835,294

0

500,000

1,000,000

1,500,000

2,000,000

2,500,000

3,000,000

Areas Comparison (𝛍2)

Area

AREA = R²


…We need a better & sustained “embolicprotection device”….

ROADSAVER/CASPERTerumo/Microvention

CAROTID STENTGore

CGUARDInspire MD

Macro stent frame Closed cell nitinol Open cell nitinol Open cell nitinol

Mesh position inside outside Outside

Mesh material nitinol PTFE PET

Mesh structure braided interwoven Single fiber knitted

Pore size (µm) 375 500 150-180


CLINICAL EVIDENCE

Hopf-Jensen et al.2015 (7 pts)

J Endovasc TherInitial experience

30-day / 6-month FU

Nerla et al.2016 (150 pts)

EuroInterventionItalian registry

30-day FU

Bosiers et al.2018 (100 pts)

EuroInterventionCLEAR-ROAD study

12-month FU

Machnik et al.

2017 (40 pts)

Postepy Kardiol

Interwencyjnej

Retrospective study

30-day FU

Nerla et al.

2018 (150 pts)

EuroIntervention

Italian registry

12-month FU

Bosiers et al.

2016 (100 pts)

EuroIntervention

CLEAR-ROAD study

30-day FU

Ruffino et al.

2019 (50 pts)

Cardiovasc Intervent Radiol

DW-MRI study

Roadsaver vs CGuard

30-day FU

Ierardi et al.

2019 (13 pts)

Radiol Med

ISR study

6- / 12-month FU

Castagno et al.2016 (4 pts)

Ann Vasc SurgCase series (DW-MRI)

3-month FU

Kedev et al.2015 (10 pts)Am J Cardiol

Feasibility study30-day FU

Ruffino et al.

2016 (23 pts)

Cardiovasc Intervent Radiol

DW-MRI study

30-day / 6-month FU

Umemoto et al.

2017 (16 pts)

EuroIntervention

OCT study

Roadsaver vs CGuard

30-day FU

ROADSAVERObservational Study

2000 pts

Ongoing

DW-MRI: Diffusion-Weighted Magnetic Resonance Imaging; DS(MI): any Death/Stroke/(Myocardial infarction); EPD: Embolic Protection Device; FU: Follow-Up; IIT: Investigator-Initiated Trial;

ISR: In-Stent Restenosis; OCT: Optical Coherence Tomography; pts: Patients; Sx: Symptomatic patients TLR: Target Lesion Revascularization


Roadsaver stent : Clear-road study

Bosiers M et al. EuroIntervention. 2016;12(5):e671-6 ; EuroIntervention. 2018;14(10):1144-1146


Roadsaver stent : Italian Registry

Nerla R et al. EuroIntervention. 2016;12(5):e677-83 - EuroIntervention. 2018;14(10):1144-1146

Conclusion : The use of the Roadsaver stent in high-risk clinical or anatomical conditions is associated with good short-/mid-term results. Roadsaver stent is not associated with a higher rate of 12-month ISR


Roadsaver stent : Roadsaver Registry

Presented by Muller Hulsbeck S @CIRSE2019, Barcelona, Spain



Presented by Ralf Langhof @LINC2020, Leipzig, Germany

Patient characteristics

Procedural characteristics

Lesion characteristics



Presented by Muller Hulsbeck S @CIRSE2019, Barcelona, Spain


Cguard (Inspire MD)

STUDY N pts Procedural success(%)

30 day SDR (%)12 months Stroke (%)

New ipsilateral DWI MRI lesions post proc (%)

(1)CARENET 30 100 03,3

37(30d MRI : complete resolution of all but 1

(2)IRON GuardMC Italian Registry

200(8,5% symptomatics)

98,8 3,53,5

19,6(61/165 DWI MRI’s)

(3) Wissgott et al 30 100 00 (6months)

0(19/30 underwent 30 d DWI

MRI without new lesions)

(4) Paradigm 101(54% symptomatics)

99,1 0,91,8

na

(5) Casana et al 82(19% symptomatics)

100 1,2 23,8% 24%pts DW-MRI

1.Schofer J et al. JACC CardioVasc Interv. 2015, Aug ;8(9):1229-342.Capoccia L et al. Eurointervention Oct 2018 ; doi:10.4244/EIJ-D-18-002413.Wissgott C et al. J Endovasc Ther. 2016 Oct 12

4. Musialek P et al. Eurointervention 2016;12:e658-70 & update presentation @TCT2016

5. Casana R et al. Eur J Vasc Endovasc Surg. 2017 Dec;54(6):681-687. doi: 10.1016/j.ejvs.2017.09.015. Epub 2017 Oct 28.


Cguard (Inspire MD)

Musialek P et al. Presented @EuroPCR, May 2018, Paris, France (24months) & TCT 2018, San Diego, US (36, 48 months)


Meta-analysis556 patients

556 patients


Meta-analysis


In Perspective…

TRENDS in SD-rates @ 30 DAYS

Conventional Stents

CEA

Dual Layer Mesh Stents

6.4

6.7

4.5

5.7

8.2

4.6

3.3

8.5

0 1 2 3 4 5 6 7 8 9

CAPTURE - ACCULINK - N=3500

CREST - VARIOUS STENTS - N=668

SAPPHIRE - PRECISE STENT - N=2001

SVS REGISTRY - VARIOUS STENTS - N=2763

ARCHER POOLED - ACCULINK - N=581

EXACT - X ACT - N=1500

ACT I - VARIOUS STENTS - N=1089

ICSS - VARIOUS STENTS - N=853

2.6

5.4

5.2

0 1 2 3 4 5 6

ACT I - N=364

CREST - N=653

ICSS - N=857

3.5

1

2.1

2.7

0

1.4

0 1 2 3 4

IRONGUARD - CGUARD - N=200

PARADIGM EXTENDED - CGUARD - N=402

CLEAR ROAD - ROADSAVER - N=100

ROADSAVER REGISTRY - N=480

ITALIAN REGISTRY NERLA - ROADSAVER - N=150

META-ANALYSIS STABILE - MMS - N=556

2,0N=845


My reason number 1 for CAS guidelines review…

CHANGE : THERE IS CLASS IIa LEVEL BEVIDENCE OF REDUCTION RISK … RECOMMENDATION… LET US RANDOMIZE !!


My reason number 2 for CAS guidelines review…

RECOMMENDATION… LET US RANDOMIZE !!

CHANGE : CAS WITH MMS IS AN ALTERNATIVE TO CEA !!

SYMPTOMATIC PATIENTS


My reason number 3 & 4 for CAS guidelines review…

CHANGE : MAKE 1 RECOMMENDATION CEA OR CAS WITH MMS SHOULD BE CONSIDERED IF SD Ratio <3%

ASYMPTOMATIC PATIENTS

CHANGE : CAS WITH MMS may be considered…


Conclusion• Post 30 day results of CAS are as good as CEA ; Room for improvement first 30

days : we need to protect against smaller and later emboli!!!

• New stent designs play here an important role : MM or DL stents are “sustained, ‘small emboli’ protection devices”. A lot of clinical trials, although notrandomized yet, show very promising results in terms of SDR’s, in the first 30 days post procedure and on the longer run (ISR doesn’t seem to be an issue)

• In my opinion, based on these -new technology-data, the ESVS guidelines need to be adapted on 4 recommendations, positioning MM-CAS at the same level of CEA. Sponsors/clinical researchers need to consider a head to head RCT in high-experienced centers

Koen Deloose, MD

Head Dept Vascular Surgery

AZ Sint Blasius

Dendermonde, Belgium

CAS:

Time to revisit the guidelines?

cas · randomized yet, show very promising results in terms of sdrs, in the first 30 days post...

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