Intracranial Atherosclerosis Life after SAMMPRIS · Atherosclerosis Life after SAMMPRIS Hans Henkes...
Transcript of Intracranial Atherosclerosis Life after SAMMPRIS · Atherosclerosis Life after SAMMPRIS Hans Henkes...
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Intracranial Atherosclerosis
Life after SAMMPRIS
Hans Henkes Klinikum Stuttgart, Germany
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The goal was to show the superiority of intracranial stenting. The initial idea to use a coronary drug eluting stent was rejected by the FDA.
Against the advise of the inventors of the Wingspan System (a conventional old balloon and a self-expanding [aneurysm] stent with enhanced radial force) the „Stenting versus Aggressive Medical Management for Preventing Recurrent stroke in Intracranial arterial Stenosis“ (SAMMPRIS) study was initiated.
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451 patients in the acute phase after TIA or cerebral ischemia due to a high grade stenosis of a large intracranial artery
50 US centers
aggressive medical treatment (AMT) vs.
AMT + Stent-PTA (Wingspan)
(AMT = 325 mg ASA, 75 mg Clopidogrel for 90 days, Rusovastatin, blood pressure normalizing, life-style modification)
Chimowitz 2011
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Primary endpoints - stroke or death within the first 30 days after enrollment
or after Stent-PTA during the follow-up period
- stroke in the territory of the target artery after 30 days
- for cross overs (from AMT to Stent-PTA): stroke or death within 30 days
N = 451
AMT = 227
AMT + Stent-PTA = 224
Chimowitz 2011
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AMT Stent
Primary endpoint 30 days 5.8% 14.7%
Primary endpoint 1 year 12.2% 20%
Chimowitz 2011
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complications in Stent-PTA arm: 33 out of 224 (14.7%) patients
30 complications due to Stent-PTA 3 complications of diagnostic DSA
those 30 procedural complications included
19 ischemic (12 perforator strokes, 3 embolic, 2 perforator & embolic, 2 stent occlusions)
11 hemorrhagic (6 ICH, 5 SAH) !!!!!!!!!!!!
Chimowitz 2011
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In SAMMPRIS the wrong physicians treated the wrong stenoses with the wrong device:
- many intracranial stenoses are not equally suitable for AMT
and Stent-PTA
- the qualification criteria for the physicians performing the procedures in the stent arm were inadequate
- the enrollment rate per center was way too low
- the Wingspan system was already outdated
- the (high) in-stent re-stenosis rate after Wingspan was not addressed
However: SAMMPRIS confirms the high stroke rate under AMT (12% primary endpoint in 1 year under AMT)
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Clinical trials concerning the treatment of intracranial
atherosclerotic arterial stenoses, comparing medical
regime with surgical or endovascular procedure can not
properly reflect the clinical reality and the medical demands;
the structure of these studies rather creates an „artefact“
than allowing a reasonable comparison of different treatment
modalities.
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The atherosclerotic stenoses of an intracranial artery is a
progressive disease. Any known medical treatment (either
antiaggregation or anticoagulation) will not remove an
atherosclerotic stenosis. It may prevent distal emboli and
may allow leptomeningeal collaterals to develop; the efficacy
of this process is essentially unpredictable.
After a „maturation“ of several months or years, many
stenoses will simply be untreatable by endovascular means,
mainly due to an inabilty of microwire or balloon passage
distal to the stenosis.
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Arguments for a medical treatment
- less than 50% stenosis
- asymptomatic while under (dual) platelet function
inhibition
- sufficient leptomeningeal collaterals
- „only“ perforator ischemia, no infarcts due do hemodynamic
compromise
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Arguments for an endovascular treatment
- more than 70% stenosis
- TIA or cerebral ischemia despite dual antiaggregation or
anticoagulation
- progessive stenosis with poor or missing collaterals
- hemodynamic compromise due to stenosis
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pre post
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Treatment options for intracranial atherosclerotic stenoses
ASA
ASA + Clopidogrel or Prasugrel or Ticagrelor
DOAC + ASA, DOAC + Clopidogrel
Balloon angioplasty only
Balloon angioplastie + selfexpanding stent
Selfexpanding stent only
Balloonexpandible bare metal stent
Balloonexpandible drug eluting stent
Direct bypass
Indirect bypass
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The endovascular treatment of intracranial stenoses
- can be a technically demanding procedure
- can be associated with significant risks
- is hardly ever a standardized treatment
- must be weight against treatment alternatives on an individual basis
- the documented rate of permanent morbidity and mortality related to intracranial stent PTA procedures in a given center and for a given operator has to be below 10%
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Intracranial stent PTAs should only be performed in
specialized neurovascular centers, including
- vascular Neurology
- vascular Neurosurgery
- Neuroanesthesiology
- infrastructure (e.g., Multiplate, ICU, Stroke Unit, etc.)
- to be discussed: procedure frequency or case load,
institutional experience, operator experience… (qualification
issues)
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Kurre 2010 Intrastent severe complications 7%
Dorn 2012 Various severe complications 8%
Vajda 2012 Enterprise severe complications 8%
Vajda 2012 DEB & Enterprise severe complications 5%
Vajda 2012 Coroflex Please severe complications 4 %
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Wingspan?
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Wingspan has a higher radial force than Neuroform
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pre
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Gateway 2/15 8atm WingSpan 2,5/15
post
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5 Mo: recurrence 6 Mo: occlusion stroke
follow-up
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Enterprise1
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29.11.07
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20.2.08
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Intracranial ISRS
Autor N= Stent-Typ restenosis
occlusion
ipsilateral TIA
stroke
Jiang
(2012) 454
216
balloon expandible
selfexpanding
20%
28% 11%
Vajda
(2012) 209 Enterprise 25% 9.3%
Jiang
(2012) 100 Wingspan 27% (45 angio FU)
11%
Costalat
(2011) 60 Wingspan 17% 6%
Zhu
(2010) 61
balloon expandible
30% n.a.
Miao
(2009) 79
balloon expandible
20% 25%
Levy
(2007) 78 Wingspan 36% 27.6%
Jiang
(2007) 94
balloon expandible
20% 26%
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ISRS – over time
Vajda et al. Neurosurgery 2012
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Drug Eluting Stents
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Drug Eluting Stents
47 SeQuent ISAR (Sirolimus)
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Indications and Results
Efficacy
• All DES reduce the likelihood of re-intervention at the target vessel compared to BMS
• EVEROLIMUS, SIROLIMUS, ZOTAROLIMUS- Resolute are the most efficatious
Safety
• No difference in procedural mortality compared to BMS
• All DES (but not Paclitaxel DES) reduced the risk of MI
• EVEROLIMUS has the best safety profile concerning stent thrombosis
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Drug Eluting Balloons
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Drug Eluting Balloons
50
SeQuent Please, Sequent Please NEO
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Results and Indications
ISRS
DEB vs. uncoated PTA
Event free survival at 2 years (Stent thrombosis, TLR, MI, Stroke, death)
Scheller 2008
DEB vs. DES (Paclicatxel)
Event free survival at 2 years (Stent thrombosis, TLR, MI, death)
Unverdorben 2009)
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3 months f/u 1.5 mm 2.5 mm SeQuent Please DEB
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12 months f/u
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ISRS treatment with DEB
Vajda et al. AJNR 2011
20 conventional balloons– 43 SeQuent Please DEBs
6 % „failed attempts“ with SeQuent Please!
5 x
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DEB and Enterprise
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DEB and Enterprise
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DEB and Enterprise
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3 month FU
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DEB and Enterprise
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DEB and Enterprise
Vajda et al. Cardiovasc Intervent Radiol 2012
54 stenoses (52 patients)
technical failure 19 %
30 d Stroke, death 8.8 %
8.9 months FU 0%
restenoses 3 %
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DES in Neuroradiology
author n=
type of stent failure restenosis occlusion
Vajda
(2012) 106 Coroflex Please 7% 3.8% 0.9%
Lu
(2012) 24
Taxus Express
Excell
Firebird
0% 0% 0%
Steinfort
(2007) 13 Taxus 0% 0% 0%
Qureshi
(2006) 21 Cypher
Taxus express 14% 14% 0%
Gupta
(2006) 29 Cypher 10% 5% 0%
Abou-Chebl
(2005) 8 Cypher
Taxus 0% 0% 0%
60
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TAXUS™ Element™ Stent
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Recoil – flexibility – wall apposition
Taxus element 3 x 20
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Results with Taxus Element
N= 78 stenoses
0
5
10
15
20
25
30
35
petrös kavernös intradural M1 V3 V4 BA
Length of stenoses
Median 6.4 mm (4-14 mm)
Stent dimensions
diameter:
slightly undersized
length:
as short as possible (8 mm)
(6x Taxus > 8 mm)
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Technical success
In 68 / 78 stenoses successful (87%)
10 failures (13%)
3 conventional PTA
1 DEB
1 DEB & Enterprise
3 PTA & Enterprise
1 treated with a smaller Taxus Element
1 transbrachial approach, success with Taxus Element
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Results with Taxus Element
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Taxus Element – technical failure
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Results with Taxus Element
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1.5 mm 2 mm Attempt 2.25 / 8
Taxus Element
- 6F Envoy
- 6 F Vista brite Tip
Post PTA and Enterprise
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Taxus Element – technical failure
Results with Taxus Element
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Robust access required
1.5 mm PTA
DAC 0.57; 115 cm
8F Vista Brite Tip
Taxus element 2.25 x 8
@ 11 atm
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Results with Taxus Element
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Robust access required
Anterior circulation
- 8 F Vista Brite Tip
- 0.57 DAC or
- 0.58 NavienA+
- 115 cm!
- Traxcess EX
Posterior circulation
- 6 F Vista Brite Tip
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Results with Taxus Element
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57 stenoses with F/U DSA
Median 131 days(42 – 378)
•1 (1.8%) stent occlusion
•1 (1.8%) 57% stenosis
ISRS
Taxus element M1 re 10/2011 De novo Stenose M1 li
10/2012
TIA
Stentverschluss
10/2012
asymptomatisch
09/2011 After treatment 04/2012
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Results with Taxus Element
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Clinical results
1 (1.8%) ipsilateral stroke
- Clopidogrel was stopped after 9 months
1 (1.8%) stroke in another vascular territory
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Results with Taxus Element
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Acute stroke
n= 8
Loading with 600 mg Clopidogrel and 500 mg ASA
prior to transport
or via gastric tube prior to the procedure
1 intraprocedural thrombus formation
treated with an IV Integrilin bolus
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Results with Taxus Element
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Acute stroke
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Results with Taxus Element
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Acute stroke
1.5 mm
2 mm
mTE pREset 4 / 20
1 passage
Early stent occlusion
Taxus Element 2.25 / 8
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Results with Taxus Element
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Acute stroke
Pre Integrilin Post 8 mg Integrilin IV
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Results with Taxus Element
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Acute stroke
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Results with Taxus Element
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Our current concept
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Primary treatment
Most stenosis: PTA with a conventional balloon (pITA)
Increased recurrence risk: PTA with a DEB (SeQuent Neo Please)
Dissection, recoiling: PTA + selfexpanding stent (pITA, SeQuent Neo Please, Enterprise2)
Short stenosis, straight vessels...: DES (Coroflex ISAR)
Avoid snow plow effect: no PTA, just SE stent (Solitaire)
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Our current concept
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In stent re-stenosis
DEB or DES (SeQuent Neo Please or Coroflex ISAR)
PTA (pITA)
Adjacent de novo stenosis
like primary treatment
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PTA (pITA)
78 MS & Vasculitis
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PTA (pITA)
79 MS & Vasculitis
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PTA (pITA)
80 Synchro2 0.014´´, pITA 1.5 mm, 8 atm
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PTA (pITA)
81 pre
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PTA (pITA)
82 Lumen at least double
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84