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STENTING VS MEDICAL MANAGEMENT
IN INTRACRANIAL ARTERIAL STENOSIS
FOR- STENTING

Dr Prashant Makhija
EVIDENCE
 8–10% of all ischemic strokes in America, 30% to 50% of
strokes in the Asian population1

 With medical therapy alone risk of recurrent stroke
unacceptably high, approximately 23% at 1 year1
 Several studies demonstrate success with intracranial stenting
 SSYLVIA Trial- 61 pts(70.5% intracranial stenosis), 95% success
rate, 1 mth 6.6% strokes & 0% mortality, 7.3% strokes later
than 1 mth, FDA granted a humanitarian device exemption2
1.

J NeuroIntervent Surg 2012 4: 397-406

2.

AJNR: 26, October 2005
Study

n

Technical
success rate
(%)

30 day ipsilat
stroke /death
rate

Wingspan
study(2007)

45

100

4.5

Fiorella et
al(2007)

78

98.8

6.1

NIH
registry(2008)

129

96.7

9.6

 Anand Alurkar et al (2013)- 182 patients, 97.44% success
rate, 1mth stroke incidence 11 (5.64%), of which 2 (1.02%) were
major, 2 deaths(mortality=1.09%)
 Simon Chun Ho Yu et al (2013)- 65 pts, 93.8% success rate, 66
stenotic lesions, ISR 16.7%, periprocedural stroke or death rate
was 6.1%, no interval strokes 1-year follow-up
THE OPPOSITION- SAMMPRIS
 SAMMPRIS- RCT 451 pts, 30-day rate of stroke or death was
14.7% in the PTAS group and 5.8% in the medicalmanagement group
 Why so ?
 Experience - higher rate in the current study does not reflect
inexperience of the operators (NIH registry data- 9% at high
enrolling sites versus 23% at low enrolling sites)
 inherently high risk to the procedures with the device used in the
trial, which does not decline with user experience
 Design - 2-step procedure with a long exchange wire
 difficulty with wire control, can cause perforations and
subarachnoid hemorrhage or wire injury of small perforating
arteries
 Vessel size & lesion- trial mandated that lesions had to be 14 mm
long and arteries had to have a normal diameter of 2.0 to 4.5 mm
 treatment of small vessels(2.5 to 2.75 mm)is problematic, more
likely to have restenosis, acute thrombosis, more prone to injury
with PTAS
 >10 mm (Mori C) lesions, higher rates of death, ipsilateral stroke,
in stent restenosis after angioplasty
 Medical therapy- team (neurologist, study coordinator, lifestyle
coach), study coordinator counted pts’ antiplatelet medications,
lifestyle coach developed personal action plans, contacted pts every
2 wks for the first 3 months & then monthly thereafter
 Idealistic , difficult to achieve in “real-world” situations
1.
2.

Michael P. Marks. Stroke. 2012;43:580-584
Alex Abou-Chebl and Helmuth Steinmetz. Stroke. 2012;43:616-620
CONCLUSION
 SAMMPRIS trial, set a higher bar for the investigation of
endovascular therapy for symptomatic intracranial stenosis

 Supports modification but not discontinuation of our approach to
intracranial angioplasty and/or stent placement for intracranial
stenosis
 PTAS remains a valuable tool for patients refractory to medical
therapy
 Do Not Throw the Baby Out with the Bathwater…
(T. KRINGS )

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Stenting vs medical management in intracranial stenosis

  • 1. STENTING VS MEDICAL MANAGEMENT IN INTRACRANIAL ARTERIAL STENOSIS FOR- STENTING Dr Prashant Makhija
  • 2. EVIDENCE  8–10% of all ischemic strokes in America, 30% to 50% of strokes in the Asian population1  With medical therapy alone risk of recurrent stroke unacceptably high, approximately 23% at 1 year1  Several studies demonstrate success with intracranial stenting  SSYLVIA Trial- 61 pts(70.5% intracranial stenosis), 95% success rate, 1 mth 6.6% strokes & 0% mortality, 7.3% strokes later than 1 mth, FDA granted a humanitarian device exemption2 1. J NeuroIntervent Surg 2012 4: 397-406 2. AJNR: 26, October 2005
  • 3. Study n Technical success rate (%) 30 day ipsilat stroke /death rate Wingspan study(2007) 45 100 4.5 Fiorella et al(2007) 78 98.8 6.1 NIH registry(2008) 129 96.7 9.6  Anand Alurkar et al (2013)- 182 patients, 97.44% success rate, 1mth stroke incidence 11 (5.64%), of which 2 (1.02%) were major, 2 deaths(mortality=1.09%)  Simon Chun Ho Yu et al (2013)- 65 pts, 93.8% success rate, 66 stenotic lesions, ISR 16.7%, periprocedural stroke or death rate was 6.1%, no interval strokes 1-year follow-up
  • 4. THE OPPOSITION- SAMMPRIS  SAMMPRIS- RCT 451 pts, 30-day rate of stroke or death was 14.7% in the PTAS group and 5.8% in the medicalmanagement group  Why so ?  Experience - higher rate in the current study does not reflect inexperience of the operators (NIH registry data- 9% at high enrolling sites versus 23% at low enrolling sites)  inherently high risk to the procedures with the device used in the trial, which does not decline with user experience  Design - 2-step procedure with a long exchange wire  difficulty with wire control, can cause perforations and subarachnoid hemorrhage or wire injury of small perforating arteries
  • 5.  Vessel size & lesion- trial mandated that lesions had to be 14 mm long and arteries had to have a normal diameter of 2.0 to 4.5 mm  treatment of small vessels(2.5 to 2.75 mm)is problematic, more likely to have restenosis, acute thrombosis, more prone to injury with PTAS  >10 mm (Mori C) lesions, higher rates of death, ipsilateral stroke, in stent restenosis after angioplasty  Medical therapy- team (neurologist, study coordinator, lifestyle coach), study coordinator counted pts’ antiplatelet medications, lifestyle coach developed personal action plans, contacted pts every 2 wks for the first 3 months & then monthly thereafter  Idealistic , difficult to achieve in “real-world” situations 1. 2. Michael P. Marks. Stroke. 2012;43:580-584 Alex Abou-Chebl and Helmuth Steinmetz. Stroke. 2012;43:616-620
  • 6. CONCLUSION  SAMMPRIS trial, set a higher bar for the investigation of endovascular therapy for symptomatic intracranial stenosis  Supports modification but not discontinuation of our approach to intracranial angioplasty and/or stent placement for intracranial stenosis  PTAS remains a valuable tool for patients refractory to medical therapy  Do Not Throw the Baby Out with the Bathwater… (T. KRINGS )