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
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
Study n Technicalsuccess 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
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 medical-management 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. Michael P. Marks. Stroke. 2012;43:580-584
2. 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 )