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 )