1. Kaleida Global Vascular Center UB Translational Research Center
Jacobs Institute
UB Translational Research Center

2. Travis Dumont MD Shady Jansen L. N. Hopkins MD
Symptomatic Intracranial Stenosis: Why Did SAMPRAS Fail, and How Do We Manage the Refractory Patient?
Travis Dumont MD
Shady Jansen
L. N. Hopkins MD

3. LN Hopkins, MD I disclose the following financial relationship(s):
Consultant/Honoraria - Abbott, BARD, Boston Scientific, Cordis, Toshiba, Gore, Medtronic
Financial Interest - Access Closure, Boston Scientific, Claret, Osteal, Vascular Dynamics, Square One
Director - Access Closure, Claret, Osteal
University Grants/Research Support -
Boston Scientific, Cordis, Micrus, Toshiba, St Jude

4. Intracranial Stenosis Common … Dangerous…Treatable with Risk
7-10% of Ischemic CVA’s
70-90,000 CVA’s
15% Recurr Rate
Warning TIA- 20%
Natural Hx (Sx stenosis) is Poor
Med therepy 12-24% 1 Yr M&M
Coumadin is dangerous (WASID)
Primary Stenting high risk
Restenosis is common (25-40% BMS)

5. WASID trial Enrollment stopped due to
increased adverse events in warfarin group
incidence of ischemic stroke 22% in both groups
Conclusion: Warfarin has significantly higher adverse events and no benefit over aspirin

7. Aggressive Medical Management alone
Study Design
450 patients
Angioplasty and Stenting (Wingspan System) + Aggressive Medical Management
vs.
Aggressive Medical Management alone

8. SAMMPRIS Trial stopped due to increased complications in surgical arm
30 day stroke or death
14.7% in Surgical arm
5.8% in Medical arm
p = 0.002
Note: incidence of stroke events lower than treatment with aspirin or warfarin in WASID

9. Aggressive Medical Management
Aspirin 325 mg / day for entire follow-up
Clopidogrel 75mg per day for 90 days
Aggressive, protocol driven risk factor management primarily targeting systolic blood pressure < 140 mm Hg (130 mm Hg diabetics) and low density cholesterol < 70 mg / dl
Intervent USA – a lifestyle modification program

10. 30-day results Among 33 strokes in PTAS group,
Primary Endpoint
AMM
n = 227
PTAS
n = 224
Ischemic stroke in randomized vessel territory 10 23
Ischemic stroke in other vessel territory 2
Symptomatic brain hemorrhage
(5 reperfusion)
(4 wire perforation)
Non-stroke related death 1
Totals
13 (5.8%)
33(14.7%)
Among 33 strokes in PTAS group,
25 within 1 day of the procedure, 8 within 2-6 days

11. SAMMPRIS Results >30 days
Beyond 30 days, the rates of stroke
in the territory of the stenotic artery
are similar in the two groups
(13 in each group)
*fewer than half the patients have been followed for one year (results as of April 28, 2011)

12. SAMMPRIS Results: Current 1-Yr Rate
1-year rate of the primary endpoint
20.0% in PTAS group
12.2% in AMM group
30-day rate of the primary endpoint
14.7% PTAS vs. 5.8% AMM

13. SAMMPRIS: What went wrong
“Hot Plaques” (within 30 days of sx)
Plaque snowplow effect = perforator infarction
Too much revascularization = reperfusion hge
Cheese grater effect = embolization, art injury
Wire perforation, vessel rupture
Wingspan (1st gen- open cell) ?? wrong technology

14. What Went “Right” With SAMMPRIS
12.2 % 1 year end point
Not so great… ?? 2 yrs
WASID > 20%
“Aggressive medical management”
FU every 2 weeks
Free meds
Lifestyle coach
Is this realistic and achievable ??

15. What about MORI 1998 Study Not Headed
A cerebral arteriographic classification for intracranial stenosis
Lesson:
Long complex, angulated hot lesions can not be treated aggressively safely

16. MORI Classification
Type A: short (5 mm ), concentric or moderately eccentric, and less than totally occlusive.
Type B, tubular (5–10 mm ), extremely eccentric, and moderately angulated (curved), or chronic and totally occlusive for less than 3 months.
Type C, diffuse (>10 mm ), extremely angulated (>90°) with an excessively tortuous proximal segment, or chronic and totally occlusive for 3 months or longer.

17. Mori Results The clinical success rates for type were:
A- 92% , B- 86% , C- 33%
Angiographic restenosis:
A- 0% , B- 33% , C- 100%
Ipsilateral ischemic stroke:
A- 8%, B- 12%, C - 56%, at 1 year

18. How we do it???

19. Endovascular Treatment Intracranial Atherosclerotic Disease
Staged Angioplasty and Stent
Submaximal Angioplasty
Allow Healing
Delayed Stent (undresized) PRN

20. Could the answer come from an old solution?

21. Submaximal Angioplasty: UBNS Experience 2007-2011
41 patients: 1 year stroke-free survival 93%
2 perioperative complications
Vessel perforation: pt died POD 4
Reperfusion hemorrhage: MRS 3 -> 4
1 30 day – 1year ischemic event

22. CASE
45 year old man presents with left hand numbness TIA. Cardioembolic workup was negative, but angiography confirmed right MCA near-occlusive stenosis.

23. Angioplasty
Pre-plasty
Post-plasty
1.5MM Balloon

24. 6 months post-plasty:
no symptoms

25. Hypothesis
Patients with symptomatic intracranial stenosis treated with sub maximal angioplasty will fare better than patients treated with medical management alone due to improved blood flow and limited perioperative morbidity.
Do No HARM !

26. Approved and Awaiting Enrollment of First Patient
Prospective registry (planned 120 patients at 10 centers)
Same as SAMMPRIS:
entry criteria
follow-up
endpoints

27. “Don’t hurt my brain, its my second favorite organ.”
Woody Allen