Download slides

Kaleida Global Vascular Center
Jacobs Institute
UB Translational Research Center
Symptomatic Intracranial Stenosis:
Why Did SAMPRAS Fail, and How Do
We Manage the Refractory Patient?
Travis Dumont MD
Shady Jansen
L. N. Hopkins MD
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
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)
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
Study Design
450 patients
Angioplasty and Stenting (Wingspan System) +
Aggressive Medical Management
vs.
Aggressive Medical Management alone
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
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
30-day results
Primary Endpoint
AMM
n = 227
PTAS
n = 224
Ischemic stroke in randomized vessel territory
10
23
Ischemic stroke in other vessel territory
2
0
Symptomatic brain hemorrhage
0
10
(5 reperfusion)
(4 wire
perforation)
Non-stroke related death
1
0
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
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)
SAMMPRIS Results: Current 1Yr 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
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
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 ??
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
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.
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
HOW WE DO IT???
Endovascular Treatment
Intracranial Atherosclerotic Disease
Staged Angioplasty and Stent
1) Submaximal Angioplasty
2) Allow Healing
3) Delayed Stent (undresized) PRN
Could the answer come from
an old solution?
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
CASE
• 45 year old man
presents with left hand
numbness TIA.
Cardioembolic workup
was negative, but
angiography
confirmed right MCA
near-occlusive
stenosis.
Angioplasty
Preplasty
Postplasty
1.5MM Balloon
6 months
post-plasty:
no symptoms
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 !
Approved and Awaiting
Enrollment of First Patient
• Prospective registry (planned 120
patients at 10 centers)
• Same as SAMMPRIS:
− entry criteria
− follow-up
− endpoints
“Don’t hurt my brain, its my second favorite organ.”
Woody Allen