Angioplasty

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Angioplasty

A Randomized Comparison of Primary

Angioplasty versus Stent Placement

for Symptomatic Intracranial Stenosis

M. Fareed K. Suri MD, Saqib A Chaudry MD,

Shahram Majidi MD, Farhan Siddiq MD,

Gustavo J. Rodriguez MD, Adnan I. Qureshi MD

Zeenat Qureshi Stroke Research Center

University of Minnesota, Minneapolis, MN


Evolution of endovascular treatment for

intracranial atherosclerotic disease

Primary angioplasty

Balloon expandable

stents

Angioplasty +

self-expanding stent

1990 1995 2000 2005

Re: Qureshi AI. Lancet. 2004 Mar 6;363(9411):804-13.


Primary angioplasty

Stent placement


Primary angioplasty

Better angiographic results!!!

But better clinical outcomes??

Stent placement


Selection of treatment modality

• No clear data are available to support the

effectiveness of primary angioplasty over

stent placement for treatment of

intracranial stenosis.

Consensus conference on intracranial

atherosclerotic disease: rationale,

methodology, and results

Qureshi AI, Feldmann E, Gomez CR, Johnston SC, Kasner SE,

Quick DC, Rasmussen PA, Suri MF, Taylor RA, Zaidat OO. J

Neuroimaging. 2009 Oct;19 Suppl 1:1S-10S.


Results of a three center study

SAMMPRIS

eligible (N=69)

Angioplasty

(n=30)

Stent

(n=39)

3.3% 10.2%

One-Month Stroke/Death

SAMMPRIS

ineligible (N=27)

7.4%

Siddiq F: Neurosurgery 2012: in press.


FEASIBILITY

Objectives

The LONG-TERM aim of the study is to

compare the clinical and angiographic

efficacy of primary angioplasty and

angioplasty followed by stent placement

in preventing restenosis, stroke,

requirement for second treatment, and

death in patients with symptomatic

intracranial stenosis.


Angioplasty versus Stent:

Inclusion Criteria

Intracranial stenosis that results in angiographically

visible reduction of lumen of the affected artery.

Stenosis of the subject artery is greater than 70%;

OR the patient has previously failed antithrombotic or

anticoagulant therapy with stenosis of 50% or greater.

Stenosis involving the arteries within the cranium or

those encased by the cranial bones. These include

petrous and cavernous segments of the internal carotid

artery and the intradural segment of the vertebral

artery.

Ischemic events referable to the artery with the

stenosis in the last 3 months.


Angioplasty versus Stent:

Inclusion Criteria

Intracranial stenosis that results in angiographically

visible reduction of lumen of the affected artery.

Stenosis of the subject Greater artery is or greater equal to than 70% 70%;

OR the patient has previously failed OR antithrombotic or

anticoagulant therapy with Greater stenosis or equal of 50% to or 50% greater.

Stenosis involving the (if arteries medication within failure) the cranium or

those encased by the cranial ----by bones. angiography

These include

petrous and cavernous segments of the internal carotid

artery and the intradural segment of the vertebral

artery.

Ischemic events referable to the artery with the

stenosis in the last 3 months.


Angioplasty versus Stent:

Exclusion Criteria

Proximal occlusive disease greater than 50%, either

in the proximal carotid artery, common carotid artery,

cervical internal carotid artery, or the cervical

vertebral artery that would preclude safe introduction

of a guiding catheter or guiding sheath

Severe peripheral vascular disease which precludes

successful insertion and catheterization.

Stroke in the last 7 days of sufficient size (on CT or

MRI) that places him/her at risk of hemorrhagic

conversion during the procedure

Severe vascular tortuosity or anatomy that would

preclude the safe introduction of a stent delivery

device or balloon catheter or microwire.


Angioplasty versus Stent:

Exclusion Criteria

Proximal occlusive disease greater than 50%, either

in the proximal carotid artery, common carotid artery,

cervical internal carotid Both artery, procedures or the are cervical possible

vertebral artery that would preclude AND safe introduction

of a guiding catheter Can be performed or guiding sheath with reasonable safety

Severe peripheral (interventionalist’s vascular disease which judgment)

precludes

successful insertion and catheterization.

Stroke in the last 7 days of sufficient size (on CT or

MRI) that places him/her at risk of hemorrhagic

conversion during the procedure

Severe vascular tortuosity or anatomy that would

preclude the safe introduction of a stent delivery

device or balloon catheter or microwire.


Randomized-random number generating computer

program and provided in sealed envelops

Primary

angioplasty

Angioplasty-

Gateway PTA

Balloon Catheter

(Boston Scientific

Corporation, MA)

Aspirin (325

mg/d)+

Clopidogrel

(75mg/d)X3 d

IV heparin ACT

250s-350s

NA Aspirin (325

mg/d)+

Clopidogrel

(75mg/d)X30 d

Stent placement

Angioplasty-

Gateway PTA

Balloon Catheter

(Boston Scientific

Corporation, MA)

Wingspan® Stent

System (Boston

Scientific

Corporation, MA)


Statistical considerations

Feasibility study

40 patients (intended)

Institutional Review Board approval at

two hospitals.

Voluntary temporary suspension of

recruitment after results of

SAMMPRIS trial.


Patients

23 patients screened; 18 randomized

Primary

angioplasty

Versus Stent

placement

10 patients 8 patients

1 intent to

treat


Angiographic results

Primary

angioplasty

Patients

5/10 patients


Patients

Fluoroscopic time and contrast used

Primary

angioplasty

37±11 min Fluoroscopic

time

Versus Stent

placement

42±9 min

145±53 ml Contrast used 138±41 ml

91±38 min Procedure

time

110±46 min


Patients

1 month rate of stroke/death

Primary

angioplasty

Versus Stent

placement

10 patients 8 patients

1 0


• 80 M

Adverse event

• Minor ischemic stroke + intracranial

vertebral artery stenosis (75%)

• Primary angioplasty

• Post-procedure stenosis (50%)

• Intracranial hemorrhage (day 1)


Conclusions

• A randomized trial comparing primary

angioplasty to angioplasty followed by stent

placement is feasible.

• The 1 month stroke/death event rate is low

with primary angioplasty and comparable to

stent placement.

• These results warrant further studies using

larger sample sizes and long-term

ascertainments.


Thank you

Zeenat Qureshi Stroke Research Center 2012

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