Target Lesion Revascularization After Wingspan
Assessment of Safety and Durability
David J. Fiorella, MD, PhD; Elad I. Levy, MD; Aquilla S. Turk, DO; Felipe C. Albuquerque, MD;
G. Lee Pride, Jr, MD; Henry H. Woo, MD; Babu G. Welch, MD; David B. Niemann, MD;
Phillip D. Purdy, MD; Beverly Aagaard-Kienitz, MD; Peter A. Rasmussen, MD;
L. Nelson Hopkins, MD; Thomas J. Masaryk, MD; Cameron G. McDougall, MD
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Background and Purpose—In-stent restenosis (ISR) occurs in approximately one-third of patients after the percutaneous
transluminal angioplasty and stenting of intracranial atherosclerotic lesions with the Wingspan system. We review our
experience with target lesion revascularization (TLR) for ISR after Wingspan treatment.
Methods—Clinical and angiographic follow-up results were recorded for all patients from 5 participating institutions in our
US Wingspan Registry. ISR was defined as ⬎50% stenosis within or immediately adjacent (within 5 mm) to the
implanted stent and ⬎20% absolute luminal loss.
Results—To date, 36 patients in the registry have experienced ISR after percutaneous transluminal angioplasty and stenting
with Wingspan. Of these patients, 29 (80.6%) have undergone TLR with either angioplasty alone (n⫽26) or angioplasty
with restenting (n⫽3). Restenting was performed for in-stent dissections that occurred after the initial angioplasty. Of
the 29 patients undergoing TLR, 9 required ⱖ1 interventions for recurrent ISR, for a total of 42 interventions. One major
complication, a postprocedural reperfusion hemorrhage, was encountered in the periprocedural period (2.4% per
procedure; 3.5% per patient). Angiographic follow-up is available for 22 of 29 patients after TLR. Eleven of 22 (50%)
demonstrated recurrent ISR at follow-up angiography. Nine patients have undergone multiple retreatments (2
retreatments, n⫽6; 3 retreatments, n⫽2; 4 retreatments, n⫽1) for recurrent ISR. Nine of 11 recurrent ISR lesions were
located within the anterior circulation. The mean age for patients with recurrent anterior circulation ISR was 57.9 years
(vs 81 years for posterior circulation ISR).
Conclusions—TLR can be performed for the treatment of intracranial Wingspan ISR with a relatively high degree of
safety. However, the TLR results are not durable in ⬇50% of patients, and multiple revascularization procedures may
be required in this subgroup. (Stroke. 2009;40:106-110.)
Key Words: intracranial atherosclerotic disease 䡲 poststenting in-stent restenosis 䡲 target lesion revascularization
䡲 Wingspan stent system
I
n-stent restenosis (ISR) after percutaneous transluminal
angioplasty and stenting for intracranial atherosclerotic
disease occurs in approximately one-third of patients treated
with the Wingspan system.1,2 Target lesion revascularization
(TLR) refers to any procedure performed to restore luminal
patency after there has been late luminal loss attributable to
ISR. There is an extensive body of literature characterizing
TLR in the coronary circulation, but there are no data that
specifically address intracranial TLR.3–7 We present the first
series to our knowledge of intracranial TLR with attention to
periprocedural safety and durability.
Patients and Methods
Patient and Institutional Enrollment
All patients with intracranial atherosclerotic disease undergoing
attempted treatment with the Wingspan system were prospectively
enrolled into a multicenter, intention-to-treat registry that included
the Barrow Neurological Institute, Cleveland Clinic, State University
of New York at Buffalo, University of Texas Southwestern, and
University of Wisconsin. The institutional review board at each
institution approved the use of Wingspan under a Humanitarian
Device Exemption, as well as the collection and sharing of registry
data among the participating centers.
Received May 13, 2008; accepted May 28, 2008.
From Departments of Neurosurgery and Neuroradiology (D.J.F., P.A.R., T.J.M.), Cleveland Clinic Foundation, Cleveland, Ohio; Departments of
Neurosurgery and Radiology and Toshiba Stroke Research Center (E.I.L., L.N.H.), School of Medicine and Biomedical Sciences, University at Buffalo,
State University of New York, Millard Fillmore Gates Hospital, Kaleida Health, Buffalo, NY; Departments of Radiology and Neurosurgery (A.S.T.),
Medical University of South Carolina, Charleston, SC; Department of Neurosurgery (F.C.A., C.G.M.), Barrow Neurological Institute, Phoenix, Ariz;
Departments of Neurosurgery and Neuroradiology (L.P., B.G.W., P.D.P.), University of Texas Southwestern, Dallas, Tex; Departments of Neurological
Surgery and Radiology (H.H.W.), University at Stony Brook, State University of New York, Stony Brook, NY; Departments of Neurosurgery and
Neuroradiology (D.N., B.A.-K.), University of Wisconsin, Madison, Wisc.
Correspondence to David J. Fiorella, MD, PhD, Barrow Neurosurgical Associates, Ltd, Phoenix–Main Office, 2910 N. 3rd Avenue, Phoenix, AZ 85013.
E-mail [email protected]
© 2008 American Heart Association, Inc.
Stroke is available at http://stroke.ahajournals.org
DOI: 10.1161/STROKEAHA.108.525774
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Fiorella et al
Target Lesion Revascularization After Wingspan
107
Data Collection
Clinical and angiographic data were collected at the time of the
initial procedure and at 3 to 6 months and 12 to 15 months thereafter
according to a standardized follow-up protocol. Clinical data were
also collected at discharge and between 2 and 6 weeks after the
original procedure. ISR was defined as ⬎50% stenosis (using the
technique established in the Warfarin-Aspirin Symptomatic Intracranial Disease study8), within or immediately adjacent (within 5 mm)
to the implanted stent, and ⬎20% absolute luminal loss (ie, ⬎20%
increase in posttreatment stenosis). For patients with ISR undergoing
TLR, angiographic and clinical follow-up were performed at 3 to 6
months and 9 to 15 months after retreatment.
Original Stenting Technique
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The original percutaneous transluminal angioplasty and stenting
was performed using the Wingspan system as described previously.9 Patients were typically maintained on dual antiplatelet therapy
through the time of their initial angiographic follow-up with the
intention to discontinue clopidogrel if angiography showed no ISR.
In patients with ISR, dual antiplatelet therapy was typically continued, in preparation either for reintervention or for stroke
prophylaxis.2,10
Retreatments
Patients with late luminal loss meeting the registry definitions for
ISR were considered candidates for lesion revascularization. No
TLR procedures were performed in patients who did not meet ISR
criteria. The decision to perform retreatment was based entirely on
the opinion of the interventionist. There was no predetermined protocol
that defined indications for reintervention in registry patients.
Access was typically achieved through the common femoral
artery. All retreatment procedures were performed through a 6-Fr
system. The targeted parent vessel was accessed with a 6-Fr guiding
catheter (Envoy or Envoy XB, Cordis; or Neuron, Penumbra Inc).
Heparinization was instituted to a targeted activated coagulation time
of 250 to 300 seconds. In most cases, after conventional catheterbased angiography, an SL-10 (Boston Scientific), Prowler-10 (Cordis), or Echelon-10 (Micro Therapeutics/ev3) microcatheter was
manipulated across the target lesion using a 0.014-inch Synchro
(Boston Scientific) or Transcend EX Soft Tip (Boston Scientific)
microwire. The microcatheter was then exchanged over a 0.014-inch
Transcend Floppy (Boston Scientific), Luge (Boston Scientific), or
PVS (Boston Scientific) exchange microwire for an angioplasty
balloon. The remaining lesions were primarily crossed with the
angioplasty balloon and a Transcend 300-cm exchange length
0.014-inch microwire (Boston Scientific). In each case, the balloon
diameter was sized to ⬇80% of the “normal” parent vessel diameter.
The balloon length was selected to match the length of the lesion.
When possible, the angioplasty balloon was maintained completely
within the confines of the stent during angioplasty. Angioplasty was
performed under fluoroscopic control with a slow, graded inflation
of the balloon to a pressure of between 6 and 12 atmospheres for
⬇120 seconds. After angioplasty, the balloon was removed; conventional angiography was repeated maintaining wire access across the
lesion.
In cases (n⫽4) in which an in-stent dissection was noted,
restenting was sometimes performed if the operator thought that the
dissection could potentially limit flow. In each case, this was
performed with the Wingspan system, as described previously.9
After reintervention, the dual antiplatelet regimen was usually
maintained until follow-up angiography was performed (typically
between 3 and 6 months after the reintervention). Provided that no
recurrent ISR had developed, clopidogrel was usually discontinued
after follow-up angiography. All patients remained on aspirin therapy (325 mg daily) indefinitely after treatment. ISR lesions were
categorized using the modified Mehran system10,11:
Class I: Focal. Lesions involving less than half of the length of the
stented segment and either involving the end of the stent (IA), the
body of the stent (IB), or multiple foci (IC).
Figure 1. A 53-year-old man initially underwent percutaneous
transluminal angioplasty and stenting with Wingspan for a right
supraclinoid internal carotid artery stenosis symptomatic with
stroke while administered clopidogrel. The 3-month follow-up
angiogram demonstrates focal ISR (a). After angioplasty, control
angiography demonstrates an in-stent dissection flap at the
angioplasty site (b, arrow). This in-stent dissection was secured
with a second Wingspan stent (c, arrow).
Class II: Diffuse intrastent group. Lesions involving more than
half of the length of the stented segment but contained within the
confines of the stented segment.
Class III: Proliferative group. Lesions involving more than half of
the length of the stented segment, extending beyond the confines of
the stented segment.
Class IV: Complete stent occlusion.
All imaging was reviewed by a single neuroradiologist (D.F.) who
determined percentage of stenosis and modified Mehran
classification.
Results
Imaging follow-up was available for 129 treated lesions (75
anterior circulation, 54 posterior circulation) in the present
series. Thirty-six of 129 (27.9%) patients with treated lesions
with imaging follow-up experienced ISR. Of these 36, 29
(80.6%) underwent TLR with either angioplasty alone
(n⫽26) or angioplasty with restenting (n⫽3). Restenting was
performed for in-stent dissections that occurred after the
initial PTA (Figure 1). Among the retreated lesions, 23 were
located within the anterior circulation (79.3%) vs 6 in the
posterior circulation.
ISR lesions selected for retreatment were often either
symptomatic (n⫽4), angiographically more severe (longer
segment involved or greater percentage of stenosis) than the
presenting stenosis (n⫽8), or both (n⫽9). In some cases
(n⫽8), however, retreatment was performed in the absence of
either of these factors. When symptomatic (n⫽13), approximately two-thirds of patients presented with transient ischemic attack (n⫽9) and one-third (n⫽4) presented with ipsilateral stroke.
Of the 29 patients undergoing primary TLR, 9 required ⱖ1
interventions for recurrent ISR, for a total of 42 TLR
interventions. Only 1 major complication, a postprocedural
reperfusion hemorrhage, was encountered during TLR (complication rates: 2.4% per procedure; 3.5% per patient). This
patient had poorly controlled hypertension in the immediate
periprocedural period.
Angiographic follow-up is available for 22 of 29 patients
after primary TLR. Eleven of 22 (50%) patients demonstrated
recurrent ISR at follow-up angiography. Subsequently, 9 of
these patients have undergone multiple retreatments (2 retreatments, n⫽6; 3 retreatments, n⫽2; 4 retreatments, n⫽1)
for recurrent ISR (Figures 2 and 3).
108
Stroke
January 2009
Figure 3. Flowchart demonstrating the outcomes in patients
undergoing primary TLR for ISR. Of the 22 patients with followup, 11 (50%) demonstrated recurrent ISR. Nine of these 11
patients underwent ⱖ1 sessions of retreatment for recurrent
ISR. ISR indicates in-stent restenosis; Re-Re*-PTA, ⱖ1 angioplasty treatments that occurred after the primary TLR; TLR, target lesion revascularization.
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The angiographic pattern of ISR did not seem to influence
the risk of recurrence after TLR. Of those with a durable
result after TLR, 8 lesions were focal and 3 were diffuse, vs
those with recurrent ISR, of which 7 were focal and 4 were
diffuse (Table).
Figure 2. A 55-year-old woman who was using aspirin initially
presented with a right hemisphere stroke, ipsilateral to a preocclusive stenosis of the right supraclinoid internal carotid artery.
Immediate postprocedure angiogram shows no residual stenosis
(a). Fourteen weeks after the initial treatment, she returned with
episodic left hand and arm numbness and weakness while
using aspirin and clopidogrel. Follow-up angiography (b) demonstrated high-grade, diffuse ISR. She underwent angioplasty
alone for retreatment with improvement in the luminal diameter;
a small focal, nonflow-limiting dissection flap is evident along
the proximal aspect of the stent (c). Her symptoms resolved
after retreatment but recurred 14 weeks later. Follow-up angiography at this time demonstrated diffuse, recurrent ISR (d). The
lesion was retreated a second time with angioplasty alone with
restoration of luminal diameter (e) and resolution of symptoms.
Twelve weeks later, she returned with recurrent symptoms,
again with high-grade, diffuse, recurrent ISR on angiography (f).
Retreatment with angioplasty again yielded luminal restoration
and resolution of symptoms (g). Only 9 weeks later, recurrent
symptoms again prompted angiography (h), which again demonstrated recurrent severe, diffuse ISR, again necessitating
retreatment (i). Please note that some of the imaging (b) and
clinical history for this patient were included in a previous manuscript and are reproduced with permission from Turk AS, Levy
EI, Albuquerque FC, Pride GL Jr, Woo H, Welch BG, Niemann
DB, Purdy PD, Aagaard-Kienitz B, Rasmussen PA, Hopkins LN,
Masaryk TJ, McDougall CG, Fiorella D. Influence of patient age
and stenosis location on Wingspan in-stent restenosis. AJNR
Am J Neuroradiol. 2008;29:23–27.
Nine of 11 (81.8%) recurrent ISR lesions were located
within the anterior circulation. These lesions involved the
supraclinoid internal carotid artery (n⫽3), cavernous internal
carotid artery (n⫽2), petrous internal carotid artery (n⫽1),
and middle cerebral artery (n⫽3). Both posterior circulation
lesions involved the basilar artery (n⫽2). Nine of 17 (52.9%)
anterior circulation ISR lesions that were retreated demonstrated recurrent ISR vs 2 of 5 (40%) posterior circulation
lesions. The mean age for patients with recurrent anterior
circulation ISR was 57.9 years (n⫽9) vs 81 years for
posterior circulation ISR (n⫽2).
Discussion
The most important findings of this study are: (1) TLR of ISR
after Wingspan percutaneous transluminal angioplasty and
stenting of intracranial atherosclerotic vessels is relatively
safe, with a major complication rate of ⬍3% per lesion
treated; (2) the results of TLR are often not durable, with 50%
of patients demonstrating recurrent ISR at follow up; and (3)
a small subset of patients have lesions that seem refractory to
retreatment with angioplasty, often undergoing ⱖ1 additional
retreatments for recurrent ISR (Figure 2).
ISR occurs in ⬇30% of patients after percutaneous transluminal angioplasty and stenting with Wingspan.1,2 Similar
rates of ISR have reported for balloon-expandable stents used
to treat atherostenosis of the intracranial12 as well as the
coronary13 circulation. Numerous strategies for TLR after
late-luminal loss attributable to ISR have been devised,
including balloon angioplasty, restenting, mechanical debulking, brachytherapy, implantation of drug-eluting stents, and,
more recently, reangioplasty with drug-eluting balloons.3,6,7,14 –19 Balloon angioplasty remains the first-line
treatment option for recurrent ISR in coronary vessels;
however, recurrence rates are typically ⬎40%.4 To this point,
Table. Angiographic Pattern of ISR and Durability of
Retreatment
Angiographic Pattern of
ISR, Modified Mehran
Classification10,11
Retreatment Durable,
N of Lesions
Retreatment Not Durable,
N of Lesions
IA
2
0
IB
6
6
IC
0
1
II
3
3
III
0
1
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no study has addressed the safety or durability of reangioplasty for intracranial ISR.
Reintervention for ISR appeared to be as safe, if not safer
than, the initial treatment. We encountered only 1 significant
complication in the context of 42 retreatments. That complication was a reperfusion hemorrhage that occurred hours after
the procedure in the setting of suboptimal postprocedural
blood pressure control and as such was potentially avoidable.
Although there was only a single clinically evident neurological complication, lesion retreatment could be technically
challenging. We encountered 4 in-stent dissections after
angioplasty; however, all were clinically silent. In addition,
gaining access across the in situ stents to perform angioplasty
was, at times, challenging.1
The results of TLR were durable in only half of the patients
treated. The other half demonstrated recurrent ISR at followup, often prompting ⱖ1 additional retreatments. In this small
subset of “refractory patients,” retreatment has been followed
by recurrent symptomatic restenoses at intervals of 2 to 3
months (Figure 2). For these patients, most of whom have
anterior circulation disease, we have begun to explore other
retreatment options, including drug-eluting stents and repeat
angioplasty with a drug-eluting balloon.15–17 Although surgical bypass represents an option, patients with intracranial
middle cerebral artery stenosis represented the worst subgroup for surgical therapy, with an event rate nearly double
that for the medical therapy arm in the extracranial–intracranial arterial bypass trial.20 In patients with internal carotid artery
stenosis, no benefit over medical therapy was evident.20
In our registry patients, ISR occurred with greater frequency after the treatment of anterior circulation lesions.2
Similarly, anterior circulation stenoses accounted for the
majority of lesions both in which TLR was performed
(⬇80%) and in which recurrent ISR developed after primary
TLR (⬇80%). Although the number of patients with posterior
circulation ISR undergoing revascularization in our series
was quite small (n⫽6), the incidence of recurrent ISR in the
anterior circulation (52.9%) trended slightly higher than in
the posterior circulation (40%). In addition, the average age
of patients with recurrent ISR after TLR in the anterior
circulation (57.9 years) trended lower than for posterior
circulation patients (81 years). These observations suggest
that younger patients with anterior circulation stenosis may
be predisposed not only to ISR but also to recurrent ISR after
retreatment. No trend was evident with respect to the angiographic pattern of ISR at presentation and the subsequent
durability of retreatment.
Although the present study provides some insight into the
safety and durability of TLR, very little is known to this point
regarding the long-term natural history of this disease process
on medical therapy. It is equally unclear what represents
“optimal” medical therapy for these patients and exactly what
the threshold should be for reintervention (particularly in
asymptomatic patients). We expect that additional data may
become available during the upcoming Stent Placement vs
Aggressive Medical Management for the Prevention of Recurrent Stroke in Intracranial Stenosis study and associated
substudies to better elucidate these issues.
Target Lesion Revascularization After Wingspan
109
Limitations
The present study has several important limitations. First,
despite the overall large size of the US Wingspan registry
series, we were studying a relatively small subset of the
overall group. As such, our ability to perform multivariate
analyses to identify specific factors that may predispose these
patients to recurrent restenosis after TLR was limited. Second, the rationale on the part of the operators governing their
decisions whether (or not) to retreat asymptomatic patients
with ISR was not prospectively collected. Although unlikely,
it is possible that unknown factors influencing these treatment
decisions could have introduced a selection bias into the data.
Summary
TLR of intracranial ISR with angioplasty alone is relatively
safe. However, half of patients demonstrate recurrent ISR
after retreatment. A small subset of these patients has lesions
that are “refractory” to angioplasty alone and demonstrate
multiple instances of recurrent ISR, which are typically
symptomatic and require numerous retreatments.
Acknowledgment
The authors thank Paul H. Dressel, BFA, for preparation of
the illustrations.
Sources of Funding
The US Wingspan registry is supported by a research grant from
Boston Scientific.
Disclosures
Aagaard-Kienitz received a research grant (⬎$10 000) from Micrus
Endovascular and is a Consultant and member of the Advisory Board
(⬍$10 000 each) for Micrus Endovascular and MicroVention/
Terumo. Albuquerque received Honoraria (⬍$10 000 each) from
ev3 and Micrus. Fiorella received grant support (⬎$10 000 each)
from Boston Scientific and NIH-SAMMPRIS, is a member of the
Speakers’ Bureau (⬍$10 000 each) for Boston Scientific, Cordis,
MicroVention, and Micrus, received Honoraria (⬍$10 000 each)
from Boston Scientific, Cordis, MicroVention, Micrus, has ownership interest (⬎$10 000) in Revasc Inc (purchased by Micrus), and
is a Consultant and member of the Advisory Board for Micrus
(⬍$10 000). Hopkins received a research grant (⬍$10 000 each)
from Boston Scientific, Cordis, Micrus, received Honoraria
(⬍$10 000 each) from Bard, Boston Scientific, and Cordis, has
ownership interest (⬍$10 000 each) in AccessClosure, Boston Scientific, Micrus, Square One Inc, and is a Consultant and member of
the Advisory Board (⬍$10 000 each) for Abbott, Bard, Boston
Scientific, Cordis, and Micrus. Levy received a research grant
(⬎$10 000 each) from Boston Scientific and ev3, received other
research support (⬎$10 000) from Boston Scientific and Wingspan
devices, received an Honorarium (⬎$10 000) from Boston Scientific, is a Consultant and member of the Advisory Board (⬎$10 000
each) for Cordis Neurovascular and Micrus Endovascular, and has
received carotid stent training fees from Abbott Vascular and ev3 for
carotid stent training (⬎$10 000 each). Masaryk has nothing to
disclose. McDougall received an Honorarium (⬍$10 000) from
Boston Scientific, is a Consultant and member of the Advisory Board
(⬍$10 000 each) for Cordis Neurovascular and ev3. Niemann
received Honoraria (⬍$10 000 each) from Boston Scientific and
Micrus, and is a Consultant and member of the Advisory Board
(⬍$10 000 each) for Boston Scientific and Micrus. Pride is employed by (⬍$10 000) by ev3 Neurovascular (clinical proctor) and
received Honoraria (⬍$10 000 each) from Boston Scientific (meeting) and Cordis Neurovascular (alteplase). Purdy received an Honorarium (⬍$10 000) from Cordis Corporation (J&J) and received
royalties (⬎$10 000) from Cordis Corporation (J&J). Rasmussen
110
Stroke
January 2009
received an Honorarium (⬍$10 000) from Boston Scientific. Turk is
a Consultant and member of the Advisory Board (⬎$10 000) for
Boston Scientific. Welch received a research grant (⬍$10 000) from
Boston Scientific, is a member of the Speaker’s Bureau (⬍$10 000)
for Medtronic, and received an Honorarium (⬍$10 000) from Boston
Scientific. Woo received an Honorarium (⬍$10 000) from Micrus
Endovascular and is a Consultant and member of the Advisory Board
(⬎$10 000) for Micrus Endovascular.
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Stroke. 2009;40:106-110; originally published online October 16, 2008;
doi: 10.1161/STROKEAHA.108.525774
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