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(Stroke. 1995;26:1200-1204.)
© 1995 American Heart Association, Inc.

Articles

Safety and Efficacy of Percutaneous Transluminal Angioplasty for Intracranial Atherosclerotic Stenosis

Presented in abstract form at the 19th International Joint Conference on Stroke and Cerebral Circulation, San Diego, Calif, Feb 17-19, 1994.

Wayne M. Clark, MD; Stanley L. Barnwell, MD, PhD; Gary Nesbit, MD; Oisin R. O'Neill, MD, FRCSI; Michael L. Wynn, DO Bruce M. Coull, MD

From the Oregon Stroke Center, Departments of Neurology (W.M.C., M.L.W., B.M.C.), Neurosurgery, Radiology, and the Dotter Interventional Institute (W.M.C., S.L.B., G.N.), Oregon Health Sciences University, Portland; and the Neurology (B.M.C.) and Neurosurgery (O.R.O'B.) Services, Portland Veterans Administration Medical Center, Oregon.

Correspondence to Dr Wayne M. Clark, Department of Neurology L104, Oregon Health Sciences University, 3181 SW Sam Jackson Park Rd, Portland, OR 97201. E-mail clark w@ohsu.edu.

	Abstract

Top Abstract Introduction Subjects and Methods Results Discussion References

 
Background and Purpose Percutaneous transluminal angioplasty (PCTA) is increasingly used to treat extracerebral arterial stenosis. The present study evaluates the safety and efficacy of PCTA treatment of symptomatic intracranial atherosclerotic stenosis.

Methods A series of 22 vessels in 17 patients were treated with PCTA. All patients had recurrent neurological symptoms referable to the stenotic vessel despite optimal medical therapy. Critical (>70%) arterial stenosis was confirmed by angiogram, and angioplasty was performed with a 3.0- to 3.5-mm Stealth balloon.

Results The average preangioplasty stenosis (North American Symptomatic Carotid Endarterectomy Trial criteria) was 72±8% (mean±SD), with a significant improvement seen after angioplasty; the best angiographic stenosis (after healing of intimal injury, if any) was 43±24% (P<.001). Overall PCTA was successful in 82% of the vessels. There were two strokes during angioplasty for a 30-day morbidity rate of 9.1% per treated vessel and 11.7% per case. The other 15 patients were clinically evaluated at 3 and 6 months; all cases were without further events. Restenosis was evaluated in 8 patients (12 vessels) with an angiogram at 6 months showing further improvement compared with the initial post-PCTA stenosis (51±10% versus 37±21% [P=.05]).

Conclusions PCTA may be a beneficial therapy in selected cases of symptomatic intracranial atherosclerotic stenosis. Further study using a randomized trial is needed.

Key Words: angioplasty, transluminal • cerebral arteries • endovascular therapy

	Introduction

Top Abstract Introduction Subjects and Methods Results Discussion References

 
Percutaneous transluminal angioplasty (PCTA) is an established method of treating coronary, femoral, renal, and other arterial stenosis. PCTA has recently been used to treat extracranial stenosis secondary to atherosclerosis,^{1 2 3 4 5 6 7} fibromuscular dysplasia,^{8 9} and vasculitis.¹⁰ The overall efficacy rates (less than 50% residual stenosis) for these studies range from 50% to 70% with a reported 5% to 10% complication rate.¹¹ However, treatment of intracranial vessels has been avoided because of concerns about inducing ischemia through thromboemboli and risk of vessel rupture.

Recent advances in microcatheter and balloon technology have led to a renewed interest in treating intracranial lesions. Several studies have found PCTA to be very beneficial in cases of intracranial vasospasm in subarachnoid hemorrhage.^{12 13 14 15} There have been several case reports of successful treatment of intracranial atherosclerosis,^{1 2} but these have not been evaluated in a larger series. This study was undertaken to evaluate the safety and efficacy of PCTA in our group of selected patients with high-grade intracranial stenosis who were symptomatic despite optimal medical therapy.

	Subjects and Methods

Top Abstract Introduction Subjects and Methods Results Discussion References

 
Between July 1992 and July 1994 transluminal balloon angioplasty was performed in 22 intracranial vessels in 17 patients. All patients gave written informed consent to participate, with treatment being offered on a compassionate-use basis. Selection criteria for therapy included (1) at least 70% stenosis of one intracranial vessel; (2) recurrent transient ischemic attack or stroke referable to this vessel (see Table) despite maximal medical therapy, which included therapeutic anticoagulation or in some cases combined aspirin and anticoagulation; and (3) stenosis presumed secondary to atherosclerosis.

View this table: [in this window] [in a new window]   Table 1. Results of Percutaneous Transluminal Angioplasty for Intracranial Stenosis

All patients had a complete neurological examination, routine laboratory tests, and head CT before angiogram. Baseline four-vessel angiography was performed to evaluate the collateral supply distal to the stenotic vessel, to look for tandem stenotic lesions, and to evaluate the size of the normal vessel adjacent to the stenosis. The size of the normal vessel was determined by placing 10-mm round markers on both sides and the front and back of the head. Anteroposterior and lateral radiographs were obtained. On the assumption that the normal vessel was midway between the two markers, a 10-mm standard was made by averaging the largest diameter of the two circles (which appear oblong if they are not exactly perpendicular to the x-ray beam). The normal vessel was then measured with this standard.

A 6F sheath was placed in the femoral artery. Heparin (5000 U IV) was administered at the start of the procedure, and an activated clotting time was measured to ensure that it was greater than 200 seconds. A 6F guiding catheter (Cordis Envoy, Cordis Endovascular System) was navigated over a 0.035-in guide wire into the cervical portion of the vertebral or internal carotid artery. A balloon dilation catheter (Stealth, Target Therapeutics Inc) was navigated over a 0.014-in guide wire (Dasher-14, Target Therapeutics Inc) across the lesion. The choice of inflated diameter of the balloon angioplasty catheter was determined by the diameter of the normal adjacent vessel. The inflated balloon diameter did not exceed the diameter of the normal vessel. The length of the balloon was determined by the length of the stenotic lesion. The length of the balloon exceeded the length of the stenosis by at least 5 mm. The guide wire was removed and replaced with a Stealth valve wire with a 2-cm tip. The balloon was inflated to 7 atm for 10 seconds using a 75% mixture of Isovue-300 and saline. With the balloon deflated but still in position, a contrast injection was made through the guiding catheter to assess response to the angioplasty. If the vessel was still stenosed and if there was slow blood flow around the balloon, the angioplasty was repeated once or twice. If tandem lesions were present, the more severely stenotic lesion was treated first. A repeat angiogram was then performed to assess vessel stenosis and to look for evidence of distal embolization.

Heparin was continued after the procedure, with the dose adjusted to maintain the partial thromboplastin time at 45 to 60 seconds. The femoral artery sheath was removed with the patient still receiving heparin. Manual femoral artery compression for 15 minutes generally was sufficient to obtain hemostasis.

All patients were monitored in the neurological critical care unit for at least 24 hours. A detailed neurological examination was performed immediately after angioplasty and then daily during hospitalization. In most cases, the patients were discharged within 48 hours. Patients were treated with Coumadin (international normalized ratio, 2.0 to 2.5) for at least 3 months. All cases were clinically evaluated at 3 and 6 months. A repeated angiogram was performed at approximately 6 months in twelve cases to evaluate restenosis and assess the need for continued anticoagulation.

All angiograms were later read by an independent neuroradiologist not involved in the angioplasty procedure who was blinded to the angioplasty status of each film. Stenosis was measured by the criteria of the North American Symptomatic Carotid Endarterectomy Trial (NASCET) (comparing diameter at the site of greatest narrowing to diameter of normal artery distal to lesion).¹⁶ Overall treatment efficacy was determined by corrected paired t tests.

	Results

Top Abstract Introduction Subjects and Methods Results Discussion References

 
The clinical and angiographic features of all patients entered into this study are given in the Table. There were 2 women and 15 men aged 57 to 79 years. All patients had recurrent neurological symptoms referable to the stenotic vessel before treatment. The initial head CT was negative in patients with transient ischemic attacks and showed one or more ischemic strokes in patients with fixed deficits. Four patients had multiple vessels treated. Angioplasty was performed in these additional vessels if it was felt that they were likely contributing to the patients' recurrent symptoms. PCTA was performed on 22 vessels, including 16 vertebral or basilar and 6 internal carotid or middle cerebral arteries (MCA). The baseline angiogram showed a preangioplasty stenosis of 72±8% (mean±SD). Although at least one vessel in every case was initially graded as at least 70%, the measured stenosis was later reduced in some cases by the independent neuroradiologist (see Table).

There was a significant (P<.0001) reduction in stenosis to 51±18% seen on the immediate post-PCTA angiogram. However, three of the vessels showed evidence of intimal injury (small intimal dissections or thrombosis) on the acute-stage films, making it difficult to accurately estimate the residual stenosis. These cases all showed resolution of these processes on subsequent angiograms. The subsequent angiogram was substituted for the acute-stage angiogram in these cases to determine an overall "best angiographic stenosis" after angioplasty of 43±23%. Eight of the patients (12 vessels) underwent a repeated angiogram at 6 months to evaluate restenosis. In these cases, the degree of stenosis actually improved from an acute post-PCTA residual stenosis of 51±10% to 37±21% at approximately 6 months (P=.05). We did not obtain repeated angiograms for the other 9 patients because of lack of insurance authorization or patient reluctance. In two cases (nos. 2 and 17), we initially attempted opening the stenosis with intra-arterial urokinase. No improvement in stenosis was seen, and PCTA was performed the following day. Illustrative cases are shown in Figs 1 and 2.

Pre- and post-PCTA brain single-photon emission CT (SPECT) scans were performed with 24.2 mCi of ^99mTc-labeled hexamethylpropyleneamine oxime in three patients (nos. 8, 12, and 18; Table). Scans obtained after PCTA showed at least a 20% improvement in the pre-PCTA perfusion defects in all three patients. A representative example is shown in Fig 1C.

View larger version (62K): [in this window] [in a new window]   Figure 1. Findings in a 63-year-old man with recurrent aphasia and right hemiplegia receiving Coumadin (case 6). A, Preangioplasty digital subtraction angiogram (lateral view) shows 70% stenosis of distal cavernous left internal carotid artery (LICA). B, Postangioplasty lateral view shows 50% residual stenosis of distal cavernous LICA. C, Brain single-photon emission CT scan was performed with 24.2 mCi of 99mTc-labeled hexamethylpropyleneamine oxime. Preangioplasty tomographic images (left) show perfusion defects in the left basal ganglia, thalamus, and temporoparietal and frontal regions (closed arrows). Postangioplasty images (right) show resolution of these perfusion defects (open arrows).

There were no cases of vessel rupture or death. There were two strokes associated with PCTA for a major complication rate of 9.1% per vessel and a complication rate of 12% per case. One patient had a large MCA stroke during PCTA due to an intimal dissection, causing a complete occlusion of the MCA. This patient did not respond to attempts of repeat angioplasty or thrombolysis. The second patient had a pontine stroke presumably due to a penetrating branch artery occlusion during PCTA of the basilar artery. Additional mild complications included headache in one patient, transient diplopia in one patient, and asymptomatic intimal dissection in three patients (Table).

Results of follow-up are shown in the Table. Excluding the two patients with PCTA-related strokes, all patients had resolution of symptoms with no further neurological events at 3 and 6 months. In addition, during 22±16 months of long-term follow-up (range, 8 to 54 months), no strokes occurred in the territory of the PCTA-treated artery.

	Discussion

Top Abstract Introduction Subjects and Methods Results Discussion References

 
In this study, we found that PCTA could successfully treat intracranial atherosclerotic stenosis with a relatively low complication rate. Overall, we observed a 29% absolute improvement in stenosis. In the coronary circulation, a "successful angioplasty" is defined as at least a 20% relative improvement with less than a 50% residual stenosis.¹⁷ Using these criteria, we found that 82% of the vessels were successfully treated. This degree of efficacy is slightly higher than the 50% to 70% rate of successful vessel reopening with PCTA reported in the extracranial circulation.¹¹ Previous experience with PCTA in the intracranial circulation is limited. Higashida et al² treated five distal vertebral artery lesions and three basilar artery lesions with PCTA as part of a larger series. Six of their patients (75%) had successful vessel reopening. Brückmann et al¹ reported successful PCTA in two cases with distal vertebral stenosis. In terms of clinical efficacy, 82% of our cases (14/17) were free of cerebrovascular events at 6 months. This compares favorably with the 86% reported rate of symptom resolution reported after PCTA of the proximal vertebral artery.¹⁸

We experienced a 9.1% rate of major complication (stroke) associated with PCTA. However, since we did not obtain routine imaging studies after PCTA, it is possible that silent cerebral infarcts may have been missed. Our complication rate is lower than the 38% major per-vessel complication rate (two strokes, one rupture) in the eight intracranial PCTA patients from the Higashida et al² study and is similar to the 6% to 10% complication rate reported for extracranial PCTA.^{11 19} Although the complication rate in our study is higher than the approximately 6% combined mortality and morbidity rates reported for carotid endarterectomy,²⁰ there are limited data on the complication rate of surgical treatment of intracranial stenosis. For the intracranial circulation, the best estimate for the anterior circulation comes from the Extracranial/Intracranial Arterial Bypass Study, in which a rate of 4.5% was reported.²¹ For the posterior circulation, various reconstructive methods have been attempted for extracranial vertebral stenosis, with combined mortality and morbidity rates of up to 12% reported.²² Rates in the intracranial posterior circulation would be expected to be even higher because of difficult surgical access. Three vessels (14%) showed evidence of an intimal dissection after the procedure. There were no associated symptoms, and all patients showed improvement on repeated angiography. We did not see an improvement in the angiographic stenosis with urokinase treatment before PCTA in the two patients in whom this was performed. This is in contrast to other reported cases.²³

We did not find evidence of early restenosis at 6 months and actually found further improvement compared with immediately after angiography due to resolution of intimal injury. This is in contrast to the findings in PCTA of coronary vessels, for which early restenosis rates of 25% to 35% have been reported.²⁴ In PCTA of extracranial brachiocephalic vessels, Higashida et al² reported that 6% of their patients (12 of 198) had to have a second PCTA within 12 months because of symptomatic restenosis.²⁵ Of 13 cases with proximal vertebral stenosis, Brückmann et al¹ reported two (15%) with asymptomatic restenosis within 15 months. Possible explanations for the lower early restenosis rates in PCTA of cerebral compared with cardiac vessels include larger cerebral vessel diameters, less intimal injury because of lower balloon inflation pressures, that treated cerebral arteries are usually not end vessels, and potential differences in underlying pathogenesis. We do not know if our patients develop restenosis after 6 months, although none of the patients reported a stroke in the corresponding territory over the next 2 years. All of our patients received Coumadin for 3 to 6 months after PCTA. The majority of patients were then switched to aspirin. The ideal medical management after intracranial PCTA has not been established, and other centers are using aspirin only immediately after PCTA.¹⁵

Our selection criteria for PCTA included symptomatic critical intracranial stenosis. This criterion was selected in part on the basis of the NASCET results, in which cases with greater than 70% stenosis had a 26% 2-year stroke rate despite the best medical therapy.¹⁶ The natural history of symptomatic posterior circulation is not as well defined. Cartlidge et al²⁶ and Heyman et al²⁷ reported that transient ischemic attacks of the posterior circulation were associated with a 35% risk of infarction within 5 years. The Warfarin-Aspirin Symptomatic Intracranial Disease Study (WASID) recently reported a 22% 14-month stroke rate in 15 patients with symptomatic stenosis of the intracranial vertebral or basilar arteries.²⁸

PCTA may be a useful therapy in selected cases with symptomatic intracranial stenosis. The procedure produced excellent symptom reduction, and we did not find evidence of early restenosis. Further clinical study using a NASCET-type protocol is needed to determine whether PCTA is superior to the best medical management alone for symptomatic intracranial stenosis.

View larger version (71K): [in this window] [in a new window]   Figure 2. Findings in a 72-year-old man with recurrent diplopia and left-sided weakness receiving heparin. A, Preangioplasty digital subtraction angiogram (anteroposterior view) shows 52% stenosis of the right vertebral artery near the posterior inferior cerebellar artery and 72% stenosis of the distal basilar artery. B, Postangioplasty anteroposterior view shows 21% residual stenosis of the right vertebral artery and 45% residual stenosis of the distal basilar artery with an irregular dissection noted. C, Anteroposterior view at 6-month follow-up shows further improvement in the right vertebral artery. The basilar artery stenosis is essentially unchanged, although there is some improvement noted in the dissection.

	Acknowledgments

 
This study was supported in part by a National Institutes of Health clinician investigator development award (Dr Clark).

Received January 16, 1995; revision received April 5, 1995; accepted April 5, 1995.

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