Primary Stenting for Acute Ischemic Stroke Using the Enterprise Intracranial Stent: 2-Year Results of a Phase-I Trial.

BACKGROUND: The preliminary results of a prospective consecutive series of 20 patients who underwent Enterprise-assisted recanalization for acute ischemic stroke were recently reported. Recanalization to thrombolysis in myocardial infarction (TIMI) grade 2 (n = 6) or 3 (n = 12) flow was achieved in 18 patients (90% revascularization rate). Good outcome (modified Rankin Scale [mRS] score of ≤2) was obtained in 10 patients (50%) at 30 days. Here, we report the 2-year clinical follow-up data for patients enrolled in that prospective study. METHODS: Study patients were scheduled for examinations 2 years postprocedure at which time mRS and Barthel indices were obtained. RESULTS: Among 12 survivors at 2 years, 11 of the 20 (55%) study patients improved to mRS score ≤2 and 1 (5%) patient was disabled with an mRS 4. Of the 11 patients with mRS 0-2 scores, 10 patients had a Barthel index of 100, and the 11th had a Barthel index of 95. One patient improved from mRS 3 to 2 during the interval between the 6- and 12-month postintervention evaluations after intervention. Eight of 13 (62%) survivors underwent follow-up imaging at 6 months without evidence of instent stenosis or thrombosis. CONCLUSION: At 2 years of follow-up, improvement in quality of life after acute stroke intervention was sustained; and 11 of 12 (92%) survivors had an excellent functional outcome. Improvement in functional status can occur even up to 1 year after stroke intervention. These results 2 years after acute stroke intervention demonstrate sustained benefit from acute intervention. ABBREVIATIONS: AISacute ischemic strokeCTcomputed tomographicFDAFood and Drug AdministrationIVintravenousMCAmiddle cerebral arterymRSmodified Rankin ScaleNIHSSNational Institutes of Health Stroke Scale ScoreSWIFTSolitaire FR With the Intention For Thrombectomy (SWIFT)TIMIthrombolysis in myocardial infarctiontPAtissue plasminogen activatorTREVOThrombectomy REvascularization of large Vessel Occlusions.

Prospective randomized trial of venous angioplasty in MS (PREMiSe).

OBJECTIVE: We report the results of the investigation of safety and efficacy of venous angioplasty in patients with multiple sclerosis (MS) with findings of extracranial venous anomalies, considered hallmarks of chronic cerebrospinal venous insufficiency (CCSVI), in a 2-phase study (ClinicalTrials.gov NCT01450072). METHODS: Phase 1 was an open-label safety study (10 patients); phase 2 was sham-controlled, randomized, and double-blind (10 sham procedure, 9 treated). All study patients fulfilled venous hemodynamic screening criteria indicative of CCSVI. Assessment was at 1, 3, and 6 months postprocedure with MRI, clinical, and hemodynamic outcomes. Primary endpoints were safety at 24 hours and 1 month, venous outflow restoration >75% at 1 month, and effect of angioplasty on new lesion activity and relapse rate over 6 months. Secondary endpoints included changes in disability, brain volume, cognitive tests, and quality of life. RESULTS: No perioperative complications were noted; however, one patient with history of syncope was diagnosed with episodic bradycardia requiring placement of a pacemaker before discharge. Doppler evidence-based venous hemodynamic insufficiency severity score (VHISS) was reduced >75% compared to baseline in phase 1 (at 1 month) but not phase 2. In phase 2, higher MRI activity (cumulative number of new contrast-enhancing lesions [19 vs 3, p = 0.062] and new T2 lesions [17 vs 3, p = 0.066]) and relapse activity (4 vs 1, p = 0.389) were identified as nonsignificant trends in the treated vs sham arm over 6 months. Using analysis of covariance, significant cumulative new T2 lesions were related to larger VHISS decrease (p = 0.028) and angioplasty (p = 0.01) over the follow-up. No differences in other endpoints were detected. CONCLUSION: Venous angioplasty is not an effective treatment for MS over the short term and may exacerbate underlying disease activity. CLASSIFICATION OF EVIDENCE: This is a Class I study demonstrating that clinical and imaging outcomes are no better or worse in patients with MS identified with venous outflow restriction who receive venous angioplasty compared to sham controls who do not receive angioplasty. This study also includes a Class IV phase 1 study of safety in 10 patients receiving the angioplasty procedure.

Midterm clinical and angiographic follow-up for the first Food and Drug Administration-approved prospective, Single-Arm Trial of Primary Stenting for Stroke: SARIS (Stent-Assisted Recanalization for Acute Ischemic Stroke).

BACKGROUND: Although early data demonstrate encouraging angiographic results following intracranial stent deployment for acute ischemic stroke, longer-term follow-up is necessary to evaluate the clinical outcomes, as well as the durability of angiographic results. OBJECTIVE: We report 6-month clinical and radiologic follow-up data of the 20 patients prospectively enrolled in the Stent-Assisted Recanalization in acute Ischemic Stroke (SARIS) trial. METHODS: Twenty patients were prospectively enrolled to receive self-expanding intra-arterial stents as first-line therapy for acute ischemic stroke treatment. Patients were scheduled for follow-up 6-months after treatment for clinical evaluation (modified Rankin Scale [mRS] score obtained by a trained certified research nurse/nurse practitioner) and repeat cerebral angiography. Angiographic interpretation was performed by an independent adjudicator. RESULTS: At 6 months, the mRS score was ≤3 in 60% of patients (n = 12) and was ≤2 in 55% of patients (n = 11). Mortality at the 6-month follow-up was 35% (n = 7). Follow-up angiography was performed for 85% (11 of 13) of surviving patients. All patients undergoing angiographic follow-up demonstrated Thrombolysis in Myocardial Infarction 3 flow on digital subtraction angiography or stent patency on computed tomographic angiography. None of the patients demonstrated evidence of in-stent stenosis (≥50% vessel narrowing). CONCLUSION: The midterm angiographic and clinical results following intracranial stent deployment for acute ischemic stroke are encouraging. Further study of primary stent-for-stroke treatment is warranted.

Staged stent-assisted angioplasty for symptomatic intracranial vertebrobasilar artery stenosis.

OBJECT: Medically refractory symptomatic vertebrobasilar atherosclerotic disease has a poor prognosis. Studies have shown that longer (> or = 10 mm), eccentric, high-grade (> 70%) stenoses portend increased procedure-related morbidity. The authors reviewed their experience to determine whether a staged procedure consisting of angioplasty followed by delayed (> or = 1 month later) repeated angioplasty and stent placement reduces the morbidity associated with endovascular treatment of symptomatic basilar and/or intracranial vertebral artery (VA) stenoses. METHODS: The authors retrospectively reviewed the medical records in a consecutive series of eight patients who underwent planned stent-assisted angioplasty for medically refractory, symptomatic atherosclerotic disease of the intracranial posterior circulation between February 1999 and January 2002. Staged stent-assisted angioplasty was planned for these patients because the extent and degree of stenosis of the VA and/or basilar artery (BA) lesion portended an excessive procedure-related risk. The degree of stenosis, recent onset of symptoms (unstable plaque), vessel tortuosity, and lesion length and morphological feaures were contributing factors in determining procedure-related risk. Patient records were analyzed for location and degree of stenosis, preprocedural regimen of antiplatelet and/or anticoagulation agents, devices used, procedure-related complications, and clinical and radiographic outcomes. Among the patients in whom staged stent-assisted angioplasty was planned, vessel dissection, which necessitated immediate stent placement, occurred during passage of the balloon in one of them. In a second patient, the stent could not be maneuvered through the tortuous VA. In a third patient, the VA and BAs remained widely patent after angioplasty alone, and therefore stent placement was not required. Significant complications among the eight patients included transient aphasia and hemiparesis in one and a groin hematoma that necessitated surgical intervention in another; there was no permanent neurological morbidity. The mean stenosis before treatment was 78%, which fell to 54% after angioplasty, and the mean residual stenosis after stent placement was 30%. At the last follow-up examination, none of the treated patients had further symptoms attributable to the treated stenosis. CONCLUSIONS: The novel combination of initial angioplasty followed by delayed endoluminal stent placement may reduce the neurological morbidity associated with endovascular treatment of long, high-grade stenotic lesions. Attempting to cross high-grade stenoses with higher-profile devices such as stents may result in an embolic shower. Furthermore, neointimal proliferation and scar formation after angioplasty result in a thickened fibrous layer, which may be protective during delayed stent deployment. Larger-scale studies involving multiple centers are needed to elucidate further the lesion morphological characteristics and patient population most likely to benefit from staged procedures.