Sirolimus-eluting stents in the canine cerebral vasculature: a prospective, randomized, blinded assessment of safety and vessel response

Levy, Elad I.; Hanel, Ricardó A.; Howington, Jay U.; Nemes, Balázs; Boulos, Alan S.; Tio, Fermin O.; Paciorek, Ann M.; Amlani, Shoaib; Kagan-Hallett, Kathleen S; Fronckowiak, Mary Duffy; Guterman, Lee R.; Hopkins, L. Nelson

doi:10.3171/jns.2004.100.4.0688

Cited by 44 publications

(23 citation statements)

References 24 publications

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“…The safety of DES in the intracranial vasculature was studied in a model using Cypher (Cordis Corp) stents in the BA artery of dogs. 4 This study found no evidence of arterial or brain tissue toxicity and concluded that these devices were safe within the intracranial vasculature. The total dose of drug released to tissues by DES is very small compared with the known toxic doses of both sirolimus and paclitaxel, and tissue toxicity does not appear to be an issue.…”

Section: Discussionmentioning

confidence: 70%

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Drug-Eluting Stents for the Treatment of Intracranial Atherosclerosis

Aböu-Chebl

Bashir

Yadav

2005

Stroke

124

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Background and Purpose-Intracranial stenting is associated with a 32% rate of restenosis. Drug-eluting stents (DES) have revolutionized the treatment of coronary artery disease and have greatly reduced the risk of in-stent stenosis. We present our experience with the feasibility and safety of using DES for patients with symptomatic intracranial atherosclerosis. Methods-All of the patients had Ͼ70% stenoses and had failed maximal medical therapy. They were pretreated with aspirin, clopidogrel, and intraprocedural heparin. All of the lesions were predilated, and balloons and stents were slightly undersized. Clopidogrel and aspirin were continued for 1 year, and patients had clinical follow-up and vascular imaging at 30 days, 6 months, and 1 year. Results-Eight patients with intracranial internal carotid artery (3), middle cerebral (2), basilar (2), and vertebral artery (1) stenoses were successfully treated with 4 Cypher (Cordis Corp) and 4 Taxus (Boston Scientific Inc) stents. The mean stenosis severity was reduced from 84.4%Ϯ10.2% to 2.5%Ϯ4.6%. One patient had an intraprocedural retinal embolism, but there were no other complications. Over a mean follow-up of 11.1Ϯ4.9 months (range, 2 to 17.3 months), patients have had repeat angiography (5)

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Section: Discussionmentioning

confidence: 70%

“…4 We have used DES to treat 8 patients with intractable cerebral ischemia attributable to intracranial atherosclerosis. In this report, we present our clinical results with angiographic follow-up.…”

mentioning

confidence: 99%

Drug-Eluting Stents for the Treatment of Intracranial Atherosclerosis

Aböu-Chebl

Bashir

Yadav

2005

Stroke

124

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“…9,10 A study on the placement of sirolimus-eluting stents in canine cerebral arteries did not reveal histological evidence of toxicity. 11 This represents the largest experience to date with the use of DESs for these arteries. The compounds used on these stents, sirolimus and paclitaxel, have been shown to reduce the response of neointimal hyperplasia by blocking mitogen-induced smooth muscle proliferation.…”

Section: Discussionmentioning

confidence: 94%

Safety, Feasibility, and Short-Term Follow-Up of Drug-Eluting Stent Placement in the Intracranial and Extracranial Circulation

Gupta

Al-Ali

Thomas

et al. 2006

Stroke

177

110

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Background and Purpose-The use of bare metal stents to treat symptomatic intracranial stenosis may be associated with significant restenosis rates. The advent of drug-eluting stents (DESs) in the coronary circulation has resulted in a reduction of restenosis rates. We report our technical success rate and short-term restenosis rates after stenting with DESs in the intracranial and extracranial circulation. Methods-This study was a retrospective review of the period between April 1, 2004, and April 15, 2006, of 59 patients with 62 symptomatic intracranial or extracranial atherosclerotic lesions at 2 medical centers (University of Pittsburgh and Borgess Medical Center). Results-The mean age of our cohort was 61Ϯ12 years. The location of the 62 lesions was as follows: extracranial vertebral artery 31 (50%), intracranial vertebral artery or basilar artery 18 (29%), extracranial internal carotid artery (ICA) near the petrous bone 5 (8%), and intracranial ICA 8 (13%). There were 2 (3%) periprocedural complications: 1 non-flow-limiting dissection and 1 disabling stroke. Fifty vessels were available for follow-up angiography or computed tomography angiography at a median time of 4.0Ϯ2 months. A total of 2 of 36 extracranial stents (7%) and 1 of 26 intracranial stents (5%) were found to have restenosis Ն50% at follow-up. Conclusions-This report demonstrates that DES delivery in the intracranial and extracranial circulation is technically feasible. A small percentage of patients developed short-term in-stent restenosis. Longer-term follow-up is required in the setting of a prospective study to determine the late restenosis rates for DESs in comparison with bare metal stents.

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“…This was the first published series describing the use of drug-eluting stents in humans after an initial study of sirolimus-coated Cypher stent (Cordis Corp.) deployment in canine basilar arteries showed promising results. 21 The group prospectively selected 8 patients with symptomatic intracranial stenosis that was greater than 70% and refractory to medical management. The authors used coronary drug-eluting stents to treat the patients' diseased vessels.…”

Section: Drug-eluting Stentsmentioning

confidence: 99%

Applications of stenting for intracranial atherosclerosis

Ding

Liu²

2011

FOC

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Intracranial atherosclerosis presents a therapeutic challenge to medical and surgical physicians alike. Despite maximal medical therapy, the stroke rate from this disease is still high, especially when arterial stenosis is severe and patients are symptomatic. Open surgical therapy has yet to be shown to be a more efficacious treatment than medical therapy alone, largely due to the relatively high rates of perioperative complications. Angioplasty has a similar fate, with the risk of periprocedural complications outweighing the overall benefit of treatment. With the advent of stents for use in intracranial vasculature, new hope has arisen for the treatment of intracranial atherosclerosis. The NEUROLINK system, the drug-eluting stents Taxus and Cypher, the flexible Wingspan stent, the Apollo stent, and the Pharos stent have all been used in various prospective and retrospective clinical studies with varying technical and clinical results. The authors' objective is to review and loosely compare the data presented for each of these stenting systems. While the Wingspan stent appears to have somewhat of an advantage with regard to technical success in comparison with the other stenting systems, the clinical follow-up time of its studies is too short to properly compare its complication rates with those of other stents. Before we continue to move forward with stenting for intracranial stenosis, a randomized prospective trial is ultimately needed to directly compare intracranial stenting to medical therapy.

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Sirolimus-eluting stents in the canine cerebral vasculature: a prospective, randomized, blinded assessment of safety and vessel response

Cited by 44 publications

References 24 publications

Drug-Eluting Stents for the Treatment of Intracranial Atherosclerosis

Drug-Eluting Stents for the Treatment of Intracranial Atherosclerosis

Safety, Feasibility, and Short-Term Follow-Up of Drug-Eluting Stent Placement in the Intracranial and Extracranial Circulation

Applications of stenting for intracranial atherosclerosis

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