sirolimus and Intracranial-Arteriosclerosis

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.. All of the patients had >70% 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.. 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%+/-10.2% to 2.5%+/-4.6%. One patient had an intraprocedural retinal embolism, but there were no other complications. Over a mean follow-up of 11.1+/-4.9 months (range, 2 to 17.3 months), patients have had repeat angiography (5) or transcranial Doppler with or without CT angiography (3). None of the patients have had clinical or significant angiographic restenosis or required target vessel revascularization.. Elective intracranial stenting with DES appears to be feasible and safe, but additional clinical experience is required to assess its efficacy.

Topics: Adult; Aged; Cerebral Angiography; Drug Implants; Female; Follow-Up Studies; Humans; Intracranial Arteriosclerosis; Male; Middle Aged; Paclitaxel; Prospective Studies; Sirolimus; Stents; Ultrasonography

The safety and efficacy of drug-eluting balloon on the treatment of intracranial atherosclerotic stenosis (ICAS) remain unclear. Here, we present our observation in a cohort study on the safety and efficacy of rapamycin-eluting balloon for patients with ICAS.. A total of 80 ICAS patients with stenosis degree of 70-99% were included. All patients were treated with rapamycin-eluting balloon and were followed up for 12 months after operation.. All patients were successfully treated, where the mean stenosis severity reduced from 85.1 ± 7.6 to 6 ± 4.9%. 8 patients experienced immediate post-operational complications. Two patients passed away during the first month of the follow-up period. Recurrent ischemic syndrome and angiographic restenosis only appeared 7 days after operation. During later follow-up period, none of the patients had clinical angiographic restenosis or needed target vessel revascularization.. Our data suggest that intracranial stenting with rapamycin-eluting balloon seems to be safe and effective, although more clinical data are needed to support this notion.

Topics: Cohort Studies; Constriction, Pathologic; Coronary Angiography; Coronary Restenosis; Drug-Eluting Stents; Humans; Intracranial Arteriosclerosis; Sirolimus; Stents; Treatment Outcome

High in-stent restenosis (ISR) rates have been reported after treatment of intracranial atherosclerotic stenosis (ICAS). Balloon-mounted drug-eluting stent (DES) implantation has led to an ISR reduction in coronary vessels and may provide a solution to overcome this obstacle in the intracranial circulation. We present our initial experience with the everolimus-eluting stent (EES; Abbott Vascular, Abbott Park, Illinois, USA), a second-generation balloon-mounted DES, for ICAS treatment.. A retrospective review of prospectively collected endovascular data at our institution resulted in the identification of six patients with ICAS treated with EES. Data collected included patient demographics, presentation, comorbidities and lesion, intervention and follow-up details.. These six patients had >70% angiographic ICAS and history of stroke or recurrent transient ischemic attacks, despite aspirin therapy and medical management of comorbidities. Lesions were located in the V4-vertebral artery segment (n=2), M1 middle cerebral artery segment (n=1), proximal basilar artery (n=1), supraclinoid internal carotid artery (n=1) and petrous internal carotid artery (n=1). Average stenosis severity was 82.8±6.6% (median, 80%); average lesion length was 10.2±2.2 mm. Stent placement was successful in all cases. Average postintervention stenosis was 5.5±4.4% (median, 7.5%). One patient had postintervention reperfusion hemorrhage that required urgent decompressive craniectomy. None of the five patients with angiographic follow-up (5-6 months) had ISR. The six patients had 4-10 months of clinical follow-up. Only the patient with reperfusion hemorrhage had decreased functional status after treatment (modified Rankin scale score=4) and is making a slow recovery.. This study confirms feasibility of use of a second-generation DES for ICAS and provides short-term follow-up results.

Topics: Adult; Aged; Aged, 80 and over; Catheterization; Drug-Eluting Stents; Everolimus; Follow-Up Studies; Humans; Intracranial Arteriosclerosis; Middle Aged; Prospective Studies; Radiography; Retrospective Studies; Sirolimus; Treatment Outcome

Use of the sirolimus-eluting stent has led to a reduction of in-stent stenosis following treatment of coronary atherosclerosis, whereas treatment of intracranial atherosclerosis with bare-metal stents results in excessive restenosis rates of approximately 40%. Neurotoxicity effects and vessel injury are unknown in the cerebral vasculature. To assess the safety profile and vascular effects of sirolimus-coated stents, the authors conducted a prospective comparative study in which drug-eluting and bare-metal stents were implanted in the canine basilar artery (BA).. Sixteen mongrel dogs were randomized (eight animals per group) to receive either bare-metal 1.5 x 8-mm (six-cell) stents or sirolimus-eluting stents of the same dimensions. Interventionists, histopathologists, and histopathology technicians who participated in the study were blinded to the stent characteristics. Stents were implanted in the canine BA. Serial peripheral blood samples were obtained during the 1st week after implantation to determine the time-dependent serum concentration of sirolimus. Follow-up angiographic studies were performed 30 days after stent implantation to assess the effects of stent placement on the BA and brainstem perforating vessels. Explantation of the stent and BA was performed immediately after angiography by using a pressurized formalin fixation procedure. Histological and computer-assisted morphometric analyses of specimens obtained in each animal were performed. Sirolimus could not be detected in peripheral blood samples obtained later than 24 hours posttreatment. On follow-up angiography, all perforating vessels observed on initial angiograms remained patent, and no evidence of parent vessel damage or pseudoaneurysm formation was observed. Explanted vessels and brainstem sections did not demonstrate evidence of histological neurotoxicity, such as gliosis or infarction. No significant differences were found in the time to endothelialization of bare-metal and sirolimus-coated stents. Smooth-muscle cell (SMC) proliferation, the putative agent for restenosis, was lower in animals receiving sirolimus-coated stents (p = 0.003). Additionally, intimal fibrin density was increased in the dogs treated with sirolimus-coated stents (p < 0.0001). Histological evidence of an inflammatory response demonstrated a trend toward a reduced response in the sirolimus group (mean 0.58) compared with the bare-metal group (mean 0.83, p = 0.33).. No neurotoxic effects were observed in the intracranial vessel walls or brainstem tissue in which sirolimus-coated stents were implanted. Compared with bare-metal stents, the sirolimus-coated devices did not impair endothelialization and, furthermore, tended to reduce the proliferation of SMCs. These findings indicate that sirolimus-coated devices may inhibit in-stent stenosis. Further studies with longer-term follow up are required to assess the restenosis rates of sirolimus-coated stents implanted in the intracranial vasculature.

Topics: Animals; Disease Models, Animal; Dogs; Immunosuppressive Agents; Intracranial Arteriosclerosis; Prospective Studies; Random Allocation; Single-Blind Method; Sirolimus; Stents; Treatment Outcome; Vertebrobasilar Insufficiency