Gandini Roberto, Chiaravalloti Antonio, Pampana Enrico, Massari Francesco, Morosetti Daniele, Spano Sergio, Loreni Giorgio, Simonetti Giovanni
Fondazione I.R.C.C.S. Policlinico Tor Vergata-- Department of Diagnostic Imaging, Molecular Imaging, Interventional Radiology and Radiation Therapy, Rome, Italy.
Clin Neurol Neurosurg. 2013 Jun;115(6):741-7. doi: 10.1016/j.clineuro.2012.08.037. Epub 2012 Sep 16.
Intracranial atherosclerosis may be the underlying pathology in up to 15% of ischemic strokes, but may account for about 40% of strokes in some populations. After an ischemic event determined by intracranial atherosclerosis, patients have a 12% annual risk of stroke recurrence, mostly during the first year.
To evaluate procedural safety, clinical outcome and restenosis rate of Wingspan stent placement.
Twenty-one caucasoid patients were enrolled. Target patients were affected by high-grade, symptomatic, intracranial atherosclerotic lesions, were on antithrombotic therapy and at high stroke risk. All patients were treated with the Wingspan stent system.
Technical success resulted 100%, with all target lesions being reduced to <50%. No stroke or death were observed at 30. The mean percent of stenosis was reduced from a middle value of 84% to a middle value of 17% after stent placement. Medium follow-up was 19.5months (range 6-36months). No stroke or death occurred in any patient. None of the patients presented a <50% stent patency rate at follow-up.
The short-term results and follow up analysis provide evidence demonstrating the safety of the Wingspan system when used in high-risk patient population. Due to concerns regarding long-term stent patency and ischemic events occurrence emerged from clinical trials such as the SAMMPRIS, intracranial angioplasty and stent with the Wingspan system should be considered only for high risk patients in which it may be considered the only viable therapeutic option.
颅内动脉粥样硬化可能是高达15%的缺血性卒中的潜在病理机制,但在某些人群中可能占卒中的约40%。在由颅内动脉粥样硬化确定的缺血事件后,患者每年有12%的卒中复发风险,大多在第一年。
评估Wingspan支架置入术的操作安全性、临床结局和再狭窄率。
纳入21例白种人患者。目标患者患有高级别、有症状的颅内动脉粥样硬化病变,正在接受抗血栓治疗且卒中风险高。所有患者均采用Wingspan支架系统治疗。
技术成功率为100%,所有目标病变均缩小至<50%。30天时未观察到卒中或死亡。支架置入后狭窄平均百分比从中值84%降至中值17%。中位随访时间为19.5个月(范围6 - 36个月)。所有患者均未发生卒中或死亡。随访时无患者出现支架通畅率<50%的情况。
短期结果和随访分析提供了证据,证明Wingspan系统用于高危患者人群时的安全性。由于诸如SAMMPRIS等临床试验中出现了对长期支架通畅性和缺血事件发生的担忧,颅内血管成形术和使用Wingspan系统的支架仅应考虑用于可能被认为是唯一可行治疗选择的高危患者。