Resolute Onyx 支架治疗症状性颅内狭窄的 30 天结局：与颅内狭窄患者接受支架置入术与强化药物治疗预防卒中复发试验的多中心倾向评分匹配比较。
Thirty-Day Outcomes of Resolute Onyx Stent for Symptomatic Intracranial Stenosis: A Multicenter Propensity Score-Matched Comparison With Stenting Versus Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis Trial.
机构信息
Department of Neurosurgery, University of Missouri, Columbia, Missouri, USA.
Medical University of South Carolina, Charleston, South Carolina, USA.
出版信息
Neurosurgery. 2023 Jun 1;92(6):1155-1162. doi: 10.1227/neu.0000000000002338. Epub 2023 Jan 9.
BACKGROUND
Symptomatic intracranial atherosclerotic disease (sICAD) is estimated to cause 10% of strokes annually in the United States. However, treatment remains a challenge with several different stenting options studied in the past with unfavorable results.
OBJECTIVE
To report the 30-day stroke and/or death rate associated with intracranial stent placement for sICAD using Resolute Onyx Zotarolimus-Eluting Stent (RO-ZES) and provide a comparison with the results of Stenting Versus Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) trial.
METHODS
Prospectively maintained databases across 8 stroke centers were used to identify adult patients treated with RO-ZES for sICAD between January 2019 and December 2021. Primary end point was composite of 30-day stroke, intracerebral hemorrhage, and/or death. Propensity score matching was performed using age, hypertension, lipid disorder, cigarette smoking, and symptomatic target vessel to create a matched group for comparison between RO-ZES and the SAMMPRIS medical management and treatment groups (SAMMPRIS percutaneous angioplasty and stenting [S-PTAS]).
RESULTS
A total of 132 patients met the inclusion criteria for analysis (mean age: 64.2 years). Mean severity of stenosis was 81.4% (±11.4%). A total of 4 (3.03%) stroke and/or deaths were reported within 30 days of treatment in the RO-ZES group compared with 6.6% in the SAMMPRIS medical management group (OR [odds ratio] 2.26, 95% CI 0.7-9.56, P = .22) and 15.6% in the S-PTAS group (OR 5.9, 95% CI 2.04-23.4, P < .001). Propensity score match analysis of 115 patients in each group demonstrated 30-day stroke and/or death rate of 2.6% in the RO-ZES group and 15.6% in the S-PTAS group (OR 6.88, 95% CI 1.92-37.54, P < .001).
CONCLUSION
Patients treated with RO-ZES had a relatively low 30-day stroke and/or death rate compared with the S-PTAS group. Further large-scale prospective studies are warranted to evaluate the safety and efficacy of RO-ZES for the treatment of sICAD.
背景
据估计，在美国，症状性颅内动脉粥样硬化性疾病（sICAD）每年导致 10%的中风。然而，由于过去研究过几种不同的支架置入治疗方法，结果并不理想，因此治疗仍然是一个挑战。
目的
报告使用 Resolute Onyx Zotarolimus-Eluting Stent（RO-ZES）治疗 sICAD 的颅内支架置入术后 30 天内的中风和/或死亡率，并与 Stenting Versus Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis（SAMMPRIS）试验的结果进行比较。
方法
使用 8 个卒中中心的前瞻性维护数据库，确定 2019 年 1 月至 2021 年 12 月期间接受 RO-ZES 治疗 sICAD 的成年患者。主要终点是 30 天内中风、颅内出血和/或死亡的复合事件。使用年龄、高血压、血脂异常、吸烟和症状性靶血管进行倾向评分匹配，创建一个匹配组，以比较 RO-ZES 与 SAMMPRIS 药物治疗和治疗组（SAMMPRIS 经皮血管成形术和支架置入术[S-PTAS]）之间的差异。
结果
共 132 例患者符合纳入标准进行分析（平均年龄：64.2 岁）。狭窄程度平均为 81.4%（±11.4%）。RO-ZES 组治疗后 30 天内报告了 4 例（3.03%）中风和/或死亡，而 SAMMPRIS 药物治疗组为 6.6%（OR[比值比]2.26，95%CI0.7-9.56，P=0.22），S-PTAS 组为 15.6%（OR5.9，95%CI2.04-23.4，P<.001）。在每个组的 115 名患者中进行倾向评分匹配分析，RO-ZES 组 30 天内的中风和/或死亡率为 2.6%，S-PTAS 组为 15.6%（OR6.88，95%CI1.92-37.54，P<.001）。
结论
与 S-PTAS 组相比，接受 RO-ZES 治疗的患者 30 天内的中风和/或死亡率相对较低。需要进一步进行大规模前瞻性研究，以评估 RO-ZES 治疗 sICAD 的安全性和有效性。
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