PCSK9抑制剂在颅内外动脉粥样硬化性狭窄患者支架植入术前应用的临床价值

Clinical Value of Application of PCSK9 Inhibitors before PTAS in the Patients with Intracranial and Extracranial Atherosclerotic Stenosis

摘要: 目的：探究颅内外动脉粥样硬化性狭窄患者经皮颅内外支架植入术前加用PCSK9抑制剂对血脂水平、支架内再狭窄发生率及缺血性卒中发生或复发率的影响。方法：本研究收集了自2023年6月至2024年7月在包头市中心医院住院治疗并符合入排标准的患者115例。根据治疗方法不同分为阿利西尤单抗联合阿托伐他汀治疗组60例(阿利西尤单抗治疗组)和单纯阿托伐他汀治疗组55例(阿托伐他汀治疗组)。收集两组患者的一般基线资料、手术情况及围手术期并发症、术后影像资料及化验等。结果：(1) 术后30天和180天阿利西尤单抗治疗组的LDL-C水平明显低于单纯阿托伐他汀治疗组，有统计学差异(P < 0.05)；阿利西尤单抗治疗组在术后30天和180天LDL-C达标率均显著高于单纯阿托伐他汀治疗组，有统计学差异(P < 0.05)。(2) 两组共有11例在术后180天出现支架内再狭窄(In-Stent Restenosis, ISR)，阿利西尤单抗治疗组ISR发生率明显低于单纯阿托伐他汀治疗组(3.33%比16.36%，P = 0.040)，比较有统计学差异(P < 0.05)。(3) 两组共有5例患者在术后7~180天出现缺血性卒中，阿利西尤单抗治疗组缺血性卒中发生率低于阿托伐他汀治疗组(1.67%比7.27%，P = 0.310)，比较无统计学差异(P > 0.05)。(4) 两组患者术后7~180天均未发生出血性卒中；两组患者手术成功率均为100%；两组患者围手术期并发症发生率比较无统计学差异(P > 0.05)。(5) 糖尿病、吸烟史、术后即刻靶血管狭窄程度 > 30%是ISR的危险因素，注射阿利西尤单抗是ISR的保护因素(P < 0.05)。结论：颅内外动脉粥样硬化性狭窄患者接受血管内支架成形术前，在他汀类药物治疗的基础上联合阿利西尤单抗能够短期内迅速降低LDL-C水平并达标，能够显著降低术后180天ISR发生率。本研究目前不能证明在他汀类药物治疗的基础上联合阿利西尤单抗能够降低IS事件的发生率。

Abstract: Objective: To investigate the effects of adding PCSK9 inhibitors before percutaneous intracranial and extracranial stent implantation in patients with atherosclerotic stenosis on lipid levels, in-stent restenosis (ISR) incidence, and the occurrence or recurrence rate of ischemic stroke. Methods: This study enrolled 115 patients hospitalized at Baotou Central Hospital from June 2023 to July 2024 who met the inclusion criteria. Based on treatment methods, they were divided into two groups: The alirocumab combined with atorvastatin group (60 cases, alirocumab group) and the atorvastatin-alone group (55 cases, atorvastatin group). General baseline data, surgical details, perioperative complications, postoperative imaging, and laboratory results were collected for both groups. Results: (1) At 30 and 180 days postoperatively, LDL-C levels in the alirocumab group were significantly lower than those in the atorvastatin-alone group (P < 0.05). In terms of LDL-C < 1.4 mmol/L, the alirocumab treatment group was significantly higher than the atorvastatin treatment group at 30 days and 180 days postoperatively (P < 0.05). (2) A total of 11 cases developed ISR within 180 days postoperatively. The ISR incidence in the alirocumab group was significantly lower than in the atorvastatin-alone group (3.33% vs. 16.36%, P = 0.040), showing statistical significance (P < 0.05). (3) Five patients experienced ischemic stroke between 7 and 180 days postoperatively. The incidence in the alirocumab group was lower than in the atorvastatin group (1.67% vs. 7.27%, P = 0.310), but the difference was not statistically significant (P > 0.05). (4) No hemorrhagic strokes occurred in either group between 7 and 180 days postoperatively. The surgical success rate was 100% in both groups, and there was no significant difference in perioperative complication rates (P > 0.05). (5) Diabetes, smoking history, and immediate postoperative target vessel stenosis > 30% were risk factors for ISR, while alirocumab injection was a protective factor (P < 0.05). Conclusion: In patients with intracranial and extracranial atherosclerotic stenosis undergoing endovascular stenting, adding alirocumab to statin therapy rapidly reduced LDL-C levels to target ranges in the short term and significantly decreased the 180-day ISR incidence. However, this study did not demonstrate that combining alirocumab with statins reduces the incidence of ischemic stroke events.