背景:无症状颈动脉狭窄(ACAS)患者的颈动脉内膜切除术(CEA)仍然是一个有争议的话题。目前的建议是基于20多年前进行的随机试验,药物治疗的改进可能降低了脑缺血事件(CIE)的风险。本研究对ACAS患者正在进行的前瞻性观察研究的结果进行中期分析,以评估其在现实世界中的CIE风险。
方法:这是一项前瞻性观察性队列研究,研究对象为ACAS>60%(NASCET标准)患者,该患者在单一双工超声(DUS)血管实验室(试验注册:NCT04825080)中进行。由于患者的预期寿命较短(<3年)或没有斑块易损性的迹象(溃疡,回声核心)。患者招募于2019年1月开始,并于2020年3月结束,目标样本量为300名患者。计划进行为期5年的随访。临床特征,危险因素,医学疗法被记录在案,and,必要时,最好的药物治疗(BMT),涉及抗血小板药物,血压控制,和他汀类药物,在临床就诊时推荐。主要终点是评估CIEs(包括中风,短暂性脑缺血发作,Am-fugax)与ACAS同侧斑块进展率和患者生存率。随访包括年度临床访视和颈动脉DUS检查,辅之以每隔六个月的电话采访。
结果:该研究包括307名患者,平均年龄为80±7岁,其中55%是男性。61例(20%)患者存在超过60%的对侧狭窄。77%的患者接受BMT。平均随访41±9个月,发生7次侧向中风和9次TIA,导致14CIEs(2例患者同时出现TIA和卒中)。根据Kaplan-Meier分析,4年CIE率为6±2%,年CIE率为1.5%。与稳定斑块患者相比,58例(19%)患者的狭窄进展与较高的4年估计CIE率相关(10.3%vs3.2%,P=0.01)。同样,对侧颈动脉狭窄>60%与较高的4年估计CIE率相关:11.7%vs2.9%,P=.002。在多因素COX分析中,这些因素与CIE的高风险独立相关:危险比(HR):3.2;95%置信区间:1.1-9.2和HR:3.6;95%CI:1.2-10.5。
结论:这项前瞻性研究的中期结果表明,CIE在ACAS患者中的发生率不可低估,斑块进展和对侧狭窄是CIEs的主要预测因子。
BACKGROUND: Carotid endarterectomy (CEA) in patients with asymptomatic carotid stenosis (ACAS) remains a subject of debate. Current recommendations are based on randomized trials conducted over 20 years ago and improvements in medical therapies may have reduced the risk of cerebral ischemic events (CIE). This
study presents a mid-term analysis of results from an ongoing prospective observational
study of ACAS patients to assess their CIE risk in a real-world setting.
METHODS: This is a prospective observational cohort
study of patients with ACAS >60 % (NASCET criteria) identified in a single duplex ultrasonography (DUS) vascular laboratory (
trial registered: NCT04825080). Patients were not considered for CEA due to their short life expectancy (<3 year) or absence of signs of plaque vulnerability (ulceration, ipoechogenic core). Patient enrollment started in January 2019 and ended in March 2020 with a targeted sample size of 300 patients.A 5-year follow-up was scheduled. Clinical characteristics, risk factors, and medical therapies were documented, and, when necessary, the best medical therapy (BMT), involving antiplatelet agents, blood pressure control, and statins, was recommended during clinical visits. The primary endpoint was to asses CIEs (including strokes, transient ischemic attacks, amaurosis-fugax) ipsilateral to ACAS along with plaque progression rate and patients survival. Follow-up involved annual clinical visit and carotid DUS examination, complemented by telephone interviews at six-month intervals.
RESULTS: The
study included 307 patients, with an average age of 80 ± 7 years, of whom 55 % were male. Contralateral stenosis exceeding 60 % was present in 61 (20 %) patients. Seventy-seven percent of patients were on BMT. At a mean follow-up of 41±9 months, 7 ispilateral strokes and 9 TIAs occurred, resulting in 14 CIEs (2 patients experienced both TIA and stroke). According to Kaplan-Meier analysis, the 4-year CIE rate was 6±2 %, with an annual CIE rate of 1.5 %. Fifty-eight (19 %) patients had a stenosis progression which was associated with a higher 4-year estimated CIE rate compared to patients with stable plaque (10.3 % vs 3.2 %, P=.01). Similarly, a contralateral carotid stenosis >60 % was associated with a higher 4-year estimated CIE rate: 11.7 % vs 2.9 %, P=.002. These factors were independently associated with high risk for CIE at the multivariate COX analysis: Hazard Ratio (HR): 3.2; 95 % Confidence Interval: 1.1-9.2 and HR: 3.6; 95 % CI: 1.2-10.5.
CONCLUSIONS: The mid-term results of this prospective
study suggest that the incidence of CIE in ACAS patients should not be underestimated, with plaque progression and contralateral stenosis serving as primary predictors of CIEs.