Randomized Controlled Trial of Cilostazol Addition for In-Stent Restenosis After Carotid Artery Stenting.

IF 7.8 1区医学 Q1 CLINICAL NEUROLOGY

Stroke Pub Date : 2024-12-01 Epub Date: 2024-11-25 DOI:10.1161/STROKEAHA.124.047210

Hiroshi Yamagami, Tomohiko Ozaki, Kuniaki Ogasawara, Izumi Nagata, Yuji Matsumaru, Shinichi Yoshimura, Makoto Sasaki, Kazuyuki Nagatsuka, Kazuo Minematsu, Yoji Nagai, Chiaki Sakai, Yasushi Matsumoto, Masayuki Ezura, Hideyuki Ishihara, Nobuyuki Sakai

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引用次数: 0

Abstract

Background: Restenosis after carotid artery stenting (CAS) is associated with the risk of developing ischemic stroke. We aimed to evaluate the inhibitory effect of cilostazol addition on in-stent restenosis (ISR) in patients treated with CAS.

Methods: In a randomized, open-label, blind-end point trial, patients with symptomatic and asymptomatic carotid artery stenosis and scheduled for CAS were randomly assigned to adding cilostazol (50 or 100 mg, twice per day) on other antiplatelets from 3 days before CAS or not adding cilostazol. Concomitant use of other antiplatelets was unrestricted. ISR was diagnosed by a peak systolic velocity of at least 1.75 m/s on duplex ultrasonography. The primary outcome was incidence of ISR within 2 years after CAS. Secondary outcomes included occurrences of cardiovascular events or any death and hemorrhagic events.

Results: Participants were recruited from December 2010 to September 2015. Although the sample size was initially set to be 900 (450 in each group), 631 patients (mean age 69.9 years, 558 men, 325 in the cilostazol, and 306 in the noncilostazol group) were included in the primary analysis. Within 2 years' follow-up, ISR occurred in 31 of 325 patients (cumulative incidence 10.8%) in the cilostazol group and 46 of 306 patients (19.6%) in the noncilostazol group (hazard ratio, 0.64 [95% CI, 0.41-1.0]; P=0.056). In the exploratory analysis, incidence of ISR beyond 30 days after CAS was lower in the cilostazol group than in the noncilostazol group (10.3% versus 19.3%; P=0.040). Incidences of cardiovascular events or any death and hemorrhagic events were similar between the groups (6.2% versus 6.7% and 2.3% versus 1.4%, respectively).

Conclusions: The addition of cilostazol to other antiplatelet agents could contribute to the reduction of ISR in the chronic stage of patients who underwent CAS, the authenticity of which depends on further studies with sufficient statistical power.

Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01261234.

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添加西洛他唑治疗颈动脉支架术后支架内再狭窄的随机对照试验

背景：颈动脉支架置入术（CAS）后的再狭窄与缺血性卒中的发病风险有关。我们旨在评估添加西洛他唑对接受 CAS 治疗的患者支架内再狭窄（ISR）的抑制作用：在一项随机、开放标签、盲端点试验中，计划接受 CAS 的有症状和无症状颈动脉狭窄患者被随机分配到在 CAS 前 3 天起在其他抗血小板药物基础上加用西洛他唑（50 或 100 毫克，每天两次）或不加用西洛他唑。同时使用其他抗血小板药物不受限制。ISR的诊断标准是双相超声波检查的收缩压峰值速度至少达到1.75 m/s。主要结果是 CAS 术后 2 年内的 ISR 发生率。次要结果包括心血管事件或任何死亡和出血事件的发生率：参与者招募时间为 2010 年 12 月至 2015 年 9 月。尽管样本量最初设定为900人（每组450人），但631名患者（平均年龄69.9岁，558名男性，西洛他唑组325人，非西洛他唑组306人）被纳入主要分析。在 2 年的随访中，西洛他唑组 325 例患者中有 31 例（累计发生率为 10.8%）发生了 ISR，非西洛他唑组 306 例患者中有 46 例（19.6%）发生了 ISR（危险比为 0.64 [95% CI, 0.41-1.0]；P=0.056）。在探索性分析中，西洛他唑组 CAS 后 30 天后 ISR 的发生率低于非西洛他唑组（10.3% 对 19.3%；P=0.040）。两组心血管事件或任何死亡和出血事件的发生率相似（分别为6.2%对6.7%和2.3%对1.4%）：结论：在其他抗血小板药物的基础上加用西洛他唑有助于减少CAS患者慢性期的ISR，但其真实性取决于是否有足够的统计能力进行进一步的研究：URL：https://www.clinicaltrials.gov；唯一标识符：NCT01261234。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Stroke 医学-临床神经学

CiteScore

13.40

自引率

6.00%

发文量

2021

审稿时长

3 months

期刊介绍： Stroke is a monthly publication that collates reports of clinical and basic investigation of any aspect of the cerebral circulation and its diseases. The publication covers a wide range of disciplines including anesthesiology, critical care medicine, epidemiology, internal medicine, neurology, neuro-ophthalmology, neuropathology, neuropsychology, neurosurgery, nuclear medicine, nursing, radiology, rehabilitation, speech pathology, vascular physiology, and vascular surgery. The audience of Stroke includes neurologists, basic scientists, cardiologists, vascular surgeons, internists, interventionalists, neurosurgeons, nurses, and physiatrists. Stroke is indexed in Biological Abstracts, BIOSIS, CAB Abstracts, Chemical Abstracts, CINAHL, Current Contents, Embase, MEDLINE, and Science Citation Index Expanded.