Clinical Research Center for Medicine, International University of Health and Welfare, Center for Brain and Cerebral Vessels, Sanno Medical Center, Tokyo, Japan.
Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan.
Int J Stroke. 2023 Apr;18(4):426-432. doi: 10.1177/17474930221112343. Epub 2022 Jul 21.
We previously reported that dual antiplatelet therapy (DAPT) with cilostazol was superior to aspirin or clopidogrel for the prevention of recurrent stroke and vascular events in a subgroup analysis of intracranial arterial stenosis in the Cilostazol Stroke Prevention Study for Antiplatelet Combination (CSPS.com), a randomized controlled trial.
We conducted another subgroup analysis to investigate the benefit of DAPT with cilostazol in patients with extracranial arterial stenosis (ECAS) and those without arterial stenosis.
We compared the risk of recurrent ischemic stroke, vascular events, and major bleeding between DAPT with cilostazol plus aspirin or clopidogrel and aspirin or clopidogrel alone in patients with ischemic stroke between 8 and 180 days before starting trial treatment and ECAS or without arterial stenosis.
The median follow-up period was 1.4 years. The risk of recurrent ischemic stroke (hazard ratio (HR): 1.04, 95% confidence interval (CI): 0.42-2.57) and vascular events (HR: 0.97, 95% CI: 0.42-2.24) did not differ between the two groups for the 253 patients with ECAS, whereas they were lower (HR: 0.36, 95% CI: 0.18-0.74 and HR: 0.47, 95% CI: 0.26-0.85, respectively) in the DAPT group for the 944 patients without arterial stenosis. The risk of major bleeding did not differ between the groups in patients with ECAS (HR: 0.58, 95% CI: 0.05-6.39) or without arterial stenosis (HR: 0.79, 95% CI: 0.27-2.26).
DAPT with cilostazol might be beneficial for prevention of recurrent stroke and vascular events in patients without arterial stenosis but not in those with ECAS.
We will make the deidentified participant data from this research available to the scientific community with as few restrictions as feasible, while retaining exclusive use until the publication of major output.
我们之前报道过,在 Cilostazol Stroke Prevention Study for Antiplatelet Combination(CSPS.com)的一项颅内动脉狭窄亚组分析中,与阿司匹林或氯吡格雷相比,西洛他唑双联抗血小板治疗(DAPT)在预防复发性卒中和血管事件方面更具优势,这是一项随机对照试验。
我们进行了另一项亚组分析,以研究西洛他唑 DAPT 在颅外动脉狭窄(ECAS)患者和无动脉狭窄患者中的获益。
我们比较了在开始试验治疗前 8 至 180 天内发生缺血性卒中和 ECAS 或无动脉狭窄的患者中,西洛他唑 DAPT 联合阿司匹林或氯吡格雷与阿司匹林或氯吡格雷单独治疗的复发性缺血性卒中和血管事件以及大出血的风险。
中位随访时间为 1.4 年。在 253 例 ECAS 患者中,两组之间复发性缺血性卒中和血管事件的风险无差异(风险比(HR):1.04,95%置信区间(CI):0.42-2.57 和 HR:0.97,95%CI:0.42-2.24),而在 944 例无动脉狭窄的患者中,DAPT 组的风险较低(HR:0.36,95%CI:0.18-0.74 和 HR:0.47,95%CI:0.26-0.85)。在有 ECAS 的患者(HR:0.58,95%CI:0.05-6.39)或无动脉狭窄的患者(HR:0.79,95%CI:0.27-2.26)中,两组之间大出血的风险无差异。
西洛他唑 DAPT 可能有益于预防无动脉狭窄患者的复发性卒中和血管事件,但对 ECAS 患者无益。
我们将以尽可能少的限制向科学界提供本研究的去标识化参与者数据,同时在发表主要结果之前保留独家使用权。