小后循环缺血性卒中的PCISOS风险分布分层异质性结果:CHANCE-2试验的事后分析

IF 8.9 1区 医学 Q1 CLINICAL NEUROLOGY
Xiaoyu Lin, Cang Guo, Xia Meng, Xingquan Zhao, Hao Li, Yongjun Wang, Jialei Yang
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引用次数: 0

摘要

背景:后循环缺血性卒中(PCIS)的风险分层具有挑战性。尽管后循环缺血性卒中结局评分(PCISOS)是为了解决这一问题而开发的,但其在轻度PCIS中的应用以及在临床试验或治疗反应亚组中识别同质人群的应用仍不确定。方法:CHANCE-2(氯吡格雷在高风险急性非致残性脑血管事件患者中的应用)是一项多中心随机试验,纳入了携带CYP2C19功能缺失等位基因的轻度卒中或高风险短暂性脑缺血发作患者。患者接受替格瑞-阿司匹林或氯吡格雷-阿司匹林治疗。该次要分析纳入了PCIS患者,根据PCISOS分为低(≤15)、中(16-20)和高风险(≥21)组。主要终点为90天卒中复发率。使用Cox和逻辑回归模型分析结果,调整与每个比较相关的显著不平衡基线协变量。结果:1379例PCIS患者(中位年龄64.0[56.6-70.7]岁,男性67.4%)中,低、中、高危PCISOS组90天卒中复发率分别为6.0%、8.2%、18.5% (PPtrend=0.008)。修改后的Rankin量表(mRS)评分在2 ~ 6个结局中也观察到类似的关联(中危校正比值比为2.21 [95% CI, 1.28-3.84];高危校正比值比为3.53 [95% CI, 1.42-8.74]; PtrendPinteraction=0.03)。PCISOS≤15的患者较美国国立卫生研究院卒中量表评分≤3的患者预后较好(改良Rankin量表评分0-1)(P=0.02)。结论:PCISOS为轻度PCIS提供了有效的风险分层,确定了具有异质性结局风险和对替格瑞洛-阿司匹林不同反应的亚组。PCISOS≥21的患者是美国国立卫生研究院卒中量表定义的轻度卒中的高危亚组,但仍未被充分研究,未来的试验可能会从量身定制的策略中受益。与美国国立卫生研究院卒中量表评分≤3相比,PCISOS≤15的阈值可以更准确地定义真正的低危患者,从而提高PCIS研究的试验效率和精度。注册:网址:https://www.clinicaltrials.gov;唯一标识符:NCT04078737。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
PCISOS Risk Profiles Stratify Heterogeneous Outcomes in Minor Posterior Circulation Ischemic Stroke: A Post Hoc Analysis of the CHANCE-2 Trial.

Background: Risk stratification in posterior circulation ischemic stroke (PCIS) is challenging. Although the Posterior Circulation Ischemic Stroke Outcome Score (PCISOS) was developed to address this, its utility in minor PCIS and in identifying homogeneous populations for clinical trials or treatment-responsive subgroups remains uncertain.

Methods: CHANCE-2 (Clopidogrel in High-Risk Patients With Acute Non-disabling Cerebrovascular Events-II) was a multicenter, randomized trial that enrolled patients with minor stroke or high-risk transient ischemic attack who carried CYP2C19 loss-of-function alleles. Patients received ticagrelor-aspirin or clopidogrel-aspirin. This secondary analysis included patients with PCIS, stratified into low- (≤15), intermediate- (16-20), and high-risk (≥21) groups based on PCISOS. The primary outcome was 90-day stroke recurrence. Outcomes were analyzed using Cox and logistic regression models, adjusting for significantly imbalanced baseline covariates relevant to each comparison.

Results: Among 1379 patients with PCIS (median age, 64.0 [56.6-70.7] years; 67.4% male), 90-day stroke recurrence occurred in 6.0%, 8.2%, and 18.5% of the low-, intermediate-, and high-risk PCISOS groups, respectively (P<0.001). Risk increased progressively (adjusted hazard ratios for intermediate-risk, 1.32 [95% CI, 0.87-2.02]; high-risk, adjusted hazard ratio, 3.02 [95% CI, 1.52-6.02]; Ptrend=0.008). Similar associations were observed for modified Rankin Scale (mRS) score of 2 to 6 outcomes (adjusted odds ratio for intermediate-risk, 2.21 [95% CI, 1.28-3.84]; high-risk, 3.53 [95% CI, 1.42-8.74]; Ptrend<0.001). A treatment-by-risk interaction was observed: ticagrelor-aspirin reduced the modified Rankin Scale score of 1 to 6 rates in low- and intermediate-risk patients, but not in high-risk patients (Pinteraction=0.03). Favorable outcome (modified Rankin Scale score of 0-1) was more common in patients with PCISOS ≤15 than in those with National Institutes of Health Stroke Scale score ≤3 (P=0.02).

Conclusions: PCISOS provides effective risk stratification in minor PCIS, identifying subgroups with heterogeneous outcome risks and differential response to ticagrelor-aspirin. Patients with PCISOS ≥21, a high-risk subgroup within National Institutes of Health Stroke Scale-defined minor strokes, remain underexplored and may benefit from tailored strategies in future trials. A threshold of PCISOS ≤15 may more accurately define truly low-risk patients than National Institutes of Health Stroke Scale score ≤3, thereby improving trial efficiency and advancing precision in PCIS research.

Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04078737.

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来源期刊
Stroke
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.
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