Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
China National Clinical Research Center for Neurological Diseases, Beijing, China.
JAMA Netw Open. 2024 Aug 1;7(8):e2430820. doi: 10.1001/jamanetworkopen.2024.30820.
The China Antihypertensive Trial in Acute Ischemic Stroke II (CATIS-2) suggests that early antihypertensive treatment did not reduce the risk of dependency or death in acute ischemic stroke (AIS), compared with delayed treatment. Single subcortical infarction (SSI) is an important stroke subtype, and the association of antihypertensive timing with clinical outcomes is unclear.
To investigate the association of early vs delayed antihypertensive treatment with clinical outcomes in patients with SSI, stratified by the presence of parent artery disease (PAD) stenosis.
DESIGN, SETTING, AND PARTICIPANTS: This secondary analysis of the CATIS-2 randomized clinical trial included 106 hospitals in China between June 2018 and July 2022. In CATIS-2, patients with AIS within 24 to 48 hours of symptoms onset and elevated systolic blood pressure were eligible. Patients with SSI detected in diffusion-weighted imaging were included in the current post hoc subgroup analysis. Patients were grouped into (1) SSI with PAD stenosis and (2) SSI without PAD stenosis. Statistical analysis was performed from July 2023 to May 2024.
Early (immediate) vs delayed (starting on day 8) antihypertensive therapy.
Primary outcome was the combination of functional dependency or death (modified Rankin Scale score ≥3) at 90 days.
Among 997 patients with SSI in CATIS-2 (mean [SD] age, 62.4 [9.8] years; 612 [61.4%] men), 116 (11.6%) had SSI with PAD and 881 (88.4%) had SSI without PAD. There was no significant difference in the primary outcome between early and delayed antihypertensive treatment groups among all patients with SSI (8.8% vs 7.1%; OR, 1.25 [95% CI, 0.79-1.99]; P = .34). Among patients with SSI with PAD, early antihypertensive treatment was associated with increased risk of the primary outcome compared with delayed treatment (23.4% vs 7.7%; OR, 3.67 [95% CI, 1.14-11.86]; P = .03); this finding was not observed in patients with SSI without PAD (6.6% vs 7.1%; OR, 0.93 [95% CI, 0.55-1.57]; P = .77). Significant interaction with treatment and presence of PAD stenosis was detected for the primary outcome (P for interaction = .04).
In this secondary analysis of a randomized clinical trial, early antihypertensive treatment was associated with an increased risk of functional dependency or death at 90 days among patients with SSI and coexisting PAD stenosis, compared with delayed antihypertensive treatment. Further studies are warranted for individualized BP management in patients with SSI by the presence of PAD.
ClinicalTrials.gov Identifier: NCT03479554.
中国急性缺血性脑卒中降压试验 II 期（CATIS-2）表明，与延迟治疗相比，急性缺血性脑卒中（AIS）患者的早期降压治疗并未降低依赖或死亡的风险。单一皮质下梗死（SSI）是一种重要的脑卒中亚型，降压时机与临床结局的关联尚不清楚。
研究在 CATIS-2 随机临床试验中，根据有无大动脉粥样硬化性狭窄（PAD），早期与延迟降压治疗与 SSI 患者临床结局的关系。
设计、地点和参与者：这是 CATIS-2 随机临床试验的二次分析，纳入了 2018 年 6 月至 2022 年 7 月中国的 106 家医院。在 CATIS-2 中，入选的患者为 AIS 发病后 24 至 48 小时且收缩压升高的患者。当前的事后亚组分析纳入了在弥散加权成像中发现 SSI 的患者。将患者分为（1）存在 PAD 狭窄的 SSI 和（2）不存在 PAD 狭窄的 SSI。统计分析于 2023 年 7 月至 2024 年 5 月进行。
早期（即刻）与延迟（第 8 天开始）降压治疗。
主要结局是 90 天时功能依赖或死亡（改良 Rankin 量表评分≥3）的联合。
在 CATIS-2 中，997 例 SSI 患者中（平均[标准差]年龄 62.4[9.8]岁；612 例[61.4%]为男性），116 例（11.6%）存在 PAD 狭窄的 SSI，881 例（88.4%）不存在 PAD 狭窄的 SSI。所有 SSI 患者中，早期与延迟降压治疗组的主要结局无显著差异（8.8% vs 7.1%；OR，1.25[95%CI，0.79-1.99]；P=0.34）。在存在 PAD 的 SSI 患者中，与延迟降压治疗相比，早期降压治疗与更高的主要结局风险相关（23.4% vs 7.7%；OR，3.67[95%CI，1.14-11.86]；P=0.03）；而在不存在 PAD 的 SSI 患者中，这两组之间无显著差异（6.6% vs 7.1%；OR，0.93[95%CI，0.55-1.57]；P=0.77）。对主要结局进行治疗与 PAD 狭窄的交互检验，发现存在显著交互作用（P 交互=0.04）。
在这项随机临床试验的二次分析中，与延迟降压治疗相比，在存在 PAD 狭窄的 SSI 患者中，早期降压治疗与 90 天时的功能依赖性或死亡风险增加相关。需要进一步研究以确定 PAD 存在时 SSI 患者的个体化血压管理。
ClinicalTrials.gov 标识符：NCT03479554。
