Supplementary Material for: Treatment strategies and prognosis for moderate stroke patients in China

Introduction: Moderate stroke patients with National Institutes of Health Stroke Scale (NIHSS) score of 4–10 and without intravenous thrombolysis or endovascular treatment are basically excluded from current secondary prevention trials. We aimed to explore the effectiveness of mono- vs. dual-antiplatelet (DAPT) treatment strategies against subsequent stroke for these patients in a nationwide cohort.
Methods: Data were derived from the Third China National Stroke Registry (CNSR-Ш). In this prospective nationwide cohort, moderate ischemic stroke patients with NIHSS 4–10 and without intravenous thrombolysis or endovascular treatment were included and categorized into mono- or dual-antiplatelet groups. Demographics, medical history, NIHSS score, imaging and laboratory data were collected. The outcomes were stroke recurrence and all-cause mortality at 3 months and at 1 year, respectively. Cox proportional-hazards models were utilized to investigate the association of treatment strategies and prognosis.
Results: Of a total of 2 414 patients enrolled in the study, 1 633 (67.6%) received clopidogrel or aspirin and 781 (32.4%) received DAPT. Recurrent stroke occurred in 108 (6.6%) patients of the mono-antiplatelt group and 40 (5.1%) patients of the DAPT group ( adjusted hazard ratio [aHR] 0.73, 95% confidential interval [CI] 0.47-1.13, P=0.16) at 3 months, and the rate of stroke recurrence was 10.7% in the mono-antiplatelet group and 8.6% in the DAPT group ( aHR 0.81, 95% CI 0.58-1.13, P=0.22) at 12 months. The DAPT paradigm was not significantly associated with death at 3 months (0.6% vs 0.3%, a HR 0.28, 95%CI 0.04-2.25) but significantly reduced the mortality at 12 months (2.3% vs 1.0%, aHR 0.41, 95% CI 0.17-0.98, P=0.046).
Conclusions: In moderate stroke patients presenting within 24 hours of symptom onset, the addition of clopidogrel 75 mg to aspirin might not be associated with lower risk of recurrent stroke than aspirin or clopidogrel alone.

引言：本项研究针对美国国立卫生研究院卒中量表（NIHSS）评分为4-10分的轻度卒中患者，这些患者未接受静脉溶栓或血管内治疗，基本被排除在当前的二级预防临床试验之外。本研究旨在探索对于此类患者，单抗血小板治疗与双抗血小板治疗（DAPT）策略在预防后续卒中方面的有效性，研究数据来源于第三届中国国家卒中登记系统（CNSR-Ш）。在该项前瞻性全国性队列研究中，纳入了NIHSS评分为4-10分的轻度缺血性卒中患者，且未接受静脉溶栓或血管内治疗，并将患者分为单抗血小板治疗组和双抗血小板治疗组。收集了患者的基线人口统计学、病史、NIHSS评分、影像学和实验室数据。研究终点为3个月和1年时的卒中复发率和全因死亡率。利用Cox比例风险模型探讨了治疗策略与预后的关联。结果：在总共2414名入组的患者中，1633名（67.6%）患者接受了氯吡格雷或阿司匹林治疗，781名（32.4%）患者接受了DAPT治疗。在单抗血小板治疗组中，3个月时卒中复发发生率为6.6%（108/1633），在DAPT治疗组中为5.1%（40/781）（调整后的风险比[aHR] 0.73，95%置信区间[CI] 0.47-1.13，P=0.16）；在12个月时，单抗血小板治疗组的卒中复发率为10.7%，而DAPT治疗组为8.6%（aHR 0.81，95% CI 0.58-1.13，P=0.22）。DAPT治疗模式与3个月时的死亡率无显著关联（0.6% vs 0.3%，aHR 0.28，95% CI 0.04-2.25），但显著降低了12个月时的死亡率（2.3% vs 1.0%，aHR 0.41，95% CI 0.17-0.98，P=0.046）。结论：对于症状发作后24小时内就诊的轻度卒中患者，将氯吡格雷75mg添加至阿司匹林治疗可能并不会降低复发卒中的风险，与单独使用阿司匹林或氯吡格雷相比。