Stroke Center & Department of Neurology, Division of Life Sciences and Medicine, the First Affiliated Hospital of USTC, University of Science and Technology of China, Hefei, Anhui, China.
Department of Pathology, The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China.
BMC Neurol. 2021 Jun 24;21(1):237. doi: 10.1186/s12883-021-02268-8.
Studies have suggested that glycoprotein IIb/IIIa antagonists such as tirofiban are beneficial for patients with acute coronary syndromes. However, it is still uncertain about the efficacy and safety of tirofiban in patients with acute ischemic stroke (AIS).
In this prospective non-randomized study, 255 AIS patients were recruited from 4 comprehensive stroke centers in China between January, 2017 and May, 2018. Among them,169 patients were treated with aspirin plus clopidogrel and 86 patients were treated with tirofiban. The primary functional outcome was the distribution of the 90 days' modified Rankin Scale (mRS). The safety outcomes included the incidence of intracranial hemorrhage (ICH) at discharge and mortality at 3 months.
In the propensity score matched cohort, tirofiban alone was noninferior to the dual antiplatelet with regard to the primary outcome (adjusted common odds ratio, 0.97; 95% confidence interval, 0.46 to 2.04; P = 0.93). Mortality at 90 days was 10% in the dual antiplatelet group and 8% in the tirofiban group (adjusted odds ratio 0.75; 95% CI 0.08 to 7.40, p = 0.81). There was no difference of the ICH rate between two groups (adjusted odds ratio 0.44; 95% CI 0.13 to 1.48, p = 0.18). In the inverse probability of treatment weighting-propensity score-adjusted cohort, similar differences were found for functional and safety outcomes.
Our study suggested that tirofiban use appears to be safe as monotherapy in AIS treatment compared with common dual antiplatelet therapy, however, no improvement in functional outcomes was found.
Chinese clinical trial registry, ChiCTR2000034443 , 05/07/2020. Retrospectively registered.
研究表明，血小板糖蛋白Ⅱb/Ⅲa 拮抗剂（如替罗非班）对急性冠状动脉综合征患者有益。然而，替罗非班在急性缺血性脑卒中（AIS）患者中的疗效和安全性仍不确定。
本前瞻性非随机研究共纳入 2017 年 1 月至 2018 年 5 月中国 4 家综合卒中中心的 255 例 AIS 患者。其中，169 例患者接受阿司匹林联合氯吡格雷治疗，86 例患者接受替罗非班治疗。主要功能结局为 90 天改良 Rankin 量表（mRS）分布。安全性结局包括出院时颅内出血（ICH）发生率和 3 个月时死亡率。
在倾向评分匹配队列中，替罗非班在主要结局方面不劣于双联抗血小板治疗（调整后常见优势比，0.97；95%置信区间，0.46 至 2.04；P=0.93）。双联抗血小板组 90 天死亡率为 10%，替罗非班组为 8%（调整后比值比，0.75；95%CI，0.08 至 7.40，p=0.81）。两组 ICH 发生率无差异（调整后比值比，0.44；95%CI，0.13 至 1.48，p=0.18）。在逆概率治疗加权倾向评分调整队列中，功能和安全性结局也发现了类似的差异。
与常规双联抗血小板治疗相比，替罗非班作为 AIS 治疗的单一疗法似乎是安全的，但功能结局未见改善。
中国临床试验注册中心，ChiCTR2000034443，2020 年 5 月 7 日。回顾性注册。
