Argatroban in Patients With Acute Ischemic Stroke With Early Neurological Deterioration: A Randomized Clinical Trial

Argatroban in Patients With Acute Ischemic Stroke With Early Neurological Deterioration: A Randomized Clinical Trial

February 2024 | Xuting Zhang, MD; Wansi Zhong, MD; Rui Xue, MD; Haidi Jin, MM; Xiaoxian Gong, MD; Yuhui Huang, MD; Fujian Chen, MM; Mozi Chen, MM; Liqun Gu, BD; Yebao Ge, BD; Xiaodong Ma, BD; Bifeng Zhong, BD; Mengjie Wang, MD; Haitao Hu, MD; Zhicai Chen, MD; Shengqiang Yan, MD; Yi Chen, MD; Xin Wang, BD; Xiaoling Zhang, MM; Dongjuan Xu, BD; Yuping He, MM; Minfang Lou, BD; Aiju Wang, BD; Xiong Zhang, MD; Li Ma, BD; Xiaodong Lu, BD; Jianer Wang, BD; Qiong Lou, MM; Ping'an Qian, BD; Guomin Xie, BD; Xiaofen Zhu, BD; Songbin He, MM; Jin Hu, BD; Xiongjie Wen, BD; Yan Liu, MM; Yanwen Wang, MM; Jingjing Fu, MD; Weiniv Fan, BD; David Liebeskind, MD; Changzheng Yuan, MD; Min Lou, MD, PhD
A randomized clinical trial evaluated the efficacy of argatroban in patients with acute ischemic stroke (AIS) and early neurological deterioration (END). The study enrolled 628 patients, with 314 in each group. Participants were randomly assigned to receive argatroban plus standard antiplatelet therapy or standard antiplatelet therapy alone. The primary outcome was a good functional outcome at 90 days, defined as a modified Rankin Scale (mRS) score of 0 to 3. The argatroban group had a higher rate of good functional outcomes (80.5%) compared to the control group (73.3%), with a statistically significant difference (risk difference, 7.2%; 95% CI, 0.6%-14.0%). No significant difference in symptomatic intracranial hemorrhage was observed between the groups (0.9% vs 0.7%). The study found that argatroban combined with antiplatelet therapy improved functional outcomes in patients with AIS and END without increasing the risk of major intracranial or extracranial hemorrhage. The results support the use of argatroban in patients with END. The study was well-designed, with a large sample size and rigorous statistical analysis. However, the study had limitations, including an open-label design and potential bias from crossover patients. The findings suggest that early use of argatroban may be beneficial in patients with AIS and END, but further research is needed to confirm the optimal timing and long-term effects of anticoagulation therapy in this population.A randomized clinical trial evaluated the efficacy of argatroban in patients with acute ischemic stroke (AIS) and early neurological deterioration (END). The study enrolled 628 patients, with 314 in each group. Participants were randomly assigned to receive argatroban plus standard antiplatelet therapy or standard antiplatelet therapy alone. The primary outcome was a good functional outcome at 90 days, defined as a modified Rankin Scale (mRS) score of 0 to 3. The argatroban group had a higher rate of good functional outcomes (80.5%) compared to the control group (73.3%), with a statistically significant difference (risk difference, 7.2%; 95% CI, 0.6%-14.0%). No significant difference in symptomatic intracranial hemorrhage was observed between the groups (0.9% vs 0.7%). The study found that argatroban combined with antiplatelet therapy improved functional outcomes in patients with AIS and END without increasing the risk of major intracranial or extracranial hemorrhage. The results support the use of argatroban in patients with END. The study was well-designed, with a large sample size and rigorous statistical analysis. However, the study had limitations, including an open-label design and potential bias from crossover patients. The findings suggest that early use of argatroban may be beneficial in patients with AIS and END, but further research is needed to confirm the optimal timing and long-term effects of anticoagulation therapy in this population.
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[slides and audio] Argatroban in Patients With Acute Ischemic Stroke With Early Neurological Deterioration