Safety and efficacy of argatroban combined with antiplatelet therapy for acute mild-to-moderate ischemic stroke with large artery atherosclerosis.

BACKGROUND AND PURPOSE: Patients with stroke due to large artery atherosclerosis are at risk of early progression and recurrence. The efficacy and safety of argatroban in stroke patients who did not receive reperfusion therapy, and which patients may benefit from it, are uncertain.

METHODS: We conducted a cohort study to assess whether argatroban given within 72 hours of symptom onset, combined with antiplatelet therapy, improved neurological outcomes of patients with acute mild to moderate ischemic stroke in China. Patients were divided into the combined treatment group and the control group. Inverse probability of treatment weighting was used to balance baseline covariates. The primary efficacy outcome is the proportion of mRS score 0-2 at 90 days. The secondary efficacy outcomes included END proportion, change in NIHSS score from the baseline to day 7, recurrent cardiovascular events, and cardiovascular death. The safety outcomes were hemorrhagic transformation (HT) of infarction and organ hemorrhage at 7 days.

RESULTS: Compared with the control group, a higher proportion of mRS (0-2) at 90 days was found in patients in the combined treatment group (85.3% vs 74.5%, p=0.042). There was no significant difference in the safety outcomes between the two groups. Exploratory subgroup analysis showed positive associations with argatroban combined therapy and good prognosis in NIHSS score ≥5 and age ≥70 subgroups.

CONCLUSIONS: Our study suggested that argatroban can improve neurological outcomes for mild to moderate LAA patients but not increase the risk of bleeding.