Efficacy of argatroban plus alteplase versus intravenous alteplase according to diabetes mellitus in acute ischemic stroke

We conducted a post hoc analysis of the ARAIS (Argatroban Plus Recombinant Tissue-Type Plasminogen Activator for AIS) trial to investigate whether diabetes mellitus (DM) affects the efficacy of argatroban plus alteplase in patients with acute ischaemic stroke (AIS). Patients were categorized into DM and non-DM subgroups. In each subgroup, outcomes were compared between the argatroban plus alteplase group and the alteplase alone group. Additionally, the interaction between DM and treatment efficacy was assessed. The primary outcome was excellent functional outcome at 90 days, which was defined as a modified Rankin Scale score of 0-1. A total of 696 patients were included in this study. Regarding the primary outcome, the treatment effect was comparable between the argatroban plus alteplase group and the alteplase alone group both in the DM subgroup (58.4% versus 63.0%; adjusted risk difference, 1.1%; 95% CI, -13.8% to 16.1%; P = 0.88) and the non-DM subgroup (65.8% versus 65.3%; adjusted risk difference, 0.9%; 95% CI, -6.9% to 8.7%, P = 0.81). No significant interaction was observed between DM and treatment effect on the primary outcome (P = 0.93). Compared with alteplase alone, the efficacy of argatroban plus alteplase in achieving excellent functional outcomes at 90 days did not differ by DM status in patients with AIS.