Clinical efficacy and safety of tenecteplase combined with argatroban for acute ischemic stroke: A single-center retrospective cohort study

Acute ischemic stroke remains a major cause of death and disability, and intravenous thrombolysis is central to early reperfusion; however, post-lysis thrombin activity may contribute to rethrombosis and incomplete reperfusion. We conducted a single-center retrospective cohort study of consecutive adults with acute ischemic stroke admitted between January 2023 and December 2024, comparing a control regimen of standard-dose recombinant tissue plasminogen activator (alteplase 0.9 mg/kg, maximum 90 mg) with an observation regimen of low-dose recombinant tissue plasminogen activator (0.6 mg/kg, maximum 60 mg) plus argatroban initiated after thrombolysis in clinically stable patients. Because treatment strategy was selected in routine care rather than randomly assigned, all comparative findings were interpreted as associations. Among 125 patients (control n = 67; observation n = 58) with comparable baseline characteristics, the observation regimen was associated with greater early neurological improvement on the National Institutes of Health Stroke Scale at 24 hours (median change, 4 vs 3; P = .001) and day 7 (6 vs 4; P < .001), with higher responder rates (National Institutes of Health Stroke Scale decrease ≥4) at 24 hours (67.2% vs 41.8%; P = .004) and day 7 (81.0% vs 59.7%; P = .010). Favorable 90-day functional outcomes on the modified Rankin Scale (mRS) were more frequent (mRS 0-1: 69.0% vs 47.8%, P = .017; mRS 0-2: 87.9% vs 70.1%, P = .016), with a more favorable ordinal mRS distribution (P = .001). Recanalization was more frequent (P = .028), infarct growth was lower (P = .001), and early neurological deterioration was less common (P = .037). Symptomatic intracranial hemorrhage and other adverse events were uncommon, without significant between-group differences. These real-world findings should be considered hypothesis-generating and require prospective randomized validation.