Argatroban plus aspirin versus aspirin in acute ischemic stroke.

Objectives: Anticoagulant therapy in the acute phase of AIS remains controversial. The aim of this study was to investigate whether argatroban benefited early stroke outcomes compared with antiplatelet treatment.

Methods: We reviewed data from 1,485 patients with AIS hospitalized at Tianjin Union Medical Center (TUMC) between 1 January 2013 and 31 December 2015 from the TUMC registry database. Patients were divided into two groups: an antiplatelet group (aspirin 300 mg daily) and an argatroban group (argatroban 60 mg for 2 days followed by 20 mg daily; or 20 mg daily - both regimens combination with aspirin 100 mg daily). Two primary outcomes, change in NIHSS score (baseline-discharge) and intracerebral hemorrhage, were investigated.

Results: No major symptomatic intracerebral hemorrhages were observed in either group. Both groups had significantly decreased NIHSS scores at discharge (Z = -14.617, P < 0.001 and Z = -6.385, P < 0.001, respectively), and there were no significant group differences in NIHSS score change (Z = -1.888, P = 0.059). In the mild stroke subgroup, the argatroban group had a worse NIHSS score at discharge (Z = -6.148, P = 0.002), while the aspirin group had an improved NIHSS score (Z = -4,423, P < 0.001). In the moderate stroke subgroup, both groups had significantly decreased NIHSS scores at discharge (Z = -13.260, P < 0.001 and Z = -7.108, P < 0.001, respectively) and there were no significant group differences in NIHSS score changes (Z = -1.888, P = 0.059).

Conclusion: Argatroban is effective and safe for the treatment of moderate AIS with similar efficacy to high-dose aspirin in the acute phase of AIS, although no additional benefit on short-term outcome was observed. For patients with mild AIS, argatroban may be inferior to high-dose aspirin.