Key result
DAPT fails to improve 90-day functional outcomes over alteplase in minor stroke with normal renal function.
Why the study?
It was unknown whether renal function modifies therapeutic responses to dual antiplatelet therapy versus intravenous thrombolysis in acute minor ischemic stroke.
Does dual antiplatelet therapy improve excellent functional outcome at 90 days in patients with minor acute ischemic stroke compared to intravenous alteplase, and is this effect modified by baseline renal function?
RCT (n=615)
Open-label
Yes
Yes
Does dual antiplatelet therapy improve excellent functional outcome at 90 days in patients with minor acute ischemic stroke compared to intravenous alteplase, and is this effect modified by baseline renal function?
In patients with minor acute ischemic stroke, baseline renal function did not significantly modify the comparative efficacy of dual antiplatelet therapy versus alteplase for achieving excellent functional outcome at 90 days.
No significant DAPT benefit over alteplase in normal renal function; leaves open modification by renal impairment in randomized trials.
Background This secondary analysis of the ARAMIS trial evaluated renal function’s modifying effects on therapeutic responses to dual antiplatelet therapy (DAPT) versus intravenous thrombolysis in acute minor ischemic stroke. Methods Based on the as-treated set, we stratified patients by admission estimated glomerular filtration rate into three groups: normal renal function (≥90 mL/min/1.73 m 2 ), mildly decreased renal function (eGFR 60 to 89 mL/min/1.73 m 2 ), and moderate to severe impairment renal function group (<60 mL/min/1.73 m 2 ). The primary endpoint was excellent functional outcome defined as a modified Rankin Scale score of 0–1 at 90 days. Results Among 615 analyzed patients, 367 (59.7%) exhibited normal renal function, 209 (34.0%) exhibited mildly decreased renal function and 39 (6.3%) exhibited moderate to severe impairment renal function. A numerically higher rate of excellent functional outcome was found in normal renal function patients with DAPT vs. alteplase (94.4% vs. 90.4%; p = 0.147), while no intergroup difference emerged in mildly decreased renal function patients (93.9% vs. 93.7%; p = 0.958) and moderate to severe impairment renal function patients (93.8% vs. 95.7%; p = 0.792). There was no significant interaction between treatment and renal function on the primary outcome (adjusted interaction p = 0.337). Conclusion Among patients with normal renal function, DAPT was associated with a numerically higher, but not statistically significant, rate of excellent functional outcome in patients with minor nondisabling acute ischemic stroke presenting within 4.5 h of symptom onset compared with alteplase. Clinical trial registration ClinicalTrials.gov , identifier NCT03661411.
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He et al. (2025) conducted an RCT in Minor nondisabling acute ischemic stroke (n=615). Dual antiplatelet therapy (DAPT) vs. Intravenous alteplase (0.9 mg/kg) was evaluated on Excellent functional outcome (mRS 0-1) at 90 days in patients with normal renal function (OR 1.81, 95% CI 0.81-4.04, p=0.147). Dual antiplatelet therapy did not significantly improve the rate of excellent functional outcome at 90 days compared to alteplase in minor stroke patients with normal renal function (94.4% vs. 90.4%; OR 1.81).
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