Clinical question: Is dual antiplatelet therapy (DAPT) non-inferior to intravenous (IV) thrombolysis in patients with minor non-disabling acute ischemic strokes (AIS)?
Background: Minor strokes comprise about half of all AIS but the evidence for IV thrombolytics in this cohort has been inconclusive. While prior studies have confirmed the superiority and safety of short-term DAPT in acute minor strokes compared to aspirin alone; no studies have previously compared DAPT versus IV thrombolytics.
Study design: Multi-center, randomized, open-label, blinded endpoint assessment, non-inferiority trial
Setting: 38 hospitals in China
Synopsis: 760 adult patients with AIS (National Institutes of Health Stroke Scale Score [NIHSS] <=5) presenting within 4.5 hours of symptom onset; participants were randomly assigned to DAPT (clopidogrel and aspirin for approximately 12 days) or IV alteplase. Both groups then received guideline-based antiplatelet therapy. The primary outcome was an excellent functional outcome, defined as a modified Rankin Scale score of 0 or 1, at 90 days. The median NIHSS was 2, and approximately 70% of the patients were men. At 90 days, 93.8% in the DAPT group and 91.4% in the alteplase group achieved an excellent functional outcome. The risk difference met the non-inferiority criteria (P <0.001). The alteplase group (6.5%) had more spontaneous intracranial hemorrhages and other bleeding events compared to the DAPT group (1.9%). The DAPT group had fewer patients with early neurological deterioration at 24 hours (defined as a greater than two increase on the NIHSS). Study limitations are the potential lack of generalizability and the lack of robust data on subgroup analysis based on the etiology of stroke. Secondary outcomes and subgroup analyses should be interpreted with caution.
Bottom line: In patients with non-disabling AIS presenting early, DAPT was non-inferior compared to IV alteplase with regard to excellent functional outcomes at 90 days and had fewer bleeding events.
Citation: Chen H, et al. Dual antiplatelet therapy vs alteplase for patients with minor nondisabling acute ischemic stroke: The ARAMIS randomized clinical trial. JAMA. 2023;329(24):2135–44.
Dr. Subramany is a hospitalist and assistant professor of medicine at the University of New Mexico Hospital, Albuquerque, N.M.