Clinical question: Is dual antiplatelet therapy (DAPT) non-inferior to intravenous thrombolysis in patients with minor non-disabling acute ischemic stroke?
Background: Intravenous thrombolytics are recommended for patients with acute ischemic stroke within 4.5 hours of symptom onset. Prior clinical trials including PRISMS, POINT, and CHANCE studies had confirmed the efficacy and safety of DAPT.
Study design: Multicenter, randomized, open label, blinded non-inferiority trial.
Setting: 38 hospitals in China from October 2018 through April 2022
Synopsis: 760 patients with acute minor non-disabling ischemic stroke (NIHSS score less than or equal to 5 with less than or equal to 1 point on single-item scores such as vision, language, neglect, or single-limb weakness) were randomized in a 1:1 ratio to receive DAPT or IV alteplase within 4.5 hours of symptoms. The DAPT group received aspirin and clopidogrel for 12 (+/-2) days followed by guideline-based antiplatelet treatment until 90 days. Patients with pre-stroke disability scores greater than 2, a history of intracerebral hemorrhage, or a definite indication for anticoagulation were excluded. Clinical assessments were performed at baseline, 24 hours, and seven, 12, and 90 days after randomization with excellent functional outcomes defined by modified Rankin scores 0 to 1. A generalized linear model with binomial distribution and link identity function was performed for the primary outcome, -4.5 % was used as a non-inferiority margin in this trial. 93.8% of patients in the DAPT group compared to 91.4 % on alteplase had modified Rankin scores of 0 or 1 at 90 days. One patient in the DAPT group experienced symptomatic intracranial hemorrhage along with six patients with other bleeding events compared to three and 19 patients respectively in the alteplase group.
Bottom line: DAPT is non-inferior to intravenous alteplase with regards to excellent functional outcome at 90 days among patients with minor non-disabling acute ischemic stroke treated within 4.5 hours of symptom onset and is associated with less bleeding as well as fewer early neurological deterioration events.
Citation: Chen HS, 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. Pannu
Dr. Pannu is a hospitalist at Atrium Health Wake Forest Baptist, and an assistant professor in internal medicine at Wake Forest University School of Medicine, both in Winston-Salem, N.C.