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Adjunctive Intravenous Anti-Clotting Drugs Do Not Improve Stroke Outcomes
Adding the anti-clotting drugs argatroban or eptifibatide to routine intravenous thrombolysis treatment in patients with acute ischemic stroke did not reduce poststroke disability, and was associated with an increase in mortality, according to a study published in the New England Journal of Medicine.
The findings stem from an adaptive phase 3 randomized controlled trial conducted at 57 sites in the United States. Researchers investigated whether the anticoagulant agent argatroban or the antiplatelet agent eptifibatide could prevent further clots and improve outcomes in 514 patients with acute ischemic stroke who received intravenous thrombolysis within 3 hours of symptom onset. Among participants, 59 received intravenous argatroban, 227 received intravenous eptifibatide, and 228 received intravenous placebo within 75 minutes of thrombolysis initiation.
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The trial’s primary efficacy outcome was the utility-weighted 90-day modified Rankin scale score, a 0-to-10 scale on which higher scores signal better outcomes.
According to the study, 90-day mean Rankin scale scores were 5.2±3.7 with argatroban, 6.3±3.2 with eptifibatide, and 6.8±3.0 with placebo. The incidence of symptomatic intracranial hemorrhage, the trial’s primary safety outcome, was 4% with argatroban, 3% with eptifibatide, and 2% with placebo.
Meanwhile, 90-day mortality was 24% in the argatroban group, 12% in the eptifibatide group, and 8% in the placebo group, the study found.
“We’re a little disappointed in the results,” said study corresponding author Opeolu Adeoye, MD, head of the department of emergency medicine at Washington University School of Medicine in St. Louis, Missouri. “But it’s meaningful to optimal patient care that we’ve answered the question definitively. Neither of the drugs helps prevent further clots.”
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