MedWire News: The EARLY trial shows no clear risks or benefits from adding extended-release dipyridamole to aspirin within 24 hours after a stroke or transient ischemic attack (TIA).
The results of the Fast Assessment of Stroke and TIA (FASTER) trial indicated that adding clopidogrel to aspirin within 24 hours after stroke onset may reduce recurrent stroke rates.
For the EARLY trial, which is published in The Lancet Neurology, 543 patients were instead randomly assigned to receive extended-release dipyridamole in addition to aspirin or aspirin alone starting from within 24 hours after symptom onset. After 7 days, all patients were given the combination antiplatelet treatment.
The primary outcome of no or mild disability on a telephone-administered modified Rankin Scale (mRS) at 90 days was achieved by 56% of patients who had received dipyridamole during the first 7 days after stroke and 52% of those who had not.
Rates of the composite endpoint of major vascular events and bleeding complications were also similar between the groups, at 10% versus 15% of patients in the early and late dipyridamole groups, respectively. Nonfatal stroke was slightly, although not significantly, less common in the early dipyridamole groups, at 6% versus 10% in the late group.
Overall, vascular events occurred at a similar rate in both groups during the first week, but became less common in the early than late dipyridamole groups thereafter, although this was not statistically significant.
Reinhard Dengler (Medizinische Hochschule Hannover, Germany) and colleagues say that they also conducted a pooled analysis of the EARLY and FASTER data, finding that early combined antiplatelet treatment reduced patients’ risk for vascular events by a significant 32%.
In an accompanying commentary, Harold Adams (University of Iowa College of Medicine, Iowa City, USA) said: “The EARLY trial is a step forward in testing the usefulness of different antiplatelet drugs for patients with a recent non-disabling stroke or TIA.”
But he added: “Unfortunately, the results are not definitive.”
He said that treatment in the EARLY trial began too late to directly influence outcome, so any benefits would result from reducing the rate of recurrent events during the first week. As the trial was relatively small, the event rates during this time were too low to detect treatment differences.
“Questions persist about the usefulness of early treatment with aspirin, clopidogrel alone or with aspirin, or aspirin plus extended-release dipyridamole,” concluded Adams. “The data from the EARLY trial might be used to help plan future trials that test both the efficacy and safety of starting therapies to prevent recurrent events within the first hours or days after a TIA or ischemic stroke.”
MedWire (www.medwire-news.md) is an independent clinical news service provided by Current Medicine Group, a trading division of Springer Healthcare Limited. © Springer Healthcare Ltd; 2010
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