NEW YORK -- October 20, 2009 -- A study published online first and appearing in the December edition of The Lancet Neurology adds further evidence to back the extension of the treatment window for stroke using alteplase to 4.5 hours.
Previously published research from the European Cooperative Acute Stroke Study III (ECASS III) has shown that alteplase leads to better outcomes than placebo in stroke patients in the 3.0 to 4.5 hour window post stroke.
In the current study, Werner Hacke, MD, Department of Neurology, University of Heidelberg, Heidelberg, Germany, and colleagues did secondary analyses using different endpoints to confirm or refute the efficacy and safety outcomes in the primary analysis in ECASS III. They also looked for evidence of confounding factors or subgroups that might differentially affect treatment outcome.
A total of 418 patients were assigned to alteplase in the 3.0 to 4.5 hours window post stroke, and 403 were assigned to placebo.
Although not significant in every case, all additional endpoints showed at least a clear trend in favour of alteplase. This included patients aged over and under 65 years, men and women, and patients with or without a history of diabetes, stroke or high blood pressure. Alteplase was also beneficial regardless of the severity of the stroke.
"Our results support the use of this thrombolytic drug in the extended period across a broad range of patient subgroups who meet the requirements of the European product label but miss the approved treatment window of 0 to 3 hours," the authors wrote.
"Even with these encouraging findings, the most important principle of acute stroke intervention should, however, not be lost -- time remains critical and fast treatment still provides the greatest chance of recovery."
In an accompanying comment, Patrick Lyden, MD, Cedars-Sinai Medical Center, Los Angeles, California, said: "Thrombolytic therapy benefits patients, should be given as early as possible, offers sustained benefit, and is cost-effective. The physician must, as always, diligently undertake a careful history and physical examination, look at the non-contrast brain CT (computed tomography) scan carefully, and follow the appropriate protocol. All of these steps will result in substantial benefit to public health and will safely benefit many patients. But 'time is brain', and therapy must be given as soon as possible after the patient arrives -- there is indeed not a moment to lose."
SOURCE: The Lancet Neurology
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