Landmark Study Shows Thrombolytic Treatment Improves Outcomes In Stroke When Given Up To 4.5 Hours After Symptom Onset

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Main Category: Stroke
Also Included In: Clinical Trials / Drug Trials
Article Date: 02 Oct 2008 - 10:00 PST

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Thrombolytic treatment with Actilyse (alteplase; Boehringer Ingelheim) significantly reduces the risk of patients with mild to moderate stroke being left with any residual disability when given within 4.5 hours of symptom onset - extending the time for administration beyond the currently licensed three hours - according to a major study reported at the recent World Stroke Congress (24-27 September, Vienna, Austria).

The ECASS 3 study (European Cooperative Acute Stroke Study) randomised 821 stroke patients to alteplase or placebo, in addition to standard therapy, when treatment was initiated between three and 4.5 hours after stroke onset. Results showed that patients treated with alteplase gained a 34% improvement in the odds of recovering with no residual disability (modified Rankin Score 0-1) at 90 days after their stroke, compared to those given placebo (52.4% vs 45.2%; odds ratio 1.34; 95% confidence interval 1.02-1.76; p=0.04).

Reporting the findings, Professor Werner Hacke, Professor of Neurology at the University of Heidelberg, Germany, emphasised that early thrombolytic treatment achieves the best outcomes. However, he said: "The new data show that stroke can be effectively managed also in patients who are unable to reach a stroke centre within three hours." He added: "A large group of patients currently excluded by the three-hour limit may benefit from this therapy."

As expected with a thrombolytic, the incidence of intracranial haemorrhage was higher with alteplase. Intracranial haemorrhage of any type occurred in 27.0% of alteplase-treatment patients, compared to 17.6% of those given placebo (p=0.001). However, symptomatic intracranial haemorrhage affected only 2.4% of patients, and 0.2% of the placebo group (p=0.008). Mortality was low in both groups, with no difference between the two (7.7% with alteplase vs 8.4%; p=0.68) (NEJM 2008; 359: 1317-1329).

"Adding one and a half hours to the time window for thrombolytic use will certainly increase the number of patients who can benefit. However, this treatment has the optimal effort if given early. This trial has shown that there is more time for patients but not for the treating physician, who should aim to treat as quickly as possible," concluded Professor Hacke. He predicted that the new findings would very quickly be incorporated into stroke treatment guidelines, and hoped that they would result in a doubling of the number of stroke patients given thrombolytic treatment.

Links

-- Boehringer Ingelheim
-- World Stroke Congress
-- ECASS 3 study (European Cooperative Acute Stroke Study)

Written by
Susan Mayor PhD
Medical journalist, London, UK
susanmayor (at) mac.com
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