Alteplase effective within 4.5 hrs: ECASS 3

Kolkata, Oct 28 : On account of World Stroke Day, which falls on October 29 this year; the Indian Stroke Association joined the Stroke Associations across the world in recognizing that Alteplase is effective even if it is administered within 4.5 hours of onset of ischaemic stroke.

This recognition followed after the recommendations from the European Stroke Organisation (ESO), the American Stroke Association and the Lancet based on the key results from the European Cooperative Acute Stroke Study (ECASS 3). It was earlier believed that Alteplase would be effective only even if it was administered within 3 hours of the onset of ischaemic stroke in a patient.

ECASS 3, a randomised, double-blind, placebo-controlled trial, showed for the first time that thrombolysis with Alteplase can increase the likelihood of achieving good outcome with only minimal or no disability after an acute ischaemic stroke when administered in an extended time-window from 3 to 4.5 hours after symptom onset. This news comes shortly after The Lancet selected ECASS 3 as one of the top three papers of 2008, and Lancet editors singled out the study as their choice for paper of the year.

Writing in the 24 January 2009 issue of The Lancet, Executive Editor William Summerskill said that ECASS 3 and the other papers of the year 'embody the can-do spirit of visionary research. They extend the horizon of our understanding and add to our tools for treating important common health problems that were once believed overwhelming.'

The World Health Organization estimates that 5.7 million people in the world die each year from stroke. Among survivors, 40 pc experience moderate to severe disability and 10 pc require institutional care. For patients with an acute ischaemic stroke the only treatment currently available is Alteplase, which has to be administered within 3 hours of symptom onset according to its currently approved label.

Back home in India, according to WHO's Workshop Report on Stroke Surveillance in India by the Division of Non-Communicable Diseases by the Government of India & the Indian Council of Medical Research; there are 16,67,372 stroke attacks in India every year and 4568 stroke attacks everyday. Of this, 800-1000 people die of stroke everyday; whereas 1000-1500 people get paralysed for life after they suffer from stroke.

Dr. Subhash Kaul, President of Indian Stroke Association said; 'We are proud of the success of ECASS 3 and would like to thank everyone who participated in this landmark study on acute ischaemic stroke for having achieved this breakthrough in stroke treatment'.

'This time-window of an additional 1.5 hours is like a miracle of hope and life for a stroke victim for whom every ticking second is precious,' said Dr. M V Padma, Associate Professor, Department of Neurology, AIIMS.

The ECASS 3 trial was set up to investigate whether Alteplase can also safely extend the benefit of treatment in the 3 to 4.5 hour time window.

ECASS 3 included 821 patients in 15 European countries who were recruited by a team of investigators led by Professor Werner Hacke of the University of Heidelberg. Results were published in the New England Journal of Medicine in September 2008.