regional medical center: Is Alteplase Safe For Stroke Patients Over 80? Researchers Say Yes

Is Alteplase Safe For Stroke Patients Over 80? Researchers Say Yes

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Main Category: Stroke
Article Date: 24 May 2012 - 15:00 PDT

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Each year in the UK around 30,000 individuals aged 80+ suffer a stroke. However, alteplase - an injectable drug that helps breakdown blood clots - is not licensed to treat stroke in individuals aged 80 years and over.

Although the drug can be used in several conditions including ischemic stroke, heart attacks and pulmonary embolism, the time window in which the drug can be administered safely and effectively after a stroke is still debated.

Two studies published in The Lancet reveal the benefits of alteplase in stroke patients age 80+ and also confirm the benefits of rapid treatment.

The first study reports the results of the third International Stroke Trial (IST-3). In the trial, Professor Peter Sandercock, University of Edinburgh and Western General Hospital, Edinburgh, UK, evaluated 3,035 patients at 156 hospitals in 12 countries in order to determine whether stroke patients treated within 6 hours in clinical trials might benefit (ie, be alive and independent in daily living). 53% of study participants were older than 80 years of age.

At present, thrombolysis is known to benefit individuals under the age of 80 who are treated within 4-5 hours of acute ischemic stroke.

The researchers assigned 1,515 participants to receive alteplase and 1,520 to the control group.

At 6 months, the researchers found that 554 (37%) of participants in the alteplase group were alive and were able to live independently, compared with 534 (35%) in the control group.

According to the researchers, for every 1,000 patients treated within 6 hours of onset, 14 more patients were alive and independent. In addition, the team found that patients treated with alteplase were 27% more likely to survive with less disability.

80% of patients treated within three hours were aged over 80 years and according to the results the benefit of alteplase was significantly greater; for every 1,000 patients treated, at six months 80 more patients were alive and living independently.

In the alteplase group, 104 (7%) of participants experienced either a fatal or non-fatal symptomatic hemorrhage within 7 days compared with 16 (1%) in the control group.

The 7 day mortality rate was greater in the alteplase group (163 [11%) than in the control group (107 [7%]).

However, the team found that between 7 days and 6 months the number of deaths was comparable between the two groups 408 (27%) in the alteplase group vs. 407 (27%) in the control group.

The researchers explained:

"For the types of patient recruited in IST-3 (about three quarters of whom were randomized after 3 h, and half of all patients were older than 80 years of age), by 6 months there was evidence that alteplase improved function outcome.
The data also add weight to the policy of treating patients as soon as possible, and justify extending treatment to patients older than 80 years of age. The data do not support any restriction of treatment on the basis of stroke severity or the presence of early ischemic change on the baseline brain scan."

In the study, Professor Joanna Wardlaw, University of Edinburgh and Western General Hospital, Edinburgh, UK, and her team compared results from the IST-3 trial with other major trials on alteplase.

The researchers examined 7,012 patients and found that for every 1,000 patients assigned to intravenous alteplase within 6 hours after stroke, 42 more patients were alive and living independently; and 55 more patients had the better outcome of being alive with a favourable outcome at the end of follow-up.

This benefit occurred even though there was an increase in the incidence of early symptomatic intracranial hemorrhages and early deaths. However, these hazards were offset by a reduction in mortality rates between 7 days and end of follow-up at 3-6 months. According to the researchers, no effect on deaths from all causes was observed, and the incidence of patients who were dependent decreased.

Results from the study showed that treatment within 3 hours of stroke resulted in significantly better outcomes:

an 87 per 1,000 increase in the number of patients who were alive
90 per 1,000 increase in patients alive and living independently

In addition, the benefits of alteplase were comparable for patients older than 80 years and for younger patients, especially with early treatment. For patients aged 80+ who received treatment within three hours, 96 more patients per 1,000 were alive and living independently.

According to the researchers they are still unsure as to what the exact time window for benefit of alteplase treatment is. Results from the study indicate that the benefit may extend beyond 4-5 hours, and possible as late as 6 hours in some patients. However, the time probably varies with patients characteristics, which were not possible to identify from this study.

The researchers conclude:

"The evidence indicates that intravenous alteplase increases the proportion of patients who are alive with favorable outcome and alive and independent at final follow-up. The data strengthen previous evidence to treat patients as early as possible after acute ischemic stroke, although some patients might benefit up to 6 h after stroke.
This study will be important for understanding the true health economic effect of thrombolytic treatment. If small gains in functional ability by 3-6 months translate into greater long-term survival free of disability, this is likely to reduce health-care costs and increase quality of life and cost effectiveness."

In a joint comment, Dr Didier Leys and Dr Charlotte Cordonnier, Department of Neurology, Stroke Unit, Roger Salengro Hospital, Lille, France, said:

"The key message of IST-3 and the updated meta-analysis is that many eligible patients from subgroups excluded by the European license should now be given alteplase.

Every stroke patient should therefore be classed as a candidate for thrombolysis and managed as a medical emergency irrespective of age, severity, and clinical presentation. The default situation for the first health care professional who identifies the stroke patient should be to treat, and the role of stroke and emergency physicians is now not to identify patients who will be given alteplase, but to identify the few who will not."

Written By Grace Rattue
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

Additional

References

Citations

"The benefits and harms of intravenous thrombolysis with recombinant tissue plasminogen activator within 6 h of acute ischaemic stroke (the third international stroke trial [IST-3]): a randomised controlled trial"
The IST-3 collaborative group
The Lancet, May 2012, doi: 10.1016/S0140-6736(12)60768-5

"Recombinant tissue plasminogen activator for acute ischaemic stroke: an updated systematic review and meta-analysis "
Prof Joanna M Wardlaw MD, Prof Veronica Murray MD, Prof Eivind Berge MD, Prof Gregory del Zoppo MD, Prof Peter Sandercock DM, Prof Richard L Lindley MD, Geoff Cohen PhD
The Lancet , May 2012, doi: 10.1016/S0140-6736(12)60738-7

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Kamis, 24 Mei 2012

Is Alteplase Safe For Stroke Patients Over 80? Researchers Say Yes

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