Alteplase benefits older people too

People more than 80 years old who have suffered a stroke can benefit from rapid treatment with alteplase, research has shown. The study, published online first today in The Lancet, found that some people may benefit from the drug even as late as 6 hours after their stroke.

Alteplase is not licensed for people aged 80 or more – although in the UK a third of all strokes occur in this age group – and the benefits of thrombolysis have been thought to outweigh its risks only when given within 4.5 hours of stroke.

Researchers in Edinburgh set out to see whether or not treatment later than that might benefit people who have had an cute ischaemic stroke, and to see whether benefits still outweighed risks in older patients.

They enrolled 3035 people – from 156 hospitals in 12 countries – who had had an acute ischaemic stroke; of these, 1617 were more than 80 years old. About half were randomised to immediate thrombolysis with alteplase, and half to control.

People treated with alteplase within 6 hours of stroke were not, overall, significantly more likely than controls to be alive and independent 6 months later. However, the odds of surviving with less disability, measured using a five point scale from no disability to very severe problems or death, were 27% greater in the alteplase group. The benefit in terms of disability level was much greater for people treated within 3 hours of stroke, 80% of whom were older than 80 years.

Death within one week was more common in the alteplase group, but by six months cumulative mortality was similar (27%) in each group.

The authors said that their findings “add weight to the policy of treating patients as soon as possible, and justify extending treatment to patients older than 80 years of age”.

A meta-analysis published at the same time found that giving alteplase within 6 hours of stroke increased the likelihood of early death and early symptomatic intracranial haemorrhage – but overall, treated patients were much more likely to be alive and independent at the end of follow-up than those not given alteplase.

This analysis also showed that treatment within 3 hours of stroke produced the best outcomes, but that the ‘window for benefit’ probably extended beyond 4.5 hours, and as far as 6 hours in certain patients. Patients more than 80 years old benefited at least as much from treatment as their younger peers, especially if they were given alteplase within 3 hours.

The authors concluded: “The evidence indicates that intravenous alteplase increases the proportion of patients who are alive with favourable outcome and alive and independent at final follow-up. The data strengthen previous evidence to treat patients as early as possible after acute ischaemic 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 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.”