Expert guidelines are yet to specify an upper age limit for alteplase for thrombolysis of acute ischemic stroke (AIS). The European regulatory criteria constricted its use to patients aged from 18-80 years. Pooled analyses of randomized controlled trials (RCT) and registry data were performed to evaluate the benefit-risk profile of alteplase for AIS among patients aged more than 80 years to support a regulatory application in lifting the upper age restriction.

Individual patient data were assessed from seven trials of alteplase (0.9 mg/kg) versus open control for AIS or placebo, along with the European SITS-UTMOST registry database. Clinical outcomes, including good functional outcome, were evaluated in the full RCT and registry populations, and specified age-based subgroups who met existing European regulatory criteria for alteplase, excluding upper age restriction. Amongst patients aged above 80 years, alteplase versus placebo was correlated with a higher proportion of good stroke outcome (19.1% vs. 13.1%) and similar 90-day mortality (29.5% vs. 30.2%). The odds of a good stroke outcome following alteplase allocation in the entire RCT population were independent of age.

In conclusion, the collective analyses of individual patient data from registry studies and randomized trials indicate that intravenous alteplase for AIS has a favorable benefit-risk profile in patients aged above 80 years when administered according to other European regulatory criteria. Notably, age alone is no longer a barrier to alteplase treatment for AIS.