Alteplase administration in acute ischemic stroke patients aged >80 years was associated with a higher proportion of good functional outcomes compared to control (19.1% vs 13.1%; P=0.0109).
Meta-Analysis
Yes
Does alteplase improve functional outcomes in patients aged >80 years with acute ischemic stroke?
Alteplase improves functional outcomes without increasing 90-day mortality in patients aged >80 years with acute ischemic stroke, supporting its use without an upper age limit.
Absolute Event Rate: 19.1% vs 13.1%
p-value: p=0.0109
Background/Purpose: Expert guidelines specify no upper age limit for alteplase for thrombolysis of acute ischemic stroke (AIS) but, until recently, European regulatory criteria restricted its use to patients aged 18 to 80 years. We performed pooled analyses of randomized controlled trial (RCT) and registry data to evaluate the benefit-risk profile of alteplase for AIS among patients aged >80 years to support a regulatory application to lift the upper age restriction. Methods: Individual patient data were evaluated from 7 randomized trials of alteplase (0.9 mg/kg) versus placebo or open control for AIS, and the European SITS-UTMOST registry database. Clinical outcomes, including good functional outcome (score 0–1, modified Rankin Scale day 90 or Oxford Handicap Score day 180), were evaluated in the full RCT and registry populations, and specified age-based subgroups (≤80 or >80 years) who met existing European regulatory criteria for alteplase, excluding upper age restriction. Results: Regardless of treatment allocation, 90-day mortality was lower among RCT patients aged ≤80 versus >80 years who otherwise met existing European regulatory criteria (246/2405 10.2% versus 307/1028 29.9%, respectively). Among patients aged >80 years, alteplase versus placebo was associated with a higher proportion of good stroke outcome (modified Rankin Scale score 0–1; 99/518 19.1% versus 67/510 13.1%; P =0.0109) and similar 90-day mortality (153/518 29.5% versus 154/510 30.2%; P =0.8382). The odds of a good stroke outcome following alteplase allocation in the full RCT population were independent of age ( P =0.7383). Good stroke outcome was reported for almost half (4821/11 169 43.2%) of the patients who received alteplase in routine practice. Outcomes in routine practice supported those achieved in RCTs. Conclusions: Alteplase for AIS has a positive benefit-risk profile among patients aged >80 years when administered according to other regulatory criteria. Alteplase for AIS should be evaluated on an individual benefit-risk basis.
Bluhmki et al. (Thu,) conducted a meta-analysis in Acute ischemic stroke. Alteplase vs. Placebo or open control was evaluated on Good functional outcome (score 0-1, modified Rankin Scale day 90 or Oxford Handicap Score day 180) (p=0.0109). Alteplase administration in acute ischemic stroke patients aged >80 years was associated with a higher proportion of good functional outcomes compared to control (19.1% vs 13.1%; P=0.0109).
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: