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ENCHANTED: Low-dose alteplase not superior to standard dose in certain subgroups
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Low-dose alteplase was not clearly superior compared with standard-dose alteplase on death or disability in demographic subgroups of patients with acute ischemic stroke, according to a secondary analysis of data from the ENCHANTED trial, published in JAMA Neurology.
In the ENCHANTED trial, researchers compared low-dose alteplase (Activase, Genentech) with standard-dose alteplase to determine the optimal dose in Asian patients with acute ischemic stroke. They found that low-dose alteplase did not show noninferiority.
“However, the ENCHANTED trial did show that low-dose alteplase was noninferior for overall functional recovery through ordinal analysis of the [modified Rankin Scale] and resulted in significantly less severe [symptomatic intracerebral hemorrhage] than did standard-dose alteplase,” Xi Wang, PhD, of The George Institute for Global Health at the University of New South Wales, Sydney, and colleagues wrote. “Therefore, it is plausible that low-dose alteplase may be a preferable treatment for certain types of patients.”
Wang and colleagues studied 3,310 patients (mean age, 67 years; 38% women) who had acute ischemic stroke as confirmed by brain imaging from March 2012 to August 2015. Participants were randomly assigned to low-dose alteplase (0.6 mg/kg; 15% as bolus, 85% as infusion over 1 hour) or standard-dose alteplase (0.9 mg/kg; 10% as bolus, 90% as infusion over 1 hour).
The primary endpoint was poor outcome defined by death and any disability scored by the Rankin Scale at 90 days.
When stratified by age, ethnicity or severity of stroke, there were no significant differences in treatment effects from low-dose alteplase compared with the standard dose (P for interaction > .37 for all).
Compared with standard-dose alteplase, low-dose treatment effects on function outcome were similar between Asian (OR = 1.05; 95% CI, 0.9-1.22) and non-Asian adults (OR = 0.93; 95% CI, 0.76-1.14; P for interaction = .32).
Reductions in rates of symptomatic intracerebral hemorrhage with low-dose alteplase were consistent vs. the standard dose, but not statistically significant by age, ethnicity or severity.
alteplase was associated with a lower risk of [symptomatic intracerebral hemorrhage] for patients of increasing age, with Asian or non-Asian ethnicity and with increasing neurological severity,” the researchers wrote. “These results suggest that decisions about the dose of alteplase used in thrombolysis-eligible patients with [acute ischemic stroke] should not be based solely on age, ethnicity or stroke severity.” – by Cassie Homer
Disclosures: Wang reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.
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