RAISE
Trial question
Is reteplase superior to alteplase in patients with AIS?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
29.0% female
71.0% male
N = 1412
1412 patients (416 female, 996 male).
Inclusion criteria: patients aged 18-80 years with ischemic stroke within 4.5 hours after symptom onset.
Key exclusion criteria: endovascular thrombectomy; weight > 120 kg or < 45 kg; timing of stroke symptoms not known; mRS score ≥ 2 points; history of intracerebral hemorrhage; history of stroke, severe cerebral trauma, or other severe traumas within 3 months.
Interventions
N=707 reteplase (a bolus of 18 mg followed 30 minutes later by a second bolus of 18 mg).
N=705 alteplase (intravenous dose of 0.9 mg/kg, maximum dose of 90 mg).
Primary outcome
Percentage of patients achieving excellent functional outcome at day 90
79.5%
70.4%
79.5 %
59.6 %
39.8 %
19.9 %
0.0 %
Reteplase
Alteplase
Significant
increase ▲
NNT = 10
Significant increase in the percentage of patients achieving excellent functional outcome at day 90 (79.5% vs. 70.4%; RR 1.13, 95% CI 1.05 to 1.21).
Secondary outcomes
Significant increase in mRS score of 0-2 at day 90 (85.3% vs. 79.8%; RR 1.07, 95% CI 1.02 to 1.12).
Significant decrease in median mRS score at day 90 (0 vs. 1; OR 0.61, 95% CI 0.27 to 0.95).
Significant increase in early dramatic recovery at day 7 (73.5% vs. 66.5%; RR 1.1, 95% CI 1.02 to 1.19).
Safety outcomes
No significant difference in symptomatic ICH within 36 hours and serious adverse events within 90 days.
Conclusion
In patients aged 18-80 years with ischemic stroke within 4.5 hours after symptom onset, reteplase was superior to alteplase with respect to the percentage of patients achieving excellent functional outcome at day 90.
Reference
Shuya Li, Hong-Qiu Gu, Hao Li et al. Reteplase versus Alteplase for Acute Ischemic Stroke. N Engl J Med. 2024 Jun 27;390(24):2264-2273.
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