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Published on: November 26, 2013
Reteplase versus Alteplase for Acute Ischemic Stroke
Shuya Li1, Hong-Qiu Gu1, Hao Li1
1From the Departments of Neurology (S.L., H.L., X.W., Yilong Wang, Z.L., X.M., X.Z., L.L., Yongjun Wang) and Clinical Trial Center (S.L., H.L., X.W., Yilong Wang, Z.L., X.M., X.Z., L.L., Yongjun Wang), and the China National Clinical Research Center for Neurologic Diseases (S.L., H.-Q.G., H.L., X.W., A.J., Yilong Wang, Z.L., X.M., X.Z., L.L., Yongjun Wang), Beijing Tiantan Hospital, Capital Medical University, Beijing, the Emergency Department, Linfen Central Hospital, Linfen (S.G.), the Department of Neurology, Ke shi ke teng Banner Traditional Chinese Medicine and Mongolian Medical Hospital, Chifeng (G.L.), the Department of Neurology, Linyi People's Hospital, Linyi (F.C.), the Department of Neurology, Xianyang Hospital of Yan'an University, Xianyang (W.W.), and the Department of Neurology, Halison International Peace Hospital, Hengshui (Y. Wei) - all in China.
Background:
Alteplase is the standard agent used in early reperfusion therapy, but alternative thrombolytic agents are needed. The efficacy and safety of reteplase as compared with alteplase in patients with acute ischemic stroke are unclear.
Methods:
We randomly assigned patients with ischemic stroke within 4.5 hours after symptom onset in a 1:1 ratio to receive intravenous reteplase (a bolus of 18 mg followed 30 minutes later by a second bolus of 18 mg) or intravenous alteplase (0.9 mg per kilogram of body weight; maximum dose, 90 mg). The primary efficacy outcome was an excellent functional outcome, defined as a score of 0 or 1 on the modified Rankin scale (range, 0 [no neurologic deficit, no symptoms, or completely recovered] to 6 [death]) at 90 days. The primary safety outcome was symptomatic intracranial hemorrhage within 36 hours after symptom onset.
Results:
A total of 707 patients were assigned to receive reteplase, and 705 were assigned to receive alteplase. An excellent functional outcome occurred in 79.5% of the patients in the reteplase group and in 70.4% of those in the alteplase group (risk ratio, 1.13; 95% confidence interval [CI], 1.05 to 1.21; P<0.001 for noninferiority and P = 0.002 for superiority). Symptomatic intracranial hemorrhage within 36 hours after disease onset was observed in 17 of 700 patients (2.4%) in the reteplase group and in 14 of 699 (2.0%) of those in the alteplase group (risk ratio, 1.21; 95% CI, 0.54 to 2.75). The incidence of any intracranial hemorrhage at 90 days was higher with reteplase than with alteplase (7.7% vs. 4.9%; risk ratio, 1.59; 95% CI, 1.00 to 2.51), as was the incidence of adverse events (91.6% vs. 82.4%; risk ratio, 1.11; 95% CI, 1.03 to 1.20).
Conclusions:
Among patients with ischemic stroke within 4.5 hours after symptom onset, reteplase was more likely to result in an excellent functional outcome than alteplase. (Funded by China Resources Angde Biotech Pharma and others; RAISE ClinicalTrials.gov number, NCT05295173.).
