Intra-Arterial Alteplase After Successful Endovascular Reperfusion in Patients Without Intravenous Thrombolysis: A Subgroup Analysis of the PEARL Randomized Clinical Trial
In brief
Intra-arterial alteplase nearly doubled excellent recovery after thrombectomy without IV thrombolysis
In this prespecified analysis of 189 patients, 43% given intra-arterial alteplase after successful thrombectomy had excellent function at 90 days, compared with 23% receiving standard care. Symptomatic brain bleeding and mortality did not differ significantly, but this subgroup result does not settle safety or show whether the benefit applies beyond patients who did not receive IV thrombolysis.
- Journal
- Journal of the American Heart Association (Q1)
- Published
- 23 October 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Dongshu Xie, Haiwei Li, Dengxing Li, Weidong Huang, Xuejing Lin, Zhenhong Deng, et al.
- PMID
- 42924842
- DOI
- 10.1161/JAHA.126.049961
Why clinicians should know about it
- Picked for Neurology (clinical) (paper of the day, 26 October 2026): Randomized-trial subgroup tests post-thrombectomy alteplase
Abstract
BACKGROUND: For patients with large-vessel occlusion stroke who undergo endovascular thrombectomy without prior intravenous thrombolysis, the efficacy and safety of adjunctive intra-arterial alteplase (IAA) after successful endovascular reperfusion remain uncertain. METHODS: This was a prespecified subgroup analysis of the PEARL (Intra-Arterial Alteplase After Successful Endovascular Reperfusion in Acute Stroke) randomized clinical trial conducted at 28 centers in China, focusing on patients who underwent endovascular thrombectomy without prior intravenous thrombolysis. Patients were stratified by treatment assignment: IAA treatment versus standard treatment (control). The primary efficacy outcome was the proportion of patients achieving excellent functional outcome, defined as a modified Rankin Scale score of 0 to 1 at 90 days. Safety outcomes included symptomatic intracranial hemorrhage, any intracranial hemorrhage within 36 hours, and 90-day all-cause mortality. RESULTS: Among 324 patients originally randomized in the PEARL trial, 189 underwent endovascular thrombectomy without prior intravenous thrombolysis and were included in this analysis. Of the 189 patients, 95 were assigned to the IAA treatment group and 94 to the standard treatment group. Excellent functional outcome at 90 days was significantly higher in the IAA treatment group compared with the standard treatment group (43.2% [41/95] versus 22.6% [21/93]; adjusted risk ratio [aRR], 1.86; 95% CI, 1.19-2.91; P=0.007). The absolute risk reduction was 20.6% (95% CI, 7.0%-33.1%). Results were consistent in per-protocol sensitivity analyses (P=0.002). No significant differences were observed in symptomatic intracranial hemorrhage (aRR, 0.93; 95% CI, 0.28-3.13; P=0.908), any intracranial hemorrhage (aRR, 1.04; 95% CI, 0.68-1.60; P=0.843), or 90-day mortality (hazard ratio [HR], 1.00; 95% CI, 0.49-2.04; P>0.99). CONCLUSIONS: In patients who did not receive prior intravenous thrombolysis, adjunctive IAA after successful endovascular thrombectomy was associated with a higher likelihood of excellent functional outcome at 90 days, without an apparent increase in symptomatic intracranial hemorrhage or mortality. REGISTRATION: URL: clinicaltrials.gov; Unique Identifier: NCT05856851.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.