Intra-Arterial Alteplase After Successful Endovascular Reperfusion in Patients Without Intravenous Thrombolysis: A Subgroup Analysis of the PEARL Randomized Clinical Trial.
Xie D, Li H, et al. • Journal of the American Heart Association • 2026
In patients who did not receive prior intravenous thrombolysis, adjunctive intra-arterial alteplase 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.
Key Findings
Results
Among patients who underwent endovascular thrombectomy without prior intravenous thrombolysis, intra-arterial alteplase (IAA) led to a significantly higher proportion with excellent functional outcome (mRS 0-1) at 90 days than standard treatment.
Excellent functional outcome: 43.2% (41/95) in the IAA group versus 22.6% (21/93) in the standard treatment group.
Adjusted risk ratio (aRR) 1.86; 95% CI, 1.19-2.91; P=0.007.
Absolute risk reduction was 20.6% (95% CI, 7.0%-33.1%).
Results
The benefit of IAA on excellent functional outcome was consistent in per-protocol sensitivity analyses.
The per-protocol sensitivity analysis yielded P=0.002 for the primary outcome.
The primary outcome was mRS 0-1 at 90 days.
Results
IAA was not associated with a significant increase in symptomatic intracranial hemorrhage.
aRR, 0.93; 95% CI, 0.28-3.13; P=0.908.
Symptomatic intracranial hemorrhage was assessed as a safety outcome within 36 hours.
Results
IAA was not associated with a significant difference in any intracranial hemorrhage within 36 hours.
aRR, 1.04; 95% CI, 0.68-1.60; P=0.843.
Results
90-day all-cause mortality did not differ between the IAA and standard treatment groups.
Hazard ratio 1.00; 95% CI, 0.49-2.04; P>0.99.
Methods
This prespecified subgroup analysis of the multicenter PEARL trial included 189 of 324 randomized patients who underwent thrombectomy without prior intravenous thrombolysis.
PEARL was conducted at 28 centers in China.
95 patients were assigned to IAA and 94 to standard treatment; 188 (95 vs 93) were analyzed for the primary outcome.
Primary efficacy outcome was mRS 0-1 at 90 days; safety outcomes were symptomatic ICH, any ICH within 36 hours, and 90-day all-cause mortality.
Trial registration: NCT05856851.
What This Means
This study looked at stroke patients caused by a blocked large brain artery who had a clot-removal procedure (endovascular thrombectomy) but had not first received clot-dissolving drugs through a vein. After the procedure had successfully reopened the artery, some patients were also given the clot-dissolving drug alteplase directly into the artery, while others received standard care. The analysis was a prespecified subgroup of the larger PEARL trial, run at 28 centers in China, and included 189 patients.
At 90 days, about 43% of patients who received the added alteplase had an excellent recovery (little or no disability), compared with about 23% of those who received standard care. Rates of brain bleeding, including symptomatic bleeding, and death at 90 days were not meaningfully different between the groups, although the small number of such events limits how confidently safety can be judged.
This research suggests that giving alteplase into the artery after successful thrombectomy may improve recovery in patients who did not get intravenous clot-dissolving treatment, without an apparent rise in major bleeding or death. Because this is a subgroup analysis of a single trial with a modest number of patients, the findings would need confirmation in further studies.
Xie D, Li H, Li D, Huang W, Lin X, Deng Z, et al.. (2026). Intra-Arterial Alteplase After Successful Endovascular Reperfusion in Patients Without Intravenous Thrombolysis: A Subgroup Analysis of the PEARL Randomized Clinical Trial.. Journal of the American Heart Association. https://doi.org/10.1161/JAHA.126.049961