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Peer-reviewedCC BY-NC-NDJournal of the American Heart Association

Intra‐Arterial Alteplase After Successful Endovascular Reperfusion in Patients Without Intravenous Thrombolysis: A Subgroup Analysis of the PEARL Randomized Clinical Trial

1 more authors
7 affiliations
  1. 1Sun Yat‐sen Memorial Hospital, Sun Yat‐sen University
  2. 2Baise People's Hospital
  3. 3Xinhui People's Hospital
  4. 4Lianzhou People's Hospital
  5. 5Sun Yat‐Sen Memorial Hospital, Sun Yat‐Sen University
  6. 6Zhongshan School of Medicine, Sun Yat‐Sen University
  7. 7Top Talent Innovation Laboratory

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.

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BibTeX
@article{xie2026intraarterial,
  title = {{Intra‐Arterial Alteplase After Successful Endovascular Reperfusion in Patients Without Intravenous Thrombolysis: A Subgroup Analysis of the PEARL Randomized Clinical Trial}},
  author = {Dongshu Xie and Haiwei Li and Dengxing Li and Weidong Huang and Xuejing Lin and Zhenhong Deng and Xi Chen and Xinguang Yang and Yongteng Xu and Songhua Xiao and Jiyun Feng and Yamei Tang and Xiaoming Rong},
  journal = {Journal of the American Heart Association},
  year = {2026},
  month = oct,
  doi = {10.1161/jaha.126.049961},
  url = {https://www.ahajournals.org/doi/10.1161/JAHA.126.049961},
  note = {CC BY-NC-ND},
}
RIS
TY  - JOUR
TI  - Intra‐Arterial Alteplase After Successful Endovascular Reperfusion in Patients Without Intravenous Thrombolysis: A Subgroup Analysis of the PEARL Randomized Clinical Trial
AU  - Dongshu Xie
AU  - Haiwei Li
AU  - Dengxing Li
AU  - Weidong Huang
AU  - Xuejing Lin
AU  - Zhenhong Deng
AU  - Xi Chen
AU  - Xinguang Yang
AU  - Yongteng Xu
AU  - Songhua Xiao
AU  - Jiyun Feng
AU  - Yamei Tang
AU  - Xiaoming Rong
PY  - 2026
DA  - 2026/10/23
JO  - Journal of the American Heart Association
DO  - 10.1161/jaha.126.049961
UR  - https://www.ahajournals.org/doi/10.1161/JAHA.126.049961
AB  - 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.
SN  - 2047-9980
ER  -