Thrombectomy for Stroke With Large Infarct on Noncontrast CT The TESLA Randomized Clinical Trial

Albert J. Yoo, Osama O. Zaidat*, Sunil A. Sheth, Ansaar T. Rai, Santiago Ortega-Gutierrez, Curtis A. Given, Syed F. Zaidi, Ramesh Grandhi, Hugo Cuellar, Maxim Mokin, Jeffrey M. Katz, Amer Alshekhlee, Muhammad A. Taqi, Sameer A. Ansari, Adnan H. Siddiqui, Nobl Barazangi, Joey D. English, Alberto Maud, Jawad Kirmani, Rishi GuptaDileep R. Yavagal, Jason Tarpley, Dhruvil J. Pandya, Marshall C. Cress, Sushrut Dharmadhikari, Kaiz S. Asif, Tareq Kass-Hout, Ajit S. Puri, Nazli Janjua, Aniel Q. Majjhoo, Aamir Badruddin, Randall C. Edgell, Rakesh Khatri, Larry Morgan, Anmar Razak, Alicia Zha, Priyank Khandelwal, Nils Mueller-Kronast, Dennis J. Rivet, Thomas Wolfe, Brian Snelling, Ali Sultan-Qurraie, Shao-Pow Lin, Rajkamal Khangura, Alejandro M. Spiotta, Parita Bhuva, Sergio Salazar-Marioni, Eugene Lin, TESLA Investigators, Wim H. van Zwam

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

1 Downloads (Pure)

Abstract

Importance Recent large infarct thrombectomy trials used heterogeneous imaging modalities and time windows for patient selection. Noncontrast computed tomographic (CT) scan is the most common stroke imaging approach. It remains uncertain whether thrombectomy is effective for patients with large infarcts identified using noncontrast CT alone within 24 hours of stroke onset. Objective To evaluate the effect of thrombectomy in patients with a large infarct on a noncontrast CT scan within 24 hours of onset. Design, Setting, and Participants Open-label, blinded-end point, bayesian-adaptive randomized trial with interim analyses for early stopping (futility or success) or population enrichment, which was conducted at 47 US academic and community-based stroke thrombectomy centers. Three hundred patients presenting within 24 hours with anterior-circulation, large-vessel occlusion and large infarct on noncontrast CT scan, with Alberta Stroke Program Early CT Scores of 2 to 5, were randomized to undergo thrombectomy or usual care. Enrollment occurred July 16, 2019 to October 17, 2022; final follow-up, January 25, 2023. Intervention The intervention patients (n = 152) underwent endovascular treatment using standard thrombectomy devices and usual medical care. Control patients (n = 148) underwent usual medical care alone. Main Outcomes and Measures The primary efficacy end point was improvement in 90-day functional outcome measured using mean utility-weighted modified Rankin Scale (UW-mRS) scores (range, 0 [death or severe disability] to 10 [no symptoms]; minimum clinically important difference, 0.3). A bayesian model determined the posterior probability that the intervention would be superior to usual care; statistical significance was a 1-sided posterior probability of .975 or more. The primary adverse event end point was 90-day mortality; secondary adverse event end points included symptomatic intracranial hemorrhage and radiographic intracranial hemorrhage. Results The trial enrolled 300 patients (152 intervention, 148 control; 138 females [46%]; median age, 67 years), without early stopping or enrichment; 297 patients completed the 90-day follow-up. The mean (SD) 90-day UW-mRS score was 2.93 (3.39) for the intervention group vs 2.27 (2.98) for the control group with an adjusted difference of 0.63 (95% credible interval [CrI], -0.09 to 1.34; posterior probability for superiority of thrombectomy, .96). The 90-day mortality was similar between groups: 35.3% (53 of 150) for the intervention group vs 33.3% (49 of 147) for the control group. Six of 151 patients (4.0%) in the intervention group and 2 of 149 (1.3%) in the control group experienced 24-hour symptomatic intracranial hemorrhage. Fourteen patients of 148 (9.5%) in the intervention group vs 4 of 146 (2.7%) in the control group experienced parenchymal hematoma type 1 hemorrhages; 14 (9.5%) in the intervention group vs 5 (3.4%) in the control group experienced parenchymal hematoma type 2 hemorrhages; and 24 (16.2%) in the intervention group vs 9 (6.2%) in the control group experienced subarachnoid hemorrhages. Conclusions and Relevance Among patients with a large infarct on noncontrast CT within 24 hours, thrombectomy did not demonstrate improvement in functional outcomes. But the width of the credible interval around the effect estimate includes the possibility of both no important effect and a clinically relevant benefit, so the potential role of thrombectomy with this imaging approach and time window will likely require additional study.
Original languageEnglish
Article number13933
Pages (from-to)1355-1366
Number of pages12
JournalJAMA-Journal of the American Medical Association
Volume332
Issue number16
DOIs
Publication statusPublished - 22 Oct 2024

Keywords

  • ACUTE ISCHEMIC-STROKE
  • INTRAARTERIAL TREATMENT
  • CEREBRAL INFARCT
  • MANAGEMENT
  • BENEFITS
  • EFFICACY
  • SAFETY

Fingerprint

Dive into the research topics of 'Thrombectomy for Stroke With Large Infarct on Noncontrast CT The TESLA Randomized Clinical Trial'. Together they form a unique fingerprint.

Cite this