Journal article
Thrombectomy for Stroke With Large Infarct on Noncontrast CT: The TESLA Randomized Clinical Trial
JAMA : the journal of the American Medical Association, Vol.332(16), pp.1355-1366
10/22/2024
DOI: 10.1001/jama.2024.13933
PMCID: PMC11420819
PMID: 39374319
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. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03805308
Details
- Title: Subtitle
- Thrombectomy for Stroke With Large Infarct on Noncontrast CT: The TESLA Randomized Clinical Trial
- Creators
- Albert J YooOsama O ZaidatSunil A ShethAnsaar T RaiSantiago Ortega-GutierrezCurtis A GivenSyed F ZaidiRamesh GrandhiHugo CuellarMaxim MokinJeffrey M KatzAmer AlshekhleeMuhammad A TaqiSameer A AnsariAdnan H SiddiquiNobl BarazangiJoey D EnglishAlberto MaudJawad KirmaniRishi GuptaDileep R YavagalJason TarpleyDhruvil J PandyaMarshall C CressSushrut DharmadhikariKaiz S AsifTareq Kass-HoutAjit S PuriNazli JanjuaAniel Q MajjhooAamir BadruddinRandall C EdgellRakesh KhatriLarry MorganAnmar RazakAlicia ZhaPriyank KhandelwalNils Mueller-KronastDennis J RivetThomas WolfeBrian SnellingAli Sultan-QurraieShao-Pow LinRajkamal KhanguraAlejandro M SpiottaParita BhuvaSergio Salazar-MarioniEugene LinAbdul R TarabishyEdgar A SamaniegoMurali K KolikondaMouhammad A JumaaVivek K ReddyPankaj SharmaOlvert A BerkhemerPieter-Jan van DoormaalAdriaan C. G. M van EsWim H van ZwamBart J EmmerLudo F BeenenCharles B. L. M MajoieNancy BudererMichelle A DetryAnna BosseTodd L GravesChristina SaundersLucas ElijovichAshutosh JadhavMary PattersonHannah SlightKristine BelowSami Al KasabTESLA Randomized Clinical Trial Investigators
- Resource Type
- Journal article
- Publication Details
- JAMA : the journal of the American Medical Association, Vol.332(16), pp.1355-1366
- DOI
- 10.1001/jama.2024.13933
- PMID
- 39374319
- PMCID
- PMC11420819
- NLM abbreviation
- JAMA
- ISSN
- 0098-7484
- eISSN
- 1538-3598
- Publisher
- American Medical Association
- Grant note
No Statement Available
- Language
- English
- Electronic publication date
- 09/23/2024
- Date published
- 10/22/2024
- Academic Unit
- Neurology; Radiology; Iowa Neuroscience Institute; Neurosurgery
- Record Identifier
- 9984719238702771
Metrics
44 Record Views