Thrombectomy for Stroke With Large Infarct on Noncontrast CT
Authors:   The Writing Committee for the TESLA Investigators, White Rhonda , Gembreska Kerry , Chaubal Varun , AlMajali Mohammad , Ashouri Yazan , Olvany Jasmine M. , Ibrahim Laila A. , Previti Michael , Huffaker Shannon , Froman Dione , Balousek Peter , Gatscher Bridget , Erickson Amy , Nguyen Laura , Dulai Teji , Rodriguez Gustavo J. , Sheriff Faheem , Ren Zeguang , Guerrero Waldo , Vakharia Kunal , Ballekere Anjan , Abdelkhaleq Rania , Iyyangar Ananya , Azeem Hussain , Nahhas Michael , Mahapatra Ashutosh , Rulloda Raquel , Morsi Rami Z. , Thind Sonam , Mansour Ali , Lee Harrison , Calhoun Sara M , Burns Misty L , Murali Kolikonda , Liu Kenneth , Gross Kathleen , Perez Lynn , Ghazal Nabil , Gross Katharine , Otis Danielle , Burkholder Tatiana , Torres Kelly , Carolan-Katz Lisa , Carew Timothy , Pyle Trudy , Buitenwerf Anita , VanderBroek Courtney , Harning Julie , Holmstedt Christine , Mohamed Ghada , Kicielinski Kimberly , Lena Jonathan , Ozark Shelly , Banerjee Chirantan , Grewal Parneet , Wabnitz Ashley , Libman Richard , Woo Henry , Teron Molina Ina , Schwartz Erin , Dee Alicia , Anghel Sandra , Batanero Daphne , Scicutella Thomas , Arora Rohan , Kelly Christina , Kapoor Gaurav , Link Thomas , Koul Prateeka , Dalal Siddharth , Ballout Ahmad , Pasram Kirendra , Lao Emma , Brinkley Charell , Dima Richard , Iqbal Sabah , Bhuva Parita , Hansen Paul , Soomro Jazba , Mir Osman , Ajoboye Norman , Cajavilca Christian , Turabova Charoskhon , Farooqui Imran , Fares Mary-Ann , Yeboah Kevin , Greco Jonathan , Whitis Jessica , Rao Sowmya , Vo Peggy , West Lametria , Lu Jing , Matheri Pauline , Sauder Rocio , Jackson Brenda , Paradise Scott , Clark Shonda , Hughes Charles R. , Park Yong H. , Park Joseph J. , Dhand Sabeen , O'Connor Paul J. , Gaston Margaret , Raygoza Stephanie M. , Valdez Krystal J. , Khandelwal Priyank , Joseph Pradeep , Nagurka Roxanne , Desai Shashvat M , Leira Enrique , Shaban Amir , Ghannam Malik , Roeder Hannah , Olalde Heena , Dlouhy Katheleen , Derdeyn Colin , Hayaawa Minako , Mehta Siddhart , Fourcand Farah , Amireh Abdallah , Zacharatos Haralabos , Parboji Vimla , Shownkeen Harish N. , Mazumdar Avi , Fill Bryan , Chwastowska Eva , Holanday Izabela , Baligod Rosemarie R. , Schmidt Jennifer , Boo SoHyun , Tarabishy Abdul , Vu Phong , Turner Ryan , Czaplicki Michael , Domico Jennifer , Kaur Paramjot , Saini Vasu , Burks Joshua Burks , Abecassis Joshua , Linares Guillermo , Vanchhani Jay , Foreman Paul , Carlo Charlene , Pakulski Melanie B. , Philip Diane L. , Burgess Richard E. , Kung Vieh (Lisa) M. , Shawver Julie , Hendricks-Jones Melinda , Hajjar Monica M. , Robbins Sarah , Sedlak Emily , Dwyer Trisha A. , Crayne Christopher , Rao Rahul R. , Panda Swayamprava , Mosier Sherry L , Singh Jasmeet , Levy Elad I , Davies Jason , Snyder Kenneth , Brown Scott , Nguyen Thanh N. , Gress Daryl , Dippel Diederik W.J. , Smith Wade S. , Darkhabani Ziad , Dandapat Sudeepta , Szarzynski Kindy , Dhariwala Batul , Hollrith Tonya , Thoreson Laura , Scott Margaret , Kerr Veronica , Atwal Gursant , Rose-Finnell Linda , Maley Christine , Sukhumaran Madhav , Jahromi Babak , Cantrell Donald , Abdalla Ramez , Potts Matthew , Shaibani Ali , Muzaffar Ayesha , Cardoso-Mendoza Esmeralda , Reddy Vivek , Hannon Peter , Chung Lee , Tekiela Peter , Hoversten Knut , DeWitt Dana , Wold Jana , Kilburg Craig , Taussky Phil , Alexander Matthew , Renner David , Chauhan Muhammed , Ansari Safdar , Ross Tom , Sharma Pankaj , Ansari Junaid , DeAlba Luis , Adeeb Nimer , Savardekar Amey , Kelly Roger , Chernyshev Oleg , Carroll Kimberly , Glassy Nathaniel , Geraghty Scott , Sullivan Diana , Pasawala Mira , Levesque April , Atkin Laura , Hall Emma , Romo Elida , Rayes Mahmoud , Naravetla Bharath , Stearn Jonathan , Onishchuk Valentyna , Thompson Emily , Roberts Marci , Singla Amit , Vulkanov Volodymyr , Nimchinsky Esther , Biswas Arundhati , Hidalgo Andrea , Montealegre Nora , Sanchez Yesenia , Vechera Anastasia , Mercado Nicole , Unzen Jennifer , Khaldi Ahmad , Horn Chris , Owada Kumiko , Martinez Raisa , Nwosu Ugo , Ononiwu Erica , Modak Janhavi , Grimmett Kasey , Aureli Sharon , Mitchell Sandy , Boak Jenny , Blaske Lonna , Lee Vivien , Powers Ciaran , Minjee Shahid , Youssef Patrick , Ye Weiping , Hamed Mohammad , Herren Luke , Yoo Albert J. , Zaidat Osama O. , Sheth Sunil A. , Rai Ansaar T. , Ortega-Gutierrez Santiago , Given Curtis A. , Zaidi Syed F. , Grandhi Ramesh , Cuellar Hugo , Mokin Maxim , Katz Jeffrey M. , Alshekhlee Amer , Taqi Muhammad A. , Ansari Sameer A. , Siddiqui Adnan H. , Barazangi Nobl , English Joey D. , Maud Alberto , Kirmani Jawad , Gupta Rishi , Yavagal Dileep R. , Tarpley Jason , Pandya Dhruvil J. , Cress Marshall C. , Dharmadhikari Sushrut , Asif Kaiz S. , Kass-Hout Tareq , Puri Ajit S. , Janjua Nazli , Majjhoo Aniel Q. , Badruddin Aamir , Edgell Randall C. , Khatri Rakesh , Morgan Larry , Razak Anmar , Zha Alicia , Khandelwal Priyank , Mueller-Kronast Nils , Rivet Dennis J. , Wolfe Thomas , Snelling Brian , Sultan-Qurraie Ali , Lin Shao-Pow , Khangura Rajkamal , Spiotta Alejandro M. , Bhuva Parita , Salazar-Marioni Sergio , Lin Eugene , Tarabishy Abdul R. , Samaniego Edgar A. , Kolikonda Murali K. , Jumaa Mouhammad A. , Reddy Vivek K. , Sharma Pankaj , Berkhemer Olvert A. , van Doormaal Pieter-Jan , van Es Adriaan C. G. M. , van Zwam Wim H. , Emmer Bart J. , Beenen Ludo F. , Majoie Charles B. L. M. , Buderer Nancy , Detry Michelle A. , Bosse Anna , Graves Todd L. , Saunders Christina , Elijovich Lucas , Jadhav Ashutosh , Patterson Mary , Slight Hannah , Below Kristine , Al Kasab Sami ,   TESLA Investigators
Published: September 2024

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