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Among patients with ischemic stroke secondary to large vessel occlusion and eligible for thrombolysis, is endovascular treatment alone noninferior to intravenous alteplase plus endovascular treatment with regard to functional independence?
In this randomized clinical trial that included 234 patients with acute ischemic stroke, the proportion who achieved functional independence at 90 days was 54.3% in the endovascular treatment alone group vs 46.6% in the intravenous alteplase plus endovascular treatment group, a difference that met the prespecified noninferiority margin of 10%.
Among patients with acute ischemic stroke due to large vessel occlusion and eligible for thrombolysis, endovascular treatment alone, compared with intravenous alteplase plus endovascular treatment, met the prespecified statistical threshold for noninferiority for the outcome of 90-day functional independence, although the clinical acceptability of the threshold for noninferiority should be considered when interpreting the results.
For patients with large vessel occlusion strokes, it is unknown whether endovascular treatment alone compared with intravenous thrombolysis plus endovascular treatment (standard treatment) can achieve similar functional outcomes.
To investigate whether endovascular thrombectomy alone is noninferior to intravenous alteplase followed by endovascular thrombectomy for achieving functional independence at 90 days among patients with large vessel occlusion stroke.
Design, Setting, and Participants
Multicenter, randomized, noninferiority trial conducted at 33 stroke centers in China. Patients (n = 234) were 18 years or older with proximal anterior circulation intracranial occlusion strokes within 4.5 hours from symptoms onset and eligible for intravenous thrombolysis. Enrollment took place from May 20, 2018, to May 2, 2020. Patients were enrolled and followed up for 90 days (final follow-up was July 22, 2020).
A total of 116 patients were randomized to the endovascular thrombectomy alone group and 118 patients to combined intravenous thrombolysis and endovascular thrombectomy group.
Main Outcomes and Measures
The primary end point was the proportion of patients achieving functional independence at 90 days (defined as score 0-2 on the modified Rankin Scale; range, 0 [no symptoms] to 6 [death]). The noninferiority margin was −10%. Safety outcomes included the incidence of symptomatic intracerebral hemorrhage within 48 hours and 90-day mortality.
The trial was stopped early because of efficacy when 234 of a planned 970 patients had undergone randomization. All 234 patients who were randomized (mean age, 68 years; 102 women [43.6%]) completed the trial. At the 90-day follow-up, 63 patients (54.3%) in the endovascular thrombectomy alone group vs 55 (46.6%) in the combined treatment group achieved functional independence at the 90-day follow-up (difference, 7.7%, 1-sided 97.5% CI, −5.1% to ∞)P for noninferiority = .003). No significant between-group differences were detected in symptomatic intracerebral hemorrhage (6.1% vs 6.8%; difference, −0.8%; 95% CI, −7.1% to 5.6%) and 90-day mortality (17.2% vs 17.8%; difference, −0.5%; 95% CI, −10.3% to 9.2%).
Conclusions and Relevance
Among patients with ischemic stroke due to proximal anterior circulation occlusion within 4.5 hours from onset, endovascular treatment alone, compared with intravenous alteplase plus endovascular treatment, met the prespecified statistical threshold for noninferiority for the outcome of 90-day functional independence. These findings should be interpreted in the context of the clinical acceptability of the selected noninferiority threshold.
Chinese Clinical Trial Registry: ChiCTR-IOR-17013568
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Corresponding Authors: Qingwu Yang, MD, PhD, Department of Neurology, Xinqiao Hospital and The Second Affiliated Hospital, Army Medical University (Third Military Medical University), No. 183 Xinqiao Main St, Shapingba District, Chongqing 400037, China (email@example.com); Raul G. Nogueira, MD, Department of Neurology, Marcus Stroke & Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, 80 Jesse Hill Jr Dr SE, Room 8D108A, Atlanta, GA 30303 (firstname.lastname@example.org).
Accepted for Publication: December 3, 2020.
Author Contributions: Drs Q. Yang and Nogueira had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Drs Zi and Z. Qiu are co–first authors. Drs Q. Yang and Nogueira are co–corresponding authors.
Concept and design: Zi, Z. Qiu, F. Li, Sang, D. Wu, W. Liu, Shuai, Nogueira, Q. Yang.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: All authors.
Critical revision of the manuscript for important intellectual content: Zi, Z. Qiu, F. Li, Sang, D. Wu, W. Luo, W. Liu, Z. Zhou, Bai, Q. Yang.
Statistical analysis: W. Luo, Shuai Liu, X. Huang.
Obtained funding: Zi, Z. Qiu, F. Li, Sang, Q. Yang.
Administrative, technical, or material support: Zi, Z. Qiu, F. Li, Sang, D. Wu, W. Luo, Shuai Liu, Yuan, Song, Z. Shi, W. Huang, Min Zhang, W. Liu, Z. Guo, T. Qiu, Q. Shi, P. Zhou, L. Wang, Fu, Shudong Liu, S. Yang, S. Zhang, Z. Zhou, X. Huang, Y. Wang, J. Luo, Bai, Min Zhang, Y. Wu, Zeng, Wan, C. Wen, H. Wen, Ling, Z. Chen, Peng, Ai, F. Guo, H. Li, J. Guo, Guan, Zhiyi Wang, Y. Liu, Pu, Zhen Wang, H. Liu, L. Chen, J. Huang, G. Yang, Gong, Shuai, Q. Yang.
Supervision: Zi, Z. Qiu, F. Li, Sang, D. Wu, Shuai, Nogueira, Q. Yang.
Conflict of Interest Disclosures: Dr Nogueira reported receiving consulting fees for advisory roles with Anaconda, Biogen, Cerenovus, Genentech, Imperative Care, Medtronic, Phenox, Prolong Pharmaceuticals, and Stryker Neurovascular and having stock options for advisory roles with Astrocyte, Brainomix, Cerebrotech, Ceretrieve, Corindus Vascular Robotics, Vesalio, Viz-AI, and Perfuze. No other disclosures were reported.
Funding/Support: The study was supported by grants 81525008, 81901236, 81801157 from the National Natural Science Foundation of China, 2019ZX001 from the Chongqing Major Disease Prevention and Control Technology Research Project, 2019XLC2008 2019XLC3016 from the Clinical Medical Research Talent Training Program of Army Medical University, and 2018JSLC0017 from the Major Clinical Innovation Technology Project of the Second Affiliated Hospital of Army Medical University.
Role of the Funder/Sponsor: The sponsors had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Group Information: The DEVT Trial members are listed in Supplement 1.
Data Sharing Statement: See Supplement 5.
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