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Original Investigation
January 19, 2021

Effect of Endovascular Treatment Alone vs Intravenous Alteplase Plus Endovascular Treatment on Functional Independence in Patients With Acute Ischemic Stroke: The DEVT Randomized Clinical Trial

Author Affiliations
  • 1Department of Neurology, Xinqiao Hospital and The Second Affiliated Hospital, Army Medical University (Third Military Medical University), Shapingba District, Chongqing, China
  • 2Department of Neurology, The 903rd Hospital of The Chinese People’s Liberation Army, Xihu District, Hangzhou, China
  • 3Department of Neurology, Affiliated Hangzhou First People’s Hospital, Zhejiang University School of Medicine, Hangzhou, China
  • 4Huaian Medical District of Jingling Hospital, Medical School of Nanjing University, Huaian, China
  • 5Department of Neurosurgery, The 904th Hospital of The Chinese People’s Liberation Army, Wuxi, China
  • 6Department of Neurology, Maoming Traditional Chinese Medicine Hospital, Maonan District, Maoming, China
  • 7Department of Neurology, Wuhan No. 1 Hospital, Qiaokou District, Wuhan, China
  • 8Department of Neurology, The First People’s Hospital of Zigong, Da'an District, Zigong, China
  • 9Department of Neurology, The First People’s Hospital of Xiangyang, Fancheng District, Xiangyang, China
  • 10Department of Neurology, The Third People’s Hospital of Zigong, Gongjing District, Zigong, China
  • 11Department of Neurology, Xuzhou Central Hospital, Quanshan District, Xuzhou, China
  • 12Department of Neurology, Yongchuan Hospital of Chongqing Medical University, Chongqing Key Laboratory of Cerebrovascular Disease Research, Yongchuan District, Chongqing, China
  • 13Department of Neurology, The 902nd Hospital of The Chinese People’s Liberation Army, Yuhui District, Bengbu, China
  • 14Department of Neurology, The Affiliated Hospital of Yangzhou University, Guangling District, Yangzhou, China
  • 15Department of Neurology, Yijishan Hospital of Wannan Medical College, Wuhu, China
  • 16Department of Neurology, The Fifth People’s Hospital of Chengdu, Wenjiang District, Chengdu, China
  • 17Department of Neurology, Sichuan Mianyang 404 Hospital, Fucheng District, Mianyang, China
  • 18Department of Neurology, The First Affiliated Hospital of Henan Science and Technology University, Jianxi District, Luoyang, China
  • 19Department of Neurology, Jiangmen Central Hospital, Pengjiang District, Jiangmen, China
  • 20Department of Neurology, Chongzhou People's Hospital, Chongzhou, China
  • 21Department of Neurology, Ganzhou People's Hospital, Zhanggong District, Ganzhou, China
  • 22Department of Neurology, Yangluo District of Hubei Zhongshan Hospital, Qiaokou District, Wuhan, China
  • 23Department of Neurology, Nanyang Central Hospital, Wolong District, Nanyang, China
  • 24Department of Neurology, Xiangyang Central Hospital, Xiangcheng District, Xiangyang, China
  • 25Department of Neurology, Zhongshan People's Hospital, Zhongshan, China
  • 26Department of Neurology, Mianzhu People's Hospital, Mianzhu, China
  • 27Department of Neurology, Deyang People’s Hospital, Jingyang District, Deyang, China
  • 28Department of Neurology, Taihe Affiliated Hospital of Shiyan, Shiyan, China
  • 29Department of Neurology, Sichuan Provincial People’s Hospital, Qingyang District, Chengdu, China
  • 30Department of Neurology, Zhongnan Hospital of Wuhan University, Wuchang District, Wuhan, China
  • 31Department of Neurology, Chongqing Three Gorges Central Hospital, Wanzhou District, Chongqing, China
  • 32Department of Neurology, The Third Affiliated Hospital of Guangzhou Medical University, Liwan District, Guangzhou, China
  • 33Department of Neurology, Huazhou People’s Hospital, Hexi District, Huazhou, China
  • 34Department of Neurology, Lu'an People’s Hospital, Jin'an District, Lu'an, China
  • 35Department of Neurology, Hubei Provincial People's Hospital, Wuchang District, Wuhan, China
  • 36Department of Neurology, Changsha Central Hospital, Yuhua District, Changsha, China
  • 37Department of Neurology, Marcus Stroke & Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, Atlanta, Georgia
JAMA. 2021;325(3):234-243. doi:10.1001/jama.2020.23523
Visual Abstract. Effect of Endovascular Treatment Alone vs Endovascular Treatment Plus IV Alteplase on Functional Independence Among Patients With Acute Ischemic Stroke
Effect of Endovascular Treatment Alone vs Endovascular Treatment Plus IV Alteplase on Functional Independence Among Patients With Acute Ischemic Stroke
Conversations with Dr Bauchner (21:48)
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Key Points

Question  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?

Findings  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%.

Meaning  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.

Abstract

Importance  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.

Objective  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).

Interventions  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.

Results  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.

Trial Registration  Chinese Clinical Trial Registry: ChiCTR-IOR-17013568

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