The Endovascular Stroke Treatment Only (ESTO) Trial. A Phase 2 Open Label Multicenter Trial Endovascular Stroke Treatment Only (ESTO) Trial

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Adnan. Qureshi
Erdem Gurkas
Atilla Ozcan Ozdemir
Cetin Kursad Akpınar
Aysenur Onalan
Ozlem Aykac
Bilgehan Atılgan Acar
Türkan Acar
Xiaoyu Ma
Wei Huang

Abstract

Background and Aims— We performed a phase 2 trial to determine whether mechanical thrombectomy (MT) alone in acute ischemic stroke patients demonstrates “promise” or a lack thereof (“futility”) compared with those treated with intravenous (IV) recombinant tissue plasminogen activator (rt-PA) (historical controls).


Methods— Subjects with a baseline National Institutes of Health Stroke Scale (NIHSS) score ≥6 who presented within 4.5 hours of symptom onset with documented occlusion of intracranial internal carotid artery, or M1 or M2 segment of the middle cerebral artery on computed tomographic angiography were treated with MT alone. The primary outcome was functional independence defined by a modified Rankin scale (mRS) of 0-2 at 90 days post recruitment.


Results— The 72 subjects (median baseline NIHSS score of 17) were treated with MT with a median time from symptom onset of 180 minutes with complete and partial angiographic recanalization observed in 45 and 27 patients, respectively. Symptomatic intracerebral hemorrhage (≥4 points NIHSS score increase) within 24 hours was observed in none of the 72 subjects. Overall, functional independence at 90 days was observed in 38 (52.8%) of 72 subjects. The rate was higher than the rate of functional independence in a comparable historical cohort of patients treated with IV rt-PA (52.8% versus 35.9%, p=0.032) enabling us to reject the futility hypothesis.


Conclusions— Due to the relatively high rates of functional independence at 90 days observed in this phase 2 trial, a randomized phase 3 comparing standard intravenous rt-PA followed by MT with primary MT is being planned.

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How to Cite
Qureshi, A., Gurkas, E., Ozdemir, A. O., Akpınar, C. K., Onalan, A., Aykac, O., Acar, B. A., Acar, T., Ma, X., & Huang, W. (2023). The Endovascular Stroke Treatment Only (ESTO) Trial. A Phase 2 Open Label Multicenter Trial: Endovascular Stroke Treatment Only (ESTO) Trial. Journal of Vascular and Interventional Neurology, 14(2), 1–21. Retrieved from https://ojs.jvin.org/index.php/jvin/article/view/15
Section
Original research article
Author Biographies

Erdem Gurkas, MD.

Department of Neurology, Kartal Dr. Lutfi Kirdar City Hospital, Istanbul, Turkey

Atilla Ozcan Ozdemir, MD.

Eskisehir Osmangazi University Medical Faculty, Stroke Center, Eskisehir, Turkey

Cetin Kursad Akpınar, MD.

Deparment of Neurology, Samsun Training and Research Hospital, Samsun University, Samsun, Turkey

Aysenur Onalan, MD.

Department of Neurology, Kartal Dr. Lutfi Kirdar City Hospital, Istanbul, Turkey

Ozlem Aykac, MD.

Eskisehir Osmangazi University Medical Faculty, Stroke Center, Eskisehir, Turkey

Bilgehan Atılgan Acar, MD.

Department of Neurology, Sakarya University Faculty of Medicine, Sakarya, Turkey.

Türkan Acar, MD.

Department of Neurology, Sakarya University Faculty of Medicine, Sakarya, Turkey

Xiaoyu Ma, MS.

Department of Neurology, University of Missouri, MO, USA

Wei Huang, MA.

Department of Neurology, University of Missouri, MO, USA

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