Direct transfer to angiosuite for patients with severe acute stroke treated with thrombectomy: the multicentre randomised controlled DIRECT ANGIO trial protocol

Wrong goal. 'is superior ' is not the goal to be shooting for, 100% recovery is the only goal in stroke. Haven't your mentors and senior researchers told you that? Or do they incompetently not know that either?

Direct transfer to angiosuite for patients with severe acute stroke treated with thrombectomy: the multicentre randomised controlled DIRECT ANGIO trial protocol

1. Nolwenn Riou-Comte1,
2. François Zhu2,3,
3. Aboubaker Cherifi4,
4. http://orcid.org/0000-0002-0945-5656Sébastien Richard1,
5. Lionel Nace5,
6. Gérard Audibert6,
7. Hamza Achit7,
8. Vincent Costalat8,
9. Caroline Arquizan9,
10. Olivier Beaufils10,
11. Arturo Consoli11,12,
12. Bertrand Lapergue13,
13. Thomas Loeb14,
14. Aymeric Rouchaud15,
15. Francisco Macian16,
16. Dominique Cailloce17,
17. Alessandra Biondi18,
18. Thierry Moulin19,
19. Thibaut Desmettre20,
20. Gaultier Marnat21,
21. Igor Sibon22,
22. Xavier Combes23,
23. Ariel Pablo Lebedinsky24,
24. Francis Vuillemet25,
25. Nicolas Kempf26,
26. Laurent Pierot27,
27. Solene Moulin28,
28. Philippe Lemmel29,
29. Mikael Mazighi30,
30. Raphael Blanc30,
31. Candice Sabben31,
32. Eric Schluck32,
33. Serge Bracard2,3,
34. René Anxionnat2,3,
35. Francis Guillemin33,
36. Gabriela Hossu3,4,
37. http://orcid.org/0000-0001-8424-4464Benjamin Gory2,3
38. DIRECT ANGIO Investigators

1. Correspondence to Professor Benjamin Gory; benjagory@gmail.com

Abstract

Introduction 

Mechanical thrombectomy (MT) increases functional independence in patients with acute ischaemic stroke with anterior circulation large vessel occlusion (LVO), and the probability to achieve functional independence decreases by 20% for each 1-hour delay to reperfusion. Therefore, we aim to investigate whether direct angiosuite transfer (DAT) is superior to standard imaging/emergency department-based management in achieving 90-day functional independence in patients presenting with an acute severe neurological deficit likely due to LVO and requiring emergent treatment with MT.

Methods and analysis 

 DIRECT ANGIO (Effect of DIRECT transfer to ANGIOsuite on functional outcome in patient with severe acute stroke treated with thrombectomy: the randomised DIRECT ANGIO Trial) trial is an investigator-initiated, multicentre, prospective, randomised, open-label, blinded endpoint (PROBE) study. Eligibility requires a patient ≤75 years, pre-stroke modified Rankin Scale (mRS) 0–2, presenting an acute severe neurological deficit and admitted within 5 hours of symptoms onset in an endovascular-capable centre. A total of 208 patients are randomly allocated in a 1:1 ratio to DAT or standard management. The primary outcome is the rate of patients achieving a functional independence, assessed as mRS 0–2 at 90 days. Secondary endpoints include patients presenting confirmed LVO, patients eligible to intravenous thrombolysis alone, patients with intracerebral haemorrhage and stroke-mimics, intrahospital time metrics, early neurological improvement (reduction in National Institutes of Health Stroke Scale by ≥8 points or reaching 0–1 at 24 hours) and mRS overall distribution at 90 days and 12 months. Safety outcomes are death and intracerebral haemorrhage transformation. Medico-economics analyses include health-related quality of life and cost utility assessment.

Ethics and dissemination 

 The DIRECT ANGIO trial was approved by the ethics committee of Ile de France 1. Study began in April 2020. Results will be published in an international peer-reviewed medical journal.

Trial registration number NCT03969511.