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. 2024 Dec;9(4):1083-1092.
doi: 10.1177/23969873241250212. Epub 2024 May 3.

EnDovascular therapy plus best medical treatment (BMT) versus BMT alone for medIum distal veSsel occlusion sTroke (DISTAL): An international, multicentre, randomized-controlled, two-arm, assessor-blinded trial

Psychogios Marios-Nikos  1 , Brehm Alex  1 , Fiehler Jens  2 , Fragata Isabel  3   4 , Gralla Jan  5 , Katan Mira  6 , Leker Ronen  7 , Machi Paolo  8 , Ribo Marc  9 , Saver Jeffrey L  10 , Strbian Daniel  11 , van Es Adriaan  12 , Zimmer Claus  13 , Rommers Nikki  14 , Balmer Luzia  1 , Fischer Urs  5   15
Affiliations

EnDovascular therapy plus best medical treatment (BMT) versus BMT alone for medIum distal veSsel occlusion sTroke (DISTAL): An international, multicentre, randomized-controlled, two-arm, assessor-blinded trial

Psychogios Marios-Nikos et al. Eur Stroke J. 2024 Dec.

Abstract

Rationale: Whether endovascular therapy (EVT) in addition to best medical treatment (BMT) in people with acute ischemic stroke (AIS) due to a medium distal vessel occlusion (MDVO) is beneficial remains unclear.

Aim: To determine if people experiencing an AIS due to an isolated MDVO (defined as the co- or non-dominant M2 segment, the M3 or M4 segment of the middle cerebral artery, the A1, A2, or A3 segment of the anterior cerebral artery or the P1, P2 or P3 segment of the posterior cerebral artery) will have superior outcome if treated with EVT in addition to BMT compared to BMT alone.

Sample size: To randomize 526 participants 1:1 to EVT plus BMT or BMT alone.

Methods and design: A multicentre, international, prospective, randomized, open-label, blinded-endpoint (PROBE) superiority trial.

Outcomes: The primary efficacy endpoint is the distribution of disability levels on the modified Rankin Scale at 90 days. Secondary clinical efficacy outcomes include normalized change in National Institutes of Health Stroke Scale score from baseline to day 1, cognitive outcome at 90 days, and health-related quality of life at 90 days. Safety outcomes include all serious adverse events, symptomatic intracranial hemorrhage within 24 h, and all-cause mortality up to 90 days. Secondary imaging outcomes include successful reperfusion at end of EVT procedure and recanalization of target artery at 24 h.

Discussion: DISTAL will inform physicians whether EVT in addition to BMT in people with AIS due to a MDVO is more efficacious than BMT alone.

Keywords: Ischemic stroke; distal vessel occlusion; endovascular therapy; mechanical thrombectomy; medium vessel occlusion.

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Conflict of interest statement

Declaration of conflicting interestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: This is an academic investigator-initiated trial.Marios Psychogios: Grants from the Swiss National Science Foundation (SNF) for the DISTAL trial (33IC30_198783), ICARUS (32003B_220118) and TECNO trial (32003B_204977), Grant from Bangerter-Rhyner Stiftung for the DISTAL trial. Unrestricted Grants for the DISTAL trial from Stryker Neurovascular Inc., Medtronic Inc., Phenox GmbH, Penumbra Inc. and Rapid Medical Inc., Sponsor-PI SPINNERS trial (Funded by a Siemens Healthineers AG Grant), Research agreement with Siemens Healthineers AG, Local PI for the ACT in STROKE, ASSIST, EXCELLENT, TENSION, COATING, SURF and ESCAPE-NEXT trials. Speaker fees: Stryker Neurovascular Inc., Medtronic Inc., Penumbra Inc., Acandis GmbH, Phenox GmbH, Siemens Healthineers AG.Alex Brehm: none.Jens Fiehler: Research support: German Ministry of Science and Education (BMBF), German Ministry of Economy and Innovation (BMWi), German Research Foundation (DFG), European Union (EU), Hamburgische Investitions- und Förderbank (IFB), Medtronic, Microvention, Route92, Stryker. Consultant for: Acandis, Bayer, Cerenovus, Covidien, Medtronic, Microvention, Penumbra, Phenox, Roche, Stryker, TG Medical. Stockholder: Tegus Medical, Eppdata, Vastrax.Isabel Fragata: outside the trial: Speakers honorarium from Terumo and Medtronic; Vice President of the Portuguese Neurointerventional Society.Jan Gralla: Global PI of STAR (NCT01327989) and Swift Direct (NCT03192332) (Medtronic), Consultancy for Johnson & Johnson/Cerenovus.Mira Katan: Research support of the SNF, main applicant of the MOSES trial (182267), the Crescendo ERA NET Neuron (213471); grants from the Swiss Heart Foundation; participation on advisory boards and/or speaker honoraria for Medtronic, BMS Pfizer/Jansen and Astra Zeneca. In kind contributions from BRAHMS Thermofisher Scientificand Roche Diagnostics. All not related to this study.Ronen Leker: Speaker honoraria from IscemaView, Bayer, Boehringer Ingelheim, Pfizer, Jansen, Biogen, Medtronic and Abott, and consultation fees from Filterlex.Paolo Machi: Consultant for Medtronic, Stryker and Mivi Neuroscience.Marc Ribo: Personal fees from Anaconda Biomed, Nora Health, AptaTargets, Cerenovus, Medtronic, Methinks, Philips, Sanofi, Stryker, Balt, Boehringer Ingelheim and Rapid AI outside the submitted work.Jeffrey L Saver: Consulting fees for advising on rigorous and safe clinical trial design and conduct from Medtronic, NeuroMerit, Neuronics, Phenox, Phillips, and Rapid Medical.Daniel Strbian: none.Adriaan van Es: none.Nikki Rommers: none.Claus Zimmer: No relevant relationships regarding activities related to the present article. He has served on scientific advisory boards for Philips and Bayer Schering and as co-editor on the Advisory Board of Clinical Neuroradiology; has received speaker honoraria from Bayer-Schering and Philips; the institution has received research support and investigator fees for clinical studies from Biogen Idec, Quintiles, MSD Sharp & Dome, Boehringer Ingelheim, Inventive Health Clinical UK Ltd., Advance Cor, Brainsgate, Pfizer, Bayer-Schering, Novartis, Roche, Servier, Penumbra, WCT GmbH, Syngis, SSS International Clinical Research, PPD Germany GmbH, Worldwide Clinical Trials Ltd., Phenox, Covidien, Actelion, Medivation, Medtronic, Harrison Clinical Research, Concentric, Pharmtrace, Reverse Medical Corp., Premier Research Germany Ltd., Surpass Medical Ltd., GlaxoSmithKline, AXON Neuroscience, Bristol-Myers Squibb, Genentech, Acandis, EISAI, NeuroRx, Italfarmaco, Bioclinica, MIAC and IXICO. No patents issued and pending.Luzia Balmer: none.Urs Fischer: Research support of the Swiss National Science Foundation and the Swiss Heart Foundation; PI of the ELAN trial, Co-PI of the DISTAL, TECNO, SWIFT DIRECT, SWITCH, ELAPSE and ICARUS trial; research grants from Medtronic (BEYOND SWIFT, SWIFT DIRECT), from Stryker, Rapid medical, Penumbra, Medtronic and Phenox (DISTAL), and from Boehringer Ingelheim (TECNO), whereas all fees were paid to the institution; consultancies for Medtronic, Stryker, and CSL Behring (fees paid to institution); participation in an advisory board for Alexion/Portola, Boehringer Ingelheim, Biogen and Acthera (fees paid to institution); member of a clinical event committee (CEC) of the COATING study (Phenox) and member of the data and safety monitoring committee (DSMB) of the TITAN, LATE_MT and IN EXTREMIS trials; presidency of the Swiss Neurological Society.

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Graphical abstract
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Figure 1.
Patient flow chart.
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