Background: The benefit of combined treatment with intravenous thrombolysis before endovascular thrombectomy in patients with acute ischaemic stroke caused by large vessel occlusion remains unclear. We hypothesised that the clinical outcomes of patients with stroke with large vessel occlusion treated with direct endovascular thrombectomy within 4·5 h would be non-inferior compared with the outcomes of those treated with standard bridging therapy (intravenous thrombolysis before endovascular thrombectomy).
Methods: DIRECT-SAFE was an international, multicentre, prospective, randomised, open-label, blinded-endpoint trial. Adult patients with stroke and large vessel occlusion in the intracranial internal carotid artery, middle cerebral artery (M1 or M2), or basilar artery, confirmed by non-contrast CT and vascular imaging, and who presented within 4·5 h of stroke onset were recruited from 25 acute-care hospitals in Australia, New Zealand, China, and Vietnam. Eligible patients were randomly assigned (1:1) via a web-based, computer-generated randomisation procedure stratified by site of baseline arterial occlusion and by geographic region to direct endovascular thrombectomy or bridging therapy. Patients assigned to bridging therapy received intravenous thrombolytic (alteplase or tenecteplase) as per standard care at each site; endovascular thrombectomy was also per standard of care, using the Trevo device (Stryker Neurovascular, Fremont, CA, USA) as first-line intervention. Personnel assessing outcomes were masked to group allocation; patients and treating physicians were not. The primary efficacy endpoint was functional independence defined as modified Rankin Scale score 0-2 or return to baseline at 90 days, with a non-inferiority margin of -0·1, analysed by intention to treat (including all randomly assigned and consenting patients) and per protocol. The intention-to-treat population was included in the safety analyses. The trial is registered with ClinicalTrials.gov, NCT03494920, and is closed to new participants.
Findings: Between June 2, 2018, and July 8, 2021, 295 patients were randomly assigned to direct endovascular thrombectomy (n=148) or bridging therapy (n=147). Functional independence occurred in 80 (55%) of 146 patients in the direct thrombectomy group and 89 (61%) of 147 patients in the bridging therapy group (intention-to-treat risk difference -0·051, two-sided 95% CI -0·160 to 0·059; per-protocol risk difference -0·062, two-sided 95% CI -0·173 to 0·049). Safety outcomes were similar between groups, with symptomatic intracerebral haemorrhage occurring in two (1%) of 146 patients in the direct group and one (1%) of 147 patients in the bridging group (adjusted odds ratio 1·70, 95% CI 0·22-13·04) and death in 22 (15%) of 146 patients in the direct group and 24 (16%) of 147 patients in the bridging group (adjusted odds ratio 0·92, 95% CI 0·46-1·84).
Interpretation: We did not show non-inferiority of direct endovascular thrombectomy compared with bridging therapy. The additional information from our study should inform guidelines to recommend bridging therapy as standard treatment.
Funding: Australian National Health and Medical Research Council and Stryker USA.
Download full-text PDF |
Source |
---|---|
http://dx.doi.org/10.1016/S0140-6736(22)00564-5 | DOI Listing |
Orv Hetil
December 2024
1 Debreceni Egyetem, Általános Orvostudományi Kar, Aneszteziológiai és Intenzív Terápiás Klinika Debrecen, Nagyerdei krt. 98., 4032 Magyarország.
Am J Hypertens
December 2024
Department of Neurosurgery, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, China.
Background: Systolic blood pressure (BP) is a key factor in the outcomes of patients with acute ischemic stroke (AIS) receiving endovascular thrombectomy (EVT). However, the factors that mediate the association between BP and clinical outcome are unclear.
Methods: Consecutive patients with AIS in the anterior circulation underwent continuous blood pressure monitoring for 24 hours.
Stroke
January 2025
Berry Consultants LLC, Austin, TX (E.L., A.M.C., S.M.B., R.J.L.).
Clinical trials of treatments for stroke have generally utilized 2-arm, randomized designs to evaluate a single intervention against a control. Running separate clinical trials, with each addressing a single therapeutic question, is resource intensive and slows evidence generation, especially in a field with rapidly expanding treatment options and evolving practices. Platform trials-randomized clinical trials designed to evaluate multiple interventions that may enter and exit the ongoing platform based on a master protocol-accelerate the investigation of multiple therapeutic options within a single infrastructure.
View Article and Find Full Text PDFClin Neuroradiol
December 2024
Interventional Neuroradiology, Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, No.119 South 4th Ring West Road, 100070, Fengtai District, Beijing, China.
Background: The Hyperdense Middle Cerebral Artery Sign (HMCAS) is an early marker of acute MCA occlusion on non-contrast CT (NCCT), which has been linked with stroke type and thrombus composition.
Aims: To assess the prognostic value of HMCAS in M1 occlusion patients treated with endovascular thrombectomy and explore its predictive value across different patients.
Methods: Patients with M1 occlusion were selected from the ANGEL-ACT registry, which comprised 1793 individuals.
Ther Adv Neurol Disord
December 2024
Department of Neurology, Nanjing First Hospital, Nanjing Medical University, No. 68 Changle Road, Nanjing 210000, Jiangsu Province, China.
Background: Time elapsed from stroke onset and baseline infarct volume is influential on endovascular thrombectomy (EVT) outcomes.
Objectives: This study aimed to explore the utility of early infarct growth rate (EIGR) measured by apparent diffusion coefficient (ADC) in predicting symptomatic intracranial hemorrhage (sICH) of ischemic stroke patients after EVT.
Methods: We retrospectively analyzed patients from the prospectively maintained stroke registry admitted between January 2019 and March 2023, presenting with large vessel occlusive stroke in the anterior circulation.
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!