Understanding Noninferiority Trials: What Stroke Specialists Should Know.

Noninferiority trials aim to prove that the efficacy, defined in terms of a key clinical outcome, of a new treatment is not meaningfully worse than that of an established active control. Noninferiority trials are important when other aspects of care can be improved, such as convenience, toxicity, costs, and safety (nonefficacy benefits). While the motivation for a noninferiority trial is straightforward, the design, execution, and interpretation of these trials is not a trivial task.

Influence of prestroke glycemic status on outcomes by age in patients with acute ischemic stroke and diabetes mellitus.

Background: This study aimed to explore the association between admission HbA1c and the risk of 1-year vascular outcomes stratified by age group in patients with acute ischemic stroke (AIS) and diabetes mellitus (DM).

Methods: This study analyzed prospective multicenter data from patients with AIS and DM. Admission HbA1C were categorized as:≤6.

Magnitude of effect of low dose colchicine, a newly food and drug administration approved treatment for stroke prevention.

Background: As the Food and Drug Administration in June 2023 approved low dose colchicine for primary prevention of stroke and other cardiovascular events, an updated meta-analysis of stroke outcomes in randomized trials would help inform clinical practice.**** METHODS: Systematic, study-level meta-analysis of randomized clinical trials of long-term colchicine in patients with established atherosclerotic cardiovascular disease (ASCVD, preponderantly primary prevention for stroke) or following non-cardioembolic ischemic stroke/transient ischemic attack (secondary prevention). Heterogeneity was assessed with the I statistic and Cochrane's Q and potential bias assessed with the Risk of Bias 2.

Association Between Time to Treatment and Outcomes of Endovascular Therapy vs Medical Management in Patients With Large Ischemic Stroke.

Background And Objectives: Randomized trials have proven the benefit of endovascular therapy (EVT) for acute large ischemic stroke. This study was to characterize the effect of time to treatment on benefit of EVT vs medical management (MM) among patients with large ischemic stroke.

Methods: This was a post hoc analysis of the Endovascular Therapy in Acute Anterior Circulation Large Vessel Occlusive Patients with a Large Infarct Core randomized trial.

A Prospective Multicenter Analysis of Mobile Stroke Unit Cost-Effectiveness.

Objective: Given the high disease and cost burden of ischemic stroke, evaluating the clinical efficacy and cost-effectiveness of new approaches to prevent and treat ischemic stroke is critical. Effective ischemic stroke management depends on timely administration of thrombolytics after stroke onset. This study evaluates the cost-effectiveness associated with the use of mobile stroke units (MSUs) to expedite tissue plasminogen activator (tPA) administration, as compared with standard management through emergency medical services (EMS).

Mobile stroke units services in Germany: A cost-effectiveness modeling perspective on catchment zones, operating modes, and staffing.

Background And Purpose: Investigating the cost-effectiveness of future mobile stroke unit (MSU) services with respect to local idiosyncrasies is essential for enabling large-scale implementation of MSU services. The aim of this study was to assess the cost-effectiveness for varying urban German settings and modes of operation.

Methods: Costs of different operating times together with different personnel configurations were simulated.

Care Quality and Outcomes of Ischemic Stroke in Patients With Premorbid Dementia: Get With The Guidelines-Stroke Registry.

Background: Patients with premorbid dementia have been generally excluded from trials of stroke therapies, and their dementia diagnosis may affect the care received. There are few data on the quality of stroke care and outcomes in these patients.

Methods: We compared the quality of care and outcomes for acute ischemic stroke patients with versus without premorbid dementia using national data from the Get With The Guidelines-Stroke registry between July 1, 2020, and December 31, 2021.

Advancing stroke safety and efficacy through early tirofiban administration after intravenous thrombolysis: The multicenter, randomized, placebo-controlled, double-blind ASSET IT trial protocol.

Background: Intravenous thrombolysis (IVT) is the cornerstone treatment for the acute ischemic stroke (AIS) within 4.5 h after onset. Current guidelines recommend administering antiplatelet medications 24 h after IVT.

Effect of Intravenous Tirofiban Versus Placebo on First-Pass Successful Reperfusion in Endovascular Stroke Thrombectomy: Insights From the RESCUE BT Randomized Clinical Trial.

Background: First-pass successful reperfusion (FPSR), defined as a successful/complete reperfusion achieved after a single thrombectomy pass, is predictive of favorable outcome in patients with acute ischemic stroke with large-vessel occlusion. It is unknown whether intravenous tirofiban is effective in increasing the rate of FPSR in acute anterior large-vessel occlusion stroke.

Methods And Results: Patients who had acute large-vessel occlusion stroke presenting within 24 hours and underwent endovascular thrombectomy were analyzed from the RESCUE BT (Intravenous Tirofiban for Patients With Large Vessel Occlusion Stroke) clinical trial, of which the main analysis was neutral.

Efficacy and Safety of Intravenous Tenecteplase Before Endovascular Thrombectomy for Acute Ischemic Stroke: The Multicenter, Randomized, BRIDGE-TNK Trial Protocol.

Background: Six randomized trials have not detected a difference between intravenous alteplase plus endovascular thrombectomy and endovascular thrombectomy alone in stroke. Tenecteplase, a recombinant human tenecteplase tissue-type plasminogen activator, is a genetically modified variant of alteplase. It is unclear whether the outcomes are different if alteplase is replaced with tenecteplase.

Twenty Years of Sustained Improvement in Quality of Care and Outcomes for Patients Hospitalized With Stroke or Transient Ischemic Attack: Data From The Get With The Guidelines-Stroke Program.

Background: The Get With The Guidelines-Stroke program is a quality improvement initiative designed to enhance adherence to evidence-based stroke care. Since its inception in 2003, over 2800 hospitals in the United States have participated in the program.

Methods: We examined patient characteristics, adherence to performance measures, and in-hospital outcomes in patients hospitalized for acute ischemic stroke, subarachnoid hemorrhage, intracerebral hemorrhage, and transient ischemic attack in The Get With The Guidelines-Stroke hospitals from 2003 through 2022.

Adjunctive intra-arterial tenecteplase after successful endovascular thrombectomy in patients with large vessel occlusion stroke (POST-TNK): Study rationale and design.

Rationale: Adjunct intra-arterial alteplase has been shown to potentially improve clinical outcomes in patients with large vessel occlusion (LVO) stroke who have undergone successful endovascular thrombectomy. Tenecteplase, known for its enhanced fibrin specificity and extended activity duration, could potentially enhance outcomes in stroke patients after successful reperfusion when used as an adjunct intra-arterial therapy.

Aim: To explore the safety and efficacy of intra-arterial tenecteplase after successful endovascular thrombectomy in patients with LVO stroke.

Adaptive Trials in Stroke: Current Use and Future Directions.

Inclusion of adaptive design features in a clinical trial provides preplanned flexibility to dynamically modify a trial during its conduct while preserving validity and integrity. Adaptive trials are needed to accelerate the conduct of more efficient, informative, and ethical clinical research in the field of neurology. Stroke is a natural candidate for adoption of these innovative approaches to trial design.

Endovascular vs Medical Management of Acute Basilar Artery Occlusion: A Secondary Analysis of a Randomized Clinical Trial.

Importance: In several randomized clinical trials, endovascular thrombectomy led to better functional outcomes than conventional treatment at 90 days poststroke in patients with acute basilar artery occlusion. However, the long-term clinical outcomes of these patients have not been well delineated.

Objective: To evaluate 1-year clinical outcomes in patients with acute basilar artery occlusion following endovascular thrombectomy vs control.

Intracranial artery calcification: Frequency, determinants, and modification of outcomes from endovascular thrombectomy.

Introduction: Intracranial artery calcification (ICAC) is a common finding on computed tomography (CT) in patients presenting with large vessel occlusion acute ischemic stroke (LVO-AIS) and could serve as a useful biomarker of intracranial atherosclerosis and altered intracranial vessel pliability in patients undergoing endovascular thrombectomy (EVT).

Methods: This was a retrospective cohort study analyzing consecutive patients undergoing CT head prior to EVT between 2016 and 2020. Extent of ICAC proximal to the target vessel was scored using a validated grading scale examining thickness and circumferential extent of calcifications.

Modified Rankin Scale disability status at day 4 poststroke is an informative predictor of long-term day 90 outcome.

Background: Long-term disability after stroke is standardly assessed 3 months post-onset, using the modified Rankin Scale (mRS). The value of an early, day 4 mRS assessment for projecting the 3-month disability outcome has not been formally investigated.

Methods: In this cohort of patients with acute cerebral ischemia and intracranial hemorrhage, we analyzed day 4 and day 90 mRS assessments in the NIH Field Administration of Stroke Therapy- Magnesium (FAST-MAG) Phase 3 trial.