Reliability and applicability of angiographic outcome scales in WEB device-treated aneurysms: a systematic review.

Purpose: Various angiographic assessment scales have been used to report the results of endovascular treatment with the WEB device. We aimed to review the use and reliability of these scales.

Methods: We systematically reviewed studies reporting angiographic outcomes of WEB-treated aneurysms from January 2010 to May 2023.

Flow diversion for the treatment of distal circulation aneurysms: A randomized comparison.

Background And Purpose: Flow diversion (FD) has expanded beyond initial indications (proximal carotid artery aneurysms) to include distal circulation aneurysms (on the anterior, middle, or posterior cerebral arteries). Our objective was to examine results obtained from aneurysms in these locations in the Flow Diversion in the Treatment of Intracranial Aneurysms Trial (FIAT) which compared FD with alternative standard management options (ASMO).

Materials And Methods: FIAT was an all-inclusive parallel-group 1:1 randomized study comparing FD with one of 4 ASMOs (coiling +/-stenting, parent vessel occlusion (PVO), clipping, or observation, pre-specified by clinical judgment).

International practice patterns and perspectives on endovascular therapy for the treatment of cerebral venous thrombosis.

Background: Cerebral venous thrombosis (CVT) accounts for 0.5-1% of all strokes. The role of endovascular therapy (EVT) in the management of CVT remains controversial and variations in practice patterns are not well known.

Understanding the role of induction, intensions and extensions in pragmatic clinical research and practice.

Background: Pragmatic clinical research methods are poorly understood, but essential to practice outcome-based medical or surgical care. Pragmatic research aims to verify the connections between medical knowledge and the reality of practice. Its methods can be understood by reviewing the problems of induction, as well as the related linguistic and mathematical notions of intensions and extensions.

Understanding statistical populations and inferences.

Background: The term population is frequently used in clinical research and statistics, but concepts are multiple and confusing. Populations are a roundabout way of conceiving classifications, generalizations and inductive inferences. When misapplied, the term can lead to serious errors in study design, analysis and interpretation.

Trial selection criteria should not be used for clinical decisions and recommendations: the thrombectomy trials example.

Background: Despite multiple calls for more inclusive studies, most clinical trial eligibility criteria remain too restrictive. Thrombectomy trials have been no exception.

Methods: We review the landmark trials that have shown the benefits of thrombectomy, their eligibility criteria, and consequences on clinical practice.

Understanding why restrictive trial eligibility criteria are inappropriate.

Background: An important difference between explanatory and pragmatic clinical trials concerns eligibility criteria. Eligibility criteria are restrictive in explanatory trials, while pragmatic trials are more inclusive or even all-inclusive.

Methods: To better understand the diverging views regarding eligibility criteria, we examine the contrast between theoretical and clinical medicine, and 3 different research contexts: laboratory research, population studies and clinical trials.

Basilar artery occlusion management: An international survey of gender influence on management.

Background: The superiority of endovascular thrombectomy (EVT) over medical management was not established in two early basilar artery occlusion (BAO) randomized controlled trials. Despite this, many clinicians recommended EVT for acute BAO under certain circumstances. This paper aims to compare physicians' diagnostic and management strategies of BAO according to gender.

Endovascular Therapy in the Extended Time Window for Large Vessel Occlusion in Patients With Pre-Stroke Disability.

Background And Purpose: We compared the outcomes of endovascular therapy (EVT) in an extended time window in patients with large-vessel occlusion (LVO) between patients with and without pre-stroke disability.

Methods: In this prespecified analysis of the multinational CT for Late Endovascular Reperfusion study (66 participating sites, 10 countries between 2014 and 2022), we analyzed data from patients with acute ischemic stroke with a pre-stroke modified Rankin Scale (mRS) score of 0-4 and LVO who underwent EVT 6-24 hours from the time last seen well. The primary outcome was the composite of functional independence (FI; mRS score 0-2) or return to the pre-stroke mRS score (return of Rankin, RoR) at 90 days.

The use and abuse of survival analysis and Kaplan-Meier curves in surgical trials.

Background: Survival analysis based on Cox regression and Kaplan-Meier curves, initially devised for oncology trials, have frequently been used in other contexts where fundamental statistical assumptions (such as a constant hazard ratio) are not satisfied. This is almost always the case in trials that compare surgery with medical management.

Methods: We review a trial that compared extracranial-intracranial bypass surgery (EC-IC bypass) with medical management (MM) of patients with symptomatic occlusion of the carotid or middle cerebral artery, where it was claimed that surgery was of no benefit.

Safety and clinical outcomes of endovascular therapy versus medical management in late presentation of large ischemic stroke.

Introduction: The benefit of endovascular therapy (EVT) among stroke patients with large ischemic core (ASPECTS 0-5) in the extended time window outside of trial settings remains unclear. We analyzed the effect of EVT among these stroke patients in real-world settings.

Patients And Methods: The CT for Late Endovascular Reperfusion (CLEAR) study recruited patients from 66 centers in 10 countries between 01/2014 and 05/2022.

Reliability of study endpoint adjudication in a pragmatic trial on brain arteriovenous malformations.

Background: The results of a clinical trial are given in terms of primary and secondary outcomes that are obtained for each patient. Just as an instrument should provide the same result when the same object is measured repeatedly, the agreement of the adjudication of a clinical outcome between various raters is fundamental to interpret study results. The reliability of the adjudication of study endpoints determined by examination of the electronic case report forms of a pragmatic trial has not previously been tested.

Outcomes of Bridging Intravenous Thrombolysis Versus Endovascular Therapy Alone in Late-Window Acute Ischemic Stroke.

Background: Studies comparing bridging intravenous thrombolysis (IVT) with direct endovascular therapy (EVT) in patients with acute ischemic stroke who present late are limited. We aimed to compare the clinical outcomes and safety of bridging IVT in patients with acute ischemic stroke due to anterior circulation large vessel occlusion who underwent EVT 6 to 24 hours after time last known well.

Methods: We enrolled patients with anterior circulation large vessel occlusion stroke and a National Institutes of Health Stroke Scale score of ≥6 from 20 centers across 10 countries in the multicenter retrospective CLEAR study (CT for Late Endovascular Reperfusion) between January 2014 and May 2022.

Association of timing and agent for venous thromboembolism prophylaxis in patients with severe traumatic brain injury on venous thromboembolism events, mortality, neurosurgical intervention, and discharge disposition.

Background: Trauma patients are at increased risk for venous thromboembolism events (VTEs). The decision of when to initiate VTE chemoprophylaxis (VTEP) and with what agent remains controversial in patients with severe traumatic brain injury (TBI).

Methods: This comparative effectiveness study evaluated the impact of timing and agent for VTEP on outcomes for patients with severe TBI (Abbreviated Injury Scale head score of 3, 4, or 5).

Ethical Problems of Observational Studies and Big Data Compared to Randomized Trials.

The temptation to use prospective observational studies (POS) instead of conducting difficult trials (RCTs) has always existed, but with the advent of powerful computers and large databases, it can become almost irresistible. We examine the potential consequences, were this to occur, by comparing two hypothetical studies of a new treatment: one RCT, and one POS. The POS inevitably submits more patients to inferior research methodology.

Noncontrast CT Selected Thrombectomy vs Medical Management for Late-Window Anterior Large Vessel Occlusion.

Background And Objectives: There is uncertainty whether patients with large vessel occlusion (LVO) presenting in the late 6-hour to 24-hour time window can be selected for endovascular therapy (EVT) by noncontrast CT (NCCT) and CT angiography (CTA) for LVO detection. We evaluated the clinical outcomes of patients selected for EVT by NCCT compared with those medically managed in the extended time window.

Methods: This multinational cohort study was conducted at 66 sites across 10 countries.

Endovascular Parent Vessel Occlusion Versus Flow Diversion in the Treatment of Large and Giant Aneurysms: A Randomized Comparison.

Objective: Parent vessel occlusion (PVO) is a time-honored treatment for unclippable or uncoilable intracranial aneurysms. Flow diversion (FD) is a recent endovascular alternative that can occlude the aneurysm and spare the parent blood vessel. Our aim was to compare outcomes of FD with endovascular PVO.