Setting benchmark for ischemic stroke treated endovascularly: A systematic review and meta-analysis

Advancements in endovascular treatment have revolutionized the management of ischemic stroke [1], [2]. Despite these advancements, a gap persists in the lack of standardized outcome measures across studies [3], [4]. This gap hampers the ability to comprehensively assess and compare the effectiveness and safety of endovascular interventions across various clinical settings, devices, and patient demographics [5]. The need for a uniform framework to evaluate treatment outcomes is important, particularly as the diversity of endovascular modalities continues to expand.

In a systematic review, Volovici et al. [5] highlighted that in the endovascular aneurysm literature, the results for safety, effectiveness, and durability of brain aneurysm treatment had methodological flaws and incomplete reporting of relevant outcomes, which did not support these claims. Interestingly, there were no differences in the proportion of patients with poor outcomes between studies with positive, uncertain, or negative conclusions [5]. This evidence is similar to the one in stroke literature suggesting inhomogeneity of the literature for endovascular treatment reducing the possibility to adequate compare findings. In stroke medicine, it is imperative to perform adequate quality control and improvement [6]. In addition, the need for a benchmark is important for comparing results from RCTs and real-life situations in both high-and low/middle-income countries [7].

Methodologically, a new technique or device must ideally be compared with the standard of care in a dedicated randomized controlled trial RCT [8], [9]. This principle is suggested by the ICH-Guideline for Good Clinical Practise [10]. However, setting up a dedicated RCT is difficult because of the complex regulatory requirements, excessive monitoring, privacy restrictions, and suboptimal methodology [11].

This systematic review aimed to synthesize current evidence on the efficacy and safety of endovascular treatments for ischemic stroke. The goal was to propose a standardized benchmark for outcome measures derived from a meta-analytical approach to evaluate treatment effectiveness. However, to do so, two conditions must be present: predefined outcomes and a specific cutoff. By adopting the average values and 95% the confidence of interval (95% CI) from the included studies as a reference standard and assessing individual study outcomes against this benchmark in a non-inferiority framework, we introduced a methodologically rigorous and clinically relevant standard [12]. This approach, which focuses on deviation from confidence intervals, will facilitate a nuanced assessment of whether specific outcomes are superior, inferior, or equivalent to the established average, thereby providing a comparative analysis across the spectrum of endovascular treatments. The intent was to allow stakeholders to make conscious choices using rigorous scientific analyses.

Comments (0)

No login
gif