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The neurointerventional (NI) endeavor is a field of marked contrasts. Complex intracranial aneurysms, disabling strokes, and a variety of other neurovascular diseases are successfully treated through minimally invasive means. The technical and geographic growth of the field has seen a similar maturation in academic support and its resultant data. In that vein, over these past few decades single-center case series have been replaced by larger multicenter observational cohorts and ultimately by randomized controlled trials (RCTs). One of the more marked and important contrasts in the NI field exists within these RCTs—not, as many might assume, conflicting results but, instead, the quality of the underlying studies.
The pages of JNIS have chronicled these studies and we will not review the particulars of them again here. However, as with other spaces in the medical field, we have our share of both high-quality1–3 and low-quality4 studies. Some trials that the NI community collectively viewed as subpar were able to secure publication in lead journals, speaking to great variability of not just studies but review and publication. Indeed, JNIS has featured an article on some of the challenges of peer review.5
Sheth and colleagues published a recent comment called ‘Watching but not waiting: vascular neurology perspective on the disparate regulatory pathway for stroke’ in JNIS.6 They made a number of important points that should prompt conversation in our circles. The paper started with a discussion of how vascular neurologists were paying close attention to the completion of the regulatory pathway of the Watchman device for non-valvular atrial fibrillation as a cause of ischemic stroke.7 The authors lament the lack of involvement of vascular neurologists in the design of the Watchman trial and its subsequent approval pathway. We support this perspective from our neurology colleagues.
Non-inferiority versus superiority trial design
Sheth et al go …