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A revolution began when an intracranial stent originally designed for aneurysm embolization was found to be an efficient tool for recanalyzing an occluded artery. After years of design work by industry engineers to develop new devices for removing clots, the off-label use of the Solitaire revascularization device suddenly enabled fast, safe, and effective clot removal. The first retrospective review, followed by results from prospective multicenter registries, showed impressive results. Neurointerventionalists and some neurologists were so convinced by the efficacy of the technique that results from these prospective multicenter registries were enough to validate the technique for application in routine practice without further evidence.
Because of these early trial results, the usual debate about the need for randomization and its ethical dilemma began. In the meantime, three ongoing randomized studies comparing mechanical thrombectomy with medical management for acute stroke included stentriever thrombectomy among the usable techniques. Those three studies published in the same edition of the New England Journal of Medicine (Interventional Management of Stroke (IMS) III, Synthesis Expansion, Mechanical Retrieval and Recanalization of Stroke Clots Using Embolectomy (MR RESCUE)) showed that mechanical treatment was not better than medical management. In view of the tremendous enthusiasm for the Solitaire ‘stentriever’ thrombectomy technique, the results from those three negative studies were a significant shock. There was deep concern that thrombectomy might never be validated as a viable procedure, included in guidelines or reimbursed. The shadow of defeat experienced by the interventional neuroradiology field as a result of the carotid stenting versus surgery trials (Endarterectomy versus Angioplasty in Patients with Symptomatic Severe Carotid Stenosis (EVA3S), Stent-Supported Percutaneous Angioplasty of the Carotid Artery versus Endarterectomy (SPACE), International Carotid Stenting Study (ICSS)) and the Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) trial is still a ‘sore spot’.
In an ironic twist of fate, those three negative studies have had an extremely beneficial consequence. …
Contributors CC contributed to drafting and review of this manuscript.
Competing interests None declared.
Provenance and peer review Commissioned; internally peer reviewed.