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Stroke outcome measures: a tale of two trials
  1. Peter A Rasmussen
  1. Correspondence to Dr Peter A Rasmussen, Neurosurgery Department, Cerebrovascular Center, Cleveland Clinic, 9500 Euclid Ave. S-80, Cleveland, OH 44195, USA; rasmusp{at}

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We are living in a medical world where our practice is dictated by proven medical outcomes as determined by multicenter randomized clinical trials. These types of trials lead to ‘evidence-based medicine’ and ‘best practices’ in how to manage our patients. Recently, two multicenter government-funded randomized clinical trials reached endpoints which would appear to provide us with guidance in the management of subacute and chronic cerebral ischemia. These two trials report that ‘aggressive medical management (AMM)’ is superior to AMM coupled with a surgical or endovascular procedure. Careful examination of these trials, in my opinion, casts significant doubt on the validity of their conclusions and, more importantly, the current assessment metrics used to track outcome for cerebrovascular diseases.

The two trials examined the role of angioplasty and stenting in the setting of severe intracranial atherostenosis (ICAD) (SAMMPRIS) and superficial temporal to middle cerebral artery bypass (STA-MCA bypass) in the setting of symptomatic carotid occlusion (COSS). Both trials were stopped prematurely, one (COSS) ostensibly secondary to futility and the other (SAMMPRIS) secondary to an increase in serious adverse events in the surgical (endovascular) treatment arm. Both trials used stroke as the primary endpoint and both trials ignored the disabling and unnerving effects of frequent transient ischemic attacks (TIAs). In addition, within this broad category of stroke, the only further clarification and scale of severity was the highly subjective metric disabling versus non-disabling stroke.

A subgroup analysis of the International Subarachnoid Aneurysm Trial (ISAT) known …

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