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In search of the optimized stroke trial design
  1. D Fiorella1,
  2. J A Hirsch2,
  3. J Mocco3
  1. 1Department of Neurosurgery, State University of New York at Stony Brook, Stony Brook, New York, USA
  2. 2NeuroEndovascular Program, Massachusetts General Hospital, Boston, Massachusetts, USA
  3. 3Department of Neurosurgery, Vanderbilt University, Nashville, Tennessee, USA
  1. Correspondence to Dr D Fiorella, Department of Neurosurgery, State University of New York at Stony Brook, Stony Brook, NY 11794-8122, USA; David.Fiorella{at}sbumed.org, david.fiorella{at}stonybrook.edu

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“If you are explaining, you’re losing” —Ronald Reagan

There remains a widespread conviction among most neurointerventionists and many non-interventional neurologists that mechanical thrombectomy is a life- and function-saving procedure in appropriately selected patients with acute ischemic stroke from large vessel occlusion (LVO). However, this has yet to be confirmed in a randomized controlled trial (RCT) for mechanical thrombectomy. While critical analyses of recent published RCTs provide insight into how they failed to demonstrate a benefit for thrombectomy, they do not negate their impact upon our field.1 Until we provide conclusive data in support of mechanical thrombectomy, our ability to offer this procedure to patients remains in constant jeopardy. In addition, as a larger volume of negative data accrues, our opportunities to conduct RCTs in this area will ultimately dissipate. For these reasons, now—more than ever—we must carefully and thoughtfully design future trials which will investigate, and potentially validate, the utility of endovascular stroke therapy in that patient population with the greatest potential for benefit.

Designing such a trial presents a challenge from the standpoint of equipoise, as many physicians believe it unethical to randomize a ‘likely to benefit’ patient to no treatment. However, given the negative data generated to date, it would be ill-conceived to dispense with equipoise for such patients. There are many past examples where treatment advocates were equally convinced of a lack of equipoise and subsequent RCTs demonstrated no benefit for intervention (eg, SAMPRIS, ECIC Bypass, COSS).2 ,3 In fact, one might posit that, in an appropriately designed RCT, it is better that the participating interventionists are believers in the benefits of the intervention and possibly have some reservations regarding procedural equipoise, but are still committed to the trial. Indeed, we believe firmly in the role of mechanical thrombectomy in appropriately selected patients while …

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