Endovascular Stroke Trials

Is it appropriate to enroll into a clinical trial (and hence randomize to either medical or endovascular therapy) a 45-year-old patient who presents within 3 hours of onset of disabling symptoms resulting from a left M1 occlusion? This is the question many of us have faced in the course of the past few months because multiple new trials of endovascular stroke therapy have been launched on the heels of the neutral Interventional Management of Stroke (IMS)-III, Mechanical Retrieval and Recanalization of Stroke Clots Using Embolectomy (MR-RESCUE), and Local Versus Systemic Thrombolysis for Acute Ischemic Stroke (SYNTHESIS) trials.1–3 The recently published IMS-III, MR-RESCUE, and SYNTHESIS trials have raised important questions related to efficacy of intra-arterial treatment. These trials have many flaws that have been eloquently discussed in some recent editorials and have raised interesting epistemological questions.4–6 Many neurologists, neurosurgeons, and interventional neuroradiologists have argued that randomization is unethical in such circumstances because patients like this one have the potential to do well with rapid recanalization but are likely to face a lifetime of disability without it. They support their argument by pointing out the potential flaws in the previous randomized studies and the poor natural history of the disease.4,5In this article, we present a variety of perspectives on this question, reflecting the multiplicity of opinions within the stroke community. Ultimately, we think that these perspectives converge on the conclusion that we face a medical and ethical imperative to enroll our patients (even those who are young and with potentially devastating strokes) into clinical trials.Some critics of enrollment into endovascular stroke trials contend that endovascular therapy already amounts to the standard of care, and therefore, depriving patients of this treatment is negligent. Is this true? The standard of care may be …