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Date: November 21st, 2015
Guest Skeptic: Dr. Rory Spiegel is an Emergency Medicine resident in New York City. Rory is doing a resuscitation fellowship at Stony Brook University School of Medicine. He also writes a blog called EM Nerd about nihilism, medicine and the art of doing nothing.
Case: An 78-year-old woman presents to your emergency department with right arm weakness and slurred speech for the last two hours. She has a history of hypertension and diabetes. A CTA is performed that shows an Intracranial arterial occlusion of the right M1 middle cerebral artery segment.
Background: Prior to the publication of MR CLEAN and the four trials published in its wake, the data regarding endovascular therapy has been consistently negative. Over the past year five RCTs examining endovascular therapy for acute ischemic stroke have been published. In direct contrast to the three trials published in 2013, all of the recent trials were impressively positive.
Because of methodological flaws, the true size of benefit these interventions provide is still unclear. Without an understanding of this effect size, it is difficult to assess whether this benefit justifies the resources required to support its implementation on a national level.
Clinical Question: Do endovascular therapies for acute ischemic stroke lead to improved neurological outcomes when compared to medical therapies alone and what is the effect size?
Reference: Badhiwala, JH et al. Endovascular Thrombectomy for Acute Ischemic Stroke A Meta-analysis. JAMA 2015
* Population: Varied depending on primary trial’s inclusion and exclusion criteria. Essentially, patients presenting with signs and symptoms of acute ischemic stroke with either clinical or radiographic evidence of large vessel occlusion conducive to endovascular intervention.
* Intervention: Various endovascular therapies including intra-arterial tPA and clot retrieval devices.
* Comparison: Optimal medical therapy which included the use of IV tPA in the majority of the patients.
* Outcome: The authors chose to examine functional neurological status at 3-months, as assessed by an ordinal analysis of the modified Rankin Scale (mRS).
Author’s Conclusions: “Among patients with acute ischemic stroke, endovascular therapy with mechanical thrombectomy vs. standard medical care with tPA was associated with improved functional outcomes and higher rates of angiographic revascularization, but no significant difference in symptomatic intracranial hemorrhage or all-cause mortality at 90 days.”
Quality Checks for Therapeutic Systematic Reviews:
* The clinical question is sensible and answerable. Sensible yes, Answerable, with the current data, No.
* The search for studies was detailed and exhaustive. Yes but study selection was questionable.
* The primary studies were of high methodological quality. Variable
* The assessment of studies were reproducible. Yes
* The outcomes were clinically relevant. Questionable
* There was low statistical heterogeneity for the primary outcomes. No
* The treatment effect was large enough and precise enough to be clinically significant. Large enough, yes. Precise enough, No.
Key Results: In their pooled analysis, the authors found a shift towards improved functional outcomes at 90-days in the patients randomized to receive endovascular therapy when compared to standard care.
Odds Ratio 1.56 (95% CI, 1.