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Background: Endovascular treatment (EVT) for acute ischemic stroke is guided by clinical trials assumed to have high external validity. To our knowledge, this assumption has not been rigorously examined. Methods: Patients from two U.S. academic comprehensive stroke centers receiving endovascular treatment for acute ischemic stroke were retrospectively reviewed from January 2012 through December 2016. Clinical characteristics, treatment times, neuroimaging findings, and functional outcomes were compared to data from the pragmatic EVT trial, MR CLEAN. External validity was assessed quantitatively and qualitatively. Results: 236 patients presenting with anterior circulation large vessel occlusion were included. 63% (148/236) would have met criteria for MR CLEAN; the primary reason for exclusion would have been a time from symptom onset to groin puncture greater than 6 hours. Ordinal shift analysis of 90 day modified Rankin scale (mRS) of our clinical practice did not differ from the intervention arm of MR CLEAN, (p=0.26). Favorable outcome (mRS 0-2) occurred in 35% of our combined practice and in 33% of the trial intervention arm (p=0.63). The rates of hemicraniectomy (3% vs. 6% p=0.09) and PH-2 type symptomatic intracerebral hemorrhage (5.1% vs. 6.0% p=0.55) did not differ between the two groups. Conclusion: Our clinical experience was comparable to MRCLEAN, supporting the external validity of this trial to clinical practice. We treated patients who would have been excluded from this trial because of a longer time to groin puncture. Satisfactory results can be obtained with endovascular treatment, even when treating patients beyond 6 hours from symptom onset.

From Clinical Trial to Clinical Practice: Assessing the External Validity of Endovascular Treatment in Acute Ischemic Stroke