Clinical diagnosis of Lacunar stroke in the first 6 hours after symptom onset - Analysis of data from the glycine antagonist in neuroprotection (GAIN) Americas trial

Background and Purpose - Although the pathophysiological heterogeneity of stroke may be highly relevant to the development of acute-phase therapies, discriminating between ischemic stroke subtypes soon after onset remains a challenge. We conducted a study of the accuracy of a clinical diagnosis of lacunar stroke in the first 6 hours after symptom onset. Methods - We analyzed data from 1367 patients in the Glycine Antagonist In Neuroprotection (GAIN) Americas trial. The Trial of ORG10172 in Acute Stroke Treatment (TOAST) category " small vessel (lacunar)" disease at day 7 or at hospital discharge was used as the reference standard to determine the accuracy of a diagnosis of a lacunar stroke made within 6 hours of symptom onset using the Oxfordshire Community Stroke Project (OCSP) classification " LACS." Outcome was analyzed by comparing the proportions of patients classified as " LACS" at baseline or " small vessel (lacunar)" at 7 days who were dead or dependent at 3 months. Results - The positive predictive value of an OCSP diagnosis of a lacunar stroke was 76% (95% CI: 69% to 81%; sensitivity 64% [95% CI: 58% to 70%]; specificity 96% [95% CI: 95% to 97%]; negative predictive value 93% [95% CI: 92% to 94%]; accuracy 91% [95% CI: 89% to 92%]). The 3-month outcomes of patients classified as either OCSP " LACS" within 6 hours of onset or TOAST " small vessel (lacunar)" at 7 days were not significantly different. Conclusions - An OCSP LACS diagnosis made within 6 hours of stroke onset is reasonably predictive of a final diagnosis of " small vessel (lacunar)" disease made using TOAST criteria and has a similar relationship to outcome at 3 months.