Intravenous alteplase, administered within 4.5 hours of symptom onset, has proven efficacy in patients with acute ischemic stroke. This study assessed whether intra-arterial treatment plus usual care is more effective than usual care alone for patients with proximal arterial occlusion in the anterior cerebral circulation.
METHODSThis phase 3, multicenter, clinical trial compared intra-arterial treatment (intra-arterial thrombolysis, mechanical treatment or both) plus usual care (which could include intravenous administration of alteplase). The patients were 18 years of age or older, with the acute ischemic stroke caused by an intracranial occlusion in the anterior cerebral circulation artery.
Treatment had to be possible within six hours after stroke onset. Alteplase or urokinase for intraarterial thrombolysis was allowed, with the dose restricted to 30 mg of alteplase or 400, 000 IU of urokinase if intravenous alteplase was given. Mechanical treatment could involve thrombus retraction, aspiration, wire disruption or use of a retrievable stent. The primary outcome measure was the score on the modified Rankin scale at 90 days.
RESULTSThe mean age of the 500 study participants was 65 years. Better outcomes were noted for the intervention group in all categories of the modified Rankin scale except death. Functional independence at 90 days was noted in 32.6 % of the intervention group and 19.1% of the control group, with an adjusted odds ratio of 2.16. All clinical and imaging secondary outcomes favored the intervention group. No significant difference was seen in the occurrence of serious events during the 90-day follow-up.
CONCLUSIONThis study of patients with acute ischemic stroke caused by proximal intracranial arterial occlusion of the anterior circulation found that better functional recovery could be achieved with intra-arterial treatment added to usual care.