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17th November 2021
Endovascular treatment (EVT) alone, a non-surgical intervention for the sudden loss of brain function in patients who experience blood clots, does not benefit from addition of intravenous alteplase in terms of the disability outcome at 90 days. This was the conclusion of an open-label, randomised trial by a team from the Department of Neurology, AMC, the Netherlands.
Whether or not the addition of the thrombolytic agent, alteplase to EVT for patients with a stroke would be of greater benefit is unclear and was the subject of the Multicenter Randomised Clinical Trial of Endovascular Treatment for Acute Ischaemic Stroke (MR CLEAN). The trial was undertaken in 20 hospitals in the Netherlands, France and Belgium and recruited adult patients (> 18 years of age) who had an acute ischaemic stroke due to an intracranial occlusion of the anterior circulation. Included patients were those eligible for EVT and intravenous alteplase within 4.5 hours of symptom onset, defined as stroke-related neurological symptoms or the time at which the patient was last seen well. Eligible patients had a score of 2 or more on the National Institutes of Health Stroke Scale (NIHSS), which ranged from 0 (no symptoms) to a maximum of 42 (most severe deficit). Patients were randomised 1:1 to receive either EVT alone or intravenous alteplase (0.9 mg/kg, 10% as a bolus and 90% as a 1-hour infusion, prior to the initiation of EVT which was permitted before the end of the alteplase infusion. The primary endpoint of the trial was functional outcome on the modified Rankin scale which ranges from 0 (no disability) to 6 (death), which was assessed after 90 days.
In total, 539 patients were included in with final analysis, with a median age of 71 years (56.6% male) with 273 randomised to receive endovascular treatment alone. After 90 days, the median score on the modified Rankin scale was 3 in the EVT-alone group and 2 in the alteplase-EVT group with an adjusted odds ratio, OR of 0.84 (95% CI 0.62 – 1.15, p = 0.28). Mortality was 20.5% with EVT and 15.8% for the combination group, (adjusted OR = 1.39, 95% CI 0.84 – 2.30). In addition, a symptomatic intracranial haemorrhage occurred in 5.9% and 5.3% of those assigned to EVT and alteplase respectively, for which the difference was also non-significant.
Given this non-significant finding, the authors concluded that EVT alone was not superior to alteplase followed by EVT.
LeCouffe NE et al. A Randomized Trial of Intravenous Alteplase before Endovascular Treatment for Stroke. N Eng J Med 2021