IMPORTANCEWhether intravenous thrombolysis is needed in combination with mechanical thrombectomy in patients with acute large vessel occlusion stroke is unclear.OBJECTIVE To examine whether mechanical thrombectomy alone is noninferior to combined intravenous thrombolysis plus mechanical thrombectomy for favorable poststroke outcome. Investigator-initiated, multicenter, randomized, open-label, noninferiority clinical trial in 204 patients with acute ischemic stroke due to large vessel occlusion enrolled at 23 hospital networks in
DESIGN, SETTING, AND PARTICIPANTS
A 65-year-old woman underwent surgical treatment of an unruptured aneurysm in the left middle cerebral artery. Surgical craniotomy using arachnoid plasty with a fibrin sealant was completed without incident, but abrupt neurological deterioration occurred on the 9th postoperative day. Antibiotic treatment was given, but the symptoms did not resolve. Neuroimaging and physical findings indicated allergic reaction rather than infectious process. Therefore, systemic steroids were administered that resulted in dramatic resolution of symptoms. Nine months later, lymphocyte stimulation test of materials used in arachnoid plasty revealed positive response to a component of the combination pair in fibrin glue. The fibrin sealant placement method is a widely accepted and familiar technique, but surgeons should anticipate possible allergic reactions such as those observed in the present case.
A 68-year-old male presented with a syncopal attack subsequent to acute myocardial infarction. His ultrasonographic and radiological examination revealed severe left internal carotid artery (ICA) stenosis and the presence of a persistent primitive hypoglossal artery (PPHA) immediately distal to the stenosis. The bilateral anterior and left middle cerebral arteries, and the vertebrobasilar system were opacified via the stenotic ICA. Carotid arterial stenting was selected as the treatment method because the lesion was high and a shunt placement during carotid endarterectomy was considered to be technically difficult. A self-expanding stent was successfully deployed with flow control, and the patient was discharged six days after surgery without any neurological deficit. There are sixteen reported cases including ours of PPHA associated with ICA stenosis presenting with ischemic attacks of the vertebrobasilar system. To the best of our knowledge, the current case is the first report of a cervical ICA stenosis with ipsilateral carotid-basilar anastomosis treated with carotid arterial stenting.
Rationale Bridging therapy with endovascular therapy (EVT) and intravenous thrombolysis (IVT) has been reported to improve outcomes for acute stroke patients with large-vessel occlusion in the anterior circulation. While the IVT may increase the reperfusion rate, the risk of hemorrhagic complications increases. Whether EVT without IVT (direct EVT) is equally effective as bridging therapy in acute stroke remains unclear. Aim This randomized study of endovascular therapy with versus without intravenous tissue plasminogen activator for acute stroke with ICA and M1 occlusion aims to clarify the efficacy and safety of direct EVT compared with bridging therapy. Methods and design This is an investigator-initiated, multicenter, prospective, randomized, open-treatment, blinded-endpoint clinical trial. The target patient number is 200, comprising 100 patients receiving direct EVT and 100 receiving bridging therapy. Study outcome The primary efficacy endpoint is a modified Rankin Scale score of 0–2 at 90 days. Safety outcome measures are any intracranial hemorrhage at 24 h. Discussion This trial may help determine whether direct EVT should be recommended as a routine clinical strategy for ischemic stroke patients within 4.5 h from onset. Direct EVT would then become the choice of therapy in stroke centers with endovascular facilities. Trial registration UMIN000021488.
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