Rationale and aim
Acute ischemic stroke is an important cause of death and disability. The management of acute ischemic stroke treatment has been improved after introduction of IV thrombolysis and mechanical thrombectomy (EVT) for proximal intracranial occlusions. Around 20% of patients with a proximal intracranial occlusion have an tandem lesion in the cervical internal carotid artery that may need a different treatment approach. Huge variation in clinical practice exists and current guidelines suggest carotid endarterectomy (CEA) within two weeks after the initial event in order to prevent a recurrent stroke, however these recommendations are based on trials in a different population (subacute TIA, non-disabling stroke).
If a carotid stenosis is diagnosed, carotid artery stenting (CAS) can be performed during EVT. Immediate CAS may decrease the risk of recurrent stroke and effectively treat the cause of stroke in a less invasive and more cost-effective way. A major concern in acute carotid artery stenting is the need for antiplatelet therapy to prevent in-stent thrombosis, potentially leading to an increase in hemorrhagic complications. Cerebral hyperperfusion syndrome could also lead to severe complications.
This multicenter randomized clinical trial will compare two different treatment strategies in patients undergoing EVT with an ipsilateral tandem lesion (carotid artery stenosis of more than 50% or occlusion):
- Immediate CAS during EVT (before or after the intracranial thrombectomy)
- EVT without immediate CAS during EVT, but with deferred treatment by carotid revascularization (CEA or CAS) according to the current guidelines (preferably within 2 weeks after stroke onset) or best medical management in case of persisting disabling stroke.
The primary objective is to compare the efficacy of the two strategies. The secondary objective is to compare the safety of the two strategies, regarding the incidence of symptomatic intracerebral haemorrhage, recurrent stroke and early proximal carotid artery re-occlusion. The tertiary objective is to compare the quality of life and cost-effectiveness of both strategies.