Balloon Angioplasty for Symptomatic Intracranial Artery Stenosis (BASIS): protocol of a prospective, multicentre, randomised, controlled trial

Background The superiority of balloon angioplasty plus aggressive medical management(AMM)to AMM alone for symptomatic intracranial artery stenosis(sICAS)on efficacy and safety profiles still lacks evidence from randomised controlled trials(RCTs).Aim To demonstrate the design of an RCT on balloon angioplasty plus AMM for sICAS.Design Balloon Angioplasty for Symptomatic Intracranial Artery Stenosis(BASIS)trial is a multicentre,prospective,randomised,open-label,blinded end-point trial to investigate whether balloon angioplasty plus AMM could improve clinical outcome compared with AMM alone in patients with sICAS.Patients eligible in BASIS were 35–80 years old,with a recent transient ischaemic attack within the past 90 days or ischaemic stroke between 14 days and 90 days prior to enrolment due to severe atherosclerotic stenosis(70%–99%)of a major intracranial artery.The eligible patients were randomly assigned to receive balloon angioplasty plus AMM or AMM alone at a 1:1 ratio.Both groups will receive identical AMM,including standard dual antiplatelet therapy for 90 days followed by long-term single antiplatelet therapy,intensive risk factor management and life-style modification.All participants will be followed up for 3years.Study outcomes Stroke or death in the next 30 days after enrolment or after balloon angioplasty procedure of the qualifying lesion during follow-up,or any ischaemic stroke or revascularisation from the qualifying artery after 30 days but before 12 months of enrolment,is the primary outcome.Discussion BASIS trail is the first RCT to compare the efficacy and safety of balloon angioplasty plus AMM to AMM alone in sICAS patients,which may provide an alternative perspective for treating sICAS.Trial registration number NCT03703635;https://www.clinicaltrials.gov.

Current management of spontaneous intracerebral haemorrhage

Intracerebral haemorrhage(ICH)is the most devastating and disabling type of stroke.Uncontrolled hypertension(HTN)is the most common cause of spontaneous ICH.Recent advances in neuroimaging,organised stroke care,dedicated Neuro-ICUs,medical and surgical management have improved the management of ICH.Early airway protection,control of malignant HTN,urgent reversal of coagulopathy and surgical intervention may increase the chance of survival for patients with severe ICH.Intensive lowering of systolic blood pressure to<140 mm Hg is proven safe by two recent randomised trials.Transfusion of platelets in patients on antiplatelet therapy is not indicated unless the patient is scheduled for surgical evacuation of haematoma.In patients with small haematoma without significant mass effect,there is no indication for routine use of mannitol or hypertonic saline(HTS).However,for patients with large ICH(volume>30 cbic centmetre)or symptomatic perihaematoma oedema,it may be beneficial to keep serum sodium level at 140–150 mEq/L for 7–10 days to minimise oedema expansion and mass effect.Mannitol and HTS can be used emergently for worsening cerebral oedema,elevated intracranial pressure(ICP)or pending herniation.HTS should be administered via central line as continuous infusion(3%)or bolus(23.4%).Ventriculostomy is indicated for patients with severe intraventricular haemorrhage,hydrocephalus or elevated ICP.Patients with large cerebellar or temporal ICH may benefit from emergent haematoma evacuation.It is important to start intermittent pneumatic compression devices at the time of admission and subcutaneous unfractionated heparin in stable patients within 48 hours of admission for prophylaxis of venous thromboembolism.There is no benefit for seizure prophylaxis or aggressive management of fever or hyperglycaemia.Early aggressive comprehensive care may improve survival and functional recovery.

Stenting for intracranial stenosis:potential future for the prevention of disabling or fatal stroke

Intracranial stenosis is a common cause of ischaemic strokes,in particular,in the Asian,African and Hispanic populations.The randomised multicentre study Stenting and Aggressive Medical Management for the Prevention of Recurrent stroke in Intracranial Stenosis(SAMMPRIS)showed 14.7% risk of stroke or death in the stenting group versus 5.8% in the medical group at 30 days,and 23% in the stenting group versus 15% in the medical group at a median follow-up of 32.4 months.The results demonstrated superiority of medical management over stenting and have almost put the intracranial stenting to rest in recent years.Of note,16 patients(7.1%)in the stenting group had disabling or fatal stroke within 30 days mostly due to periprocedural complications as compared with 4 patients(1.8%)in the medical group.In contrast,5 patients(2.2%)in the stenting group and 14 patients(6.2%)in the medical group had a disabling or fatal stroke beyond 30 days,indicating significant benefit of stenting if periprocedural complications can be reduced.Recently,the results of the Chinese Angioplasty and Stenting for Symptomatic Intracranial Severe Stenosis trial and the Wingspan Stent System Post Market Surveillance Study(WEAVE trial)showed 2%-2.7% periprocedural complications.It is time to evaluate the role of intracranial stenting for the prevention of disabling or fatal stroke.

Update in the treatment of extracranial atherosclerotic disease for stroke prevention

Stroke is a leading cause of adult mortality and disability worldwide.Extracranial atherosclerotic disease(ECAD),primarily,carotid artery stenosis,accounts for approximately 18%-25%of ischaemic stroke.Recent advances in neuroimaging,medical therapy and interventional management have led to A significant reduction of stroke from carotid artery stenosis.The current treatment of ECAD includes optimal medical therapy,carotid endarterectomy(CEA)and carotid artery stenting(CAS).The selection of treatments depends on symptomatic status,severity of stenosis,individual factors,efficacy and risk of complications.The aim of this paper is to review current evidence and guidelines on the management of carotid artery stenosis,including the comparison of medical and interventional therapy(CAS and CEA),as well as future directions.

Coagulopathy reversal in intracerebral haemorrhage

As intracerebral hemorrahge becomes more frequent as a result of an aging population with greater comorbidities,rapid identification and reversal of precipitators becomes increasingly paramount.The aformentioned population will ever more likely be on some form of anticoagulant therapy.Understanding the mechanisms of these agents and means by which to reverse them early on is critical in managing the acute intracerebral hemorrhage.