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 random...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.展开更多
Background and purpose Hyperperfusion(HP)is a devastating complication associated with carotid artery stenting(CAS)or endarterectomy.The efficacy and safety of staged angioplasty(SAP)in patients with CAS at high risk ...Background and purpose Hyperperfusion(HP)is a devastating complication associated with carotid artery stenting(CAS)or endarterectomy.The efficacy and safety of staged angioplasty(SAP)in patients with CAS at high risk of HP remains unclear.We sought to determine whether SAP is superior to regular CAS in patients with high risk of HP.Methods A randomised,multicentre open-label clinical trial with blinded outcome assessment(STEP)was conducted.Patients with severe carotid stenosis at high risk of HP were randomly assigned(1:1)to the SAP or regular CAS group.The primary endpoint was hyperperfusion syndrome(HPS)and intracerebral haemorrhage(ICH)within 30 days after the procedure.Results From November 2014 to January 2017,a total of 64 patients were enrolled in 11 centres.33 patients were allocated to the SAP group and 31 to the regular CAS group.At 30 days,the rate of primary endpoint was 0.0%(0/33)in the SAP group and 9.7%(3/31)in the regular CAS group(absolute risk reduction(ARR),9.7%;95%CI−20.1% to 0.7%;p=0.11).As one of the secondary endpoints,the incidence of HP phenomenon(HPP)was lower in the SAP group than the regular CAS group(0.0%vs 22.6%,ARR,−22.6%;95% CI−36.8%to−10.2%;p=0.04).Conclusion The rate of HPS and ICH was not significantly lower in SAP group;the extended secondary endpoint of HPP,however,significantly reduced,which suggested that SAP may be a safe and effective carotid revascularisation procedure to prevent HP.展开更多
基金the National Natural Science Foundation of China(Number 81825007)Beijing Outstanding Young Scientist Program(Number BJJWZYJH01201910025030)+6 种基金Capital's Funds for Health Improvement and Research(2022-2-2045)National Key R&D Program of China(2022YFF1501500,2022YFF1501501,2022YFF1501502,2022YFF1501503,2022YFF1501504,2022YFF1501505)Youth Beijing Scholar Program(Number 010)Beijing Laboratory of Oral Health(PXM2021_014226_000041)Beijing Talent Project-Class A:Innovation and Development(No.2018A12)National Ten-Thousand Talent Plan-Leadership of Scientific and Technological Innovation,and National Key R&D Program of China(Number 2017YFC1307900,2017YFC1307905)Long-Term Reliability Study of the Sensors System Under Minimally Invasive Surgery Biological Conditions(Number 2021YFB3200604).
文摘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.
基金supported by National Key Research and Development Program of China(2016YFC1301501)Abbott Medical Devices Trading(Shanghai)Co.,Ltd(no grant number).
文摘Background and purpose Hyperperfusion(HP)is a devastating complication associated with carotid artery stenting(CAS)or endarterectomy.The efficacy and safety of staged angioplasty(SAP)in patients with CAS at high risk of HP remains unclear.We sought to determine whether SAP is superior to regular CAS in patients with high risk of HP.Methods A randomised,multicentre open-label clinical trial with blinded outcome assessment(STEP)was conducted.Patients with severe carotid stenosis at high risk of HP were randomly assigned(1:1)to the SAP or regular CAS group.The primary endpoint was hyperperfusion syndrome(HPS)and intracerebral haemorrhage(ICH)within 30 days after the procedure.Results From November 2014 to January 2017,a total of 64 patients were enrolled in 11 centres.33 patients were allocated to the SAP group and 31 to the regular CAS group.At 30 days,the rate of primary endpoint was 0.0%(0/33)in the SAP group and 9.7%(3/31)in the regular CAS group(absolute risk reduction(ARR),9.7%;95%CI−20.1% to 0.7%;p=0.11).As one of the secondary endpoints,the incidence of HP phenomenon(HPP)was lower in the SAP group than the regular CAS group(0.0%vs 22.6%,ARR,−22.6%;95% CI−36.8%to−10.2%;p=0.04).Conclusion The rate of HPS and ICH was not significantly lower in SAP group;the extended secondary endpoint of HPP,however,significantly reduced,which suggested that SAP may be a safe and effective carotid revascularisation procedure to prevent HP.
