Background Unruptured intracranial aneurysm treatment aims to reduce the risk of aneurysm rupture and bleeding,relieves symptoms and improve the quality of life for patients.This study aimed to assess the safety and e...Background Unruptured intracranial aneurysm treatment aims to reduce the risk of aneurysm rupture and bleeding,relieves symptoms and improve the quality of life for patients.This study aimed to assess the safety and efficacy of Pipeline Embolization Device(PED,Covidien/Medtronic,Irvine,CA)treatment for intracranial aneurysms presenting with mass effect in real-world settings.Methods We selected patients from the PED in China Post-Market Multi-Center Registry Study with mass effect presentation.The study endpoints included postoperative mass effect deterioration and mass effect relief at follow-up(3–36 months).We conducted multivariate analysis to identify factors associated with mass effect relief.Subgroup analyses by aneurysm location,size and form were also performed.Results This study included 218 patients with a mean age of 54.3±11.8 years and a female predominance of 74.0%(162/218).The postoperative mass effect deterioration rate was 9.6%(21/218).During a median follow-up period of 8.4 months,the mass effect relief rate was 71.6%(156/218).Notably,immediate aneurysm occlusion following treatment was significantly associated with mass effect relief(OR 0.392,95%CI,0.170 to 0.907,p=0.029).Subgroup analysis demonstrated that adjunctive coiling contributed to mass effect relief in cavernous aneurysms,while dense embolism impeded symptom relief in aneurysms<10mm and saccular aneurysms.Conclusions Our data confirmed the efficacy of PED in relieving mass effect.The findings of this study provide support for endovascular treatment to alleviate mass effect in unruptured intracranial aneurysms.Trial registration number NCT03831672.展开更多
Objective The impact of thrombus migration(TM)prior to endovascular thrombectomy(EVT)on clinical outcomes and revascularisation rates remains unknown.We aimed to examine whether preinterventional TM modifies the treat...Objective The impact of thrombus migration(TM)prior to endovascular thrombectomy(EVT)on clinical outcomes and revascularisation rates remains unknown.We aimed to examine whether preinterventional TM modifies the treatment effects of direct EVT versus bridging EVT in acute large vessel occlusion patients.Methods All patients undergoing catheter angiography in the Direct Intra-arterial thrombectomy in order to Revascularise acute ischaemic stroke patients with large vessel occlusion Efficiently in Chinese Tertiary hospitals:A Multicentre randomised clinical Trial were included.TM was determined by radiologists unaware of the study by analysing discrepancies between computed tomographic angiography at baseline and first-run digital subtraction angiography before EVT.The primary outcome was the score on the modified Rankin scale(mRS)assessed at 90 days.Results Of 627 included patients,the TM rate was 11.3%(71/627).In the multivariable logistic regression model,baseline National Institutes of Health Stroke Scale score(adjusted OR 0.956,95%CI 0.916 to 0.999;p=0.043)and intravenous thrombolysis(adjusted OR 2.614,95%CI 1.514 to 4.514;p<0.001)were independently associated with TM.The patients with TM were less likely to be completely recanalised than those without TM(21.27%vs 36.23%,p=0.040).The interaction of TM and the EVT treatment effect did not significantly affect mRS shift analysis(p=0.687)or mRS scores of 0 to 1(p=0.436).Conclusion Preinterventional TM does not modify the treatment effects of direct versus bridging EVT on functional outcomes in patients with acute ischaemic stroke with anterior large vessel occlusion.TM leads to a lower complete recanalisation rate.展开更多
Background Our recent pilot study suggests intra-arterial tenecteplase(TNK)during the first pass of endovascular treatment(EVT)seems safe,may increase first-pass reperfusion and good outcome in acute ischaemic stroke(...Background Our recent pilot study suggests intra-arterial tenecteplase(TNK)during the first pass of endovascular treatment(EVT)seems safe,may increase first-pass reperfusion and good outcome in acute ischaemic stroke(AIS)patients with large-vessel occlusion(LVO).Aims To determine the efficacy and safety of intra-arterial TNK administration during EVT in AIS-LVO patients presenting up to 24 hours from symptom onset.Sample size estimates A maximum of 380 patients are required to test the superiority hypothesis with 80%power according to a two-side 0.05 level of significance,stratified by age,gender,baseline systolic blood pressure,prestroke modified Rankin Scale(mRS),baseline National Institute of Health stroke scale,baseline ASPECTS,time from onset to groin puncture,intravenous thrombolysis before EVT,stroke territory and stroke aetiology.Design Intra-arterial TNK during thrombectomy for acute stroke(BRETIS-TNK II)study is a prospective,randomised,adaptive enrichment,open-label,blinded end point,multicentre study.Eligible AIS-LVO patients are randomly assigned into the experimental group and control group with a ratio of 1:1.The experimental group will be treated with intra-arterial infusion of TNK during EVT.The control group will be treated with standard EVT.Outcome The primary end point is a favourable outcome,defined as an mRS score of 0–2 at 90 days.The primary safety end point is symptomatic intracranial haemorrhage within 48 hours,which is defined as an increase in the National Institutes of Health Stroke Scale score of≥4 points as a result of the intracranial haemorrhage.Conclusions The results of BRETIS-TNK II will provide evidence for the efficacy and safety of intra-arterial TNK administration during EVT in AIS patients with LVO.展开更多
Introduction The safety outcomes of endovascular therapy for intracranial artery stenosis in a real-world stetting are largely unknown.The Clinical Registration Trial of Intracranial Stenting for Patients with Symptom...Introduction The safety outcomes of endovascular therapy for intracranial artery stenosis in a real-world stetting are largely unknown.The Clinical Registration Trial of Intracranial Stenting for Patients with Symptomatic Intracranial Artery Stenosis(CRTICAS)was a prospective,multicentre,real-world registry designed to assess these outcomes and the impact of centre experience.Methods 1140 severe,symptomatic intracranial arterial stenosis(ICAS)patients treated with endovascular therapy were included from 26 centres,further divided into three groups according to the annual centre volume of intracranial angioplasty and stent placement procedures over 2 years:(1)high volume for≥25 cases/year;(2)moderate volume for 10–25 cases/year and(3)low volume for<10 cases/year.Results The rate of 30-day stroke,transient ischaemic attack or death was 9.7%(111),with 5.4%,21.1%and 9.7%in high-volume,moderate-volume and low-volume centres,respectively(p<0.05).Multivariable logistic regression confirmed high-volume centres had a significantly lower primary endpoint compared with moderate-volume centres(OR=0.187,95%CI:0.056 to 0.627;p≤0.0001),while moderate-volume and low-volume centres showed no significant difference(p=0.8456).Conclusion Compared with the preceding randomised controlled trials,this real-world,prospective,multicentre registry shows a lower complication rate of endovascular treatment for symptomatic ICAS.Non-uniform utilisation in endovascular technology,institutional experience and patient selection in different volumes of centres may have an impact on overall safety of this treatment.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
Objectives The aim of this study was to compare complications and outcomes between intracranial aneurysms treated with the Pipeline embolisation device(PED)alone or with PED combined with coiling for different-sized a...Objectives The aim of this study was to compare complications and outcomes between intracranial aneurysms treated with the Pipeline embolisation device(PED)alone or with PED combined with coiling for different-sized aneurysms.Method Patients with aneurysms treated by PED were collected from the PED in China postmarket multicentre registry study.We performed a propensity match analysis to compare the efficacy and safety between PED alone and PED combined with coiling treatment,and then aneurysms were organised into three groups based on their size:small(≤7 mm),medium(≤15 mm to>7 mm)and large/giant(>15 mm).Complications and aneurysm occlusion rates in the aneurysm size groups were compared between PED alone and PED combined with coiling patients.Result A total of 1171 patients with 1322 aneurysms were included.All patients received clinical follow-up,while angiographic follow-up was available in 967 aneurysms.For small aneurysms,there was no difference in the aneurysm occlusion rate between two groups(79.1%vs 88.4%,respectively),while there was a significant increase in the ischaemic complication rate(8.3%vs 19.3%,respectively,p=0.0001).For medium and large/giant saccular aneurysms,PED combined with coiling significantly improved the occlusion rate(medium aneurysms:74.7%vs 88.8%,respectively,p<0.0001;large/giant saccular aneurysms:72.9%vs 86.9%,respectively,p=0.018),while there were no differences in the total complication rate.For large/giant non-saccular aneurysms,two groups showed no differences.Conclusion Use of the PED with adjunctive coils can significantly improve the occlusion rate of medium aneurysms,without increasing the total complication rate.展开更多
基金sponsored by the National Natural Science Foundation of China(82071302)Bai Qian Wan Talent Plan(2017A07)and Beijing Municipal Administration of Hospital Incubating Program(PX2016034).
文摘Background Unruptured intracranial aneurysm treatment aims to reduce the risk of aneurysm rupture and bleeding,relieves symptoms and improve the quality of life for patients.This study aimed to assess the safety and efficacy of Pipeline Embolization Device(PED,Covidien/Medtronic,Irvine,CA)treatment for intracranial aneurysms presenting with mass effect in real-world settings.Methods We selected patients from the PED in China Post-Market Multi-Center Registry Study with mass effect presentation.The study endpoints included postoperative mass effect deterioration and mass effect relief at follow-up(3–36 months).We conducted multivariate analysis to identify factors associated with mass effect relief.Subgroup analyses by aneurysm location,size and form were also performed.Results This study included 218 patients with a mean age of 54.3±11.8 years and a female predominance of 74.0%(162/218).The postoperative mass effect deterioration rate was 9.6%(21/218).During a median follow-up period of 8.4 months,the mass effect relief rate was 71.6%(156/218).Notably,immediate aneurysm occlusion following treatment was significantly associated with mass effect relief(OR 0.392,95%CI,0.170 to 0.907,p=0.029).Subgroup analysis demonstrated that adjunctive coiling contributed to mass effect relief in cavernous aneurysms,while dense embolism impeded symptom relief in aneurysms<10mm and saccular aneurysms.Conclusions Our data confirmed the efficacy of PED in relieving mass effect.The findings of this study provide support for endovascular treatment to alleviate mass effect in unruptured intracranial aneurysms.Trial registration number NCT03831672.
基金funded by the National Natural Science Foundation of China(No.81825007)Beijing Outstanding Young Scientist Program(No.BJJWZYJH01201910025030)+5 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(No.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(No.2017YFC1307900,2017YFC1307905).
文摘Objective The impact of thrombus migration(TM)prior to endovascular thrombectomy(EVT)on clinical outcomes and revascularisation rates remains unknown.We aimed to examine whether preinterventional TM modifies the treatment effects of direct EVT versus bridging EVT in acute large vessel occlusion patients.Methods All patients undergoing catheter angiography in the Direct Intra-arterial thrombectomy in order to Revascularise acute ischaemic stroke patients with large vessel occlusion Efficiently in Chinese Tertiary hospitals:A Multicentre randomised clinical Trial were included.TM was determined by radiologists unaware of the study by analysing discrepancies between computed tomographic angiography at baseline and first-run digital subtraction angiography before EVT.The primary outcome was the score on the modified Rankin scale(mRS)assessed at 90 days.Results Of 627 included patients,the TM rate was 11.3%(71/627).In the multivariable logistic regression model,baseline National Institutes of Health Stroke Scale score(adjusted OR 0.956,95%CI 0.916 to 0.999;p=0.043)and intravenous thrombolysis(adjusted OR 2.614,95%CI 1.514 to 4.514;p<0.001)were independently associated with TM.The patients with TM were less likely to be completely recanalised than those without TM(21.27%vs 36.23%,p=0.040).The interaction of TM and the EVT treatment effect did not significantly affect mRS shift analysis(p=0.687)or mRS scores of 0 to 1(p=0.436).Conclusion Preinterventional TM does not modify the treatment effects of direct versus bridging EVT on functional outcomes in patients with acute ischaemic stroke with anterior large vessel occlusion.TM leads to a lower complete recanalisation rate.
基金supported by grants from the Science and Technology Project Plan of Liao Ning Province(2022JH2/101500020)the Science and Technology Plan of Shen Yang(20-205-4-007).
文摘Background Our recent pilot study suggests intra-arterial tenecteplase(TNK)during the first pass of endovascular treatment(EVT)seems safe,may increase first-pass reperfusion and good outcome in acute ischaemic stroke(AIS)patients with large-vessel occlusion(LVO).Aims To determine the efficacy and safety of intra-arterial TNK administration during EVT in AIS-LVO patients presenting up to 24 hours from symptom onset.Sample size estimates A maximum of 380 patients are required to test the superiority hypothesis with 80%power according to a two-side 0.05 level of significance,stratified by age,gender,baseline systolic blood pressure,prestroke modified Rankin Scale(mRS),baseline National Institute of Health stroke scale,baseline ASPECTS,time from onset to groin puncture,intravenous thrombolysis before EVT,stroke territory and stroke aetiology.Design Intra-arterial TNK during thrombectomy for acute stroke(BRETIS-TNK II)study is a prospective,randomised,adaptive enrichment,open-label,blinded end point,multicentre study.Eligible AIS-LVO patients are randomly assigned into the experimental group and control group with a ratio of 1:1.The experimental group will be treated with intra-arterial infusion of TNK during EVT.The control group will be treated with standard EVT.Outcome The primary end point is a favourable outcome,defined as an mRS score of 0–2 at 90 days.The primary safety end point is symptomatic intracranial haemorrhage within 48 hours,which is defined as an increase in the National Institutes of Health Stroke Scale score of≥4 points as a result of the intracranial haemorrhage.Conclusions The results of BRETIS-TNK II will provide evidence for the efficacy and safety of intra-arterial TNK administration during EVT in AIS patients with LVO.
基金supported by the National Key Research and Development Project(2016YFC1301703)the Beijing Scientific and Technologic Project(D161100003816002).
文摘Introduction The safety outcomes of endovascular therapy for intracranial artery stenosis in a real-world stetting are largely unknown.The Clinical Registration Trial of Intracranial Stenting for Patients with Symptomatic Intracranial Artery Stenosis(CRTICAS)was a prospective,multicentre,real-world registry designed to assess these outcomes and the impact of centre experience.Methods 1140 severe,symptomatic intracranial arterial stenosis(ICAS)patients treated with endovascular therapy were included from 26 centres,further divided into three groups according to the annual centre volume of intracranial angioplasty and stent placement procedures over 2 years:(1)high volume for≥25 cases/year;(2)moderate volume for 10–25 cases/year and(3)low volume for<10 cases/year.Results The rate of 30-day stroke,transient ischaemic attack or death was 9.7%(111),with 5.4%,21.1%and 9.7%in high-volume,moderate-volume and low-volume centres,respectively(p<0.05).Multivariable logistic regression confirmed high-volume centres had a significantly lower primary endpoint compared with moderate-volume centres(OR=0.187,95%CI:0.056 to 0.627;p≤0.0001),while moderate-volume and low-volume centres showed no significant difference(p=0.8456).Conclusion Compared with the preceding randomised controlled trials,this real-world,prospective,multicentre registry shows a lower complication rate of endovascular treatment for symptomatic ICAS.Non-uniform utilisation in endovascular technology,institutional experience and patient selection in different volumes of centres may have an impact on overall safety of this treatment.
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.
基金sponsored by National Natural Science Foundation of China(grant numbers:81220108007,81801156,81801158,81471167 and 81671139).
文摘Objectives The aim of this study was to compare complications and outcomes between intracranial aneurysms treated with the Pipeline embolisation device(PED)alone or with PED combined with coiling for different-sized aneurysms.Method Patients with aneurysms treated by PED were collected from the PED in China postmarket multicentre registry study.We performed a propensity match analysis to compare the efficacy and safety between PED alone and PED combined with coiling treatment,and then aneurysms were organised into three groups based on their size:small(≤7 mm),medium(≤15 mm to>7 mm)and large/giant(>15 mm).Complications and aneurysm occlusion rates in the aneurysm size groups were compared between PED alone and PED combined with coiling patients.Result A total of 1171 patients with 1322 aneurysms were included.All patients received clinical follow-up,while angiographic follow-up was available in 967 aneurysms.For small aneurysms,there was no difference in the aneurysm occlusion rate between two groups(79.1%vs 88.4%,respectively),while there was a significant increase in the ischaemic complication rate(8.3%vs 19.3%,respectively,p=0.0001).For medium and large/giant saccular aneurysms,PED combined with coiling significantly improved the occlusion rate(medium aneurysms:74.7%vs 88.8%,respectively,p<0.0001;large/giant saccular aneurysms:72.9%vs 86.9%,respectively,p=0.018),while there were no differences in the total complication rate.For large/giant non-saccular aneurysms,two groups showed no differences.Conclusion Use of the PED with adjunctive coils can significantly improve the occlusion rate of medium aneurysms,without increasing the total complication rate.
