Although recent trials have suggested that stenting is worse than medical therapy for patients with severe symptomatic intracranial atherosclerotic stenosis, it is not clear whether this conclusion ...applies to a subset of patients with hypoperfusion symptoms. To justify for a new trial in China, we performed a multicenter prospective registry study to evaluate the safety and efficacy of endovascular stenting within 30 days for patients with severe symptomatic intracranial atherosclerotic stenosis.
Patients with symptomatic intracranial atherosclerotic stenosis caused by 70% to 99% stenosis combined with poor collaterals were enrolled. The patients were treated either with balloon-mounted stent or with balloon predilation plus self-expanding stent as determined by the operators following a guideline. The primary outcome within 30 days is stroke, transient ischemic attack, and death after stenting. The secondary outcome is successful revascularization. The baseline characteristics and outcomes of the 2 treatment groups were compared.
From September 2013 to January 2015, among 354 consecutive patients, 300 patients (aged 58.3±9.78 years) were recruited, including 159 patients treated with balloon-mounted stent and 141 patients with balloon plus self-expanding stent. The 30-day rate of stroke, transient ischemic attack, and death was 4.3%. Successful revascularization was 97.3%. Patients treated with balloon-mounted stent were older, less likely to have middle cerebral artery lesions, more likely to have vertebral artery lesions, more likely to have Mori A lesions, less likely to have Mori C lesions, and likely to have lower degree of residual stenosis than patients treated with balloon plus self-expanding stent.
The short-term safety and efficacy of endovascular stenting for patients with severe symptomatic intracranial atherosclerotic stenosis in China is acceptable. Balloon-mounted stent may have lower degree of residual stenosis than self-expanding stent.
URL: http://www.clinicaltrials.gov. Unique identifier: NCT01968122.
To date, no consensus still exists on the anesthesia strategy of endovascular treatment (EVT) for acute ischemic stroke (AIS) due to large vessel occlusion (LVO). We aimed to compare the 90-day ...outcomes, puncture-to-recanalization time (PRT), successful recanalization rate, and symptomatic intracranial hemorrhage (sICH) of patients undergoing general anesthesia (GA) or local anesthesia (LA) ± conscious sedation (CS) during the procedure.
We selected patients from the Acute Ischemic Stroke Cooperation Group of Endovascular Treatment (ANGEL) registry and divided them into the GA group and the LA ± CS group. The two groups underwent 1:1 matching under propensity score matching (PSM) analysis. Then, we compared the primary outcome including the 90-day modified Rankin Scale (mRS) 0-2, secondary outcome including the 90-day mRS, the 90-day mRS 0-1, the 90-day mRS 0-3, PRT, and successful recanalization rate as well as the safety outcome including sICH, any ICH, and 90-day mRS 6.
Among the 705 enrolled patients, 263 patients underwent GA and 442 patients underwent LA ± CS. After 1:1 PSM according to the baseline characteristics, each group has 216 patients. Patients with GA had the higher median 90-day mRS 3 (1-5) vs. 2 (1-4),
< 0.001, the lower 90-day mRS 0-2 rate (43.5 vs. 56.5%,
= 0.007), higher mortality (19.9 vs.10.2%,
= 0.005), and longer PRT 92 (60-140) vs. 70 (45-103) min,
< 0.001. There were no differences in sICH and successful recanalization rate between both the groups.
In the real-world setting, LA ± CS might provide more outcomes benefits than GA in patients with AIS-LVO during the procedure.
Background and purposeA multicentre prospective registry study of individually tailored stenting for a patient with symptomatic intracranial atherosclerotic stenosis (ICAS) combined with poor ...collaterals in China showed that the short-term safety and efficacy of stenting was acceptable. However, it remained uncertain whether the low event rate could be of a long term. We reported the 1-year outcome of this registry study to evaluate the long-term efficacy of individually tailored stenting for patients with severe symptomatic ICAS combined with poor collaterals.MethodsPatients with symptomatic ICAS caused by 70%–99% stenosis located at the intracranial internal carotid, middle cerebral, intracranial vertebral or basilar arteries combined with poor collaterals were enrolled. Balloon-mounted stent or balloon plus self-expanding stent were selected based on the ease of vascular access and lesion morphology determined by the operators. The primary outcome was the rate of 30-day stroke, transient ischaemic attack and death, and 12-month ischaemic stroke within the same vascular territory, haemorrhagic stroke and vascular death after stenting.ResultsFrom September 2013 to January 2015, 300 patients (ages 58.3±9.78 years) were recruited. Among them, 159 patients were treated with balloon-mounted stent and 141 with balloon plus self-expanding stent. During the 1-year follow-up, 25 patients had a primary end point event. The probability of primary outcome at 1 year was 8.1% (95% CI 5.3% to 11.7%). In 76 patients with digital subtraction angiography follow-up, 27.6% (21/76) had re-stenosis ≥50% and 18.4% (14/76) had re-stenosis ≥70%. No baseline characteristic was associated with the primary outcome.ConclusionThe event rate remains low over 1 year of individually tailored stenting for patients with severe symptomatic ICAS combined with poor collaterals. Further randomised trial of comparing individually tailored stenting with best medical therapy is needed.Trial registration numberNCT01968122; Results.
The effects and risks of endovascular thrombectomy 6 to 24 hours after stroke onset due to basilar-artery occlusion have not been extensively studied.
In a trial conducted over a 5-year period in ...China, we randomly assigned, in a 1:1 ratio, patients with basilar-artery stroke who presented between 6 to 24 hours after symptom onset to receive either medical therapy plus thrombectomy or medical therapy only (control). The original primary outcome, a score of 0 to 4 on the modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 4 moderately severe disability, and 6 death) at 90 days, was changed to a good functional status (a modified Rankin scale score of 0 to 3, with a score of 3 indicating moderate disability). Primary safety outcomes were symptomatic intracranial hemorrhage at 24 hours and 90-day mortality.
A total of 217 patients (110 in the thrombectomy group and 107 in the control group) were included in the analysis; randomization occurred at a median of 663 minutes after symptom onset. Enrollment was halted at a prespecified interim analysis because of the superiority of thrombectomy. Thrombolysis was used in 14% of the patients in the thrombectomy group and in 21% of those in the control group. A modified Rankin scale score of 0 to 3 (primary outcome) occurred in 51 patients (46%) in the thrombectomy group and in 26 (24%) in the control group (adjusted rate ratio, 1.81; 95% confidence interval CI, 1.26 to 2.60; P<0.001). The results for the original primary outcome of a modified Rankin scale score of 0 to 4 were 55% and 43%, respectively (adjusted rate ratio, 1.21; 95% CI, 0.95 to 1.54). Symptomatic intracranial hemorrhage occurred in 6 of 102 patients (6%) in the thrombectomy group and in 1 of 88 (1%) in the control group (risk ratio, 5.18; 95% CI, 0.64 to 42.18). Mortality at 90 days was 31% in the thrombectomy group and 42% in the control group (adjusted risk ratio, 0.75; 95% CI, 0.54 to 1.04). Procedural complications occurred in 11% of the patients who underwent thrombectomy.
Among patients with stroke due to basilar-artery occlusion who presented 6 to 24 hours after symptom onset, thrombectomy led to a higher percentage with good functional status at 90 days than medical therapy but was associated with procedural complications and more cerebral hemorrhages. (Funded by the Chinese National Ministry of Science and Technology; BAOCHE ClinicalTrials.gov number, NCT02737189.).
Previous randomised trials have shown an overwhelming benefit of mechanical thrombectomy for treating patients with stroke caused by large vessel occlusion of the anterior circulation. Whether ...endovascular treatment is beneficial for vertebrobasilar artery occlusion remains unknown. In this study, we aimed to investigate the safety and efficacy of endovascular treatment of acute strokes due to vertebrobasilar artery occlusion.
We did a multicentre, randomised, open-label trial, with blinded outcome assessment of thrombectomy in patients presenting within 8 h of vertebrobasilar occlusion at 28 centres in China. Patients were randomly assigned (1:1) to endovascular therapy plus standard medical therapy (intervention group) or standard medical therapy alone (control group). The randomisation sequence was computer-generated and stratified by participating centres. Allocation concealment was implemented by use of sealed envelopes. The primary outcome was a modified Rankin scale (mRS) score of 3 or lower (indicating ability to walk unassisted) at 90 days, assessed on an intention-to-treat basis. The primary safety outcome was mortality at 90 days. Secondary safety endpoints included the rates of symptomatic intracranial haemorrhage, device-related complications, and other severe adverse events. The BEST trial is registered with ClinicalTrials.gov, NCT02441556.
Between April 27, 2015, and Sept 27, 2017, we assessed 288 patients for eligibility. The trial was terminated early after 131 patients had been randomly assigned (66 patients to the intervention group and 65 to the control group) because of high crossover rate and poor recruitment. In the intention-to-treat analysis, there was no evidence of a difference in the proportion of participants with mRS 0–3 at 90 days according to treatment (28 42% of 66 patients in the intervention group vs 21 32% of 65 in the control group; adjusted odds ratio OR 1·74, 95% CI 0·81–3·74). Secondary prespecified analyses of the primary outcome, done to assess the effect of crossovers, showed higher rates of mRS 0–3 at 90 days in patients who actually received the intervention compared with those who received standard medical therapy alone in both per-protocol (28 44% of 63 patients with intervention vs 13 25% of 51 with standard therapy; adjusted OR 2·90, 95% CI 1·20–7·03) and as-treated (36 47% of 77 patients with intervention vs 13 24% of 54 with standard therapy; 3·02, 1·31–7·00) populations. The 90-day mortality was similar between groups (22 33% of 66 patients in the intervention vs 25 38% of 65 in the control group; p=0·54) despite a numerically higher prevalence of symptomatic intracranial haemorrhage in the intervention group.
There was no evidence of a difference in favourable outcomes of patients receiving endovascular therapy compared with those receiving standard medical therapy alone. Results might have been confounded by loss of equipoise over the course of the trial, resulting in poor adherence to the assigned study treatment and a reduced sample size due to the early termination of the study.
Jiangsu Provincial Special Program of Medical Science.
Several randomized clinical trials have recently established the safety and efficacy of endovascular treatment (EVT) of acute ischemic stroke in the anterior circulation. However, it remains ...uncertain whether patients with acute basilar artery occlusion (BAO) benefit from EVT.
To evaluate the association between EVT and clinical outcomes of patients with acute BAO.
This nonrandomized cohort study, the EVT for Acute Basilar Artery Occlusion Study (BASILAR) study, was a nationwide prospective registry of consecutive patients presenting with an acute, symptomatic, radiologically confirmed BAO to 47 comprehensive stroke centers across 15 provinces in China between January 2014 and May 2019. Patients with acute BAO within 24 hours of estimated occlusion time were divided into groups receiving standard medical treatment plus EVT or standard medical treatment alone.
The primary outcome was the improvement in modified Rankin Scale scores (range, 0 to 6 points, with higher scores indicating greater disability) at 90 days across the 2 groups assessed as a common odds ratio using ordinal logistic regression shift analysis, adjusted for prespecified prognostic factors. The secondary efficacy outcome was the rate of favorable functional outcomes defined as modified Rankin Scale scores of 3 or less (indicating an ability to walk unassisted) at 90 days. Safety outcomes included symptomatic intracerebral hemorrhage and 90-day mortality.
A total of 1254 patients were assessed, and 829 patients (of whom 612 were men 73.8%; median interquartile age, 65 57-74 years) were recruited into the study. Of these, 647 were treated with standard medical treatment plus EVT and 182 with standard medical treatment alone. Ninety-day functional outcomes were substantially improved by EVT (adjusted common odds ratio, 3.08 95% CI, 2.09-4.55; P < .001). Moreover, EVT was associated with a significantly higher rate of 90-day modified Rankin Scale scores of 3 or less (adjusted odds ratio, 4.70 95% CI, 2.53-8.75; P < .001) and a lower rate of 90-day mortality (adjusted odds ratio, 2.93 95% CI, 1.95-4.40; P < .001) despite an increase in symptomatic intracerebral hemorrhage (45 of 636 patients 7.1% vs 1 of 182 patients 0.5%; P < .001).
Among patients with acute BAO, EVT administered within 24 hours of estimated occlusion time is associated with better functional outcomes and reduced mortality.
Over the past few years, the rapid development of tactile sensing technology has contributed significantly to the realization of intuitional touch control and intelligent human-machine interaction. ...Apart from physical touch or pressure sensing, proximity sensing as a complementary function can extend the detection mode of common single functional tactile sensors. In this work, we present a transparent, matrix-structure dual functional capacitive sensor which integrates the capability of proximity and pressure sensing in one device, and the excellent spatial resolution offered by the isolated response of capacitive pixels enables us to realize precise location identification of approaching objects and loaded pressure with fast response, high stability and high reversibility.
Based on the unclear safety and effectiveness of direct balloon angioplasty as a first-line treatment for patients with acute ischemic stroke caused by large artery atherosclerosis (LAA), our paper ...would center on investigating the safety and effectiveness of this novel strategy.
A consecutive series of acute ischemic stroke patients due to intracranial atherosclerosis and short thrombus who underwent thorough direct balloon angioplasty from October 2019 to March 2021 were enrolled. The primary end point included arterial recanalization (modified Thrombolysis in Cerebral Infarction mTICI: 2b-3), and 90-day functional independence (modified Rankin ScalemRS: 0–2). The secondary end point was symptomatic intracerebral hemorrhage (sICH) and perioperative restenosis and re-occlusion of offending vessel.
68 patients were included. Mean time from onset to groin puncture was 342.5 min and 50 min for groin puncture to successful recanalization. 61 (89.7%) patients achieved successful recanalization and 41 (60.3%) acquired functional independence. 11 (16.0%) patients experienced ICH and only 3 (4.4%) for sICH. 8 (11.8%) patients developed symptomatic restenosis or re-occlusion within seven days after the operation. In addition, 16 (23.5%) patients received rescue stenting and 3 (18.8%) of this subgroup appeared immediate intra-stent thrombosis.
Direct balloon angioplasty may be a safe and effective method for the treatment of stroke caused by intracranial large arteriosclerosis occlusion.
•In Asia, ICAS is one of the significant mechanisms of ischemic stroke.•Angiogplsty as the rescue method of mechanical thrombectomy was safe.•Exploring the safety and efficacy of direct angioplasty.
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