Best Medical Treatment Group Research Articles

Mechanical Thrombectomy in Ischemic Stroke with a Large Infarct Core: A Meta-Analysis of Randomized Controlled Trials.

Background/Objectives: Endovascular treatment (EVT) is recommended for acute ischemic stroke due to large-vessel occlusion (LVO) and an Alberta Stroke Program Early CT Score (ASPECTS) ≥ 6. Randomized controlled trials (RCTs) have recently become available on EVT effects in people with LVO-related large core stroke (ASPECTS 0-5). Here, we provide an updated meta-analysis of the EVT effect on functional neurological status in people with large-core stroke. Methods: The study followed the PRISMA guidelines. PubMed, EMBASE and Cochrane Central were searched for RCTs comparing EVT vs. best medical treatment (BMT) in large-core LVO stroke. The primary outcome was functional independence at 90 days (modified Rankin Scale; mRS 0-2). The secondary outcomes were symptomatic intracranial hemorrhage (sICH), good functional outcome (mRS 0-3) and excellent functional outcome (mRS 0-1). EVT vs. BMT was compared through random effect meta-analysis. Heterogeneity was assessed with the I2 and Q test and risk of bias reported according to the RoB2 tool. Results: Six RCTs were included (n = 1656 patients). All studies had a moderate risk of bias, with blinding bias due to the nature of the intervention, potential allocation bias and incomplete outcome reporting. Functional independence was significantly more frequent in the EVT vs. BMT group (OR = 2.47, 95% CI = 1.52-4.03, p < 0.001). sICH rates (OR = 1.77, 95% CI = 1.01-3.11, p = 0.04) and good functional outcome (OR = 2.20; 95% CI = 1.72-2.81, p < 0.001) were more frequent in the EVT vs. BMT group, while the rates of mRS 0-1 did not differ. Conclusions: In patients with large-core stroke and LVO, EVT plus BMT as compared to BMT alone carries a significant increase in independent ambulation and good functional outcome at 3 months despite the marginal increase in sICH.

European stroke organisation and European society for minimally invasive neurological therapy guideline on acute management of basilar artery occlusion.

The aim of the present European Stroke Organisation (ESO) guideline is to provide evidence-based recommendations on the acute management of patients with basilar artery occlusion (BAO). These guidelines were prepared following the Standard Operational Procedure of the ESO and according to the GRADE methodology. Although BAO accounts for only 1%-2% of all strokes, it has very poor natural outcome. We identified 10 relevant clinical situations and formulated the corresponding Population Intervention Comparator Outcomes (PICO) questions, based on which a systematic literature search and review was performed. The working group consisted of 10 voting members (five representing ESO and five ESMINT) and three non-voting junior members. The certainty of evidence was generally very low. In many PICOs, available data were scarce or lacking, hence, we provided expert consensus statements. First, we compared intravenous thrombolysis (IVT) to no IVT, but specific BAO-related data do not exist. Yet, historically, IVT was standard of care for BAO patients who were also included (albeit in small numbers) in IVT trials. Non-randomised studies of IVT-only cohorts showed high proportion of favourable outcomes. Expert Consensus suggests using IVT up to 24 h unless otherwise contraindicated. We further suggest IVT plus endovascular treatment (EVT) over direct EVT. EVT on top of best medical treatment (BMT) was compared to BMT alone within 6 and 6-24 h from last seen well. In both time windows, we observed a different effect of treatment depending on (a) the region where the patients were treated (Europe vs. Asia), (b) on the proportion of IVT in the BMT arm, and (c) on the initial stroke severity. In case of high proportion of IVT in the BMT group and in patients with NIHSS below 10, EVT plus BMT was not found better than BMT alone. Based on very low certainty of evidence, we suggest EVT + BMT over BMT alone (i.e. based on results of patients with at least 10 NIHSS points and a low proportion of IVT in BMT). For patients with an NIHSS below 10, we found no evidence to recommend EVT over BMT. In fact, BMT was non-significantly better and safer than EVT. Furthermore, we found a stronger treatment effect of EVT + BMT over BMT alone in proximal and middle locations of BAO compared to distal location. While recommendations for patients without extensive early ischaemic changes in the posterior fossa can, in general, follow those of other PICOs, we formulated an Expert Consensus Statement suggesting against reperfusion therapy in those with extensive bilateral and/or brainstem ischaemic changes. Another Expert Consensus suggests reperfusion therapy regardless of collateral scores. Based on limited evidence, we suggest direct aspiration over stent retriever as the first-line strategy of mechanical thrombectomy. As an Expert Consensus, we suggest rescue percutaneous transluminal angioplasty and/or stenting after a failed EVT procedure. Finally, based on very low certainty of evidence, we suggest add-on antithrombotic treatment during EVT or within 24 h after EVT in patients with no concomitant IVT and in whom EVT was complicated (defined as failed or imminent re-occlusion, or need for additional stenting or angioplasty).

Endovascular thrombectomy for ischemic stroke with large infarct, short- and long-term outcomes: a meta-analysis of 6 randomised control trials.

Endovascular Thrombectomy (EVT) as first-line treatment of patients with large core ischemic infarct is a subject of debate. A systematic literature search was conducted in four electronic databases for randomized control trials (RCTs) comparing EVT to best medical treatment (BMT) for large core infarcts (ASPECTS ≤ 5). Relevant studies were added after screening for titles, abstracts, and complete text. Meta-analysis was performed. The continuous outcomes were analyzed using the standardized mean difference (SMD) and 95% CI, while the binary outcomes were analyzed using the risk ratio (RR) and 95% confidence interval (CI). A funnel plot was used to visually evaluate publication bias, and if feasible, Egger's test was used to validate. We included 1918 patients from six RCTs that compared EVT plus BMT and BMT alone in patients with large core infarct due to large vessel occlusion in the anterior circulation. There were 946 patients in the EVT group and 972 patients in the BMT group. The one-year outcomes are available for 314 patients in the EVT group and 292 patents in the BMT group from two RCTs. EVT group had statistically significant higher rate of 90-day mRS 0-1 (RR = 3.1, P-value < 0.0001), mRS 0-2 (RR = 2.64, P-value < 0.0001), mRS 0-3 (RR = 1.80, P-value < 0.0001), lower 90-day mean mRS score (SMD = -0.29, P-value < 0.0001), lower 90-day mortality rate (RR = 0.85, P-value = 0.015), and greater early neurological improvement (RR = 2.16, P-value < 0.00001) compared to the BMT group. However, the rates of symptomatic intracerebral hemorrhage (sICH) (RR = 1.76, P-value = 0.01) and any ICH (RR = 2.18, P-value < 0.00001) were higher in EVT group. Our finding showed that EVT plus BMT led to in an absolute improvement of 5%, 12%, and 16% in 90-day mRS 0-1, 0-2, and 0-3, respectively. In addition, patients in EVT plus BMT group had a 3% increased probability of experiencing sICH and were 32% more susceptible to any ICH. Moreover, the one-year mRS 0-2 (RR = 2.16, P-value < 0.00001) and mRS 0-3 (RR = 1.80, P-value < 0.0001) was significantly favor the EVT plus BMT over BMT alone. Although, the one-year mortality rate was not significantly differed between two groups (RR = 0.91, P-value = 0.31). There was no statistically significant difference observed between the EVT plus BMT group and the BMT group concerning new stroke, decompressive craniectomy, and serious adverse events. Combined data from six RCTs shows that EVT plus BMT provides significantly better short- and long-term functional outcomes with minimal increase in symptomatic hemorrhage over BMT in patient with large core infarcts.

A systematic review of randomized controlled trials of endovascular therapy for stroke on mortality and disability

BackgroundEndovascular treatment (EVT) has become standard of care for patients with anterior circulation large vessel occlusion (LVO) stroke, with indications having recently expanded to late time-window and large ischemic core patients. There is conflicting evidence on whether EVT reduces mortality or only disability. We performed a meta-analysis of randomized controlled trials (RCTs) to assess the effect of EVT on mortality and severe disability. MethodsWe systematically searched PubMed, Web of Science, Scopus, and Embase on November 15, 2023, to identify phase 3 RCTs comparing EVT to best medical treatment (BMT) in patients with anterior circulation LVO stroke in a common effects meta-analysis. The primary outcome was mortality at 3 months. Secondary outcomes were moderately severe or severe disability (modified Rankin Scale (mRS) score 4–5) at 3 months. Results18 studies comparing EVT to BMT were included, with a total of 4309 patients; 2159 that were treated with EVT, and 2150 treated with BMT. Mortality was significantly lower in the EVT group than in the BMT group (odds ratio (OR): 0.81, 95% CI: 0.70–0.94). Proportions of moderately severe or severe disability (OR: 0.55, 95% CI: 0.48–0.62) were also significantly lower in patients treated with EVT. ConclusionsThis meta-analysis suggests that EVT reduces both mortality and moderately severe or severe disability in patients with anterior circulation LVO stroke.

Absent leptomeningeal collateralization is associated with greatest benefit from mechanical thrombectomy in the 6-24 hour time window.

The impact of leptomeningeal collateralization on the efficacy of mechanical thrombectomy (MT) in patients with anterior circulation large vessel occlusion (aLVO) presenting in the 6-24 h time window remains poorly elucidated. Retrospective multicenter study of aLVO patients presenting between 6 and 24 h after stroke onset who received MT plus Best Medical Treatment (BMT) or BMT alone. Leptomeningeal collateralization was assessed using single-phase computed tomography angiography (grade 0: no filling; grade 1: filling ⩽50%; grade 2: filling >50% but <100%; grade 3: filling 100% of the occluded territory). Inverse probability of treatment weighted ordinal regression was performed to assess the association between treatment and shift of the modified Rankin Scale (mRS) score toward lower categories at 3 months. We used interaction analysis to explore differential treatment effects on functional outcomes (probabilities for each mRS subcategory at 3 months) at different collateral grades. Among 363 included patients, 62% received MT + BMT. Better collateralization was associated with better functional outcomes at 3 months in the BMT alone group (collateral grade 1 vs 0: acOR 5.06, 95% CI 2.33-10.99). MT + BMT was associated with higher odds of favorable functional outcome at 3 months (acOR 1.70, 95% CI 1.11-2.62) which was consistent after adjustment for collateral status (acOR 1.54, 95% CI 1.01-2.35). Regarding treatment effect modification, patients with absent collateralization had higher probabilities for a mRS of 0-4 and a lower mortality at 3 months for the MT + BMT group. In the 6-to-24-h time window, aLVO patients with absent leptomeningeal collateralization benefit most from MT + BMT, indicating potential advantages for this group despite their poorer baseline prognosis.

The dual effect of vagus nerve stimulation in pediatric patients with drug-resistant epilepsy: Is there more than seizure control?

This is a retrospective and comparative pilot study to investigate the role of vagus nerve stimulation (VNS) in improving cognitive functions in the pediatric age group with drug resistant epilepsy (DRE). It was conducted from January 2018 to February 2023. Children between the ages of 4 and 18 years were divided into two groups, the “VNS group” and the “best medical treatment (BMT) group”. Follow up period was 12 months. Demographic, clinical, etiological and investigational data were recorded. Cognitive assessment using the Modified Mini-Mental State Examination for children (MMSE) was recorded at baseline and 12 months later for each group. 76.4 % of patients were classified as epilepsy secondary to cerebral palsy. 75 % of patients showed ≥ 50 % seizure frequency reduction among the VNS group as compared to 12.5 % in the BMT group. None of both groups achieved seizure freedom. At 12 months, both BMT and VNS groups showed statistically significantly improved overall cognitive score from baseline records (p = 0.027) and (p = 0.012), respectively, with a significantly higher improvement in VNS group. Also, statistical sub-analysis of cognitive subscales in cerebral palsy patients in both groups was conducted and revealed a significant improvement (p = 0.02) in the VNS group. We concluded that there is a potential role of VNS in improving cognitive functions which was shown by using a cost-effective screening tool. A significant effect was observed specially in cerebral palsy patients. This is very beneficial in limited-resources countries since VNS has good safety profile, high seizure control, and added value to cognitive functions.

Abstract Number: LBA6 Mechanical Thrombectomy for Basilar Artery Occlusion: Systematic Review and Meta‐analysis of Randomized Controlled Trials

Introduction Acute ischemic stroke (AIS) caused by basilar artery occlusion (BAO) is known to be associated with high rates of mortality and lifelong disability. In the past few years, two clinical trials (the BEST and the BASICS trials) investigated the benefits and safety of mechanical thrombectomy (MT) for BAO and did not provide evidence to support the efficacy of MT in BAO patients. Given the recent positive results from the ATTENTION and the BAOCHE clinical trials, we conducted this meta‐analysis to provide updated collective evidence regarding the benefits of MT in patients with BAO. Methods We searched for eligible papers till June 1st, 2021, in five databases: PubMed, Web of Science, Scopus, and Embase databases using keywords and/or medical subject (MeSH) terms. We included all randomized controlled trials (RCTs) with no restrictions on publication date, data, or language of the included studies to avoid missing any relevant papers. All data were analyzed using R software. We computed the pooled risk ratios (RRs) and their corresponding 95% confidence intervals (CI), using a random‐effect model or fixed‐effect model depending on heterogeneity among the included studies. Heterogeneity was assessed with Q statistics and the I2 test considering it significant with I2 value &gt; 50% or P‐value &lt; 0.05. Results Four trials were included in this meta‐analysis, namely the BEST, the BASICS, the BAOCHE, and the ATTENTION trials. The four trials recruited a total of 988 patients. The MT group achieved a significantly higher rate of modified Rankin scale (mRS) score of 0–3 was as compared to the best medical treatment (BMT) one (RR = 1.54; 95% CI = 1.16‐2.04; P‐value = 0.002). Similarly, the mRS 0–2 rate was significantly higher in the MT group as compared to the BMT group (RR = 1.79; 95% CI = 1.09‐2.95; P‐value = 0.022). Nevertheless, heterogeneity was noticed amongst the included studies. Moreover, there was a significant reduction in the 90‐day mortality in the MT group as compared to the BMT group (RR = 0.76; 95% CI = 0.65‐0.89; P‐value = 0.002). On the other hand, there was a significantly higher rate of symptomatic intracerebral hemorrhage (sICH) in the MT group compared to the BMT group (RR = 7.48; 95% CI = 2.27‐24.61; P‐value&lt; 0.001). There with no heterogeneity observed in both outcomes of mortality and sICH. Noted that there were no significant differences in overall parenchymal hemorrhage (PH) and type I PH rates, yet type II PH was more prevalent in the MT group compared to the BMT one (RR = 5.53; 95% CI = 1.47‐20.84; P‐value = 0.011). Conclusions The current evidence favors MT for basilar artery occlusions over the conservative approach in terms of achieving higher rates of good functional outcomes and decreasing mortality rates. Further large‐scale trials of different populations are needed to corroborate these results and also to ensure generalizability.

Mechanical Thrombectomy in Acute Stroke Patients with Moderate to Severe Pre-Stroke Disability.

Background and Purpose Studies on mechanical thrombectomy (MT) in acute ischemic stroke (AIS) patients with preexisting disability are limited. We aimed to compare the outcomes of MT versus best medical treatment (BMT) in these patients. Methods In the nationwide Austrian registry and Swiss monocentric registry, we identified 462 AIS patients with pre-stroke disability (modified Rankin Scale [mRS] score ≥3) and acute large vessel occlusion. The primary outcome was returning to pre-stroke mRS or better at 3 months. Secondary outcomes were early neurological improvement (National Institutes of Health Stroke Scale score improvement ≥8 at 24 to 48 hours), 3-month mortality, and symptomatic intracerebral hemorrhage (sICH). Multivariable regression models and propensity score matching (PSM) were used for statistical analyses. Results Compared with the BMT group (n=175), the MT group (n=175) had younger age, more severe strokes, and lower pre-stroke mRS, but similar proportion of receiving intravenous thrombolysis. MT was associated with higher odds of returning to baseline mRS or better at 3 months (adjusted odds ratio [aOR], 2.5; 95% confidence interval [CI], 1.39 to 4.47), early neurological improvement (aOR, 2.62; 95% CI, 1.41 to 4.88), and lower risk of 3-month mortality (aOR, 0.29; 95% CI, 0.18 to 0.49). PSM analysis showed similar findings. MT was not associated with an increased risk of sICH (4.0% vs. 2.1% in all patients; 4.2% vs. 2.4% in the PSM cohort). Conclusions MT in patients with pre-stroke mRS ≥3 might improve the 3-month outcomes and short-term neurological impairment, suggesting that pre-stroke disability alone should not be a reason to withhold MT, but that individual case-by-case decisions may be more appropriate.

Carotid endarterectomy or stenting or best medical treatment alone for moderate-to-severe asymptomatic carotid artery stenosis: 5-year results of a multicentre, randomised controlled trial

The optimal treatment for patients with asymptomatic carotid artery stenosis is under debate. Since best medical treatment (BMT) has improved over time, the benefit of carotid endarterectomy (CEA) or carotid artery stenting (CAS) is unclear. Randomised data comparing the effect of CEA and CAS versus BMT alone are absent. We aimed to directly compare CEA plus BMT with CAS plus BMT and both with BMT only. SPACE-2 was a multicentre, randomised, controlled trial at 36 study centres in Austria, Germany, and Switzerland. We enrolled participants aged 50-85 years with asymptomatic carotid artery stenosis at the distal common carotid artery or the extracranial internal carotid artery of at least 70%, according to European Carotid Surgery Trial criteria. Initially designed as a three-arm trial including one group for BMT alone (with a randomised allocation ratio of 2·9:2·9:1), the SPACE-2 study design was amended (due to slow recruitment) to become two substudies with two arms each comparing CEA plus BMT with BMT alone (SPACE-2a) and CAS plus BMT with BMT alone (SPACE-2b); in each case in a 1:1 randomisation. Participants and clinicians were not masked to allocation. The primary efficacy endpoint was the cumulative incidence of any stroke or death from any cause within 30 days or any ipsilateral ischaemic stroke within 5 years. The primary safety endpoint was any stroke or death from any cause within 30 days after CEA or CAS. The primary analysis was by intention-to treat, which included all randomly assigned patients in SPACE-2, SPACE-2a, and SPACE-2b, analysed using meta-analysis of individual patient data. We did two-step hierarchical testing to first show superiority of CEA and CAS to BMT alone then to assess non-inferiority of CAS to CEA. Originally, we planned to recruit 3640 patients; however, the study had to be stopped prematurely due to insufficient recruitment. This report presents the primary analysis at 5-year follow-up. This trial is registered with ISRCTN, number ISRCTN78592017. 513 patients across SPACE-2, SPACE-2a, and SPACE-2b were recruited and surveyed between July 9, 2009, and Dec 12, 2019, of whom 203 (40%) were allocated to CEA plus BMT, 197 (38%) to CAS plus BMT, and 113 (22%) to BMT alone. Median follow-up was 59·9 months (IQR 46·6-60·0). The cumulative incidence of any stroke or death from any cause within 30 days or any ipsilateral ischaemic stroke within 5 years (primary efficacy endpoint) was 2·5% (95% CI 1·0-5·8) with CEA plus BMT, 4·4% (2·2-8·6) with CAS plus BMT, and 3·1% (1·0-9·4) with BMT alone. Cox proportional-hazard testing showed no difference in risk for the primary efficacy endpoint for CEA plus BMT versus BMT alone (hazard ratio [HR] 0·93, 95% CI 0·22-3·91; p=0·93) or for CAS plus BMT versus BMT alone (1·55, 0·41-5·85; p=0·52). Superiority of CEA or CAS to BMT was not shown, therefore non-inferiority testing was not done. In both the CEA group and the CAS group, five strokes and no deaths occurred in the 30-day period after the procedure. During the 5-year follow-up period, three ipsilateral strokes occurred in both the CAS plus BMT and BMT alone group, with none in the CEA plus BMT group. CEA plus BMT or CAS plus BMT were not found to be superior to BMT alone regarding risk of any stroke or death within 30 days or ipsilateral stroke during the 5-year observation period. Because of the small sample size, results should be interpreted with caution. German Federal Ministry of Education and Research (BMBF) and German Research Foundation (DFG).

Management and Outcomes of Non-A Non-B Aortic Dissection

The results of best medical treatment (BMT), endovascular based treatment (EBT), and total arch replacement (TAR) with frozen elephant trunk (FET) treatment in a single centre experience were reported in non-A non-B aortic dissection patients. From January 2016 to May 2020, 215 consecutive patients with acute or subacute non-A non-B aortic dissection were enrolled. The primary endpoints were all cause death. Secondary endpoints included follow up adverse aortic event (AE), a composite of the outcomes of dissection related death, rupture, retrograde type A aortic dissection, stent graft induced new entry tear, secondary endoleak, and follow up re-intervention. Kaplan-Meier curves were used to evaluate associations between different treatments and outcomes. Among the 215 dissection patients, 127 (59.1%) received EBT, 42 (19.5%) received TAR+ FET, and the remaining 46 (21.4%) received BMT. Thirty day mortality was higher in patients receiving TAR+ FET (7.1%) than in those treated with EBT (1.6%) or BMT (2.2%) (p= .12). However, after a median follow up of 39.1 (27.0 - 50.7) months, no additional death was recorded in the TAR+ FET group, while nine (7.3%) patients died in the EBT group and 14 (31.8%) died in the BMT group (p < .001). Specifically, EBT and TAR+ FET showed no significant difference in midterm mortality rate, follow up AE, and re-intervention for complicated or uncomplicated dissection patients involving zone 2. For patients with uncomplicated non-A non-B aortic dissection involving zone 2, EBT could profoundly decrease the mortality rate, follow up AE and re-intervention when compared with BMT (p < .010 for all), although this difference was not statistically significant between TAR+ FET and BMT. No statistical comparison was performed in patients with zone 1 involvement because of the limited number of patients. It was demonstrated that EBT or TAR+ FET might be a viable strategy for non-A non-B aortic dissection patients.

Safety and effectiveness of mechanical thrombectomy for primary isolated distal vessel occlusions: A monocentric retrospective comparative study

BackgroundDistal vessel occlusions represent about 25-40% of acute ischemic stroke (AIS), either as primary occlusion or secondary occlusion complicating mechanical thrombectomy (MT) for large vessel occlusion. ObjectiveOur aim was to evaluate safety and effectiveness of MT associated with the best medical treatment (BMT) in the management of AIS patients with distal vessel occlusion in comparison with the BMT alone. MethodsRetrospective analysis was conducted on AIS patients treated by MT+BMT for primary distal vessel occlusion between 2015 and 2020, and were compared with a historic cohort managed by BMT alone between 2006 and 2015 selected based on the same inclusion criteria. A secondary analysis was conducted using propensity score matching (PSM) including the following: NIHSS, age and treatment with intravenous thrombolysis (IVT) as covariates. ResultsOf 650 patients screened, 44 patients with distal vessel occlusions treated by MT+BMT were selected and compared with 36 patients who received BMT alone. After PSM, 28 patients in each group were matched without significant difference. Good clinical outcome defined as mRS≤2 was achieved by 53.6% of the MT+BMT group and 57% of the BMT group (OR, 0.87; 95%CI, 0.3–2.4; p = 1.00). The mortality rate was comparable in both groups (7% vs. 10.7% in MT+BMT and BMT patients, respectively; OR=0.64; 95%CI, 0.1-4; p = 1.00). Symptomatic intracranial hemorrhage (ICH) was seen in only one patient treated by MT+BMT (3.6%). ConclusionMechanical thrombectomy seems to be comparable with the best medical treatment regarding the effectiveness and safety in the management of patients with distal vessel occlusions.

Thrombectomy versus medical management for basilar artery occlusion with low-to-moderate symptoms (nihss

Patients with acute basilar artery occlusion (BAO) and mild symptoms are poorly represented in thrombectomy studies. The recent BASICS randomized controlled trial suggested that thrombectomy could be beneficial in patients with BAO and moderate or severe deficit (National Institute of Health Stroke Scale [NIHSS] greater than or equal To 10) but did not find any benefit of thrombectomy over best medical treatment (BMT) in patients with low-to-mild symptoms (NIHSS <10). To compare thrombectomy and BMT in patients with BAO and low-to-mild symptoms (NIHSS <10). Prospective non-randomized multicenter study of all consecutive patients presenting with an acute and symptomatic BAO (confirmed on noninvasive brain imaging) to 8 comprehensive stroke centers in France between January 2012 and May 2019. Patients with an initial NIHSS<10 were divided into groups received either BMT or BMT + thrombectomy.Adjustments were made using propensity-score analysis to compare both groups in terms of efficacy and safety outcomes. The main outcome was the proportion of patients achieving a favorable outcome (mRS 0-2 or equal to pre-stroke mRS) at three months follow-up. Secondary outcomes included the proportion of excellent clinical outcome (mRS 0-1 or equal to pre-stroke mRS), good clinical outcome (mRS 0-3 or equal to pre-stroke mRS) and the mortality rate at 3 months follow-up. Safety outcomes included hemorrhagic transformation at day 1 and mortality at 3 months. A total of 127 patients were included in the present study: 64 patients in the thrombectomy group and 63 patients in the BMT group. There was no difference between groups for the rate of favorable or good clinical outcome at 3 months, and rates of mortality were not significantly different. After propensity-score adjustment, thrombectomy was associated with a significantly higher chance of excellent outcome at 3 months (mRS 0-1 or equal to pre-stroke mRS) (adjusted OR, 2.68; 95%CI, 1.04 to 6.90; P=0.041). Among patients with a stroke secondary to BAO and low-to-mild symptoms (NIHSS<10), thrombectomy is associated with increased chances of having no symptom or disability at 3 months. Déclaration de liens d'intérêts Les auteurs n'ont pas transmis leur déclaration de liens d'intérêts.

Critical appraisal of evidence on bypass surgery versus endovascular treatment for intermittent claudication: a systematic review and meta-analysis.

Intermittent claudication (IC) stage of peripheral artery disease (PAD) is associated with significant impairment of quality of life. In the subset of patients with disabling IC refractory to best medical treatment (BMT), revascularization procedures may be considered. However, evidence comparing open revascularization surgery, endovascular treatment and BMT focusing on the impact on quality of life is very sparse. We aim to review clinical, anatomical and hemodynamic outcomes after bypass surgery compared to BMT and/or endovascular treatment in IC patients. We systematically reviewed controlled trials and comparative cohort studies assessing quality of life, walking performance, clinical/ symptomatic improvement, symptom recurrence, patency rates, Ankle-Brachial Index (ABI) improvement and adverse events after bypass surgery versus endovascular treatment/BMT in IC patients. Eleven studies involving 16,608 patients were included. Compared to BMT, bypass surgery was associated with a significantly greater improvement on Short-Form 36 (SF-36) physical functioning score (mean difference (MD), -14.0; 95% confidence interval [CI], -21.2 to -6.8), Walking Impairment Questionnaire (WIQ) walking distance score (MD, -0.23; 95% CI, -0.29 to -0.16) and SF-36 bodily pain score (MD, -13.0; 95% CI, -20.2 to -5.8). There were no significant differences between bypass and endovascular treatment regarding the three scores. Bypass surgery presented better primary patency rates at 1 (odds ratio [OR], 0.47; 95% CI, 0.29 to 0.76) and 5 years (OR, 0.44; 95% CI, 0.34 to 0.57) and better ABI improvement (MD, -0.07; 95% CI, -0.12 to -0.03) when compared to endovascular treatment. There were no statistically significant differences between bypass and endovascular patients regarding secondary patency rates, 30-day mortality and major amputation. Lower limb revascularization may be beneficial in patients with disabling and refractory IC when the primary goal is to improve quality of life and walking capacity. Bypass surgery is associated to better symptomatic status, long-term primary patency and ABI improvement when compared to endovascular surgery, especially in anatomically extensive disease. Further studies addressing patient-reported outcomes and including a BMT group are paramount for more robust evidence on IC treatment and, consequently, better decision making.

Successful implementation of best medical treatment for patients with asymptomatic carotid artery stenosis within a randomized controlled trial (SPACE-2)

BackgroundAsymptomatic carotid artery stenosis (ACS) can be treated with carotid endarterectomy (CEA), carotid artery stenting (CAS), or best medical treatment (BMT) only. For all treatment options, optimization of vascular risk factors such as arterial hypertension, hyperlipidemia, smoking, obesity, and insufficient physical activity is essential. Data on adherence to BMT and lifestyle modification in patients with ACS are sparse. The subject of this investigation is the implementation and quality of risk factor adjustment in the context of a randomized controlled trial.MethodsA total of 513 patients in the prematurely terminated, randomized, controlled, multicenter SPACE-2 trial (ISRCTN 78592017) were analyzed within one year after randomization into 3 groups (CEA, CAS, and BMT only) for implementation of prespecified BMT recommendations and lifestyle modifications. Measurement time points were the screening visit and visits after one month (D30), 6 months (M6), and one year (A1). Differences between groups and follow-up visits (FUVs) relative to the screening visit were investigated.FindingsFor all FUVs, a significant increase in statin medication (91% at A1; p < 0.0001) was demonstrated to be associated with a significant decrease (p < 0.01) in cholesterol levels (median 167 mg/dl at A1) and LDL cholesterol levels (median 93 mg/dl at A1). The lowest cholesterol levels were achieved by patients in the BMT group. Seventy-eight percent of all patients reached predefined target cholesterol levels (< 200 mg/dl), with significantly better rates in the BMT group (p = 0.036 at D30). Furthermore, a significant decrease in arterial blood pressure at all FUVs (p < 0.05) was associated with a significant increase in antihypertensive medication (96% at A1, p < 0.0001). However, only 28% of patients achieved the predefined treatment goal of a systolic blood pressure of ≤ 130 mmHg. Forty-two of a total of 100 smokers at the screening visit quit smoking within one year, resulting in a significant increase in nonsmokers at all FUVs (p < 0.0001). Recommended HbA1c levels (< 7%) were achieved in 82% without significant changes after one year. Only 7% of obese (BMI > 25) patients achieved sufficient weight reduction after one year without significant changes at all FUVs (median BMI 27 at A1; p = 0.1201). The BMT group showed significantly (p = 0.024) higher rates of adequate physical activity than the intervention groups. Furthermore, after one year, the BMT group showed a comparatively significantly better implementation of risk factor modification (77%; p = 0.027) according to the treating physician.InterpretationSPACE-2 demonstrated sustained improvement in the noninterventional management of vascular risk factors in patients treated in a clinical trial by general practitioners, internists and neurologists. The best implemented treatment targets were a reduction in cholesterol and HbA1c levels. In this context, a significant increase in statin use was demonstrated. Blood pressure control missed its target but was significantly reduced by intensification of antihypertensive medication. Patients on BMT only had better adjusted lipid parameters and were more physically active. However, all groups failed to achieve sufficient weight reduction. Due to insufficient patient recruitment, the results must be interpreted cautiously.Trial registration: ISRCTN Registry, ISRCTN78592017, Registered 16 June 2007, https://www.isrctn.com/search?q=78592017.

Evaluation of Endovascular Treatment for Acute Basilar Occlusion in a State-Wide Prospective Stroke Registry.

Context: Despite overwhelming evidence for endovascular therapy in anterior circulation ischemic stroke due to large-vessel occlusion, data regarding the treatment of acute basilar artery occlusion (BAO) are still equivocal. The BASICS trial failed to show an advantage of endovascular therapy (EVT) over best medical treatment (BMT). In contrast, data from the recently published BASILAR registry showed a better outcome in patients receiving EVT.Objective: The aim of the study was to investigate the safety and efficacy of EVT plus BMT vs. BMT alone in acute BAO.Methods: We analyzed the clinical course and short-term outcomes of patients with radiologically confirmed BAO dichotomized by BMT plus EVT or BMT only as documented in a state-wide prospective registry of consecutive patients hospitalized due to acute stroke. The primary endpoint was a favorable functional outcome (mRS 0–3) at hospital discharge assessed as common odds ratio using binary logistic regression. Secondary subgroup analyses and propensity score matching were added. Safety outcomes included mortality, the rate of intracerebral hemorrhages, and complications during hospitalization.Results: We included 403 patients with acute BAO (2017–2019). A total of 270 patients (67%) were treated with BMT plus EVT and 133 patients (33%) were treated with BMT only. A favorable outcome (mRS 0–3) was observed in 33.8% of the BMT and 26.7% of the BMT plus EVT group [OR.770, CI (0.50–1.2)]. Subgroup analyses for patients with a NIHSS score > 10 at admission to the hospital revealed a benefit from EVT [OR 3.05, CI (1.03–9.01)].Conclusions: In this prospective, quasi population-based registry of patients hospitalized with acute BAO, BMT plus EVT was not superior to BMT alone. Nevertheless, our results suggest that severely affected BAO patients are more likely to benefit from EVT.

Safety and effectiveness of mechanical thrombectomy for primary isolated distal vessel occlusions: retrospective observational comparative study

Distal vessel occlusions represent about 25 % to 40 % of acute ischemic stroke (AIS), either as primary occlusion or secondary occlusion complicating mechanical thrombectomy (MT) for large vessel occlusion. However, the benefit of MT remains uncertain for these occlusions. Our aim was to evaluate safety and effectiveness of MT associated with the best medical treatment (BMT) in the management of AIS patients with distal vessel occlusion in comparison with the BMT alone. Retrospective analysis was primarily conducted on AIS patients treated by MT + BMT for primary distal vessel occlusion between 2015 and 2020, and were compared with a historic cohort managed by BMT alone between 2006 and 2015 selected based on the same inclusion criteria. A secondary analysis was conducted using propensity score matching (PSM) including the following: NIHSS, age and treatment with intravenous thrombolysis (IVT) as covariates. Of 650 patients treated by MT in our centre during the predetermined periods screened, 44 patients with distal vessel occlusions treated by MT + BMT were selected and compared with 36 patients who received BMT alone. After PSM, 28 patients in each group were matched without significant difference. Good clinical outcome defined as mRS?2 was achieved by 53.6 % of the MT + BMT group and 57 % of the BMT group (OR, 0.87; 95 %CI, 0.3–2.4; P = 1.00). The mortality rate was comparable in both groups (7 % vs. 10.7 % in MT + BMT and BMT patients, respectively; OR = 0.64; 95 %CI, 0.1-4; P = 1.00). Symptomatic intracranial haemorrhage (ICH) was seen in only one patient treated by MT + BMT (3.6 %), while no patients in BMT group had symptomatic ICH. Mechanical thrombectomy seems to be comparable with the best medical treatment regarding the effectiveness and safety in the management of patients with distal vessel occlusions ( Fig. 1 ).

Interpretation of health-related quality of life outcomes in Parkinson's disease from the EARLYSTIM Study.

The EARLYSTIM Study compared deep brain stimulation (DBS) with best medical treatment (BMT) over 2-years, showing a between-group difference of 8.0 from baseline in favor of DBS in health-related quality of life (HRQoL), measured with the PDQ-39 SI (summary index). This study obtained complementary information about the importance of the change in HRQoL as measured by the PDQ-39, using anchor-based (Patient Global Impression of Change, PGIC) and distribution-based techniques (magnitude of change, effect size, thresholds, distribution of benefit) applied to the EARLYSTIM study data. Anchor-based techniques showed a difference follow-up–baseline for patients who reported “minimal improvement” of -5.8 [-9.9, -1.6] (mean [95%CI]) in the DBS group vs -2.9 [-9.0, 3.1] in the BMT group. As the vast majority (80.8%) of DBS patients reported “much or very much improvement”, this difference was explored for the latter group and amounted to -8.7 for the DBS group and -6.5 in the BMT group. Distribution-based techniques that analyzed the relative change and treatment effect size showed a moderate benefit of the DBS on the HRQoL, whereas a slight worsening was observed in the BMT group. The change in the DBS group (-7.8) was higher than the MIC (Minimally Important Change) estimated value (-5.8 by the anchor; -6.3 by triangulation of thresholds), but not in the BMT (0.2 vs. -3.0 to -5.4, respectively). Almost 90% of the patients in the DBS group declared some improvement (58.3% and 56.7% beyond the estimated MIC), which was significantly different from the BMT group whose proportions were 32.0% and 30.3%, respectively. The number needed to treat to improve ≥1 MIC by DBS vs BMT was 3.8. Change in depression, disability and pain influenced the improvement of the DBS group. DBS improved HRQoL in a high proportion of patients to a significant and moderate degree, at 2 years follow-up.

Short- and long-term cognitive effects of deep brain stimulation in the caudal zona incerta versus best medical treatment in patients with Parkinson's disease.

A growing number of studies are showing positive effects of deep brain stimulation (DBS) in the caudal zona incerta (cZi) in various tremor disorders, as well as motor symptoms of Parkinson's disease (PD). The focus of the present study was to evaluate short- and long-term cognitive effects of bilateral cZi DBS in patients with PD. Twenty-five nondemented patients with advanced PD were recruited to participate in a randomized trial of cZi DBS versus best medical treatment (BMT). The patients in the BMT group were offered surgery after 6 months. Neuropsychological evaluations focusing on assessing verbal and visuospatial memory, attention, and executive function were conducted at baseline and at 6 and 24 months after surgery. Self-reported measures of depression, anxiety, and change in "frontal" behaviors were also completed at all assessment points. Bilateral cZi DBS in patients with PD generated few adverse cognitive effects. At the short-term follow-up after 6 months, no differences were found between patients randomized to BMT and patients randomized to DBS with regard to most of the cognitive domains assessed. A transient improvement in anxiety was, however, found in the surgical group. At the long-term follow-up 24 months after cZi DBS, no major changes in global cognitive functioning were found, although a decline in attention and self-reported executive function was noted. With the exception of a decline in attention and self-reported executive function, bilateral cZi DBS for PD in appropriately screened patients appears to be generally safe with regard to cognitive function, both in the short- and long-term perspective.

Comparison of mid-term outcomes of endovascular repair and medical management in patients with acute uncomplicated type B aortic dissection

ObjectivesTo further assess the early and mid-term outcomes of thoracic endovascular aortic repair (TEVAR) in patients with acute uncomplicated type B aortic dissection (TBAD) compared with those receiving best medical treatment (BMT). MethodsBetween February 2008 and March 2018, 357 consecutive patients with acute uncomplicated TBAD were retrospectively analyzed. Among them, 191 patients underwent TEVAR, and 166 received BMT. After propensity score matching, we obtained 145 matched pairs for analysis. ResultsIn the matched population, the 30-day mortality between the TEVAR group and the BMT group showed no statistically significant difference, whereas the early adverse events rates in the TEVAR group were significantly greater than that of the BMT group (P = .003). Freedom from all-cause mortality in the TEVAR group was significantly greater than that of the BMT group (TEVAR: 91.9% at 5 years, BMT: 82.2% at 5 years, P = .028). Freedom from aortic-related mortality in the TEVAR group was significantly greater than that of the BMT group (TEVAR: 94.1% at 5 years, BMT: 86.1% at 5 years, P = .044). Multivariable Cox-hazard regression analysis demonstrated that the older age (hazard ratio [HR], 1.04; 95% confidence interval [CI], 1.01-1.08, P = .013), BMT (HR, 2.33; 95% CI, 1.08-5.05, P = .032), and the distance between the primary entry tear and the left subclavian artery <2.0 cm (HR, 2.30; 95% CI, 1.06-4.99, P = .035) were the significant risk factors for all-cause death. Given death as a competing factor, the cumulative incidence of rupture in the BMT group was significantly greater than that of the TEVAR group (BMT: 13.7% at 5 years, TEVAR: 5.1% at 5 years, P = .024). ConclusionsDespite more complications in the early stage, TEVAR was associated with decreased risk of late death and had fewer late aortic ruptures compared with BMT in patients with acute uncomplicated TBAD. Therefore, TEVAR may be considered as the first option to improve the late outcomes in these patients.

Changes in Cognition, Depression and Quality of Life after Carotid Stenosis Treatment.

Background:Although several studies have evaluated the change of cognitive performance after severe carotid artery stenosis, the results still remain elusive. The objective of this study was to assess changes in cognitive function, depressive symptoms and Health Related Quality of Life (HRQoL) after carotid stenosis revascularisation and Best Medical Treatment (BMT).Methods:Study involved 213 patients with ≥70% carotid stenosis who underwent assessment of cognitive function using Montreal Cognitive Assessment scale (MoCA), depressive symptoms - using Patient Health Questionnaire-9 (PHQ-9) and HRQoL - using Medical Outcome Survey Short Form version 2 (SF-36v2). The assessment was performed before and at 6 and 12 months follow-up periods in patients who had Carotid Endarterectomy (CEA), Carotid Artery Stenting (CAS) or received BMT only.Results:Improvement in the total MoCA scores was observed after 6 and 12 months (p<0.001, Kendall's W=0.28) in the CEA group. In the CAS group - after 12 months (p=0.01, Kendall's W=0.261) whereas in the BMT group - no significant changes (p=0.295, Kendall's W=0.081) were observed. Reduction of depressive symptoms was not found in any of the study groups. Comparing mean SF-36v2 scores in the CEA group, there was no significant difference in any of 10 subscales. Likewise in the CAS group - no significant difference in 9 of 10 subscales (p=0.028, η2=0.343) was observed. Three subscales worsened in the BMT group during the 1-year follow-up period.Conclusion:Patients with severe carotid stenosis who underwent revascularisation enhanced their cognitive performance without exerting significant change of depressive symptoms. Preoperative HRQoL may be maintained for at least one year in the CEA group.