Introduction : The ANGEL‐ASPECT trial (NCT 04551664) is an ongoing, multicenter, randomized controlled trial (RCT) currently being conducted in China. The goal of ANGEL‐ASPECT’s is to include the ...maximum patients with a true large core for whom EVT is not recommended under current guidelines with level 1 evidence. By enrolling patients with ASPECTS <6, expanding the window to 24h from stroke onset (beyond the windows in DAWN and DEFUSE3), and defining large core volume as >70 cc, ANGEL‐ASPECT maximizes the inclusion of patients with true large cores. What’s more, intracranial atherosclerotic disease (ICAD) is common in the Asian population while most of the previous trials have been performed in the Western world where ICAD is less prevalent. Methods : We reviewed the merits of ANGEL‐ASPECT’s design and suggest that it be included in the discussion of patient selection criteria in large core trials. Results : The primary goal of our trial is to determine whether EVT will benefit or harm AIS patients with LVO and a “large core” infarct. The inclusion criteria for ANGEL‐ASPECT are: 1. If ASPECTS is 3–5 and presentation is within 24 hours of onset, patients are enrolled without obtaining CTP. 2. If ASPECTS is >5 and presentation is beyond 6 hours of onset, only patients with relative cerebral blood flow (rCBF) of < 30% by CTP or apparent diffusion coefficient (ADC) of < 620 on MRI and estimated core volume of 70–100 cc are enrolled. 3. If ASPECTS is <3, only patients with rCBF < 30% or ADC on MRI < 620 and estimated core volume of 70–100 cc are enrolled. Patients are enrolled under a pre‐specified protocol. Each randomized patient is qualified by two core lab members who are available at all hours to calculate ASPECTS and infarct core volume using specialized, RAPID software. Conclusions : We believe that defining core volume using CTP can compensate for the inconsistencies of ASPECTS if we exclude patients with onset within six hours and core volume of 50–70 cc since these patients have already been shown to benefit from EVT in multiple RCTs. We believe that this decision captures more patients with true large core volumes for the trial. The ANGEL‐ASPECT inclusion criteria also eliminate the second group of “good ASPECTS + unfavorable CTP” . The sample size of our trial is calculated based on studies excluding these populations. The power of the trial was maintained for the relatively consistent large core volume patient population.
Pivotal trials have shown the tremendous efficacy of mechanical thrombectomy in proximal occlusions. However distal occlusions involving second-order branches of the middle cerebral artery and ...beyond, anterior cerebral and posterior cerebral arteries were not represented. In this study, we investigated the feasibility and safety of distal circulation mechanical thrombectomy.
A retrospective review of patients presenting with distal circulation acute ischemic stroke who underwent mechanical thrombectomy 2010 and 2018.
Of 453 patients who underwent mechanical thrombectomy for acute ischemic stroke, 76 had a distal occlusion. The mean National Institute Health Stroke Scale on admission was 12. Vessels involved included second-order branches of the middle cerebral artery (89%), third- and fourth-order branches of the middle cerebral artery (5%), second-order branch of the anterior cerebral artery (3%), and posterior cerebral artery (3%). Most procedures required 1 pass to recanalize the vessel (55%, n = 42). Thrombolysis in Cerebral Infarction score ≥IIb was achieved in 89% of subjects. Mortality rate was 8% and independent functional outcome of m Rankin score ≤2 at 3 months was seen in 64.7% with clinical follow-up. On multivariate analysis, distal circulation had a significantly shorter length of stay by about 2 days, compared with proximal circulation. Subjects with proximal occlusion were more than 5 times more likely to have a good Thrombolysis in Cerebral Infarction score compared with the distal group. There was no significant difference in periprocedural and postprocedural complications, good functional outcome at 3 months, and mortality between both groups.
Mechanical thrombectomy procedure for distal circulation strokes is as effective and safe as a proximal group. Though distal vessels supply smaller brain area; however, when symptoms are pronounced, the benefit of the procedure outweighs the risks.
Since the efficacy and safety of endovascular thrombectomy (EVT) in patients with acute ischemic stroke with a large infarct area is still inconclusive, we sought to compare functional and ...neurological outcomes with the use of endovascular thrombectomy versus medical care alone.
We searched MEDLINE (via PubMed), Embase, Cochrane Library, ClinicalTrials.gov, and the International Clinical Trials Registry Platform (ICTRP) to retrieve all the relevant randomized controlled trials (RCTs) on this topic. Review manager (RevMan) was used to perform meta-analyses using a random-effect model. Dichotomous outcomes were pooled using risk ratios (RR) with 95% confidence intervals (CIs).
Our meta-analysis included 6 RCTs with a total of 1665 patients. Most studies included patients with an ASPECTS score of 3-5. Our results demonstrate that endovascular thrombectomy significantly increased the rates of functional independence (mRS ≤ 2) (RR, 2.49; 95% CI, 1.89-3.29) and moderate neurological outcome (mRS ≤ 3) (RR, 1.90; 95% CI, 1.50-2.40) at 90 days. The benefit of EVT for these outcomes remained the same at 1-year follow-up. Endovascular thrombectomy was associated with increased rates of early neurological improvement (RR, 2.22; 95% CI, 1.53-3.22), excellent neurological recovery (mRS ≤ 1) (RR, 1.75; 95% CI, 1.02-3.03), and decreased rate of poor neurological recovery (mRS 4-6) (RR, 0.81; 95% CI, 0.76-0.86). No significant difference was found between the two groups regarding all-cause mortality (RR, 0.86; 95% CI, 0.72-1.02), decompressive craniectomy (RR, 1.32; 95% CI, 0.89-1.94), and the incidence of serious adverse effects (RR, 1.39; 95% CI, 0.83-2.32) between the two groups. Endovascular thrombectomy significantly increased the rates of any intracranial hemorrhage (RR, 1.94; 95% CI, 1.48-2.53) and symptomatic intracranial hemorrhage (RR, 1.73; 95% CI, 1.11-2.69).
Endovascular thrombectomy (EVT) significantly improves neurological and functional outcomes in patients who present within 6 hours of stroke onset with ICA and proximal M1 occlusions, and ASPECTS scores ranging from 3 to 5, compared to medical therapy alone, with an increased risk of symptomatic intracranial hemorrhage.
Randomized controlled trials have shown that mechanical thrombectomy (MT) plus best medical treatment improves outcome in stroke patients with large-vessel occlusion in the anterior circulation. ...Whether direct MT is equally effective as bridging thrombolysis (intravenous thrombolysis plus MT) in intravenous thrombolysis eligible patients remains unclear.
We compared clinical and radiological outcomes at 3 months in 249 bridging patients with 111 patients receiving direct MT for large-vessel occlusion anterior circulation stroke from 2 prospective registries (study period Essen: June 2012 to August 2013, Bern February 2009 to August 2014). We matched all patients from the direct MT group who would have qualified for intravenous thrombolysis with controls from the bridging group, using multivariate and propensity score methods. Subgroup analyses for internal carotid artery occlusions were performed.
Baseline characteristics did not differ between the direct MT group and bridging cohort, except for higher rates of coronary heart disease (
=0.029) and shorter intervals from onset to endovascular therapy (
<0.001) in the MT group. Functional outcome, mortality, and intracerebral hemorrhage did not differ, neither in univariate nor after multivariate and propensity score matching. However, in patients with internal carotid artery occlusion, mortality in the direct cohort was significantly lower.
In this matched-pair analysis, there was no difference in outcome in patients with large-vessel occlusion anterior circulation stroke treated with direct MT compared with those treated with bridging thrombolysis; however, mortality in patients with internal carotid artery occlusion treated with direct MT was significantly lower than after bridging thrombolysis. Randomized trials comparing direct MT with bridging therapy are needed.
TOTAL (N = 10 732), a randomized trial of routine manual thrombectomy vs. percutaneous coronary intervention alone in ST elevation myocardial infarction, showed no difference in the primary efficacy ...outcome but a significant increase in stroke. We sought to understand these findings.
A detailed analysis of stroke timing, stroke severity, and stroke subtype was performed. Strokes were adjudicated by neurologists blinded to treatment assignment. Stroke within 30 days, the primary safety outcome, was increased 33 (0.7%) vs. 16 (0.3%), hazard ratio (HR) 2.06; 95% confidence interval (CI) 1.13-3.75. The difference in stroke was apparent within 48 h 15 (0.3%) vs. 5 (0.1%), HR 3.00; 95% CI 1.09-8.25. There was an increase in strokes within 180 days with minor or no disability (Rankin 0-2) 18 (0.4%) vs. 13 (0.3%) HR 1.38; 95% CI 0.68-2.82 and in strokes with major disability or fatal (Rankin 3-6) 35 (0.7%) vs. 13 (0.3%), HR 2.69; 95% CI 1.42-5.08. Most of the absolute difference was due to an increase in ischaemic strokes within 180 days 37 (0.7%) vs. 21 (0.4%), HR 1.71; 95% CI 1.03-3.00, but there was also an increase in haemorrhagic strokes 10 (0.2%) vs. 2 (0.04%), HR 4.98; 95% CI 1.09-22.7. Patients that had a stroke had a mortality of 30.8% within 180 days vs. 3.4% without a stroke (P < 0.001). A meta-analysis of randomized trials (N = 21 173) showed an increase in risk of stroke (odds ratio 1.59; 95% CI 1.11-2.27) but a trend towards reduction in mortality odds ratio (odds ratio 0.87; 95% CI 0.76-1.00).
Thrombectomy was associated with a significant increase in stroke. Based on these findings, future trials must carefully collect stroke to determine safety in addition to efficacy.
Recently, 5 randomized controlled trials demonstrated the benefit of endovascular therapy compared with intravenous tissue-type plasminogen activator in acute stroke. Economic evidence evaluating ...stent retrievers is limited. We compared the cost-effectiveness of intravenous tissue-type plasminogen activator alone versus mechanical thrombectomy and intravenous tissue-type plasminogen activator as a bridging therapy in eligible patients in the UK National Health Service.
A model-based cost-utility analysis was performed using a lifetime horizon. A Markov model was constructed and populated with probabilities, outcomes, and cost data from published sources, including 1-way and probabilistic sensitivity analysis.
Mechanical thrombectomy was more expensive than intravenous tissue-type plasminogen activator, but it improved quality-adjusted life expectancy. The incremental cost per (quality-adjusted life year) gained of mechanical thrombectomy over a 20 year period was $11 651 (£7061). The probabilistic sensitivity analysis demonstrated that thrombectomy had a 100% probability of being cost-effective at the minimum willingness to pay for a quality-adjusted life year commonly used in United Kingdom.
Although the upfront costs of thrombectomy are high, the potential quality-adjusted life year gains mean this intervention is cost-effective. This is an important factor for consideration in deciding whether to commission this intervention.
Ischemic Stroke Feske, Steven K.
The American journal of medicine,
December 2021, 2021-12-00, 20211201, Letnik:
134, Številka:
12
Journal Article
Recenzirano
This concise review of the epidemiology, pathophysiology, evaluation, acute management, and prevention of ischemic stroke targets internists, family practitioners, and emergency physicians who manage ...patient with stroke.
Multiple randomized clinical trials have supported the use of mechanical thrombectomy (MT) as standard of care in the treatment of large vessel occlusion acute ischemic stroke. Optimal outcomes ...depend not only on early reperfusion therapy but also on post thrombectomy care. Early recognition of post MT complications including reperfusion hemorrhage, cerebral edema and large space occupying infarcts, and access site complications can guide early initiation of lifesaving therapies that can improve neurologic outcomes. Knowledge of common complications and their management is essential for stroke neurologists and critical care providers to ensure optimal outcomes. We present a review of the available literature evaluating the common complications in patients undergoing MT with emphasis on early recognition and management.
Purpose: To present the results of rheolytic pharmacomechanical thrombectomy (PMT) for the management of acute limb ischemia (ALI) as reported in the PEARL Registry (PEripheral Use of AngioJet ...Rheolytic Thrombectomy with a variety of catheter Lengths). Methods: A total of 283 patients (mean age 65±13 years; 170 men) presenting with ALI undergoing treatment with the AngioJet System at participating institutions were enrolled in the registry. Rutherford ALI categories included 26% with viable limbs, 38% with marginally threatened limbs, 35% with immediately threatened limbs, and <1% with irreversible damage. Procedure and follow-up data were collected for the calculation of outcomes. To control for patient selection bias, propensity score matching was used to compare outcomes for patients undergoing PMT with or without catheter-directed thrombolysis (CDT). Results: Procedure success was achieved in 235 (83%) of 283 patients. Half of the procedures (147, 52%) were completed without the need for adjunctive CDT. At 12-month follow-up, amputation-free survival and freedom from mortality were 81% and 91%, respectively; 12-month freedom from bleeding requiring transfusion was 91%, and freedom from renal failure was 95%. Subgroup analysis revealed significantly better outcomes in patients without infrapopliteal involvement and those who underwent PMT without CDT. In the matched cohorts, higher rates of procedure success, 12-month amputation-free survival, and 12-month freedom from amputation were observed in the PMT without CDT group (88% vs 74%, p=0.021; 87% vs 72%, p=0.028; 96% vs 81%, p=0.01, respectively). Conclusions: The results support the use of PMT as a first-line treatment for ALI, providing a rapid reperfusion to the extremity, reduced procedure time, and an acceptable risk profile without compromising limb salvage.
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