Advances in mechanical thrombectomy for acute ischaemic stroke from large vessel occlusions.
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ABSTRACT:
SUBMITTER: Guo X
PROVIDER: S-EPMC8717796 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Present mechanical devices are unable to achieve recanalisation in up to 20-40% of large vessel occlusion strokes. We compared efficacy and safety of the Trevo Retriever, a new stent-like device, with its US Food and Drug Administration-cleared predecessor, the Merci Retriever.In this open-label randomised controlled trial, we recruited patients at 26 sites in the USA and one in Spain. We included adults aged 18-85 years with angiographically confirmed large vessel occlusion strokes and US National Institutes of Health Stroke Scale (NIHSS) scores of 8-29 within 8 h of symptom onset. We randomly assigned patients (1:1) with sequentially numbered sealed envelopes to thrombectomy with Trevo or Merci devices. Randomisation was stratified by age (?68 years vs 69-85 years) and NIHSS scores (?18 vs 19-29) with alternating blocks of various sizes. The primary efficacy endpoint, assessed by an unmasked core laboratory, was thrombolysis in cerebral infarction (TICI) scores of 2 or greater reperfusion with the assigned device alone. The primary safety endpoint was a composite of procedure-related adverse events. Analyses were done by intention to treat. This study is registered with ClinicalTrials.gov, number NCT01270867.Between Feb 3, 2011, and Dec 1, 2011, we randomly assigned 88 patients to the Trevo Retriever group and 90 patients to Merci Retriever group. 76 (86%) patients in the Trevo group and 54 (60%) in the Merci group met the primary endpoint after the assigned device was used (odds ratio 4·22, 95% CI 1·92-9·69; p(superiority)<0·0001). Incidence of the primary safety endpoint did not differ between groups (13 [15%] patients in the Trevo group vs 21 [23%] in the Merci group; p=0·1826).Patients who have had large vessel occlusion strokes but are ineligible for (or refractory to) intravenous tissue plasminogen activator should be treated with the Trevo Retriever in preference to the Merci Retriever.Stryker Neurovascular.
| S-EPMC4176618 | biostudies-literature
Project description:Background and purposeAlthough current guidelines advocate pretreatment with intravenous thrombolysis (IVT) in all eligible patients with acute ischemic stroke with large-vessel occlusion before mechanical thrombectomy, there are observational data questioning the efficacy of this approach. One of the main arguments in favor of IVT pretreatment is the potential for tissue-type plasminogen activator-induced successful reperfusion (SR) before the onset of endovascular procedure.MethodsWe performed a systematic review and meta-analysis of randomized controlled clinical trials and observational cohorts providing rates of SR with IVT in patients with large-vessel occlusion before the initiation of mechanical thrombectomy. We also performed subgroup analyses according to study type (randomized controlled clinical trials versus observational) and according to the inclusion per protocol of patients with tandem (intracranial/extracranial) occlusions.ResultsWe identified 13 eligible studies (7 randomized controlled clinical trials and 6 observational cohorts), including 1561 patients with acute ischemic stroke (median National Institutes of Health Stroke Scale score, 17) with large-vessel occlusion. SR following IVT and before mechanical thrombectomy was documented in 11% (95% confidence interval, 7%-16%), with no difference among cohorts derived from randomized controlled clinical trials and observational studies. There was significant heterogeneity across included studies both in the overall analysis and among subgroups (I2>84%; P for Cochran Q, <0.001). Higher tissue-type plasminogen activator-induced SR rates were documented in studies reporting the exclusion of tandem occlusions (17%; 95% confidence interval, 11%-23%) compared with the rest (7%; 95% confidence interval, 4%-11%; P for subgroup differences, 0.003).ConclusionsPretreatment with systemic thrombolysis in patients with large-vessel occlusion eligible for mechanical thrombectomy results in SR in 1 of 10 cases, negating the need for additional endovascular reperfusion. Tandem occlusions seem to be the least responsive to IVT pretreatment.
| S-EPMC5742056 | biostudies-literature
Project description: Not available
| S-EPMC10569475 | biostudies-literature
Project description:Background We retrospectively compared early- (<6 hours) versus late- (6-24 hours) presenting patients using perfusion-weighted imaging selection and evaluated clinical/radiographic outcomes. Methods and Results Large vessel occlusion patients treated with mechanical thrombectomy from August 2017 to July 2020 within 24 hours of onset were retrieved from a single-center database. Perfusion-weighted imaging was analyzed by automated software and final infarct volume was measured semi-automatically within 14 days. The primary end point was good outcome (modified Rankin Scale 0-2 at 90 days). Secondary end points were excellent outcome (modified Rankin Scale 0-1 at 90 days), symptomatic intracranial hemorrhage, and death. Clinical characteristics/radiological values including hypoperfusion volume and infarct growth velocity (baseline volume/onset-to-image time) were compared between the groups. Of 1294 patients, 118 patients were included. The median age was 74 years, baseline National Institutes of Health Stroke Scale score was 14, and core volume was 13 mL. The late-presenting group had more female patients (67% versus 31%, respectively; P=0.001). No statistically significant differences were seen in good outcome (42% versus 53%, respectively; P=0.30), excellent outcome (26% versus 32%, respectively; P=0.51), symptomatic intracranial hemorrhage (6.5% versus 4.6%, respectively; P=0.74), and death (3.2% versus 5.7%, respectively; P=0.58) between the groups. The late-presenting group had more atherothrombotic cerebral infarction (19% versus 6%, respectively; P=0.03), smaller hypoperfusion volume (median: 77 versus 133 mL, respectively; P=0.04), and slower infarct growth velocity (median: 0.6 versus 5.1 mL/h, respectively; P=0.03). Conclusions Patients with early- and late-time windows treated with mechanical thrombectomy by automated perfusion-weighted imaging selection have similar outcomes, comparable with those in randomized trials, but different in infarct growth velocities. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT02251665.
| S-EPMC9075240 | biostudies-literature
Project description:Purpose: To evaluate the safety and efficacy of mechanical thrombectomy (MT) for acute stroke due to large vessel occlusion (LVO), presenting with mild symptoms. Methods: A prospective cohort study of patients with mild ischemic stroke and LVO was conducted. Patients were divided into two groups: MT group or best medical management (MM) group. Propensity score matching (PSM) was conducted to reduce the confounding bias between the groups. The primary outcome was functional independence at 90 days. The safety outcome was symptomatic intracranial hemorrhage (sICH). Univariate and multivariate logistic regression analyses were used to identify the independent factors associated with outcomes. Results: Among the 105 included patients, 43 were in the MT group and 62 in the MM group. Forty-three pairs of patients were generated after PSM. There were no significant differences in sICH rates between two groups (p = 1.000). The MT group had a higher proportion of independent outcomes (83.7% MT vs. 67.4% MM; OR 2.483; 95% CI 0.886-6.959; p = 0.079) and excellent outcomes (76.7% MT vs. 51.2% MM; OR 3.150; 95% CI 1.247-7.954; p = 0.013) compared to the MM group, especially in patients with stroke of the anterior circulation (p < 0.05). Multivariate logistic regression analysis showed that small infarct core volume (p = 0.015) and MT treatment (p = 0.013) were independently associated with excellent outcomes. Conclusions: Our results suggest that MT in stroke patients, presenting with mild symptoms, due to acute LVO in the anterior circulation may be associated with satisfactory clinical outcomes. Clinical Trial Registration: ClinicalTrials.gov, identifier: NCT04526756.
| S-EPMC8581036 | biostudies-literature
Project description:Background Recent randomized controlled clinical trials have provided solid evidence that mechanical thrombectomy (MT) coupled with best medical therapy (BMT) improve functional outcomes of acute ischemic stroke patients with large vessel occlusion compared with BMT alone. However, they provided inconclusive evidence on the benefit of MT on mortality. Methods and Results We evaluated the association of MT+BMT compared with BMT with the risk of 3-month mortality using aggregate data from all available randomized controlled clinical trials. We also sought to identify potential predictors on the mortality risk and performed univariate meta-regression analyses. Our literature search identified 11 eligible randomized controlled clinical trials, including a total of 2460 patients. The pooled rates of 3-month mortality were 15% (95% CI:12%-19%) and 19% (95% CI:16%-23%), respectively, in the MT+BMT and BMT groups. In the overall analysis MT+BMT was associated with a significantly lower risk for 3-month mortality compared with BMT (risk ratio=0.83, 95% CI:0.69-0.99; P=0.04), without heterogeneity across included studies (I2=3%, P for Cochran Q=0.41). No evidence of publication bias was present in funnel plot inspection and Egger statistical test (P=0.762). In meta-regression analyses no moderating effect on the aforementioned association was detected with patient age (P=0.254), sex (P=0.702), admission systolic blood pressure (P=0.601), admission glucose (P=0.277), onset-to-groin puncture time (P=0.985), administration of intravenous alteplase before MT (P=0.804), MT under general anesthesia (P=0.735), and successful reperfusion following MT (P=0.663). Conclusions Our meta-analysis provides evidence that MT+BMT reduces the risk of 3-month mortality compared with BMT alone. This association appears not to be moderated by individual patient or procedural characteristics.
| S-EPMC6898819 | biostudies-literature
Project description:BackgroundThe efficacy and safety of mechanical thrombectomy (MT) in acute large vessel occlusion (LVO) patients with minor stroke (NIHSS ≤ 5) remains undetermined. We aimed to compare the efficacy and safety of intra-arterial thrombolysis (IAT) alone vs. MT for LVO patients with minor stroke.MethodsPatients were selected from the Acute Ischemic Stroke Cooperation Group of Endovascular Treatment (ANGEL) registry, a prospective multicenter registry study, and divided into MT and IAT alone groups. We compared the outcome measures between the two groups, including 90-day functional outcome evaluated by the modified Rankin Scale (mRS), the final recanalization level, intracranial hemorrhage, and mortality within 90-days by logistic regression models with adjustment. Besides the conventional multivariable analysis, we performed a sensitivity analysis by adjusting the propensity score to confirm our results. The propensity score was derived using a logistic regression model.ResultsOf the 120 patients, 63 received IAT alone and 57 received MT as the first-line treatment strategy. As compared to MT group, patients in the IAT alone group were associated with a higher chance of 90-day mRS 0-2 [93.7% vs. 71.9%, odds ratio (OR) = 4.75, 95% confidence interval (CI): 1.20-18.80, P = 0.027], a high chance of 90-day mRS 0-3 (96.8% vs. 86.7%, OR = 11.35, 95% CI: 1.93-66.86, P = 0.007), a shorter median time from puncture to recanalization (PTR) (60 min vs. 100 min, β = -63.70, 95% CI: -81.79- -45.61, P < 0.001), a lower chance of any intracranial hemorrhage (ICH) within 48 h (3.2% vs. 19.3%, OR = 0.15, 95% CI: 0.03-0.79, P = 0.025), and a lower chance of mortablity within 90 days (1.6% vs. 9.2%, OR = 0.05, 95% CI: 0.01-0.57, P = 0.016). Similarly, the sensitivity analysis showed the robustness of the primary analysis.ConclusionsCompared with MT, IAT may improve 90-day clinical outcomes with decreased ICH rate and mortality in LVO patients with minor stroke.
| S-EPMC9315389 | biostudies-literature
Project description:Background and purposeMechanical thrombectomy by using a single stent retriever system has demonstrated high efficacy for recanalization of large-artery occlusions in acute stroke. We aimed to evaluate the feasibility, safety, and efficacy of a novel double Solitaire stent retriever technique as an escalating treatment for occlusions that are refractory to first-line single stent retriever mechanical thrombectomy.Materials and methodsAll patients treated with the double stent retriever technique by using the Solitaire system were retrospectively selected from 2 large neurointerventional centers. Time to recanalization, angiographic (TICI) and clinical outcomes (mRS), and complications were assessed.ResultsTen patients (median NIHSS score, 16; mean age, 70 years) with MCA M1 segment (n = 5) and terminal ICA (n = 5 including 2 ICA tandem) occlusions were included. Prior single stent retriever mechanical thrombectomy had been performed in 9 patients (median number of passes, 3). Median time to recanalization was 60 minutes (interquartile range, 45-87 minutes). Procedure-related complications occurred in 1 patient; overall mortality was 20%. Recanalization of the target vessel (TICI 2b/3) was achieved in 80%. Good clinical outcome (mRS 0-2) was 50%.ConclusionsIn this preliminary feasibility study, the double Solitaire stent retriever technique proved to be an effective method for recanalization of anterior circulation large-artery occlusions refractory to standard stent retriever mechanical thrombectomy.
| S-EPMC8013066 | biostudies-literature
Project description:OBJECTIVES:Endovascular mechanical thrombectomy is an effective but expensive therapy for acute ischaemic stroke with proximal anterior circulation occlusion. This study aimed to determine the cost-effectiveness of mechanical thrombectomy in China, which is the largest developing country. DESIGN:A combination of decision tree and Markov model was developed. Outcome and cost data were derived from the published literature and claims database. The efficacy data were derived from the meta-analyses of nine trials. One-way and probabilistic sensitivity analyses were performed in order to assess the uncertainty of the results. SETTING:Hospitals in China. PARTICIPANTS:The patients with acute ischaemic stroke caused by proximal anterior circulation occlusion within 6?hours. INTERVENTIONS:Mechanical thrombectomy within 6?hours with intravenous tissue plasminogen activator (tPA) treatment within 4.5?hours versus intravenous tPA treatment alone. OUTCOME MEASURES:The benefit conferred by the treatment was assessed by estimating the cost per quality-adjusted life-year (QALY) gained in the long term (30 years). RESULTS:The addition of mechanical thrombectomy to intravenous tPA treatment compared with standard treatment alone yielded a lifetime gain of 0.794 QALYs at an additional cost of CNY 50 000 (US$7700), resulting in a cost of CNY 63 010 (US$9690) per QALY gained. The probabilistic sensitivity analysis indicated that mechanical thrombectomy was cost-effective in 99.9% of the simulation runs at a willingness-to-pay threshold of CNY 125 700 (US$19 300) per QALY. CONCLUSIONS:Mechanical thrombectomy for acute ischaemic stroke caused by proximal anterior circulation occlusion within 6?hours was cost-effective in China. The data may be used as a reference with regard to medical resources allocation for stroke treatment in low-income and middle-income countries as well as in the remote areas in the developed countries.
| S-EPMC5855394 | biostudies-literature
Project description:Serum biomarkers are associated with hemorrhagic transformation and brain edema after cerebral infarction. However, whether serum biomarkers predict hemorrhagic transformation in large vessel occlusion stroke even after mechanical thrombectomy, which has become widely used, remains uncertain. In this prospective study, we enrolled patients with large vessel occlusion stroke in the anterior circulation. We analyzed 91 patients with serum samples obtained on admission. The levels of matrix metalloproteinase-9 (MMP-9), amyloid precursor protein (APP) 770, endothelin-1, S100B, and claudin-5 were measured. We examined the association between serum biomarkers and hemorrhagic transformation within one week. Fifty-four patients underwent mechanical thrombectomy, and 17 patients developed relevant hemorrhagic transformation (rHT, defined as hemorrhagic changes ≥ hemorrhagic infarction type 2). Neither MMP-9 (no rHT: 46 ± 48 vs. rHT: 15 ± 4 ng/mL, P = 0.30), APP770 (80 ± 31 vs. 85 ± 8 ng/mL, P = 0.53), endothelin-1 (7.0 ± 25.7 vs. 2.0 ± 2.1 pg/mL, P = 0.42), S100B (13 ± 42 vs. 12 ± 15 pg/mL, P = 0.97), nor claudin-5 (1.7 ± 2.3 vs. 1.9 ± 1.5 ng/mL, P = 0.68) levels on admission were associated with subsequent rHT. When limited to patients who underwent mechanical thrombectomy, the level of claudin-5 was higher in patients with rHT than in those without (1.2 ± 1.0 vs. 2.1 ± 1.7 ng/mL, P = 0.0181). APP770 levels were marginally higher in patients with a midline shift ≥ 5 mm than in those without (79 ± 29 vs. 97 ± 41 ng/mL, P = 0.084). The predictive role of serum biomarkers has to be reexamined in the mechanical thrombectomy era because some previously reported serum biomarkers may not predict hemorrhagic transformation, whereas the level of APP770 may be useful for predicting brain edema.
| S-EPMC8366990 | biostudies-literature