Dataset Information

Mechanical thrombectomy with retrievable stents and aspiration catheters for acute ischaemic stroke: a meta-analysis of randomised controlled trials.

ABSTRACT:

Background

Retrievable stents and aspiration catheters have been developed to provide more effective arterial recanalisation in acute ischaemic stroke.

Aims

The aim of this analysis was to test the effect of mechanical thrombectomy on mortality and long-term neurological outcome in patients presenting with acute large-vessel anterior circulation ischaemic stroke.

Methods

A structured search identified randomised controlled trials of thrombectomy (using a retrievable stent or aspiration catheter) versus control on a background of medical therapy which included intravenous thrombolysis if appropriate. The primary endpoint was disability at 90-day follow-up as assessed by the modified Rankin scale (mRS). Secondary endpoints included all-cause mortality and symptomatic intracranial haemorrhage. A Bayesian mixed-effects model was used for analysis.

Results

Twelve trials met the inclusion criteria, comprising a total of 1,276 patients randomised to thrombectomy and 1,282 patients to control. Randomisation to thrombectomy significantly reduced disability at 90 days (odds ratio [OR] 0.52, 95% credible interval [CrI] 0.46 to 0.61, probability_{(control better)}<0.0001). Furthermore, thrombectomy reduced the odds of functional dependence at 90 days, indicated by an mRS score >2 (OR 0.44, CrI 0.37 to 0.52, p<0.0001). Thrombectomy reduced all-cause mortality at 90 days (16.1% vs 19.2%, OR 0.81, 95% CrI 0.66 to 0.99, p=0.024). The frequency of symptomatic intracranial haemorrhage was similar between thrombectomy (4.2%) and control (4.0%) (OR 1.12, 95% CrI 0.76 to 1.68, p=0.72).

Conclusions

In patients with an acute anterior circulation stroke, modern device thrombectomy significantly reduces death and subsequent disability. The magnitude of these effects suggests that universal access to this treatment strategy should be the standard of care.

SUBMITTER: Rajkumar CA

PROVIDER: S-EPMC9896406 | biostudies-literature | 2022 Apr

REPOSITORIES: biostudies-literature

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Publications

Mechanical thrombectomy with retrievable stents and aspiration catheters for acute ischaemic stroke: a meta-analysis of randomised controlled trials.

Rajkumar Christopher A CA Ganesananthan Sashiananthan S Ahmad Yousif Y Seligman Henry H Thornton George D GD Foley Michael M Nowbar Alexandra N AN Howard James P JP Francis Darrel P DP Keeble Thomas R TR Grunwald Iris Q IQ Al-Lamee Rasha K RK Malik Iqbal I Shun-Shin Matthew J MJ

EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 20220401 17

<h4>Background</h4>Retrievable stents and aspiration catheters have been developed to provide more effective arterial recanalisation in acute ischaemic stroke.<h4>Aims</h4>The aim of this analysis was to test the effect of mechanical thrombectomy on mortality and long-term neurological outcome in patients presenting with acute large-vessel anterior circulation ischaemic stroke.<h4>Methods</h4>A structured search identified randomised controlled trials of thrombectomy (using a retrievable stent o ...[more]

PMID: 34503942

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Project description:ObjectiveThe Pragmatic Ischaemic Thrombectomy Evaluation (PISTE) trial was a multicentre, randomised, controlled clinical trial comparing intravenous thrombolysis (IVT) alone with IVT and adjunctive intra-arterial mechanical thrombectomy (MT) in patients who had acute ischaemic stroke with large artery occlusive anterior circulation stroke confirmed on CT angiography (CTA).DesignEligible patients had IVT started within 4.5 hours of stroke symptom onset. Those randomised to additional MT underwent thrombectomy using any Conformité Européene (CE)-marked device, with target interval times for IVT start to arterial puncture of <90 min. The primary outcome was the proportion of patients achieving independence defined by a modified Rankin Scale (mRS) score of 0-2 at day 90.ResultsTen UK centres enrolled 65 patients between April 2013 and April 2015. Median National Institutes of Health Stroke Scale score was 16 (IQR 13-21). Median stroke onset to IVT start was 120 min. In the intention-to-treat analysis, there was no significant difference in disability-free survival at day 90 with MT (absolute difference 11%, adjusted OR 2.12, 95% CI 0.65 to 6.94, p=0.20). Secondary analyses showed significantly greater likelihood of full neurological recovery (mRS 0-1) at day 90 (OR 7.6, 95% CI 1.6 to 37.2, p=0.010). In the per-protocol population (n=58), the primary and most secondary clinical outcomes significantly favoured MT (absolute difference in mRS 0-2 of 22% and adjusted OR 4.9, 95% CI 1.2 to 19.7, p=0.021).ConclusionsThe trial did not find a significant difference between treatment groups for the primary end point. However, the effect size was consistent with published data and across primary and secondary end points. Proceeding as fast as possible to MT after CTA confirmation of large artery occlusion on a background of intravenous alteplase is safe, improves excellent clinical outcomes and, in the per-protocol population, improves disability-free survival.Trial registration numberNCT01745692; Results.

Project description:PurposeIntra-arterial mechanical thrombectomy combined with appropriate patient selection (image-based selection of acute ischaemic stroke patients with large artery occlusion) yields improved clinical outcomes. We conducted a systematic review and meta-analysis, with trial sequential analysis to understand the benefits, risks and impact of new trials reporting in 2016 on the magnitude/certainty of the estimates for clinical effectiveness and safety of mechanical thrombectomy.MethodRandom effects' models were conducted of randomised clinical trials comparing mechanical thrombectomy (stent retriever or aspiration devices) with/without adjuvant intravenous thrombolysis with intravenous thrombolysis and other forms of best medical/supportive care in the treatment of acute ischaemic stroke. Study inclusion and risk of bias were assessed independently by two reviewers. Functional independence (modified Rankin Scale 0-2) and mortality at 90 days, including symptomatic intracranial haemorrhage rate were extracted. Trial sequential analysis established the strength of the evidence derived from the meta-analyses.FindingsEight trials of mechanical thrombectomy with a total sample size of 1841 (916 patients treated with mechanical thrombectomy and 925 treated without mechanical thrombectomy) fulfilled review inclusion criteria. The three most recent trials more precisely defined the effectiveness of mechanical thrombectomy (modified Rankin Scale 0 to 2; OR = 2.07, 95% CI = 1.70 to 2.51 based on data from eight trials versus OR = 2.39, 95% CI = 1.88 to 3.04 based on data from five trials). Meta-analyses showed no effect on mortality (OR = 0.81, 95% CI = 0.61 to 1.07) or symptomatic intracranial haemorrhage (OR = 1.22, 95% CI = 0.80 to 1.85) as found in analysis of first five trials. Trial sequential analysis indicated that the information size requirement was fulfilled to conclude the evidence for mechanical thrombectomy is robust.DiscussionThe impact of three recent trials on effectiveness and safety of mechanical thrombectomy was a more precise pooled effect size for functional independence. Trial sequential analysis demonstrated sufficient evidence for effectiveness and safety of mechanical thrombectomy.ConclusionNo further trials of mechanical thrombectomy versus no mechanical thrombectomy are indicated to establish clinical effectiveness. Uncertainty remains as to whether mechanical thrombectomy reduces mortality or increases risk of symptomatic intracranial haemorrhage.

Project description:IntroductionEndovascular treatment is the standard of care for acute large vessel occlusion (LVO) in the anterior circulation. However, successful complete recanalisation is considerably difficult when the vessels are severely tortuous. At the bend, the stent retriever can distort, collapse and lose its ability to capture the clot due to structural change. The aim of the present study is to evaluate the safety and efficacy of the new thrombectomy device multisegment Mechanical Thrombectomy (MT) System for endovascular treatment of acute ischaemic stroke (AIS).Methods and analysisThe present study is a prospective, multicentre, randomised controlled trial conducted in 11 stroke centres in China. The safety and efficacy of vascular recanalisation in patients with AIS who will be treated with a new thrombectomy device-multi-segment MT System or with Solitare FR within 8 hours of symptom onset will be compared. A total of 238 subjects who met the inclusion and exclusion criteria will be randomised into either a treatment group or a control group by an internet-based Central Random System in a 1:1 manner, and 30 subjects will be recruited into the small sample study. SAS V.9.4 statistical software will be used for statistical analysis of the primary endpoint indicators and other indicators.Ethics and disseminationThe study involving human participants was reviewed and approved by the Ethics Committee of Drugs (devices) Clinical Experiment in Henan Provincial People's Hospital (reference number: AF/SC-07/04.0) and other research centres participating in the clinical trial. The results yielded from this study will be presented at international conferences and sent to a peer-review journal to be considered for publication. The Standard Protocol Items: Recommendations for Interventional Trials checklist was utilised when drafting the study protocol.Trial registration numberRegistry on 10 September 2021 with Chinese clinical trial registry: ChiCTR2100051048.

Project description:BackgroundLabile blood pressure after acute ischaemic stroke requiring mechanical thrombectomy is independently associated with poor patient outcomes.ObjectivesThis study protocol describes is designed to determine whether transauricular nerve stimulation, improves baroreflex sensitivity, reduces blood pressure variability in the first 24 hours after acute ischaemic stroke requiring mechanical thrombectomy.Design: phase 2a, proof-of-concept, sham-controlled randomised trialMethods and Analysis: 36 individuals undergoing mechanical thrombectomy for acute ischaemic stroke with established hypertension aged >18 years will be randomly allocated to receive bilateral active or sham transauricular nerve stimulation for the duration of the mechanical thrombectomy procedure (AffeX-CT/001 investigational device). The intervention will be repeated for 1h the morning following the mechanical thrombectomy. Non-invasive blood pressure will be measured ≥2h for 24h after mechanical thrombectomy. Holter electrocardiographic monitoring will be recorded during transauricular nerve stimulation. Participants, clinicians and investigators will be masked to treatment allocations. The primary outcome will be the coefficient of variation of systolic blood pressure. Secondary outcomes include additional estimates of blood pressure variability and time/frequency-domain measures of autonomic cardiac modulation An adjusted sample size of 36 patients is required to have a 90% chance of detecting, as significant at the 5% level, a difference in the coefficient of variation in systolic blood pressure of 5±4mmHg between sham and active stimulation [assuming 5% non-compliance rate in each group]. Ethics: confirmed on 16 March 2023 by HRA and Health and Care Research Wales ethics committee (reference 23/WA/0013).DiscussionThis study will provide proof-of-concept data that examines whether non-invasive autonomic neuromodulation can be used to favourably modify blood pressure and autonomic control after acute ischaemic stroke requiring mechanical thrombectomy.Trial registrationTrial registration number: NCT05417009.

Project description:IntroductionSpontaneous blood pressure drop within the first 24 h has been reported following arterial recanalisation in ischaemic stroke patients. We aimed to assess if spontaneous blood pressure drop within the first hour after mechanical thrombectomy is a marker of early neurological recovery.Patients and methodsRetrospective observational single-centre study including ischaemic stroke patients treated with mechanical thrombectomy. Blood pressure parameters from admission, mechanical thrombectomy start, mechanical thrombectomy end and hourly within 24 h after mechanical thrombectomy were reviewed. Primary outcome was early dramatic neurological recovery (8-point-reduction in NIHSS or NIHSS ≤ 2 at 24 h). Secondary outcome was functional independence at 90 days (mRankin 0-2).ResultsWe included 458 patients in our analysis. Two-hundred (43.7%) patients achieved dramatic neurological recovery following mechanical thrombectomy. One hour after mechanical thrombectomy end, median systolic blood pressure was significantly different between outcome groups (129 vs. 138 mmHg, p = 0.005) and a higher drop in median systolic blood pressure was seen in the dramatic neurological recovery group (15 vs. 9 mmHg). Optimal cut-off for predicting dramatic neurological recovery was a systolic blood pressure drop of 10.5 mmHg (sensitivity 0.54, specificity 0.55, AUC 0.55). On multivariate analysis, spontaneous systolic blood pressure drop was associated with higher odds of achieving dramatic neurological recovery (OR for 10 mmHg blood pressure drop 1.14, 95% CI 1.01-1.29, p = 0.04). No significative association between any blood pressure parameter drop and functional independence at 90 days was found.DiscussionWe hypothesised that spontaneous systolic blood pressure drop is a marker of successful reperfusion and, therefore, a marker of improvement of cerebral autoregulation due to the reduced final ischaemic core.ConclusionSpontaneous systolic blood pressure drop after mechanical thrombectomy is an early predictor of dramatic neurological recovery.

Dataset Information

Mechanical thrombectomy with retrievable stents and aspiration catheters for acute ischaemic stroke: a meta-analysis of randomised controlled trials.

Background

Aims

Methods

Results

Conclusions

Publications

Mechanical thrombectomy with retrievable stents and aspiration catheters for acute ischaemic stroke: a meta-analysis of randomised controlled trials.

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