How many stroke patients might be eligible for mechanical thrombectomy?
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ABSTRACT: Introduction
Recent studies showed improved patient outcomes with endovascular treatment of acute stroke compared to medical care, including IV rtPA, alone. Seven trials have reported results, each using different clinical and imaging criteria for patient selection. We compared eligibility for different trial protocols to estimate the number of patients eligible for treatment.Patients and methods
Patient data were extracted from a single centre database that combined patients recruited to three clinical studies, each of which obtained both CTA and CTP within 6 h of stroke onset. The published inclusion and exclusion criteria of seven intervention trials (MR CLEAN, EXTEND-IA, ESCAPE, SWIFT-PRIME, REVASCAT, THERAPY and THRACE) were applied to determine the proportion that would be eligible for each of these studies.Results
A total of 263 patients was included. Eligibility for IAT in individual trials ranged from 53% to 3% of patients; 17% were eligible for four trials and under 10% for two trials. Only three patients (1%) were eligible for all studies. The most common cause of exclusion was absence of large artery occlusion (LAO) on CTA. When applying simplified criteria requiring an ASPECT score > 6, 16% were eligible for IAT, but potentially 40% of these patients were excluded by perfusion criteria and more than half by common NIHSS thresholds.Conclusion
Around 15% of patients presenting within 6 h of stroke onset were potentially eligible for IAT, but clinical trial eligibility criteria have much more limited overlap than is commonly assumed and only 1% of patients fulfilled criteria for all recent trials.
SUBMITTER: Tawil SE
PROVIDER: S-EPMC6301245 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:IntroductionEndovascular thrombectomy is a highly effective treatment for acute ischemic stroke due to large arterial occlusion. Routine provision will require major changes in service configuration and workforce. An important first step is to quantify the population of stroke patients that could benefit. We estimated the annual UK population suitable for endovascular thrombectomy using standard or advanced imaging for patient selection.Patients and methodsEvidence from randomised control trials and national registries was combined to estimate UK stroke incidence and define a decision-tree describing the endovascular thrombectomy eligible population.ResultsBetween 9620 and 10,920 UK stroke patients (approximately 10% of stroke admissions) would be eligible for endovascular thrombectomy annually. The majority (9140-9620) would present within 4 h of onset and be suitable for intravenous thrombolysis. Advanced imaging would exclude 500 patients presenting within 4 h, but identify an additional 1310 patients as eligible who present later.DiscussionInformation from randomised control trials and large registry data provided the evidence criterion for 9 of the 12 decision points. The best available evidence was used for two decision points with sensitivity analyses to determine how key branches of the tree affected estimates. Using the mid-point estimate for eligibility (9.6% of admissions) and assuming national endovascular thrombectomy coverage, 4280 patients would have reduced disability.ConclusionA model combining published trials and register data suggests approximately 10% of all stroke admissions in the UK are eligible for endovascular thrombectomy. The use of advanced imaging based on current published evidence did not have a major impact on overall numbers but could alter eligibility status for 16% of cases.
| S-EPMC5992738 | biostudies-literature
Project description:Background and Purpose- We aimed to compare functional and procedural outcomes of patients with acute ischemic stroke with none-to-minimal (modified Rankin Scale [mRS] score, 0-1) and moderate (mRS score, 2-3) prestroke disability treated with mechanical thrombectomy. Methods- Consecutive adult patients undergoing mechanical thrombectomy for an anterior circulation stroke were prospectively identified at 2 comprehensive stroke centers from 2012 to 2018. Procedural and 90-day functional outcomes were compared among patients with prestroke mRS scores 0 to 1 and 2 to 3 using χ2, logistic, and linear regression tests. Primary outcome and significant differences in secondary outcomes were adjusted for prespecified covariates. Results- Of 919 patients treated with mechanical thrombectomy, 761 were included and 259 (34%) patients had moderate prestroke disability. Ninety-day mRS score 0 to 1 or no worsening of prestroke mRS was observed in 36.7% and 26.7% of patients with no-to-minimal and moderate prestroke disability, respectively (odds ratio, 0.63 [0.45-0.88], P=0.008; adjusted odds ratio, 0.90 [0.60-1.35], P=0.6). No increase in the disability at 90 days was observed in 22.4% and 26.7%, respectively. Rate of symptomatic intracerebral hemorrhage (7.3% versus 6.2%, P=0.65), successful recanalization (86.7% versus 83.8%, P=0.33), and median length of hospital stay (5 versus 5 days, P=0.06) were not significantly different. Death by 90 days was higher in patients with moderate prestroke disability (14.3% versus 40.3%; odds ratio, 4.06 [2.82-5.86], P<0.001; adjusted odds ratio, 2.83 [1.84, 4.37], P<0.001). Conclusions- One-third of patients undergoing mechanical thrombectomy had a moderate prestroke disability. There was insufficient evidence that functional and procedural outcomes were different between patients with no-to-minimal and moderate prestroke disability. Patients with prestroke disability were more likely to die by 90 days.
| S-EPMC7367056 | biostudies-literature
Project description:INTRODUCTION: Accurate ischemic stroke (IS) etiologic diagnosis provides an appropriate secondary prevention strategy and better outcome. Currently, 45% of IS are cryptogenic urging to find novel approaches to enhance diagnostic precision and secondary stroke prevention. OBJETIVE: To study the transcriptomic content of circulating extracellular vesicles (EVs) to delineate the molecular profile and potential biomarkers of IS etiologies. RESULTS:21 consecutive patients with moderate or severe ischemic stroke (IS) and different IS etiologies were included to perform the transcriptomic analysis of plasma EVs comprising: atherothrombotic (AT, n=6), Cardioembolic (CE, n=10), and embolic stroke of undetermined source (ESUS, n=5). The RNASeq analysis of EVs detected clusters of differentially expressed genes (DEGs) related to IS etiologies.
2024-05-01 | GSE255087 | GEO
Project description:BackgroundWhether pretreatment with intravenous thrombolysis prior to mechanical thrombectomy (IVT+MTE) adds additional benefit over direct mechanical thrombectomy (dMTE) in patients with large vessel occlusions (LVO) is a matter of debate.MethodsThis study-level meta-analysis was presented in accord with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Pooled effect sizes were calculated using the inverse variance heterogeneity model and displayed as summary Odds Ratio (sOR) and corresponding 95% confidence interval (95% CI). Sensitivity analysis was performed by distinguishing between studies including dMTE patients eligible for IVT (IVT-E) or ineligible for IVT (IVT-IN). Primary outcome measures were functional independence (modified Rankin Scale≤2) and mortality at day 90, successful reperfusion, and symptomatic intracerebral hemorrhage.ResultsTwenty studies, incorporating 5279 patients, were included. There was no evidence that rates of successful reperfusion differed in dMTE and IVT+MTE patients (sOR 0.93, 95% CI 0.68 to 1.28). In studies including IVT-IN dMTE patients, patients undergoing dMTE tended to have lower rates of functional independence and had higher odds for a fatal outcome as compared with IVT+MTE patients (sOR 0.78, 95% CI 0.61 to 1.01 and sOR 1.45, 95% CI 1.22 to 1.73). However, no such treatment group effect was found when analyses were confined to cohorts with a lower risk of selection bias (including IVT-E dMTE patients).ConclusionThe quality of evidence regarding the relative merits of IVT+MTE versus dMTE is low. When considering studies with lower selection bias, the data suggest that dMTE may offer comparable safety and efficacy as compared with IVT+MTE. The conduct of randomized-controlled clinical trials seems justified.
| S-EPMC6327861 | biostudies-literature
Project description:BackgroundThe beneficial effects of endovascular treatment with new-generation mechanical thrombectomy devices compared with intravenous thrombolysis alone to treat acute large-artery ischemic stroke have been shown in randomized controlled trials (RCTs). This study aimed to estimate the cost utility of mechanical thrombectomy compared with the established standard of care.MethodsWe developed a Markov decision process analytic model to assess the cost-effectiveness of treatment with mechanical thrombectomy plus intravenous thrombolysis versus treatment with intravenous thrombolysis alone from the public payer perspective in Canada. We conducted comprehensive literature searches to populate model inputs. We estimated the efficacy of mechanical thrombectomy plus intravenous thrombolysis from a meta-analysis of 5 RCTs, and we used data from the Oxford Vascular Study to model long-term clinical outcomes. We calculated incremental cost-effectiveness ratios (ICER) using a 5-year time horizon.ResultsThe base case analysis showed the cost and effectiveness of treatment with mechanical thrombectomy plus intravenous thrombolysis to be $126?939 and 1.484 quality-adjusted life-years (QALYs), respectively, and the cost and effectiveness of treatment with intravenous thrombolysis alone to be $124?419 and 1.273 QALYs, respectively. The mechanical thrombectomy plus intravenous thrombolysis strategy was associated with an ICER of $11?990 per QALY gained. Probabilistic sensitivity analysis showed that the probability of treatment with mechanical thrombectomy plus intravenous thrombolysis being cost-effective was 57.5%, 89.7% and 99.6% at thresholds of $20?000, $50?000 and $100?000 per QALY gained, respectively. The main factors influencing the ICER were time horizon, extra cost of mechanical thrombectomy treatment and age of the patient.InterpretationMechanical thrombectomy as an adjunct therapy to intravenous thrombolysis is cost-effective compared with treatment with intravenous thrombolysis alone for patients with acute large-artery ischemic stroke.
| S-EPMC4933608 | biostudies-literature
Project description:Background and Purpose- If anterior circulation large vessel occlusion acute ischemic stroke patients presenting with ASPECTS 0-5 (Alberta Stroke Program Early CT Score) should be treated with mechanical thrombectomy remains unclear. Purpose of this study was to report on the outcome of patients with ASPECTS 0-5 treated with mechanical thrombectomy and to provide data regarding the effect of successful reperfusion on clinical outcomes and safety measures in these patients. Methods- Multicenter, pooled analysis of 7 institutional prospective registries: Bernese-European Registry for Ischemic Stroke Patients Treated Outside Current Guidelines With Neurothrombectomy Devices Using the SOLITAIRE FR With the Intention for Thrombectomy (Clinical Trial Registration-URL: https://www.clinicaltrials.gov . Unique identifier: NCT03496064). Primary outcome was defined as modified Rankin Scale 0-3 at day 90 (favorable outcome). Secondary outcomes included rates of day 90 modified Rankin Scale 0-2 (functional independence), day 90 mortality and occurrence of symptomatic intracerebral hemorrhage. Multivariable logistic regression analyses were performed to assess the association of successful reperfusion with clinical outcomes. Outputs are displayed as adjusted Odds Ratios (aOR) and 95% CI. Results- Two hundred thirty-seven of 2046 patients included in this registry presented with anterior circulation large vessel occlusion and ASPECTS 0-5. In this subgroup, the overall rates of favorable outcome and mortality at day 90 were 40.1% and 40.9%. Achieving successful reperfusion was independently associated with favorable outcome (aOR, 5.534; 95% CI, 2.363-12.961), functional independence (aOR, 5.583; 95% CI, 1.964-15.873), reduced mortality (aOR, 0.180; 95% CI, 0.083-0.390), and lower rates of symptomatic intracerebral hemorrhage (aOR, 0.235; 95% CI, 0.062-0.887). The mortality-reducing effect remained in patients with ASPECTS 0-4 (aOR, 0.167; 95% CI, 0.056-0.499). Sensitivity analyses did not change the primary results. Conclusions- In patients presenting with ASPECTS 0-5, who were treated with mechanical thrombectomy, successful reperfusion was beneficial without increasing the risk of symptomatic intracerebral hemorrhage. Although the results do not allow for general treatment recommendations, formal testing of mechanical thrombectomy versus best medical treatment in these patients in a randomized controlled trial is warranted.
| S-EPMC6430594 | biostudies-literature
Project description:A mTICI 2b or a mTICI 3 score are currently considered success following mechanical thrombectomy (MT) in acute stroke but is undetermined whether the two scores translate equivalent outcomes. We present a single-center, retrospective cohort of patients with anterior circulation stroke treated with MT and achieving a final mTICI score 2b or 3. A multimodal CT at baseline and a multimodal MRI at 24?hours assessed the growth of the infarct, and the modified Rankin Scale (mRS) assessed functional outcome at 90 days. The primary outcome was the shift analysis of the mRS at day 90 in ordinal regression adjusted for covariates (age, sex, pretreatment NIHSS score, target occlusion, infarct core, pretreatment alteplase), and the collateral score. Infarct growth was explored in a similarly adjusted multiple linear regression model. MT was started within a median of 285?minutes of symptom onset; 51 (41%) patients achieved a mTICI 2b, and 74 (59%), a mTICI 3. mTICI 3 resulted in better mRS score transitions than mTICI 2b (odds ratio 2.018 [95% CI 1.033-3.945], p?=?0. 040), and reduced infarct growth (p?=?0.002). We conclude that in patients with acute stroke receiving MT, success should be redefined as achieving a mTICI 3 score.
| S-EPMC5599658 | biostudies-literature
Project description:IntroductionMechanical thrombectomy is revolutionizing treatment of acute stroke due to large vessel occlusion (LVO). Unfortunately, use of the modified Thrombolysis in Cerebral Infarction score (mTICI) to characterize recanalization of the cerebral vasculature does not address microvascular perfusion of the distal parenchyma, nor provide more than a vascular "snapshot." Thus, little is known about tissue-level hemodynamic consequences of LVO recanalization. Diffuse correlation spectroscopy (DCS) and diffuse optical spectroscopy (DOS) are promising methods for continuous, noninvasive, contrast-free transcranial monitoring of cerebral microvasculature.MethodsHere, we use a combined DCS/DOS system to monitor frontal lobe hemodynamic changes during endovascular treatment of 2 patients with ischemic stroke due to internal carotid artery (ICA) occlusions.Results and discussionThe monitoring instrument identified a recanalization-induced increase in ipsilateral cerebral blood flow (CBF) with little or no concurrent change in contralateral CBF and extracerebral blood flow. The results suggest that diffuse optical monitoring is sensitive to intracerebral hemodynamics in patients with ICA occlusion and can measure microvascular responses to mechanical thrombectomy.
| S-EPMC6686873 | biostudies-literature
Project description:Background and purposeThe impact of anesthesia technique on the outcomes of mechanical thrombectomy for acute ischemic stroke remains an issue of debate. We investigated the association of general anesthesia with outcomes in patients undergoing mechanical thrombectomy for ischemic stroke.MethodsWe performed a cohort study involving patients undergoing mechanical thrombectomy for ischemic stroke from 2009 to 2013, who were registered in the New York Statewide Planning and Research Cooperative System database. An instrumental variable (hospital rate of general anesthesia) analysis was used to simulate the effects of randomization and investigate the association of anesthesia technique with case-fatality and length of stay.ResultsAmong 1174 patients, 441 (37.6%) underwent general anesthesia and 733 (62.4%) underwent conscious sedation. Using an instrumental variable analysis, we identified that general anesthesia was associated with a 6.4% increased case-fatality (95% confidence interval, 1.9%-11.0%) and 8.4 days longer length of stay (95% confidence interval, 2.9-14.0) in comparison to conscious sedation. This corresponded to 15 patients needing to be treated with conscious sedation to prevent 1 death. Our results were robust in sensitivity analysis with mixed effects regression and propensity score-adjusted regression models.ConclusionsUsing a comprehensive all-payer cohort of acute ischemic stroke patients undergoing mechanical thrombectomy in New York State, we identified an association of general anesthesia with increased case-fatality and length of stay. These considerations should be taken into account when standardizing acute stroke care.
| S-EPMC5263179 | biostudies-literature
Project description:Although intravenous thrombolysis increases the probability of a good functional outcome in carefully selected patients with acute ischemic stroke, a substantial proportion of patients who receive thrombolysis do not have a good outcome. Several recent trials of mechanical thrombectomy appear to indicate that this treatment may be superior to thrombolysis. We therefore conducted a systematic review and meta-analysis to evaluate the clinical effectiveness and safety of new-generation mechanical thrombectomy devices with intravenous thrombolysis (if eligible) compared with intravenous thrombolysis (if eligible) in patients with acute ischemic stroke caused by a proximal intracranial occlusion. We systematically searched seven databases for randomized controlled trials published between January 2005 and March 2015 comparing stent retrievers or thromboaspiration devices with best medical therapy (with or without intravenous thrombolysis) in adults with acute ischemic stroke. We assessed risk of bias and overall quality of the included trials. We combined the data using a fixed or random effects meta-analysis, where appropriate. We identified 1579 studies; of these, we evaluated 122 full-text papers and included five randomized control trials (n=1287). Compared with patients treated medically, patients who received mechanical thrombectomy were more likely to be functionally independent as measured by a modified Rankin score of 0-2 (odds ratio, 2.39; 95% confidence interval, 1.88-3.04; I2=0%). This finding was robust to subgroup analysis. Mortality and symptomatic intracerebral hemorrhage were not significantly different between the two groups. Mechanical thrombectomy significantly improves functional independence in appropriately selected patients with acute ischemic stroke.
| S-EPMC4926268 | biostudies-literature