Comparison of stent-retriever devices versus the Merci retriever for endovascular treatment of acute stroke.
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ABSTRACT: Background and purpose
Revascularization of large cerebral artery occlusion is the therapeutic goal in stroke therapy. Currently, many recanalization devices are in clinical use. This study compares the outcome parameters, efficacy, and safety of the new generation of stent-retriever devices with the well-established Merci retriever.Materials and methods
All patients who received endovascular mechanical recanalization therapy were prospectively registered. One hundred twenty-two patients were treated with either new stent retrievers, including the Trevo and Solitaire devices, or the Merci retriever system. Recanalization of the occluded vessel was assessed in accordance with the modified TICI score, and outcome parameters, including the NIHSS and mRS scores, were documented. Clinical status was recorded after neurointervention, at time of discharge, and after 90 days.Results
The mean age of all patients was 68 years; 54% were male, with no statistical differences in demographics between both groups. Successful recanalization (TICI 3 and TICI 2b) was achieved in 82% of patients treated with stent retrievers compared with 62% of patients treated with Merci retrievers (P = .016). In the 90-day follow-up, 65% of patients treated with stent retrievers and 35% of those treated with the Merci had achieved a good (mRS = 0-2) clinical outcome (P = .002). Patients treated with stent retrievers had a significantly shorter treatment time (72 versus 122 minutes, P < .01) and less severe intracerebral hemorrhages (10% versus 28%, P < .01).Conclusions
Patients treated with Trevo and Solitaire stents had a better revascularization rate, better clinical outcome, and lower complication rate than patients treated with the Merci retriever.
SUBMITTER: Broussalis E
PROVIDER: S-EPMC7965100 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:ImportanceAcute ischemic stroke is a leading cause of death and disability worldwide. Several recent clinical trials have shown that endovascular treatment improves clinical outcomes among patients with acute ischemic stroke.ObjectiveTo provide an overall and precise estimate of the efficacy of endovascular treatment predominantly using second-generation mechanical thrombectomy devices (stent-retriever devices) compared to medical management on clinical and functional outcomes among patients with acute ischemic stroke.Data sourcesMEDLINE, EMBASE, Cochrane Collaboration Central Register of Controlled Clinical Trials, Web of Science, and NIH ClinicalTrials.gov were searched through November 2015.Study selectionSearches returned 3,045 articles. After removal of duplicates, two authors independently screened titles and abstracts to assess eligibility of 2,495 potentially relevant publications. From these, 38 full-text publications were more closely assessed. Finally, 5 randomized controlled trials of endovascular treatment with predominant use of retrievable stents were selected.Data extraction and synthesisThree authors independently extracted information on participant and trial characteristics and clinical events using a standardized protocol. Random effects models were used to pool endovascular treatment effects across outcomes.Main outcomes and measuresThe primary outcome was better functional outcome as measured on the modified Rankin Scale at 90 days of follow-up. Secondary outcomes included all-cause mortality and symptomatic intra-cerebral hemorrhage.ResultsFive trials representing 1,287 patients were included. Overall, patients randomized to endovascular therapy experienced 2.22 times greater odds of better functional outcome compared to those randomized to medical management (95% CI, 1.66 to 2.98; P < 0.0001). Endovascular therapy was not associated with mortality [OR (95% CI), 0.78 (0.54, 1.12); P = 0.1056] or symptomatic intracerebral hemorrhage [OR (95% CI), 1.19 (0.69, 2.05); P = 0.5348]. Meta-regression analysis suggested that shorter times from stroke onset to groin puncture and from stroke onset to reperfusion result in better functional outcomes in ischemic stroke patients (P = 0.0077 and P = 0.0089). There were no significant differences in the beneficial effects of endovascular treatment on functional outcomes across categories of gender, age, stroke severity, ischemic changes on computed tomography, or intravenous tissue plasminogen activator administration.Conclusions and relevanceThis meta-analysis demonstrated superior functional outcomes in subjects receiving endovascular treatment compared to medical management. Further, this analysis showed that acute ischemic stroke patients may receive enhanced functional benefit from earlier endovascular treatment.
| S-EPMC4726653 | biostudies-literature
Project description:ObjectiveTo explore the effects of reperfusion grade rates on clinical outcomes in the setting of stent-retriever-based reperfusion therapy for anterior circulation stroke in early time windows.MethodsSystematic searching of Medline and Embase databases was performed to identify stroke trials of stent-retriever-based therapy versus standard care. Mixed effects meta-regression was used to analyze the trial-level association between reperfusion rates and clinical outcomes.ResultsA total of five trials met the inclusion criteria (n?=?1,287). Rates of successful reperfusion [modified thrombolysis in cerebral ischemia grade 2b/3] demonstrated strong evidence for an association with good functional outcomes [modified Rankin scale score (mRS) 0-2] OR 1.59 (95% CI 1.16, 2.19) p?=?0.019 and very strong evidence for an association with excellent functional outcomes (mRS 0-1) OR 2.10 (95% CI 1.46, 3.01) p?=?0.007. In addition, there was weak evidence for an association with symptomatic intracranial hemorrhage OR 0.54 (95% CI 0.28, 1.04) p?=?0.057 and mortality OR 0.69 (95% CI 0.69, 1.01) p?=?0.053.ConclusionIn early, stent-retriever-based acute ischemic stroke treatment, reperfusion appears to be a major predictor of outcomes. Every 10% increase in the rates of successful reperfusion is associated with an 11% increase in the probability of achieving good and 17% increase in the probability of achieving excellent outcomes. Symptomatic intracranial hemorrhage and mortality may be decreased as reperfusion rates are improved.
| S-EPMC5968377 | biostudies-literature
Project description:BackgroundRandomized controlled trials (RCTs) have compared mechanical endovascular therapy (MET) in addition to intravenous tissue plasminogen activator (IVtPA) to IVtPA alone for the management of acute ischemic stroke (AIS). Direct comparative studies between individual METs are not available. In lieu of head-to-head randomized control trials, we performed an adjusted indirect treatment comparison (ITC) meta-analysis to assess the comparative efficacy and safety of different METs, Solitaire+IVtPA and Penumbra+IVtPA in AIS patients.Methods and findingsWe searched MEDLINE, the Cochrane Central Register of Controlled Trials and Embase from January 1, 2005 through April 1, 2017 for RCTs in AIS patients, comparing a single MET+IVtPA to IVtPA alone and reporting shift in ordinal modified Rankin Scale (mRS) score at 90 days. Secondary endpoints included 90 day mortality and symptomatic intracranial hemorrhage (sICH). Endpoints were pooled using traditional random effects meta-analysis methods, producing odds ratios and 95% confidence intervals. Adjusted ITCs using pooled estimates were then performed. Three studies (SWIFT PRIME, EXTEND-IA, THERAPY) were included; two evaluating the Solitaire stent retriever and one the Penumbra system. Traditional meta-analysis demonstrated that each MET+IVtPA resulted in increased odds of improving ordinal mRS score vs. IVtPA alone, but did not alter the odds of death or sICH. Adjusted ITC showed no significant difference between the METs for any outcome.ConclusionNo significant difference in efficacy or safety between the Solitaire and Penumbra devices was observed.
| S-EPMC5841644 | biostudies-literature
Project description:Clinical trials have demonstrated improved 90-day outcomes for patients with acute ischemic stroke treated with stent retriever thrombectomy plus tissue-type plasminogen activator (SST+tPA) compared with tPA. Previous studies suggested that this strategy may be cost-effective, but models were derived from pooled data and older assumptions.In this prospective economic substudy conducted alongside the SWIFT-PRIME trial (Solitaire With the Intention for Thrombectomy as Primary Endovascular Treatment for Acute Ischemic Stroke), in-trial costs were measured for patients using detailed medical resource utilization and hospital billing data. Utility weights were assessed at 30 and 90 days using the EuroQol-5 dimension questionnaire. Post-trial costs and life-expectancy were estimated for each surviving patient using a model based on trial data and inputs derived from a contemporary cohort of ischemic stroke survivors.Index hospitalization costs were $17?183 per patient higher for SST+tPA than for tPA ($45?761 versus $28?578; P<0.001), driven by initial procedure costs. Between discharge and 90 days, costs were $4904 per patient lower for SST+tPA than for tPA ($11?270 versus $16?174; P=0.014); total 90-day costs remained higher with SST+tPA ($57?031 versus $44?752; P<0.001). Higher utility values for SST+tPA led to higher in-trial quality-adjusted life years (0.131 versus 0.105; P=0.005). In lifetime projections, SST+tPA was associated with substantial gains in quality-adjusted life years (6.79 versus 5.05), cost savings of $23?203 per patient and was economically dominant when compared with tPA in 90% of bootstrap replicates.Among patients with acute ischemic stroke enrolled in the SWIFT-PRIME trial, SST increased initial treatment costs, but was projected to improve quality-adjusted life-expectancy and reduce healthcare costs over a lifetime horizon compared with tPA.URL: http://www.clinicaltrials.gov. Unique identifier: NCT01657461.
| S-EPMC5461963 | biostudies-literature
Project description:PurposeThe evidence for endovascular therapy and choice of technique in distal middle cerebral artery (MCA) M2 segment occlusions in acute ischemic stroke remains controversial. We aimed to conduct a systematic review and meta-analysis primarily comparing reperfusion rates of stent-retrieval versus contact aspiration for M2 occlusions.Materials and methodsStudy selection included cohorts of patients with distal MCA occlusions in acute ischemic strokes treated with an endovascular approach including stent-retrieval or contact aspiration. Twelve studies were selected for meta-analysis for a total of 835 cases. Meta-analysis by proportions was conducted on parameters including baseline and procedural characteristics, thrombolysis in cerebral infarction (TICI) 2b-3 outcomes, and 90-day modified Rankin scale (mRS) outcomes.ResultsHypertension and hyperlipidemia were more prevalent in stent-retriever patients. Pooled baseline National Institute of Health Stroke Scale scores and Alberta Stroke Program Early Computed Tomography Score imaging scores were similar. Pooled time onset of symptoms to door arrival was higher for the stent-retrieval group (154 vs. 97.4 minutes, P=0.01), as was time to groin puncture (259.9 vs. 156.2 minutes, P=0.02), but there was no difference in procedure time. The TICI 2b-3 recanalization rate was similar (80.5% vs. 86.8%, P=0.168). The frequency of mRS 0-2 at 90-day was also similar (74.5% vs. 59.9%, P=0.120), and an excellent mRS 0-1 was lower for stent-retrievers (39.9% vs. 65.6%, P=0.003). A significant negative correlation was found between onset to groin puncture time and the proportion of patients with a good mRS (r=-0.71, P=0.048).ConclusionBoth endovascular techniques achieved recanalization rates greater than 80% and 90-day outcomes of minimal disability with similar complication rates. The literature is skewed by aspiration cases being performed sooner after onset of stroke compared to stent-retriever cases.
| S-EPMC6132031 | biostudies-literature
Project description:BACKGROUND:Although stent retriever (SR) is recommended as a frontline device of endovascular treatment (EVT) for embolic large artery occlusion causing acute ischemic stroke, contact aspiration (CA) device showed similar efficacy in the recent trials. However, the efficacy of the both devices as first-line therapy for intracranial atherosclerotic stenosis (ICAS)-related large vessel occlusion has not yet been established. Therefore, we compared the immediate effects and final outcomes of SR and CA as first-line devices for treating ICAS-related occlusions. METHODS:We retrospectively analyzed the data of patients who underwent EVT for acute ischemic stroke from the registry of three Korean hospitals. Patients with ICAS-related occlusion who were treated within 24?h of onset of the symptoms were included. We investigated immediate reperfusion performance, immediate safety outcomes, and 3-month clinical outcomes for the two first-line devices. RESULTS:Of the 720 registered patients, 111 were eligible for this study. Forty-nine patients (44.1%) used SR and 62 (55.9%) used CA as the first-line device. Achieving successful reperfusion immediately after first-line thrombectomy was more frequent in the SR group than that in the CA group (77.6% vs. 43.5%, p?=?0.001), with fewer additional rescue treatments (12.2% vs. 59.7%, p?<?0.001). The incidence of iatrogenic dissection or rupture was lower in the SR group than that in the CA group (8.2% vs. 29.0%, p?=?0.012). After additional rescue treatments, however, the final successful reperfusion rate did not differ between the two groups (SR 87.8% vs. CA 77.4%, p?=?0.247), and there was no significant difference in the 3-month good outcomes (modified Rankin Scale, p?=?0.524). CONCLUSIONS:First-line SR thrombectomy showed higher immediate reperfusion and less vessel injury for ICAS-related occlusions than CA. However, there was no significant difference in the final reperfusion status or 3-month outcomes from additional rescue treatments.
| S-EPMC7368707 | biostudies-literature
Project description:ImportanceThe benefits of endovascular revascularization using the contact aspiration technique vs the stent retriever technique in patients with acute ischemic stroke remain uncertain because of lack of evidence from randomized trials.ObjectiveTo compare efficacy and adverse events using the contact aspiration technique vs the standard stent retriever technique as a first-line endovascular treatment for successful revascularization among patients with acute ischemic stroke and large vessel occlusion.Design, setting, and participantsThe Contact Aspiration vs Stent Retriever for Successful Revascularization (ASTER) study was a randomized, open-label, blinded end-point clinical trial conducted in 8 comprehensive stroke centers in France (October 2015-October 2016). Patients who presented with acute ischemic stroke and a large vessel occlusion in the anterior circulation within 6 hours of symptom onset were included.InterventionsPatients were randomly assigned to first-line contact aspiration (n = 192) or first-line stent retriever (n = 189) immediately prior to mechanical thrombectomy.Main outcomes and measuresThe primary outcome was the proportion of patients with successful revascularization defined as a modified Thrombolysis in Cerebral Infarction score of 2b or 3 at the end of all endovascular procedures. Secondary outcomes included degree of disability assessed by overall distribution of the modified Rankin Scale (mRS) score at 90 days, change in National Institutes of Health Stroke Scale (NIHSS) score at 24 hours, all-cause mortality at 90 days, and procedure-related serious adverse events.ResultsAmong 381 patients randomized (mean age, 69.9 years; 174 women [45.7%]), 363 (95.3%) completed the trial. Median time from symptom onset to arterial puncture was 227 minutes (interquartile range, 180-280 minutes). For the primary outcome, the proportion of patients with successful revascularization was 85.4% (n = 164) in the contact aspiration group vs 83.1% (n = 157) in the stent retriever group (odds ratio, 1.20 [95% CI, 0.68-2.10]; P = .53; difference, 2.4% [95% CI, -5.4% to 9.7%]). For the clinical efficacy outcomes (change in NIHSS score at 24 hours, mRS score at 90 days) and adverse events, there were no significant differences between groups.Conclusions and relevanceAmong patients with ischemic stroke in the anterior circulation undergoing thrombectomy, first-line thrombectomy with contact aspiration compared with stent retriever did not result in an increased successful revascularization rate at the end of the procedure.Trial registrationclinicaltrials.gov Identifier: NCT02523261.
| S-EPMC5817613 | biostudies-literature
Project description:BackgroundIn patients with ischemic stroke, endovascular treatment results in a higher rate of recanalization of the affected cerebral artery than systemic intravenous thrombolytic therapy. However, comparison of the clinical efficacy of the two approaches is needed.MethodsWe randomly assigned 362 patients with acute ischemic stroke, within 4.5 hours after onset, to endovascular therapy (intraarterial thrombolysis with recombinant tissue plasminogen activator [t-PA], mechanical clot disruption or retrieval, or a combination of these approaches) or intravenous t-PA. Treatments were to be given as soon as possible after randomization. The primary outcome was survival free of disability (defined as a modified Rankin score of 0 or 1 on a scale of 0 to 6, with 0 indicating no symptoms, 1 no clinically significant disability despite symptoms, and 6 death) at 3 months.ResultsA total of 181 patients were assigned to receive endovascular therapy, and 181 intravenous t-PA. The median time from stroke onset to the start of treatment was 3.75 hours for endovascular therapy and 2.75 hours for intravenous t-PA (P<0.001). At 3 months, 55 patients in the endovascular-therapy group (30.4%) and 63 in the intravenous t-PA group (34.8%) were alive without disability (odds ratio adjusted for age, sex, stroke severity, and atrial fibrillation status at baseline, 0.71; 95% confidence interval, 0.44 to 1.14; P=0.16). Fatal or nonfatal symptomatic intracranial hemorrhage within 7 days occurred in 6% of the patients in each group, and there were no significant differences between groups in the rates of other serious adverse events or the case fatality rate.ConclusionsThe results of this trial in patients with acute ischemic stroke indicate that endovascular therapy is not superior to standard treatment with intravenous t-PA. (Funded by the Italian Medicines Agency, ClinicalTrials.gov number, NCT00640367.).
| S-EPMC3708480 | biostudies-literature
Project description:Currently, acute ischemic stroke is still a leading cause of mortality and morbidity. Approximately 2 years ago, mechanical thrombectomy was proven beneficial as a revolutionary new therapy for stroke in the MR-CLEAN trial (A Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands). However, the mechanisms by which the thrombectomy device, or stent-retriever, interacts with the thrombus are largely unknown. A better understanding could lead to improved efficacy of mechanical thrombectomy devices. Seven stent-retrievers with thrombi still entrapped were collected directly after thrombectomy. The stent-retrievers were studied using micro computed tomography, followed by scanning electron microscopy and light microscopy. Two independent observers rated interaction type and thrombus surface structure (porous filamentous or dense) at the interaction sites.A total of 79 interaction sites between thrombus and stent-retriever were categorized. Thrombus-stent-retriever interaction was found to be adhesive (n=44; 56%) or mechanical (n=35; 44%). Adhesive interaction was most frequently observed at interaction sites with a dense surface, compared with interaction sites with a porous filamentous fibrin surface (38/58; 66% versus 6/21; 29%, P=0.011). The interaction between thrombus and stent-retriever was predominantly adhesive, not mechanical. Adhesive interaction was strongly associated with the presence of a dense thrombus surface without a porous filamentous fibrin network.
| S-EPMC6064914 | biostudies-literature
Project description:BACKGROUND:There is ongoing debate regarding the optimal first-line thrombectomy technique for large-vessel occlusion. PURPOSE:We performed a systematic review and meta-analysis of comparative studies on stent retriever-first and aspiration-first thrombectomy. DATA SOURCES:We searched Ovid MEDLINE, PubMed, and EMBASE from 2009 to February 2018. STUDY SELECTION:Two reviewers independently selected the studies. The primary end point was successful reperfusion (TICI 2b/3). DATA ANALYSIS:Random-effects meta-analysis was used for analysis. DATA SYNTHESIS:Eighteen studies including 2893 patients were included. There was no significant difference in the rate of final successful reperfusion (83.9% versus 83.3%; OR = 0.87; 95% CI, 0.62%-1.27%) or good functional outcome (mRS 0-2) at 90 days (OR = 1.07; 95% CI, 0.80-1.44) between the stent-retriever thrombectomy and aspiration groups. The stent-retriever thrombectomy-first group achieved a statistically significant higher TICI 2b/3 rate after the first-line device than the aspiration-first group (74.9% versus 66.4%; OR = 1.53; 95% CI, 1.14%-2.05%) and resulted in lower use of a rescue device (19.9% versus 32.5%; OR = 0.36; 95% CI, 0.14%-0.90%). The aspiration-first approach resulted in a statistically shorter groin-to-reperfusion time (weighted mean difference, 7.15 minutes; 95% CI, 1.63-12.67 minutes). There was no difference in the number of passes, symptomatic intracerebral hemorrhage, vessel dissection or perforation, and mortality between groups. LIMITATIONS:Most of the included studies were nonrandomized. There was significant heterogeneity in some of the outcome variables. CONCLUSIONS:Stent-retriever thrombectomy-first and aspiration-first thrombectomy were associated with comparable final reperfusion rates and functional outcome. Stent-retriever thrombectomy was superior in achieving reperfusion as a stand-alone first-line technique, with lower use of rescue devices but a longer groin-to-reperfusion time.
| S-EPMC7655372 | biostudies-literature