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Safety and Efficacy of a 3-Dimensional Stent Retriever With Aspiration-Based Thrombectomy vs Aspiration-Based Thrombectomy Alone in Acute Ischemic Stroke Intervention: A Randomized Clinical Trial.

ABSTRACT: Importance:The treatment effects of individual mechanical thrombectomy devices in large-vessel acute ischemic stroke (AIS) remain unclear. Objective:To determine whether the novel 3-dimensional (3-D) stent retriever used in conjunction with an aspiration-based mechanical thrombectomy device (Penumbra System; Penumbra) is noninferior to aspiration-based thrombectomy alone in AIS. Design, Setting, and Participants:This randomized, noninferiority clinical trial enrolled patients at 25 North American centers from May 19, 2012, through November 19, 2015, with follow-up for 90 days. Adjudicators of the primary end points were masked to treatment allocation. Patients with large-vessel intracranial occlusion AIS presenting with a National Institutes of Health Stroke Scale (NIHSS) score of at least 8 within 8 hours of onset underwent 1:1 randomization to 3-D stent retriever with aspiration or aspiration alone. The primary analyses were conducted in the intention-to-treat population. Interventions:Mechanical thrombectomy using intracranial aspiration with or without the 3-D stent retriever. Main Outcomes and Measures:The primary effectiveness end point was the rate of a modified Thrombolysis in Cerebral Infarction (mTICI) grade of 2 to 3 with a 15% noninferiority margin. Device- and procedure-related serious adverse events at 24 hours were the primary safety end points. Results:Of 8082 patients screened, 198 patients were enrolled (111 women [56.1%] and 87 men [43.9%]; mean [SD] age, 66.9 [13.0] years) and randomized, including 98 in the 3-D stent retriever with aspiration group and 100 in the aspiration alone group; an additional 238 patients were eligible but not enrolled. The median baseline NIHSS score was 18.0 (interquartile range, 14.0-23.0). Eighty-two of 94 patients in the 3-D stent retriever and aspiration group (87.2%) had an mTICI grade of 2 to 3 compared with 79 of 96 in the aspiration alone group (82.3%; difference, 4.9%; 90% CI, -3.6% to 13.5%). None of the other measures were significantly different between the 2 groups. Device-related serious adverse events were reported by 4 of 98 patients in the 3-D stent retriever with aspiration group (4.1%) vs 5 of 100 patients in the aspiration only group (5.0%); procedure-related serious adverse events, 10 of 98 (10.2%) vs 14 of 100 (14.0%). A 90-day modified Rankin Scale score of 0 to 2 was reported by 39 of 86 patients in the 3-D stent retriever with aspiration group (45.3%) vs 44 of 96 patients in the aspiration only group (45.8%). Conclusions and Relevance:The present study provides class 1 evidence for the noninferiority of the 3-D stent retriever with aspiration vs aspiration alone in AIS. Future trials should evaluate whether these results can be generalized to other stent retrievers. Trial Registration:clinicaltrials.gov Identifier: NCT01584609.

SUBMITTER: Nogueira RG

PROVIDER: S-EPMC5885851 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ImportanceMechanical thrombectomy using a stent retriever or contact aspiration is widely used for treatment of patients with acute ischemic stroke due to anterior circulation large vessel occlusion, but the additional benefit of combining contact aspiration with stent retriever is uncertain.ObjectiveTo determine whether mechanical thrombectomy for treatment of anterior circulation large vessel occlusion stroke with initial contact aspiration and stent retriever combined results in better final angiographic outcome than with standard stent retriever alone.Design, setting, and participantsThis trial was a multicenter randomized, open-label, blinded end point evaluation that enrolled 408 patients from October 16, 2017, to May 29, 2018, in 11 French comprehensive stroke centers, with a 12-month outcome follow-up. Patients with a large vessel occlusion in the anterior circulation were included up to 8 hours after symptom onset. The final date of follow-up was June, 19, 2019.InterventionsPatients were randomly assigned (1:1 allocation) to receive initial thrombectomy with contact aspiration and stent retriever combined (205) or stent retriever alone (203).Main outcomes and measuresThe primary outcome was the rate of expanded Thrombolysis In Cerebral Infarction score of 2c or 3 (eTICI 2c/3; ie, scores indicate near-total and total reperfusion grades) at the end of the procedure.ResultsAmong the 408 patients who were randomized, 3 were excluded, and 405 (99.3%) patients (mean age, 73 years; 220 [54%] women and 185 [46%] men) were included in the primary analysis. The rate of eTICI 2c/3 at the end of the endovascular procedure was not significantly different between the 2 thrombectomy groups (64.5% [131 of 203 patients] for contact aspiration and stent retriever combined vs 57.9% [117 of 202 patients] for stent retriever alone; risk difference, 6.6% [95% CI, -3.0% to 16.2%]; adjusted odds ratio [OR], 1.33 [95% CI, 0.88 to 1.99]; P = .17). Of 14 prespecified secondary efficacy end points, 12 showed no significant difference. A higher rate of successful reperfusion was achieved in the contact aspiration combined with stent retriever group vs the stent retriever alone group (eTICI 2b50/2c/3, 86.2% vs 72.3%; adjusted OR, 2.54 [95% CI, 1.51 to 4.28]; P < .001) and of near-total or total reperfusion (eTICI 2c/3, 59.6% vs 49.5%; adjusted OR, 1.52 [95% CI, 1.02 to 2.27]; P = .04) after the assigned initial intervention alone.Conclusions and relevanceAmong patients with acute ischemic stroke due to large vessel occlusion, an initial thrombectomy technique consisting of contact aspiration and stent retriever combined, compared with stent retriever alone, did not significantly improve the rate of near-total or total reperfusion (eTICI 2c/3) at the end of the endovascular procedure, although the trial may have been underpowered to detect smaller differences between groups.Trial registrationClinicalTrials.gov Identifier: NCT03290885.

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.

Project description:Background and Purpose: The benefits of mechanical thrombectomy (MT) in vertebrobasilar artery occlusions have not been well-studied. We compared clinical, procedural, and safety outcomes of MT for posterior circulation (PC) vs. anterior circulation (AC) occlusions among patients in the STRATIS registry. Methods: Data from STRATIS including patient demographics, procedural characteristics, and outcomes including symptomatic intracranial hemorrhage (sICH) at 24 h, serious adverse events (SAE), substantial reperfusion [modified thrombolysis in cerebral infarction (mTICI) 2b/3], 90-day functional independence [modified Rankin Scale (mRS) 0-2], and 90-day mortality were analyzed. Univariate logistic regression was used to calculate predictors of good clinical outcome. Results: Of 984 STRATIS patients, 43 (4.4%) patients with PC occlusions [mean age 63.0 ± 13.6, 25.6% (11/43) female] and 932 (94.7%) with AC occlusions [mean age 68.5 ± 14.8, 46.9% (437/932) female] were included for analysis. Median National Institutes of Health Stroke Scale (NIHSS) scores at baseline were 17.0 (13.0, 12.0) for the AC group and 12.0 (11.0, 24.0) for the PC group. Time from onset to procedure end was longer for the PC group [median (IQR): 322.0 min (255.0-421.0) vs. 271.0 min (207.0-360.0); p = 0.007]. PC and AC groups had similar rates of substantial reperfusion [89.2% (33/37) vs. 87.7% (684/780)], procedure-related SAE [0.0% (0/43) vs. 1.7% (16/932)], sICH [0.0% (0/38) vs. 1.5% (12/795)], 90-day functional independence [66.7% (26/39) vs. 55.9% (480/858)] and mortality [12.8% (5/39) vs. 15.8% (136/861)]. National Institutes of Health Stroke Scale score and patient sex were significant univariate predictors of good clinical outcome (p < 0.05). Conclusions: Despite longer reperfusion times, MT in PC stroke has similar rates of 90-day functional independence with no significant difference in procedure-related SAE, sICH, or mortality, supporting the use of MT in PC acute ischemic stroke (AIS). Clinical Trial Registration:https://www.clinicaltrials.gov, Identifier: NCT02239640.

Project description:Background: Recent trials have proved the efficacy of mechanical thrombectomy over medical treatment for patients with acute ischemic stroke, with the balance of equivalent rates of adverse events. Stent retrievers were applied predominantly in most trials; however, the role of other thrombectomy devices has not been well validated. A direct aspiration first-pass technique (ADAPT) is proposed to be a faster thrombectomy technique than the stent retriever technique. This meta-analysis investigated and compared the efficacy and adverse events of first-line ADAPT with those of first-line stent retrievers in patients with acute ischemic stroke. Methods: A structured search was conducted comprehensively. A total of 1623 papers were found, and 4 articles were included in our meta-analysis. The Critical Appraisal Skills Programme tools were applied to evaluate the quality of studies. The primary outcome was defined as the proportion of patients with the Thrombolysis in Cerebral Ischemia (TICI) scale of 2b/3 at the end of all procedures. Secondary outcomes were the proportion of patients with functional independence (modified Rankin scale of 0-2) at the third month, the proportion of patients with the Thrombolysis in Cerebral Ischemia (TICI) scale of 2b/3 by primary chosen device, and the proportion of patients who received rescue therapies. Safety outcomes were the symptomatic intracranial hemorrhage (sICH) rate and the mortality rate within 3 months. Results: One randomized controlled trial, one prospective cohort study, and two retrospective cohort studies were included. No significant difference between these 2 strategies of management were observed in the primary outcome (TICI scale at the end of all procedures, odds ratio [OR] = 0.78), two secondary outcomes (functional independence at the third month, OR = 1.16; TICI scale by primary chosen device, OR = 1.25), and all safety outcomes (sICH rate, OR = 1.56; mortality rate, OR = 0.91). The proportion of patients who received rescue therapies was higher in the first-line ADAPT group (OR = 0.64). Conclusions: Among first-line thrombectomy devices for patients with ischemic stroke, ADAPT with the latest thrombosuction system was as efficient and safe as stent retrievers.

Project description:SubjectThis study aims to compare the clinical efficacy of aspiration thrombectomy and stent retriever thrombectomy as first-line approaches for anterior circulation large vessel cardiogenic cerebral embolism and cryptogenic stroke.MethodThis retrospective observational study included patients with anterior circulation large vessel cardiogenic cerebral embolism and cryptogenic stroke treated with endovascular therapy. Patients were grouped according to the first-line approach they received: aspiration thrombectomy or stent retriever thrombectomy. The primary outcome measure was the change in the National Institute of Health Stroke Scale (NIHSS) score from preoperative to immediate postoperative and from preoperative to discharge. Secondary indicators included the rate of favorable prognosis at discharge [Modified Rankin Scale (mRS) score ≤ 2], successful vessel recanalization rate [modified Treatment in Cerebral Ischemia (mTICI) score ≥ 2b], time from successful femoral artery puncture to successful vessel recanalization, and perioperative complications.ResultThe study included 127 cases, with 1 case withdrawal after enrollment due to a stroke of another determined cause, with 83 in the aspiration thrombectomy group and 43 cases in the stent retriever thrombectomy group. The change in NIHSS score from preoperative to immediate postoperative was 5 (1, 8) in the aspiration thrombectomy group and 1 (0, 4.5) in the stent retriever thrombectomy group. The change from preoperative to discharge was 8 (5, 12) in the aspiration thrombectomy group and 4 (0, 9) in the stent retriever thrombectomy group. The aspiration thrombectomy group exhibited significantly better prognosis rates and shorter time from successful femoral artery puncture to successful vessel recanalization. There were no significant differences between the two groups in terms of successful vessel recanalization rates and perioperative complications.ConclusionAs a first-line approach for anterior circulation large vessel cardiogenic cerebral embolism and cryptogenic stroke, aspiration thrombectomy leads to better improvement in neurological functional deficits and prognosis rates compared to stent retriever thrombectomy.

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.

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Safety and Efficacy of a 3-Dimensional Stent Retriever With Aspiration-Based Thrombectomy vs Aspiration-Based Thrombectomy Alone in Acute Ischemic Stroke Intervention: A Randomized Clinical Trial.

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