Dataset Information

First pass effect with contact aspiration and stent retrievers in the Aspiration versus Stent Retriever (ASTER) trial.

ABSTRACT:

Background

The 'first pass effect' (FPE), which was originally described with stent retrievers, designates a (near-)complete revascularization obtained after a single device pass with no rescue therapy, and is associated with improved clinical outcome and decreased mortality.

Objective

We report the rate and benefits of FPE in the Aspiration versus Stent Retriever (ASTER) trial.

Materials and methods

ASTER is a randomized trial comparing angiographic revascularization with the stent retriever (SR) and contact aspiration (CA) thrombectomy techniques, assessed by an external core laboratory using the modified Thrombolysis in Cerebral Infarction (mTICI) scale. Rates of FPE (defined by mTICI 2c/3 after a single pass with no rescue therapy) were compared between patients treated with SR and CA techniques. Outcomes were compared between FPE-SR and FPE-CA patients, and between FPE and non-FPE patients.

Results

FPE was achieved in 97/336 patients (28.9%), with no significant difference between SR and CA (respectively 53/169 patients (31.3%) vs 44/167 patients (26.3%), adjusted RR for CA versus SR 0.84, 95% CI 0.54 to 1.31; p=0.44). After prespecified adjustment for allocated arm and randomization stratification factors, FPE in patients was associated with a significantly improved clinical outcome and a decreased mortality, and a significantly lower rate of hemorrhagic transformation and procedural complications than in non-FPE patients.

Conclusion

In the ASTER trial, similar rates of FPE were achieved with SR and CA, and FPE was associated with a significantly improved outcome. New techniques and devices to improve the rate of FPE are warranted.

Trial registration number

Unique identifier: NCT02523261.

SUBMITTER: Ducroux C

PROVIDER: S-EPMC7146919 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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Publications

First pass effect with contact aspiration and stent retrievers in the Aspiration versus Stent Retriever (ASTER) trial.

Ducroux Célina C Piotin Michel M Gory Benjamin B Labreuche Julien J Blanc Raphael R Ben Maacha Malek M Lapergue Bertrand B Fahed Robert R

Journal of neurointerventional surgery 20190830 4

<h4>Background</h4>The 'first pass effect' (FPE), which was originally described with stent retrievers, designates a (near-)complete revascularization obtained after a single device pass with no rescue therapy, and is associated with improved clinical outcome and decreased mortality.<h4>Objective</h4>We report the rate and benefits of FPE in the Aspiration versus Stent Retriever (ASTER) trial.<h4>Materials and methods</h4>ASTER is a randomized trial comparing angiographic revascularization with ...[more]

PMID: 31471527

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Project description:BackgroundAlthough 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.MethodsWe 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.ResultsOf 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).ConclusionsFirst-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.

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.

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: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: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.

Dataset Information

First pass effect with contact aspiration and stent retrievers in the Aspiration versus Stent Retriever (ASTER) trial.

Background

Objective

Materials and methods

Results

Conclusion

Trial registration number

Publications

First pass effect with contact aspiration and stent retrievers in the Aspiration versus Stent Retriever (ASTER) trial.

Similar Datasets

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