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A randomized controlled trial to test efficacy and safety of thrombectomy in stroke with extended lesion and extended time window.

ABSTRACT: RATIONALE:The benefit of thrombectomy in patients with intracranial large vessel occlusion of the anterior circulation has been shown in selected patients in previous randomized controlled trials, but patients with extended ischemic lesions were excluded in the majority of these trials. TENSION aims to demonstrate efficacy and safety of thrombectomy in patients with extended lesions in an extended time window (up to 12?h from onset or from last seen well). DESIGN:TENSION is an investigator-initiated, randomized controlled, open label, blinded endpoint, European, two-arm, postmarket study to compare the safety and effectiveness of thrombectomy as compared to best medical care alone in stroke patients with extended stroke lesions defined by an Alberta Stroke Program Early Computed Tomography Scan score of 3-5 and in an extended time window. In an adaptive design study, up to 665 patients will be randomized. OUTCOMES:Primary efficacy endpoint will be clinical outcome defined by the modified Rankin Scale at 90-day poststroke. The main safety endpoint will be death and dependency (modified Rankin Scale 4-6) at 90 days. Additional effect measures include adverse events, health-related quality of life, poststroke depression, and costs utility assessment. DISCUSSION:TENSION may make effective treatment available for patients with severe stroke in an extended time window, thereby improving functional outcome and quality of life of thousands of stroke patients and reducing the individual, societal, and economic burden of death and disability resulting from severe stroke. TENSION is registered at ClinicalTrials.gov (ClinicalTrials.gov Identifier NCT03094715).

SUBMITTER: Bendszus M

PROVIDER: S-EPMC6604397 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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A randomized controlled trial to test efficacy and safety of thrombectomy in stroke with extended lesion and extended time window.

Bendszus Martin M Bonekamp Susanne S Berge Eivind E Boutitie Florent F Brouwer Patrick P Gizewski Elke E Krajina Antonin A Pierot Laurent L Randall Gary G Simonsen Claus Z CZ Zeleňák Kamil K Fiehler Jens J Thomalla Götz G

International journal of stroke : official journal of the International Stroke Society 20180829 1

<h4>Rationale</h4>The benefit of thrombectomy in patients with intracranial large vessel occlusion of the anterior circulation has been shown in selected patients in previous randomized controlled trials, but patients with extended ischemic lesions were excluded in the majority of these trials. TENSION aims to demonstrate efficacy and safety of thrombectomy in patients with extended lesions in an extended time window (up to 12 h from onset or from last seen well).<h4>Design</h4>TENSION is an inv ...[more]

PMID: 30156479

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Project description:ImportanceOnly limited data are available about a potential benefit associated with endovascular treatment (EVT) for patients with ischemic stroke presenting in the extended time window who also show signs of extensive infarction.ObjectiveTo assess the association of recanalization after EVT with functional outcomes for patients with ischemic stroke presenting in the extended time window who also show signs of extensive infarction.Design, setting, and participantsThis retrospective, multicenter cohort study included patients enrolled in the German Stroke Registry-Endovascular Treatment with an Alberta Stroke Program Early CT Score (ASPECTS) of 5 or less who presented between 6 and 24 hours after stroke onset and underwent computed tomography and subsequent EVT between July 1, 2015, and December 31, 2019.Main outcomes and measuresThe primary end point was a modified Rankin Scale (mRS) score of 3 or less at day 90. The association between recanalization (defined as the occurrence of a modified Thrombolysis in Cerebral Infarction Scale score of 2b or 3) and outcome was assessed using logistic regression and inverse probability weighting analysis.InterventionEndovascular treatment.ResultsOf 5853 patients, 285 (5%; 146 men [51%]; median age, 73 years [IQR, 62-81 years]) met the inclusion criteria and were analyzed. Of these 285 patients, 79 (27.7%) had an mRS score of 3 or less at day 90. The rate of successful recanalization was 75% (215 of 285) and was independently associated with a higher probability of reaching an mRS score of 3 or less (adjusted odds ratio, 4.39; 95% CI, 1.79-10.72; P < .001). In inverse probability weighting analysis, a modified Thrombolysis in Cerebral Infarction Scale score of 2b or 3 was associated with a 19% increase (95% CI, 9%-29%; P < .001) in the probability for an mRS score of 3 or more. Multivariable logistic regression analysis suggested a significant treatment benefit associated with vessel recanalization in a time window of up to 17.6 hours and ASPECTS of 3 to 5. The rate of secondary symptomatic intracerebral hemorrhage was 6.3% (18 of 285).Conclusions and relevanceIn this cohort study reflecting daily clinical practice, vessel recanalization for patients with a low ASPECTS and extended time window was associated with better functional outcomes in a time window up to 17.6 hours and ASPECTS of 3 to 5. The results of this study encourage current randomized clinical trials to enroll patients with a low ASPECTS, even within the extended time window.

Project description:Purpose: The Tonbridge stent is a novel retriever with several design improvements which aim to achieve promising flow reperfusion in the treatment of acute ischemic stroke (AIS). We conducted a randomized controlled, multicenter, non-inferiority trial to compare the safety and efficacy of the Tonbridge stent with the Solitaire FR. Methods: AIS patients aged 18-85 years with large vessel occlusion in anterior circulation who could undergo puncture within 6 h of symptom onset were included. Randomization was performed on a 1:1 ratio to thrombectomy with either the Tonbridge stent or the Solitaire FR. The primary efficacy endpoint was successful reperfusion using a modified thrombolysis in cerebral infarction score (mTICI) of 2b/3. Safety outcomes were symptomatic intracranial hemorrhage (sICH) within 24 ± 6 h and all-cause mortality within 90 days. A clinically relevant non-inferiority margin of 12% was chosen as the acceptable difference between groups. Secondary endpoints included time from groin puncture to reperfusion, National Institutes of Health Stroke Scale (NIHSS) score at 24 h and at 7 days, and a modified Rankin Scale (mRS) score of 0-2 at 90 days. Results: A total of 220 patients were enrolled; 104 patients underwent thrombectomy with the Tonbridge stent and 104 were treated with the Solitaire FR. In all test group patients, the Tonbridge was used as a single retriever without rescuing by other thrombectomy devices. Angioplasty with balloon and/or stent was performed in 26 patients in the Tonbridge group and 16 patients in the Solitaire group (p = 0.084). Before angioplasty, 86.5% of those in the Tonbridge group and 81.7% of those in the Solitaire group reached successful reperfusion (p = 0.343). Finally, more patients in the Tonbridge group achieved successful reperfusion (92.3 vs. 84.6%, 95% CI of difference value 0.9-16.7%, p < 0.0001). There were no significant differences on sICH within 24 ± 6 h between the two groups. All-cause mortality within 90 days was 13.5% in the Tonbridge group and 16.3% in the Solitaire group (p = 0.559). We noted no significant differences between groups on the NIHSS at either 24 h or 7 days and the mRS of 0-2 at 90 days. Conclusion: The trial indicated that the Tonbridge stent was non-inferior to the Solitaire FR within 6 h of symptom onset in cases of large vessel occlusion stroke. Clinical Trial Registration:ClinicalTrials.gov, number: NCT03210623.

Project description:ImportanceLimited data are available about the outcomes of mechanical thrombectomy (MT) for real-world patients with stroke presenting with a large core infarct.ObjectiveTo investigate the safety and effectiveness of MT for patients with large vessel occlusion and an Alberta Stroke Program Early Computed Tomography Score (ASPECTS) of 2 to 5.Design, setting, and participantsThis retrospective cohort study used data from the Stroke Thrombectomy and Aneurysm Registry (STAR), which combines the prospectively maintained databases of 28 thrombectomy-capable stroke centers in the US, Europe, and Asia. The study included 2345 patients presenting with an occlusion in the internal carotid artery or M1 segment of the middle cerebral artery from January 1, 2016, to December 31, 2020. Patients were followed up for 90 days after intervention. The ASPECTS is a 10-point scoring system based on the extent of early ischemic changes on the baseline noncontrasted computed tomography scan, with a score of 10 indicating normal and a score of 0 indicating ischemic changes in all of the regions included in the score.ExposureAll patients underwent MT in one of the included centers.Main outcomes and measuresA multivariable regression model was used to assess factors associated with a favorable 90-day outcome (modified Rankin Scale score of 0-2), including interaction terms between an ASPECTS of 2 to 5 and receiving MT in the extended window (6-24 hours from symptom onset).ResultsA total of 2345 patients who underwent MT were included (1175 women [50.1%]; median age, 72 years [IQR, 60-80 years]; 2132 patients [90.9%] had an ASPECTS of ≥6, and 213 patients [9.1%] had an ASPECTS of 2-5). At 90 days, 47 of the 213 patients (22.1%) with an ASPECTS of 2 to 5 had a modified Rankin Scale score of 0 to 2 (25.6% [45 of 176] of patients who underwent successful recanalization [modified Thrombolysis in Cerebral Ischemia score ≥2B] vs 5.4% [2 of 37] of patients who underwent unsuccessful recanalization; P = .007). Having a low ASPECTS (odds ratio, 0.60; 95% CI, 0.38-0.85; P = .002) and presenting in the extended window (odds ratio, 0.69; 95% CI, 0.55-0.88; P = .001) were associated with worse 90-day outcome after controlling for potential confounders, without significant interaction between these 2 factors (P = .64).Conclusions and relevanceIn this cohort study, more than 1 in 5 patients presenting with an ASPECTS of 2 to 5 achieved 90-day functional independence after MT. A favorable outcome was nearly 5 times more likely for patients with low ASPECTS who had successful recanalization. The association of a low ASPECTS with 90-day outcomes did not differ for patients presenting in the early vs extended MT window.

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A randomized controlled trial to test efficacy and safety of thrombectomy in stroke with extended lesion and extended time window.

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A randomized controlled trial to test efficacy and safety of thrombectomy in stroke with extended lesion and extended time window.

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