Randomized assessment of rapid endovascular treatment of ischemic stroke. Stroke advocates the adoption of these 12 key best practice strategies for reducing doortodevice times for endovascular therapy in acute ischemic stroke. Does endovascular thrombectomy benefit acute ischemic stroke. In the phase 3 escape trial, 316 patients with ischemic stroke who had a large artery occlusion were randomly assigned to standard medical care, including tissue plasminogen activator tpa where. The escapena1 trial is a multicentre, randomized, doubleblinded, placebocontrolled, parallel group, singledose design to determine the efficacy and safety of intravenous na1 in subjects with acute ischemic stroke undergoing endovascular thrombectomy. Evaluation study of congestive heart failure and pulmonary. Endovascular thrombectomy for stroke at 6 to 16 hours in this trial in patients with stroke who had a mismatch between sizes of early infarction and a hypoperfused brain region, endovascular thromb. Nct01429350 was an international, multicenter, prospective, randomized 1. A multicenter randomized controlled trial of endovascular therapy following imaging evaluation for ischemic stroke defuse 3 gregory w albers, maarten g lansberg, stephanie kemp, jenny p tsai, phil lavori, soren christensen, michael mlynash, sun kim, scott hamilton, sharon d yeatts, yuko palesch, roland bammer, joe broderick, and michael p. Thrace is a randomised controlled trial done in 26 centres in france. Improving reperfusion time within the escape endovascular. Thrombectomy 6 to 24 hours after stroke with a mismatch. Installation of adobe acrobat pro dc trial by default uninstalls any earlier version of adobe acrobat on windows devices.
Consistent trial evidence has answered this need in an. Oct 05, 2005 evaluation study of congestive heart failure and pulmonary artery catheterization effectiveness. Dcns research escapena1 cumming school of medicine. These findings will have global implications on structuring systems of care to provide timely treatment to patients with acute ischaemic stroke due to large vessel occlusion. Endovascular thrombectomy improves outcome for acute ischemic stroke patients with large artery anterior circulation strokes, when performed within 6 hours of stroke onset. The interim analysis showed a high likelihood of benefit in the endovascular group of the study. Efficacy and safety of nerinetide for the treatment of. Endovascular treatment for small core and proximal occlusion. The primary objective is to determine the efficacy of the neuroprotectant, na1, in reducing global disability in subjects with major acute ischemic stroke ais with a small established infarct core and with good collateral circulation selected for rapid endovascular revascularization. Escape the endovascular treatment for small core and. The escape trial enrolled 433 patients hospitalized with advanced hf at 26 sites in the u. Escape is the second evt trial that demonstrates the efficacy of the treatment and the first trial to demonstrate reduced mortality. Endovascular treatment for small core and proximal.
Aspiration thrombectomy after intravenous alteplase versus. The escape trial sought to prove that selected patients using ct and cta with rapid endovascular treatment using modern endovascular techniques is an e. Pdf extension of stroke care by added neuroprotection to. The design, primary end points, and results of the escape trial have been previously published. The clinical trial, known as escape endovascular treatment for small core and anterior.
Randomized assessment of rapid endovascular treatment ischemic stroke published february 11, 2015 trial was stopped early because of efficacy 316 patients with proximal large vessel occlusion lvo and good collateral circulation confirmed by cta were randomized to endovascular intervention n165 or medical management. The primary objectives of this study are to show that rapid endovascular revascularization amongst radiologically selected small coreproximal occlusion patients with ischemic stroke results in improved outcome compared to patients treated in clinical routine. Caprie was a randomised, blinded, international trial designed to assess the relative efficacy of clopidogrel 75 mg once daily and aspirin 325 mg once daily in reducing the risk of a composite outcome cluster of ischaemic stroke, myocardial infarction, or vascular death. Defuse 3 terminated early with high likelihood of benefit. Endovascular tx reduces mortality in ischemic stroke.
The escape trial,3 a multicenter randomized controlled academic trial, screened subjects fulfilling clinical eligibility criteria if they presented within 12hours of stroke symptom onset and included them only if they met prespecified neurovascular imaging criteria. Jan 29, 20 escape is a phase 3, randomized, openlabel with blinded outcome evaluation, controlled, parallel group design. Md, principle investigator, about the results of the. Factors that distinguish the escape trial from mr clean and prior trials of endovascular treatment for stroke include the use of imaging to exclude participants with a large infarct core and poor. The evaluation study of congestive heart failure and correction contact me if this article is corrected. The sponsor of the trial was the governors of the university of calgary. Jovin and nogueiras dawnrelated travel expenses were covered by stryker neurovascular for the duration of trial. Pdf comparative effectiveness of endovascular treatment. We examined actual daily healthcare utilization from stroke onset to 1 year afterward from the escape trial endovascular treatment for small core and anterior circulation proximal occlusion with. Factors that distinguish the escape trial from mr clean and prior trials of endovascular treatment for stroke include the use of imaging to exclude participants with a. The escape investigators and escape study coordinators escape trial pulmonary artery catheterization effectiveness. Background and purposeordinal outcomes, such as modified rankin scale mrs, are the standard primary end points in acute stroke trials.
Professor of neurology and neurosurgery director, upmc stroke institute director upmc center for neuroendovascular therapy university of pittsburgh medical center. Among patients with acute ischemic stroke with a proximal vessel occlusion, a small infarct core, and moderatetogood collateral circulation, rapid endovascular treatment improved functional outcomes and reduced mortality. Previous randomized trials that involved patients with acute stroke 16 showed that endovascular thrombectomy had. The endovascular treatment for small core and anterior circulation proximal occlusion with emphasis on minimizing ct to recanalization times escape trial seeks to prove that rapid endovascular therapy using modern endovascular techniques primarily using stentrievers is an efficacious treatment for patients with acute ischemic stroke. Randomized assessment of rapid endovascular treatment of. It is adapted from the ontario endovascular treatment implementation framework created by the provincial working group for evt treatment. Triage after hospitalization with advanced heart failure. Mechanical thrombectomy in acute ischemic stroke boris. The primary endpoint, the modified rankin score, will be assessed at 3 months.
Endovascular thrombectomy for acute ischemic stroke. A multicenter randomized controlled trial of endovascular. Apr 07, 2020 initiated in response to concerns regarding the safety and efficacy of pac use, the evaluation study of congestive heart failure and pulmonary artery catheterization effectiveness escape trial is the first large, multicenter, randomized clinical trial designed to evaluate the use of the pac in hf patients study design. Endovascular thrombectomy beyond 12 hours of stroke onset. Pdf comparative effectiveness of endovascular treatment for. Methodstherapy the randomized, concurrent controlled trial to assess the penumbra systems safety and effectiveness in the treatment of acute stroke. Escape is a prospective, multicenter, randomized clinical trial that will enroll subjects with the following main inclusion criteria. Dawn study main results dwi or ctp assessment with clinical mismatch in the triage of wakeup and late presenting strokes undergoing neurointervention with trevo tudor g. Binanay c1, califf rm, hasselblad v, oconnor cm, shah mr, sopko g, stevenson lw, francis gs, leier cv, miller lw. Mechanical thrombectomy trials in acute ischemic stroke. The procedure, evt, involves mechanical clot disruption embolectomy carried out by neuroradiologists, neurosurgeons, or neurologists with neurointerventional expertise.
Na1 clinical trial study newsleer issue 3, march 2018. The escape trial was funded by a consortium with grants to the university of calgary from covidien, the university of calgary hotchkiss brain institute, the department of clinical neurosciences and calgary stroke program, and the department of radiology, alberta innovateshealth solutions, the heart and stroke foundation of canada, and. Endovascular therapy following imaging evaluation for. The purpose of this report was to describe the use of a quality improvement process within an endovascular stroke trial and to assess the impact of our quality. The escape trial william fox, md current ischemic stroke management in the ed primarily centers on selective and effective administration of alteplase also known as tpa to eliminate intraarterial thrombi. The lancet, 14 march 2020, volume 395, issue 10227, pages. The recent revascat trial randomized trial of revascularization with solitaire fr device versus best medical therapy in the treatment of acute stroke due to anterior circulation large vessel occlusion presenting within 8 hours of symptom onset 1 is the latest of 5 published prospective randomized open blinded endpoint probedesigned trials. In the escape trial, 316 patients who fit the criteria for evt and arrived for treatment. Evaluation study of congestive heart failure and pulmonary artery catheterization effectiveness. The tempo1 trial tnktpa versus standard of care for minor ischemic stroke with proven occlusion was a pilot study examining thrombolysis of milder stroke patients with intracranial occlusion using tenecteplase.
Endovascular thrombectomy after largevessel ischaemic. Indepth analysis of latebreaking science oral abstracts from the international stroke convention 2015. In summary, this trial found that endovascular thrombectomy reduces disability and improves functional recovery when performed 6 to 24 hours after onset of stroke symptoms among patients with a clinical deficit that is disproportionate to infarct volume. Effect size estimates for the escape trial stroke aha journals. Endovascular treatment for small core and proximal occlusion ischemic stroke escape, solitaire fr as primary treatment for acute ischemic stroke swift prime and extending the time for thrombolysis in emergency. Although we did not observe a treatment benefit of nerinetide for the primary outcome in. Recent and current trials wakeup study currently enrolling wakeup is a european multicentre investigatorinitiated randomized placebocontrolled clinical trial of mri based thrombolysis in acute stroke patients with unknown time of symptom onset, e. However, a number of studies produced after the initial studies supporting use of tpa in ischemic. The official escape trial sponsor was the governors of the university of calgary with grants from a consortium. Added value of this study to our knowledge, the escapena1 trial is the first large trial of any neuroprotectant agent in the setting of human ischaemiareperfusion.
Download acrobat pdf file 4mb supplementary appendix. Methodstherapy the randomized, concurrent controlled trial to assess the. Stroke phase i and ii key best practice strategies for rapid assessment. Endovascular treatment evt resource centre corhealth. This trial provides evidence for offering endovascular thrombectomy up to 24 hours after onset. With this information in mind, the investigators of the wakeup stroke trial investigated whether patients with acute ischemic stroke who were last seen well more than 4. The five clinical trials included in the metaanalysis predominantly randomized. Escape was a well designed prospective, multicenter, clinical trial involving 350 patients with acute ischemic stroke due to a proximal occlusion of the anterior circulation who were randomized to either receive usual care or endovascular therapy endovascular thrombectomy or thrombolysis plus usual care. Backgroundwe aimed to assess the safety and efficacy of thrombectomy for the treatment of stroke in a trial embedded within a populationbased stroke. Among patients with acute ischemic stroke with a proximal vessel occlusion, a small infarct core, and.
Since then, two other trials evaluating endovascular interventions escape endovascular treatment for small core and proximal occlusion ischemic stroke and extend ia extending the time for. Extension of stroke care by added neuroprotection to endovascular treatment escapena1 trial. Mechanical thrombectomy is now the gold standard for acute. Efficacy and safety of nerinetide for the treatment of acute. Defuse 3 endovascular therapy following imaging evaluation for ischemic stroke 3 is. Technical endovascular management and clinical outcomes from the escape trial.
Efficacy and safety of nerinetide for the treatment of acute ischaemic stroke escape na1. Efficacy and safety of nerinetide for the treatment of acute ischaemic stroke escapena1. If you choose to retain the existing acrobat software on your machine, change the default by unchecking the remove earlier version option in acrobat downloader ui. We examined actual daily healthcare utilization from stroke onset to 1 year afterward from the escape trial endovascular treatment for small core and. Mechanical thrombectomy is now the gold standard for acute ischemic stroke. Endovascular thrombectomy is of benefit to most patients with acute ischaemic stroke caused by occlusion of the proximal anterior circulation, irrespective of patient characteristics or geographical location. Clean multi center randomized clinical trial of endovascular treatment for acute ischemic stroke in the netherlands, was published in december 2014. Minimizing ct to recanalization times escape trial was designed to test whether patients with acute ischemic stroke, who were selected on.
Clinical trial of endovascular treatment for acute ischemic stroke in the netherlands. Added value of this study to our knowledge, the escape na1 trial is the first large trial of any neuroprotectant agent in the setting of human ischaemiareperfusion. Advances in endovascular therapy for ischemic stroke. In these trials, patients with acute ischaemic stroke caused by occlusion of the proximal anterior artery circulation were randomly. Escape investigators and escape study coordinators.
Methods we formed the hermes collaboration to pool patientlevel data from. Following an interim analysis of data from the first 182 patients enrolled in defuse 3, the trial has been terminated and is no longer actively enrolling patients. Conclusions respondents generally disagreed with the use of deferred consent for enrollment in the escape trial and in stroke trials more generally. The escape trial revealed that a procedure called endovascular therapy evt increased positive outcomes by 25% and reduced the death rate by 50% from major ischemic strokes. Thrombectomy for stroke at 6 to 16 hours with selection by. Endovascular treatment in the defuse 3 study stroke. The merci retriever was the first thrombectomy device to receive us food and drug administration approval in 2004 43 and was widely used in early trials evaluating endovascular treatments for acute ischemic stroke, including synthesis, 26 mr rescue, 27 and ims iii. Evaluation of interval times from onset to reperfusion in patients undergoing endovascular therapy in the interventional management of stroke iii trial. Thrombectomy within 8 hours after symptom onset in. An overview of the new class i evidence supporting intraarterial treatment for acute ischemic stroke. Defuse 3 is a prospective randomized phase iii multicenter controlled trial of patients with acute ischemic anterior circulation strokes due to large artery occlusion treated between 616 hours of stroke onset with endovascular thrombectomy therapy vs.
Michael d hill, mayank goyal, bijoy k menon, raul g nogueira, ryan a mctaggart, andrew m demchuk, alexandre y poppe, brian h buck, thalia s field, dar dowlatshahi, brian a van adel, richard h. Endovascular treatment evt resource centre this resource centre provides health system planners and clinicians with tools and resources to support implementation of evt. Previous randomized trials that involved patients with acute stroke 16 showed that endovascular thrombectomy had a clinical benefit when it was. Endovascular treatment evt resource centre corhealth ontario. Safety and efficacy of na1 in subjects undergoing endovascular thrombectomy for stroke escapena1 the goal of the trial is to evaluate the efficacy and safety of nerinetide na1 in patients with ais with small core infarct and good collaterals undergoing endovascular thrombectomy evt. A randomised, blinded, trial of clopidogrel versus aspirin. Endovascular treatment for small core and anterior. Patients aged 1880 years with acute ischaemic stroke and proximal cerebral artery occlusion were randomly assigned to receive either intravenous thrombolysis alone ivt group or intravenous thrombolysis plus mechanical thrombectomy ivtmt group.
247 488 719 1397 116 939 860 910 1019 1403 62 911 445 1249 598 74 520 658 312 982 383 825 1100 847 928 1253 843 1057 881 1463 613 1217 1378 1489 1037 609 1099 337 325 695 1005 422 590