TENECTEPLASE IN ISCHEMIC STROKE OFFERS IMPROVED RECANALISATION: ANALYSIS OF TWO RANDOMIZED TRIALS

Author(s):  
Andrew Bivard
Stroke ◽  
2014 ◽  
Vol 45 (suppl_1) ◽  
Author(s):  
Freidrich Medlin ◽  
Michael Amiguet ◽  
Peter Vanacker ◽  
Patrik Michel

Objective: We aimed to assess effectiveness of intravenous thrombolysis (IVT) for acute ischemic stroke (AIS) depending on the presence or absence of cervical or intracranial arterial occlusion on acute CT angiography (CTA). Methods: Patients from the Acute STroke Registry and Analysis of Lausanne (ASTRAL) were included in the analysis if they had an onset-to-door-time ≤ 4hours, CTA within 24 hours of onset, premorbid modified Rankin scale (mRS) ≤ 2, and a National Institute of Health Stroke Scale score (NIHSS) >4. Patients having significant intracranial stenosis (50-99%) or receiving endovascular treatment were excluded. The primary outcome was a 3 month handicap of mRS >2. We used an interaction analysis of IVT and initial arterial occlusion after adjusting for potential confounders for the primary outcome. Results: Of 655 included patients, 382 patients (58%) showed arterial occlusion, of whom 263 (69%) received IVT. Of the 273 patients without arterial occlusion, 139 (51%) received IVT. In patients with initial arterial occlusion and after multiple adjustments, IVT was associated with lower likelihood of unfavourable outcome (adjusted OR 0.33, 95% CI 0.12-0.91, p=0.03) whereas it had no significant effect in non-occluded patients (OR 1.32, 95% CI 0.36-4.76, p=0.67). Similarly, the presence of arterial occlusion did not significantly worsen the outcome in thrombolysed patients (OR 1.99, 95% CI 0.68-5.81, p=0.21), whereas it did so in non-thrombolysed patients (OR 7.89, 95% CI 2.29-27.25, p<0.01). Conclusions: IVT for AIS is more effective in the setting of visible arterial occlusions on acute imaging. If confirmed in other studies, this information may influence thrombolysis decisions and planning of further randomized trials. Classification of evidence: This retrospective analysis provides class III evidence that IVT has less benefit in patients without visible occlusion on acute CTA.


2014 ◽  
Vol 36 (1) ◽  
pp. E5 ◽  
Author(s):  
Maxim Mokin ◽  
Alexander A. Khalessi ◽  
J Mocco ◽  
Giuseppe Lanzino ◽  
Travis M. Dumont ◽  
...  

Various endovascular intraarterial approaches are available for treating patients with acute ischemic stroke who present with severe neurological deficits. Three recent randomized trials—Interventional Management of Stroke (IMS) III, Mechanical Retrieval and Recanalization of Stroke Clots Using Embolectomy (MR RESCUE), and Synthesis Expansion: A Randomized Controlled Trial on Intra-Arterial Versus Intravenous Thrombolysis in Acute Ischemic Stroke (SYNTHESIS Expansion)—evaluated the efficacy of endovascular treatment of acute ischemic stroke and, after failing to demonstrate any significant clinical benefit of endovascular therapies, raised concerns and questions in the medical community regarding the future of endovascular treatment for acute ischemic stroke. In this paper, the authors review the evolution of endovascular treatment strategies for the treatment of acute stroke and provide their interpretation of findings and potential limitations of the three recently published randomized trials. The authors discuss the advantage of stent-retriever technology over earlier endovascular approaches and review the current status and future directions of endovascular acute stroke studies based on lessons learned from previous trials.


2018 ◽  
Vol 11 (3) ◽  
pp. 226-231 ◽  
Author(s):  
Peter Schramm ◽  
Pedro Navia ◽  
Rosario Papa ◽  
Joaquin Zamarro ◽  
Alejandro Tomasello ◽  
...  

Background and purposeThe recent randomized trials demonstrated the benefit of mechanical thrombectomy in stroke therapy. However, treatment using different strategies is an ongoing area of investigation. The PROMISE study analyzed the safety and effectiveness of the Penumbra System with the ACE68 and ACE64 reperfusion catheters in aspiration thrombectomy of stroke, using A Direct Aspiration First Pass Technique (ADAPT).MethodsPROMISE was a prospective study which enrolled 204 patients with intracranial anterior circulation large vessel occlusion (LVO) ischemic stroke in 20 centers from February 2016 to May 2017. Initial treatment was with the ACE68/ACE64 catheters within 6 hours of symptom onset. Imaging and safety review was performed by an independent Core Laboratory and a Clinical Events Committee. The primary angiographic outcome was revascularization to mTICI 2b-3 at immediate post-procedure and the primary clinical outcome was 90-day modified Rankin Scale (mRS) score ≤2. Safety assessment included device- and procedure-related serious adverse events (SAEs), symptomatic intracranial hemorrhage (sICH), mortality, and embolization of new territory (ENT).ResultsEnrolled patients had a median age of 74 (IQR 65–80) years and a median admission NIHSS of 16 (IQR 11–20). The post-procedure mTICI 2b-3 revascularization rate was 93.1% and the 90-day mRS 0–2 rate was 61%. Device- and procedure-related SAEs at 24 hours occurred in 1.5% and 3.4%, respectively, 90-day mortality was 7.5%, sICH occurred in 2.9% while ENT occurred in 1.5%.ConclusionsFor frontline therapy of LVO stroke, the ACE68/ACE64 catheters for aspiration thrombectomy were found to be safe and showed similar efficacy to randomized trials using other revascularization techniques.Clinical Trial RegistrationNCT02678169; Pre-results.


Author(s):  
RV McDonough ◽  
P Cimflova ◽  
N Kashani ◽  
JM Ospel ◽  
M Kappelhof ◽  
...  

Background: There are no recommendations regarding endovascular treatment (EVT) for patients with acute ischemic stroke (AIS) due to primary medium vessel occlusion (MeVO). The aim of this study was to examine the willingness to perform EVT among stroke physicians in patients with mild, yet personally-disabling deficits due to MeVO. Methods: In an international survey consisting of 4 cases of primary MeVOs, participants were asked whether the presence of personally-disabling deficits would influence their decision-making for EVT despite the patients having low NIHSS scores. Decision rates were calculated based on physician characteristics. Clustered univariable logistic regression was performed. Results: 366 participants from 44 countries provided 2562 answers. 56.9% opted to perform EVT in scenarios in which the deficit was relevant to the patient’s profession versus 41.0% in which no information regarding patient profession was provided (RR1.39, p<0.001). The largest effect sizes were seen for female participants (RR1.68, 95%CI:1.35-2.09), participants >60 years (RR1.61, 95%CI:1.23-2.10), with more neurointervention experience (RR1.60, 95%CI:1.24-2.06), and who personally performed >100 EVTs per year (RR1.63, 95%CI:1.22-2.17). Conclusions: The presence of a patient-relevant deficit in low NIHSS AIS due to MeVO is an important factor for EVT decision-making. This may have relevance for the conduct and interpretation of low NIHSS EVT randomized trials.


Author(s):  
Ji Y. Chong ◽  
Michael P. Lerario

Intravenous tissue plasminogen activator (IV tPA) is the mainstay of stroke therapy and is US Food and Drug Administration-approved for the treatment of acute ischemic stroke. Its benefit on functional outcome has been established in multiple randomized trials when administered within 3 hours. Select patients may be treated off-label up to 4.5 hours from symptom onset. Eligibility criteria need to be reviewed carefully to optimize benefit and to minimize complications, namely reperfusion hemorrhage.


2019 ◽  
pp. neurintsurg-2018-014569 ◽  
Author(s):  
Guillaume Turc ◽  
Pervinder Bhogal ◽  
Urs Fischer ◽  
Pooja Khatri ◽  
Kyriakos Lobotesis ◽  
...  

BackgroundMechanical thrombectomy (MT) has become the cornerstone of acute ischemic stroke management in patients with large vessel occlusion (LVO).ObjectiveTo assist physicians in their clinical decisions with regard toMT.MethodsThese guidelines were developed based on the standard operating procedure of the European Stroke Organisation and followed the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach. An interdisciplinary working group identified 15 relevant questions, performed systematic reviews and meta-analyses of the literature, assessed the quality of the available evidence, and wrote evidence-based recommendations. Expert opinion was provided if not enough evidence was available to provide recommendations based on the GRADE approach.ResultsWe found high-quality evidence to recommend MT plus best medical management (BMM, including intravenous thrombolysis whenever indicated) to improve functional outcome in patients with LVO-related acute ischemic stroke within 6 hours after symptom onset. We found moderate quality of evidence to recommend MT plus BMM in the 6–24h time window in patients meeting the eligibility criteria of published randomized trials. These guidelinesdetails aspects of prehospital management, patient selection based on clinical and imaging characteristics, and treatment modalities.ConclusionsMT is the standard of care in patients with LVO-related acute stroke. Appropriate patient selection and timely reperfusion are crucial. Further randomized trials are needed to inform clinical decision-making with regard tothe mothership and drip-and-ship approaches, anesthaesia modalities during MT, and to determine whether MT is beneficial in patients with low stroke severity or large infarct volume.


CJEM ◽  
2001 ◽  
Vol 3 (03) ◽  
pp. 180-182
Author(s):  
Michael D. Hill ◽  
Gordon J. Gubitz ◽  
Stephen J. Phillips ◽  
Alastair M. Buchan

The cautiously-worded Position Statement recently issued by the Canadian Association of Emergency Physicians (see Appendix 1) regarding the use of intravenous recombinant tissue-plasminogen activator (tPA, alteplase) for acute ischemic stroke underscores the reality that many physicians in Canada have been reluctant to embrace this therapy. Much of the caution expressed in the CAEP document is related to 2 major areas of concern: evidence of efficacy (i.e., did tPA really “prove” itself in randomized trials?) and effectiveness (i.e., are the trial results generalizable to everyday practice?). While we support the development of documents that help to clarify controversial treatments, and agree with much of what is presented in the CAEP Position Statement, we offer the following comments.


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