https://ogma.newcastle.edu.au/vital/access/ /manager/Index ${session.getAttribute("locale")} 5 Impact of computed tomography perfusion imaging on the response to tenecteplase in ischemic stroke: analysis of 2 randomized controlled trials https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:33102 15 mL, mismatch ratio > 1.8, baseline ischemic core < 70 mL, and volume of severely hypoperfused tissue < 100 mL). Patients meeting target mismatch criteria were analyzed as a subgroup to identify whether they had different treatment responses from the pooled group. Results: Of 146 pooled patients, 71 received alteplase and 75 received tenecteplase. Tenecteplase-Treated patients had greater early clinical improvement (median National Institutes of Health Stroke Scale score change: Tenecteplase, 7; alteplase, 2; P=0.018) and less parenchymal hematoma (2 of 75 versus 10 of 71; P=0.02). The pooled group did not show improved patient outcomes when treated with tenecteplase (modified Rankin scale score 0-1: odds ratio, 1.77; 95% confidence interval, 0.89-3.51; P=0.102) compared with alteplase therapy. However, in patients with target mismatch (33 tenecteplase, 35 alteplase), treatment with tenecteplase was associated with greater early clinical improvement (median National Institutes of Health Stroke Scale score change: Tenecteplase, 6; alteplase, 1; P < 0.001) and better late independent recovery (modified Rankin scale score 0-1: odds ratio, 2.33; 95% confidence interval, 1.13-5.94; P=0.032) than those treated with alteplase. Conclusions: Tenecteplase may offer an improved efficacy and safety profile compared with alteplase, benefits possibly exaggerated in patients with baseline computed tomography perfusion-defined target mismatch. Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01472926. URL: https://www.anzctr.org.au. Unique identifier: ACTRN12608000466347.]]> Wed 19 Jan 2022 15:18:46 AEDT ]]> Comparing mismatch strategies for patients being considered for ischemic stroke tenecteplase trials https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:38851  15 mL, mismatch ratio > 1.8 and ischemic core < 70 mL). We then investigated whether tenecteplase-treated patients had favorable odds of less disability (on modified Rankin scale, mRS) compared to those treated with alteplase, for clinical and imaging mismatch, respectively. Results: From 146 pooled patients, 71 received alteplase and 75 received tenecteplase. The overall pooled group did not show improved patient outcomes when treated with tenecteplase (mRS 0-1 OR 1.77, 95% CI 0.89–3.51, p = 0.102) compared with alteplase. A total of 39 (27%) patients met both clinical and imaging mismatch criteria, 25 (17%) patients met only imaging criteria, 36 (25%) met only clinical mismatch criteria and, finally, 46 (31%) did not meet either of imaging or mismatch criteria. Patients treated with tenecteplase had more favorable outcomes when they met either imaging mismatch (mRS 0–1, OR 2.33, 95% CI 1.13–5.94, p = 0.032) or clinical mismatch criteria (mRS 0–1, OR 2.15, 95% CI 1.142, 8.732, p = 0.027) but with differing proportions. Conclusion: Target mismatch selection was more inclusive and exhibited in a larger treatment effect between tenecteplase and alteplase.]]> Wed 16 Feb 2022 15:17:26 AEDT ]]> Safety and efficacy of sonothrombolysis for acute ischaemic stroke: a multicentre, double-blind, phase 3, randomised controlled trial https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:41919 Tue 16 Aug 2022 11:00:51 AEST ]]> Acute stroke imaging research roadmap III imaging selection and outcomes in acute stroke reperfusion clinical trials: consensus recommendations and further research priorities https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:25015 Thu 28 Oct 2021 13:02:55 AEDT ]]> Acute stroke imaging research roadmap II https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:19652 12 months, with the final meeting occurring during the Stroke Treatment Academy Industry Roundtable (STAIR) on March 9 to 10, 2013, in Washington, DC. This process brought together vascular neurologists, neuroradiologists, neuroimaging research scientists, members of the National Institute of Neurological Disorders and Stroke, industry representatives, and members of the US Food and Drug Administration to discuss stroke imaging research priorities, especially in the light of the recent negative results of acute stroke clinical trials that tested the concept of penumbral imaging selection. The goal of this process was to propose a research roadmap for the next 5 years. STIR recommendations include (1) the use of standard terminology, aligned with the National Institute of Neurological Disorders and Stroke Common Data Elements. ; (2) a standardized imaging assessment of revascularization in acute ischemic stroke trials, including a modified Treatment In Cerebral Ischemia (mTICI) score. ; (3) a standardized process to assess whether ischemic core and penumbral imaging methods meet the requirements to be considered as an acceptable selection tool in acute ischemic stroke trials. ; (4) the characteristics of a clinical and imaging data repository to facilitate the development and testing process described in recommendation no. 3. ; (5) the optimal study design for a clinical trial to evaluate whether advanced imaging adds value in selecting acute ischemic stroke patients for revascularization therapy. ; (6) the structure of a stroke neuroimaging network to implement and coordinate the recommendations listed above. All of these recommendations pertain to research, not to clinical care.]]> Thu 28 May 2020 06:30:04 AEST ]]> Tenecteplase in ischemic stroke offers improved recanalization https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:33105 Thu 17 Mar 2022 14:41:28 AEDT ]]> Tenecteplase versus alteplase in stroke thrombolysis: an individual patient data meta-analysis of randomized controlled trials https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:25490 Thu 17 Mar 2022 14:34:05 AEDT ]]> Endovascular equipoise shift in a phase III randomized clinical trial of sonothrombolysis for acute ischemic stroke https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:36545 post hoc analysis after excluding subjects that were recruited at centers reporting a decline in the balance of randomization between sonothrombolysis and concurrent endovascular trials. Results: From a total of 676 participants randomized in the CLOTBUST-ER trial we identified 52 patients from 7 centers with perceived equipoise shift in favor of endovascular treatment. Post hoc sensitivity analysis in the intention-to-treat population adjusted for age, National Institutes of Health Scale score at baseline, time from stroke onset to tPA bolus and baseline serum glucose showed a significant (p < 0.01) interaction of perceived endovascular equipoise shift on the association between sonothrombolysis and 3 month functional outcome [adjusted common odds ratio (cOR) in centers with perceived endovascular equipoise shift: 0.22, 95% CI 0.06–0.75; p = 0.02; adjusted cOR for centers without endovascular equipoise shift: 1.20, 95% CI 0.89–1.62; p = 0.24)]. After excluding centers with perceived endovascular equipoise shift, patients randomized to sonothrombolysis had higher odds of 3 month functional independence (mRS scores 0–2) compared with patients treated with tPA only (adjusted OR: 1.53; 95% CI 1.01–2.31; p = 0.04). Conclusion: Our experience in CLOTBUST-ER indicates that increasing implementation of endovascular therapies across major academic stroke centers raises significant challenges for clinical trials aiming to test noninterventional or adjuvant reperfusion strategies.]]> Thu 09 Dec 2021 11:02:10 AEDT ]]> EPITHET: positive result after reanalysis using baseline diffusion-weighted imaging/perfusion-weighted imaging co-registration https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:17780 1.2 and total coregistered mismatch volume was ≥10 mL. The primary outcome was a comparison of infarct growth in alteplase vs placebo patients with coregistered mismatch. Of 99 patients with baseline diffusion-weighted imaging and perfusion-weighted imaging, coregistration of both images was possible in 95 patients. Coregistered mismatch was present in 93% (88/95) compared to 85% (81/95) with standard volumetric mismatch. In the coregistered mismatch patients, of whom 45 received alteplase and 43 received placebo, the primary outcome measure of geometric mean infarct growth was significantly attenuated by a ratio of 0.58 with alteplase compared to placebo (1.02 vs 1.77; 95% CI, 0.33–0.99; P=0.0459). When using coregistration techniques to determine the presence of mismatch at study entry, alteplase significantly attenuated infarct growth. This highlights the necessity for a randomized, placebo-controlled, phase III clinical trial of alteplase using penumbral selection beyond 3 hours.]]> Sat 24 Mar 2018 07:57:41 AEDT ]]> Blood pressure excursions in acute ischemic stroke patients treated with intravenous thrombolysis https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:46103 185/105 mmHg) during the first 24 h following tPA-bolus. The majority of BP excursions (46%) occurred within the first 75 min from tPA-bolus. Patients with at least one BP excursion in the first 24 h following tPA bolus had significantly lower rates of independent functional outcome at 90 days (31 vs. 40.1%, P = 0.028). The total number of BP excursions was associated with decreased odds of 24-h clinical recovery (OR = 0.88, 95% CI:0.80–0.96), 24-h neurological improvement (OR = 0.87, 95% CI: 0.81–0.94), 7-day functional improvement (common OR = 0.92, 95% CI: 0.87–0.97), 90-day functional improvement (common OR = 0.94, 95% CI: 0.88–0.98) and 90-day independent functional outcome (OR = 0.90, 95% CI: 0.82–0.98) in analyses adjusted for potential confounders. DBP excursions were independently associated with increased odds of any intracranial hemorrhage (OR = 1.26, 95% CI: 1.04–1.53). Conclusion: BP excursions above guideline thresholds during the first 24 h following tPA administration for AIS are common and are independently associated with adverse clinical outcomes.]]> Fri 11 Nov 2022 15:33:52 AEDT ]]>