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Recanalisation therapies for wake-up stroke.

ABSTRACT: BACKGROUND:About one in five strokes occur during sleep (wake-up stroke). People with wake-up strokes have traditionally been considered ineligible for thrombolytic treatment because the time of stroke onset is unknown. However, some studies suggest that these people may benefit from recanalisation therapies. OBJECTIVES:To assess the effects of intravenous thrombolysis and other recanalisation therapies versus control in people with acute ischaemic stroke presenting on awakening. SEARCH METHODS:We searched the Cochrane Stroke Group Trials Register (last search: 9 January 2018). In addition, we searched the following electronic databases in December 2017: Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 11) in the Cochrane Library, MEDLINE, Embase, US National Institutes of Health Ongoing Trials Register ClinicalTrials.gov, World Health Organization International Clinical Trials Registry Platform (WHO ICTRP), the ISRCTN registry, and Stroke Trials Registry. We also screened references lists of relevant trials, contacted trialists, undertook forward tracking of relevant references, and contacted manufacturers of relevant devices and equipment. SELECTION CRITERIA:Randomised controlled trials of intravenous thrombolytic drugs or intra-arterial therapies in people with acute ischaemic stroke presenting upon awakening. DATA COLLECTION AND ANALYSIS:Two review authors applied the inclusion criteria, extracted data, and assessed trial quality and risk of bias using the GRADE approach. We obtained both published and unpublished data. MAIN RESULTS:We included one pilot trial with nine participants. The trial was a feasibility trial that included participants with an unknown onset of stroke and signs on perfusion computed tomography of ischaemic tissue at risk of infarction, who were randomised to alteplase (0.9 mg/kg) or placebo. One trial was prematurely terminated due to signs of efficacy of the intervention arm; we did not include this trial because we were not able to obtain data for the portion of the participants with wake-up stroke after requesting this information from the trial authors. We identified six ongoing trials. AUTHORS' CONCLUSIONS:There is insufficient evidence from randomised controlled trials for recommendations concerning recanalisation therapies for wake-up stroke. Results from ongoing trials will hopefully establish the efficacy and safety of such therapies.

SUBMITTER: Roaldsen MB

PROVIDER: S-EPMC6513546 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundThrombolytic treatment (tissue-type plasminogen activator [tPA]) is only recommended for acute ischemic stroke patients with stroke onset time <4.5 hours. tPA is not recommended when stroke onset time is unknown. Diffusion-weighted MRI (DWI) and fluid attenuated inversion recovery (FLAIR) MRI mismatch information has been found to approximate stroke onset time with some accuracy. Therefore, we developed a micro-simulation model to project health outcomes and costs of MRI-based treatment decisions versus no treatment for acute wake-up stroke patients.Methods and findingsThe model assigned simulated patients a true stroke onset time from a specified probability distribution. DWI-FLAIR mismatch estimated stroke onset <4.5 hours with sensitivity and specificity of 0.62 and 0.78, respectively. Modified Rankin Scale (mRS) scores reflected tPA treatment effectiveness accounting for patients' true stroke onset time. Discounted lifetime costs and benefits (quality-adjusted life years [QALYs]) were projected for each strategy. Incremental cost-effectiveness ratios (ICERs) were calculated for the MRI-based strategy in base-case and sensitivity analyses. With no treatment, 45.1% of simulated patients experienced a good stroke outcome (mRS score 0-1). Under the MRI-based strategy, in which 17.0% of all patients received tPA despite stroke onset times >4.5 hours, 46.3% experienced a good stroke outcome. Lifetime discounted QALYs and costs were 5.312 and $88,247 for the no treatment strategy and 5.342 and $90,869 for the MRI-based strategy, resulting in an ICER of $88,000/QALY. Results were sensitive to variations in patient- and provider-specific factors such as sleep duration, hospital travel and door-to-needle times, as well as onset probability distribution, MRI specificity, and mRS utility values.ConclusionsOur model-based findings suggest that an MRI-based treatment strategy for this population could be cost-effective and quantifies the impact that patient- and provider-specific factors, such as sleep duration, hospital travel and door-to-needle times, could have on the optimal decision for wake-up stroke patients.

Project description:ObjectivesWake-up stroke is an important clinical problem that may account for a quarter of all ischemic strokes. This study aimed to establish the safety and efficacy of intravenous thrombolytic treatment of wake-up strokes by comparing it to the standard thrombolysis treatment in strokes with clear onsets and wake-up strokes that did not receive reperfusion therapy.MethodsThis retrospective study enrolled 95 patients with ischemic strokes who underwent thrombolytic treatment with alteplase, including nine patients with wake-up strokes. The safety profile (mortality and intracranial bleeding) and efficacy (clinical and functional outcomes on admission, discharge, and 90 days after stroke onset) were evaluated.ResultsWhen assessed using the modified Rankin scale (mRs), the patients with wake-up strokes had significantly more favorable functional outcomes on discharge when compared to those who received standard thrombolysis (p = .0289). No significant differences were noted when the favorable outcome rate (mRs score = 0-2) at three months post-thrombolysis (Odds ratio [OR] = 2.07; 95% confidence interval [CI] = 0.41-10.6; p = .3807) and safety outcomes (death during hospitalization: OR = 0.49; 95% CI = 0.03-9.11; p = .6295 and intracranial bleeding 24 hr after treatment: OR = 0.43; 95% CI = 0.02-7.58; p = .5707) were compared between the two groups. The Cochran-Mantel-Haenchel shift analysis showed a significantly more favorable distribution of the mRs scores at three months after the stroke onset in the patients with wake-up strokes who were treated with alteplase compared to those who did not receive thrombolysis (OR = 1.42; 95% CI = 1.01-1.82; p = .0426).ConclusionsOur study demonstrated that in patients who awaken with stroke symptoms, intravenous thrombolytic treatment is a safe procedure that may lead to favorable outcomes. Further studies should be performed to increase the size of the group of patients with wake-up strokes who can be treated with reperfusion therapy.

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Recanalisation therapies for wake-up stroke.

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