Background: Approximately one-third of patients with symptomatic severe aortic valve stenosis scheduled for transcatheter aortic valve implantation (TAVI) have some degree of cognitive impairment. The effect of TAVI on cardiac output, cerebral blood flow (CBF), and cognitive functioning has not been systematically studied.
Methods: CAPITA (NCT05481008) is a prospective longitudinal study assessing cerebral and cognitive outcomes in patients that underwent TAVI between August 2020 and October 2022.
Background: We investigate whether the National Institutes of Health Stroke Scale (NIHSS) at 24 hours could serve as a primary outcome in acute ischemic stroke trials, and whether combining 90-day modified Rankin Scale (mRS) and 24-hour NIHSS in a hierarchical outcome could enhance detection of treatment effect, using endovascular treatment (EVT) as an exemplary study intervention.
Methods: This was a post hoc analysis of pooled data from 7 randomized EVT trials. Twenty-four-hour NIHSS as a surrogate outcome for 90-day mRS was assessed in a causal mediation model.
Background: The optimal acute management of patients with acute ischemic stroke and a tandem lesion, defined as intracranial large vessel occlusion (LVO) with concomitant carotid artery stenosis or occlusion, remains unclear. Our aim is to assess the efficacy and safety of immediate carotid artery stenting (CAS) compared to delayed management in patients undergoing endovascular treatment (EVT) for acute ischemic stroke due to tandem lesions.
Study Design: CASES is a phase 3 multicenter prospective randomized open-label blinded endpoint (PROBE) non-inferiority clinical trial.
Endovascular thrombectomy (EVT) aims at restoring blood flow in case of acute ischemic stroke by removing the thrombus occluding a large cerebral artery. During the procedure with stent-retriever, the thrombus is captured within the device, which is then retrieved, subjecting the thrombus to several forces, potentially leading to its fragmentation. In silico studies, along with mechanical characterisation of thrombi, can enhance our understanding of the EVT, helping the development of new devices and interventional strategies.
View Article and Find Full Text PDFNoninferiority trials aim to prove that the efficacy, defined in terms of a key clinical outcome, of a new treatment is not meaningfully worse than that of an established active control. Noninferiority trials are important when other aspects of care can be improved, such as convenience, toxicity, costs, and safety (nonefficacy benefits). While the motivation for a noninferiority trial is straightforward, the design, execution, and interpretation of these trials is not a trivial task.
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