1.DIRECT-SAFE: A Randomized Controlled Trial of DIRECT Endovascular Clot Retrieval versus Standard Bridging Therapy
Peter J. MITCHELL ; Bernard YAN ; Leonid CHURILOV ; Richard J. DOWLING ; Steven BUSH ; Thang NGUYEN ; Bruce C.V. CAMPBELL ; Geoffrey A. DONNAN ; Zhongrong MIAO ; Stephen M. DAVIS ;
Journal of Stroke 2022;24(1):57-64
Background:
and Purpose The benefit regarding co-treatment with intravenous (IV) thrombolysis before mechanical thrombectomy in acute ischemic stroke with large vessel occlusion remains unclear. To test the hypothesis that clinical outcome of ischemic stroke patients with intracranial internal carotid artery, middle cerebral artery or basilar artery occlusion treated with direct endovascular thrombectomy within 4.5 hours will be non-inferior compared with that of standard bridging IV thrombolysis followed by endovascular thrombectomy.
Methods:
To randomize 780 patients 1:1 to direct thrombectomy or bridging IV thrombolysis with thrombectomy. An international-multicenter prospective randomized open label blinded endpoint trial (PROBE) (ClincalTrials.gov identifier: NCT03494920).
Results:
Primary endpoint is functional independence defined as modified Rankin Scale (mRS) 0–2 or return to baseline at 90 days. Secondary end points include ordinal mRS analysis, good angiographic reperfusion (modified Thrombolysis in Cerebral Infarction score [mTICI] 2b–3), safety endpoints include symptomatic intracerebral hemorrhage and death.
Conclusions
DIRECT-SAFE will provide unique information regarding the impact of direct thrombectomy in patients with large vessel occlusion, including patients with basilar artery occlusion, with comparison across different ethnic groups.
2.Neuroimaging of Acute Ischemic Stroke: Multimodal Imaging Approach for Acute Endovascular Therapy
Mohamad ABDALKADER ; James E. SIEGLER ; Jin Soo LEE ; Shadi YAGHI ; Zhongming QIU ; Xiaochuan HUO ; Zhongrong MIAO ; Bruce C.V. CAMPBELL ; Thanh N. NGUYEN
Journal of Stroke 2023;25(1):55-71
Advances in acute ischemic stroke (AIS) treatment have been contingent on innovations in neuroimaging. Neuroimaging plays a pivotal role in the diagnosis and prognosis of ischemic stroke and large vessel occlusion, enabling triage decisions in the emergent care of the stroke patient. Current imaging protocols for acute stroke are dependent on the available resources and clinicians’ preferences and experiences. In addition, differential application of neuroimaging in medical decision-making, and the rapidly growing evidence to support varying paradigms have outpaced guideline-based recommendations for selecting patients to receive intravenous or endovascular treatment. In this review, we aimed to discuss the various imaging modalities and approaches used in the diagnosis and treatment of AIS.
3.Endovascular versus Medical Management of Acute Basilar Artery Occlusion: A Systematic Review and Meta-Analysis of the Randomized Controlled Trials
Mohamad ABDALKADER ; Stephanos FINITSIS ; Chuanhui LI ; Wei HU ; Xinfeng LIU ; Xunming JI ; Xiaochuan HUO ; Fana ALEMSEGED ; Zhongming QIU ; Daniel STRBIAN ; Volker PUETZ ; James E. SIEGLER ; Shadi YAGHI ; Kaiz ASIF ; Piers KLEIN ; Yuyou ZHU ; Bruce C.V. CAMPBELL ; Hui-Sheng CHEN ; Simon NAGEL ; Georgios TSIVGOULIS ; Zhongrong MIAO ; Raul G. NOGUEIRA ; Tudor G. JOVIN ; Wouter J. SCHONEWILLE ; Thanh N. NGUYEN ;
Journal of Stroke 2023;25(1):81-91
Background:
and Purpose The optimal management of patients with acute basilar artery occlusion (BAO) is uncertain. We aimed to evaluate the safety and efficacy of endovascular thrombectomy (EVT) compared to medical management (MM) for acute BAO through a meta-analysis of randomized controlled trials (RCTs).
Methods:
We performed a systematic review and meta-analysis of RCTs of patients with acute BAO. We analyzed the pooled effect of EVT compared to MM on the primary outcome (modified Rankin Scale [mRS] of 0–3 at 3 months), secondary outcome (mRS 0–2 at 3 months), symptomatic intracranial hemorrhage (sICH), and 3-month mortality rates. For each study, effect sizes were computed as odds ratios (ORs) with random effects and Mantel-Haenszel weighting.
Results:
Four RCTs met inclusion criteria including 988 patients. There were higher odds of mRS of 0-3 at 90 days in the EVT versus MM group (45.1% vs. 29.1%, OR 1.99, 95% confidence interval [CI] 1.04–3.80; P=0.04). Patients receiving EVT had a higher sICH compared to MM (5.4% vs. 0.8%, OR 7.89, 95% CI 4.10–15.19; P<0.01). Mortality was lower in the EVT group (35.5% vs. 45.1%, OR 0.64, 95% CI 0.42–0.99; P=0.05). In an analysis of two trials with BAO patients and National Institutes of Health Stroke Scale (NIHSS) <10, there was no difference in 90-day outcomes between EVT versus MM.
Conclusion
In this systematic review and meta-analysis, EVT was associated with favorable outcome and decreased mortality in patients with BAO up to 24 hours from stroke symptoms compared to MM. The treatment effect in BAO patients with NIHSS <10 was less certain. Further studies are of interest to evaluate the efficacy of EVT in basilar occlusion patients with milder symptoms.