Best Revascularisation Approach for Posterior Circulation Strokes With Isolated Vertebral Artery Occlusions

Study Overview
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Brief Summary
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Isolated vertebral artery occlusions (VAO) account for approximately one third of posterior circulation occlusions, but have been given the least attention among posterior circulation strokes. If the two recent ATTENTION and BAOCHE randomized clinical trials have proven the superiority of endovascular thrombectomy (EVT) in basilar artery occlusions, data on the effectiveness and harm of acute revascularization treatment on isolated VAO is scarce. We aim to investigate the impact of acute recanalisation treatments in acute ischemic stroke patients with isolated VAO. In the absence of RCT, observational data with appropriate statistical methods may give indications on benefits and harms of treating neglected stroke situations like acute vertebral occlusion. Results may also lay the basis for prospective studies, such as randomized clinical trials.

Official Title
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Best Revascularisation Approach for Posterior Circulation Strokes With Isolated Vertebral : the BRAVO Retrospective Analysis

Conditions
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Ischemic Stroke, Vertebral Artery Ischemia, Arterial Occlusive Diseases, Vertebrobasilar Insufficiency

Intervention / Treatment
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* Other: Conservative treatment (CT)
* Other: Intravenous thrombolysis (IVT)
* Other: Endovascular thrombectomy (EVT) ± intravenous thrombolysis (IVT)


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Acute ischemic stroke limited to the posterior circulation Presence of uni- or bilateral VAO (intracranial and/or extracranial) on at least one initial imaging study (CTA, MRA, DSA) IVT, EVT or bridging-treated stroke patients between 01.01.2003 and 31.12.2021 ≥ 18 years old Exclusion criteria Extension of the occlusion into the basilar artery Presence of a more distal occlusion in the pc (tandem occlusion/multilevel poster circulation occlusions) Previously known chronic occlusion of the any segment of the vertebral artery/arteries Local ethical/legal conditions in participating center not fulfilled

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| AIS and isolated VAO<br>Patients with acute ischemic stroke (AIS) and concomitant isolated intracranial and/or extracranial vertebral artery occlusion (VAO) | Other: Conservative treatment (CT)<br>* Best medical treatment without intravenous thrombolysis nor endovascular thrombectomy<br>Other: Intravenous thrombolysis (IVT)<br>* Best medical treatment with intravenous thrombolysis but without endovascular thrombectomy<br>Other: Endovascular thrombectomy (EVT) ± intravenous thrombolysis (IVT)<br>* Best medical treatment with endovascular thrombectomy with or without intravenous thrombolysis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-month modified Rankin scale | 3-month functional outcome, [range: 0-6, 0= no symptoms, 6=death] | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptomatic intracerebral haemorrhage (sICH) | Any hemorrhagic transformation temporally related to any worsening in neurological condition. [yes/no] | 7 days | 
| EVT procedural complications | Any complication attributed to the procedure (vessel perforation, vasospasm, dissection, Subarachnoid haemorrhage (SAH)/Intracerebral haemorrhage (ICH), device detachment/misplacement, embolization to new territory, access-site complications, early reocclusion, other) | During EVT procedure or peri-procedural | 
| 24-hour NIHSS | NIH Stroke Scale/Score (NIHSS). Quantifies stroke severity based on weighted clinical evaluation findings at 24h. [0-42, 0= no deficit, 42=maximum stroke severity] | 24 hours | 
| Early neurological deterioration (ENDi) | Early neurological deterioration of ischemic origin (ENDi) is defined as an increase in National Institute of Health Stroke (NIHSS) score ≥ 4 points or death within 24 hours. [yes/no] | 24 hours | 
| Cerebrovascular ischemic recurrences | Any ischemic stroke or transient ischemic attack recurrence [yes/no] | 90 days | 
| 24h and 3month mortality | Mortality at 24h and 3 months | 24h and 90 days | 
| Vessel recanalisation on follow up-imaging | Vessel recanalisation at follow-up imaging (0= no recanalisation, 1= partial recanalisation 50-99%, 2=full recanalisation, 3= initially not occluded) | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prognosis, Revascularization, Treatment