The Basilar Artery International Cooperation Study (BASICS): study protocol for a randomised controlled trial

Erik Jrj Van Der Hoeven,Andrea Zini,Patrik Michel,Jaap L Kappelle,Heinrich J Audebert,Wouter J Schonewille,Ale Algra,Mikael Mazighi,Alfonso Ciccone,Eivind Berge,Volker Puetz,Keith W Muir,Jan Albert Vos,Cristanne Ac Wijman,Víctor Obach

doi:10.1186/1745-6215-14-200

Abstract

BackgroundDespite recent advances in acute stroke treatment, basilar artery occlusion (BAO) is associated with a death or disability rate of close to 70%. Randomised trials have shown the safety and efficacy of intravenous thrombolysis (IVT) given within 4.5 h and have shown promising results of intra-arterial thrombolysis given within 6 h of symptom onset of acute ischaemic stroke, but these results do not directly apply to patients with an acute BAO because only few, if any, of these patients were included in randomised acute stroke trials.Recently the results of the Basilar Artery International Cooperation Study (BASICS), a prospective registry of patients with acute symptomatic BAO challenged the often-held assumption that intra-arterial treatment (IAT) is superior to IVT. Our observations in the BASICS registry underscore that we continue to lack a proven treatment modality for patients with an acute BAO and that current clinical practice varies widely.DesignBASICS is a randomised controlled, multicentre, open label, phase III intervention trial with blinded outcome assessment, investigating the efficacy and safety of additional IAT after IVT in patients with BAO. The trial targets to include 750 patients, aged 18 to 85 years, with CT angiography or MR angiography confirmed BAO treated with IVT. Patients will be randomised between additional IAT followed by optimal medical care versus optimal medical care alone. IVT has to be initiated within 4.5 h from estimated time of BAO and IAT within 6 h. The primary outcome parameter will be favourable outcome at day 90 defined as a modified Rankin Scale score of 0–3.DiscussionThe BASICS registry was observational and has all the limitations of a non-randomised study. As the IAT approach becomes increasingly available and frequently utilised an adequately powered randomised controlled phase III trial investigating the added value of this therapy in patients with an acute symptomatic BAO is needed (clinicaltrials.gov: NCT01717755).

Highlights

Despite recent advances in acute stroke treatment, basilar artery occlusion (BAO) is associated with a death or disability rate of close to 70%
Estimated time of BAO is defined as time of onset of acute symptoms consistent with the clinical diagnosis of basilar artery occlusion or if not known last time patient was seen normal prior to onset of these symptoms, time from symptom onset can be considerably longer than 4.5 h; 5. initiation of IA therapy should be feasible within 6 h of estimated time of BAO; 6. informed consent
The Basilar Artery International Cooperation Study (BASICS) registry observed that the risk of symptomatic intracranial haemorrhage in patients treated with IA therapy was 14% and 7% (95%CI 3-11%) in those treated with intravenous thrombolysis (IVT) only [2]

Summary

Introduction

Despite recent advances in acute stroke treatment, basilar artery occlusion (BAO) is associated with a death or disability rate of close to 70%. Randomised trials have shown the safety and efficacy of intravenous thrombolysis (IVT) given within 4.5 h and have shown promising results of intra-arterial thrombolysis given within 6 h of symptom onset of acute ischaemic stroke, but these results do not directly apply to patients with an acute BAO because only few, if any, of these patients were included in randomised acute stroke trials. Randomised trials have shown the safety and efficacy of intravenous thrombolysis given within 4.5 h and promising results of intra-arterial thrombolysis given within 6 h of symptom onset of acute ischaemic stroke [3,4,5,6,7,8] These results do not directly apply to patients with an acute BAO because only few, if any, of these patients were included in randomised acute stroke trials. Case series of patients with BAO found similar outcomes in patients treated with antithrombotic therapy, intravenous thrombolysis (IVT) or intra-arterial treatment (IAT) [11,12]

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