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The Basilar Artery International Cooperation Study (BASICS): study protocol for a randomised controlled trial.
Erik J R J van der Hoeven1, Wouter J Schonewille, Jan Albert Vos
1Department of Radiology, St Antonius Hospital, PO Box 2500, Nieuwegein EM 3430, The Netherlands.
Trials
|July 10, 2013
Summary
Acute basilar artery occlusion (BAO) has high mortality. The Basilar Artery International Cooperation Study (BASICS) trial investigates if intra-arterial treatment (IAT) after intravenous thrombolysis (IVT) improves outcomes for BAO patients.
Area of Science:
- Neurology
- Vascular Neurology
- Interventional Neurology
Background:
- Basilar artery occlusion (BAO) is a severe stroke type with high mortality and disability rates, often exceeding 70%.
- Current treatments like intravenous thrombolysis (IVT) and intra-arterial treatment (IAT) have limitations, especially for BAO, as few patients were included in major trials.
- Existing data from the Basilar Artery International Cooperation Study (BASICS) registry suggests uncertainty regarding the superiority of IAT over IVT, highlighting the need for definitive evidence.
Purpose of the Study:
- To investigate the efficacy and safety of additional intra-arterial treatment (IAT) following intravenous thrombolysis (IVT) in patients with acute basilar artery occlusion (BAO).
- To compare the outcomes of patients receiving optimal medical care alone versus those receiving optimal medical care plus additional IAT after IVT.
Main Methods:
- A randomized controlled, multicenter, open-label, phase III intervention trial with blinded outcome assessment.
- Inclusion of 750 patients aged 18-85 years with CT or MR angiography-confirmed BAO who received IVT.
- Randomization to either additional IAT followed by optimal medical care or optimal medical care alone, with IVT initiated within 4.5 hours and IAT within 6 hours of symptom onset.
Main Results:
- The primary outcome is a favorable outcome at day 90, defined as a modified Rankin Scale score of 0-3.
- Data collection and analysis are ongoing as per the trial protocol.
Conclusions:
- The observational BASICS registry, while informative, has limitations inherent to non-randomized studies.
- A large, adequately powered randomized controlled phase III trial is necessary to definitively establish the added value of IAT in acute symptomatic BAO.
- The findings will inform clinical practice guidelines for managing this critical condition.
