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PubMed
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Stroke Interventions in Clinical Trials
Printable Version
BASICS
Basilar Artery International Cooperation Study



Principal Investigator
Wouter J. Schonewille, M.D.

PI Address
Department of Neurology
University Medical Center Utrecht
St. Antonius Hospital, Nieuwegein
The Netherlands



Study Size Actual:624
Study Size Planned:500
Centers Actual:49
Centers Planned:50
Status:
Completed. As of September 2007, 624 patients had been enrolled at 49 centers worldwide. Data is being analyzed and results will be available in May 2008.

Purpose:
To obtain sufficient information about the response of basilar stroke patients to various therapies to eventually design a randomized controlled trial.

Location(s):
Europe, North America, South America, Asia, Australia

Year Started: 2002
Year Finished: 2006
Year Presented: 2010
Year Published: 2007


Design:
Prospective observational multicenter database.

Inclusion Criteria
Patients with radiologically confirmed symptomatic basilar artery occlusion will be eligible for this trial.

Patient Involvement:
All patients will be clinically evaluated and will receive standard care according to their physicians' discretion.

Primary Outcome:
Patients will be sorted into three groups -- those who have received antithrombotics, those who have received intravenous thrombolytics, and those who have received intraarterial thrombolytics -- and will be analyzed with respect to the mortality rate, the incidence of poor clinical outcome (modified Rankin scale 4-5), and the frequency of good clinical outcome (modified Rankin scale 0-3).

Results:
Study Outcomes From November 2002 until December 2006 data have been collected on 400 patients, from 42 centers in 12 countries. Most patients were treated with IA therapy (55%), followed by antithrombotics (29%) and IV thrombolysis (6%). The overall mortality was 45%.

No differences were observed in baseline variables across the compared groups with the exception of patients with presumed atherosclerotic occlusions being older than those with embolic occlusions (p=0.03). Recanalization was a strong predictor of good outcome (OR 6.3, 95% CI 2.4-16.5). There was a trend towards higher recanalization rates (78% vs 63%, p=0.11) with mechanical thrombectomy (MT) compared to pharmacological thrombolysis (PT) alone, yet the opposite trend was observed with regards to good outcome (28% vs 39%,
p0.10). The complication rate, including symptomatic hemorrhage (13%), was similar for both PT and MT groups (23% vs 24% respectively). Distal basilar occlusions had a similar rate of recanalization to other locations, but a higher rate of good outcomes compared to both mid-basilar and proximal occlusions (p=0.001). Embolic occlusions had a higher rate of recanalization (76% vs 61%, p0.01) and better outcome (40% vs 21%, p=0.006) than atherosclerotic ones. Conclusion: Recanalization is a strong predictor of good outcome in BAO treated with endovascular therapy. Pharmacological and mechanical endovascular therapies
had similar recanalization and complication rates and similar outcomes. Distal and embolic basilar artery occlusions carry a better chance of recanalization and good outcome.

Source of Information:
Presented at 12th European Stroke Conference [May 2003]. Presented at the 30th International Stroke Conference [February 2005].
Presented at 14th European Stroke Conference [May 2005].
Presented at the 2006 International Stroke Conference [February 2006].
Presented at the 2010 International Stroke Conference [February 2010].

Web Links and Publications:
Treatment and outcomes of acute basilar artery occlusion in the Basilar Artery International Cooperation Study (BASICS): a prospective registry study.
Lancet Neurol 2009 Aug;8(8):724-30

The basilar artery international cooperation study (BASICS).
Int J Stroke 2007 Aug;2(3):220-3

BRAINS (Basic Registry Aneurysmal Ischemia and Neuromuscular Studies)

This information last updated on: 6/22/2010

Reviewed on: 05/19/2009.

UID: 477

   

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