ISAT 1

Trial question
What is the role of endovascular detachable coil treatment in patients with ruptured intracranial aneurysms?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
63.0% female
37.0% male
N = 2143
2143 patients (1344 female, 799 male).
Inclusion criteria: patients with ruptured intracranial aneurysms.
Key exclusion criteria: subarachnoid hemorrhage occurred > 28 days before randomisation, patient unsuitable for one or both treatments, consent was refused, patient participating in another randomised clinical trial of a treatment for subarachnoid hemorrhage.
Interventions
N=1073 endovascular treatment (endovascular treatment by detachable platinum coils).
N=1070 neurosurgical treatment (clipping the neck of the aneurysm).
Primary outcome
Dependency or death at 1 year
23.7%
30.6%
30.6 %
23.0 %
15.3 %
7.7 %
0.0 %
Endovascular treatment
Neurosurgical treatment
Significant decrease ▼
NNT = 14
Significant decrease in dependency or death at 1 year (23.7% vs. 30.6%; RR 0.77, 95% CI 0.66 to 0.91).
Safety outcomes
No significant difference in frequency of preprocedural rebleeding.
Significant difference in risk of rebleeding from ruptured aneurysm after 1 year (0.16% vs. 0%).
Conclusion
In patients with ruptured intracranial aneurysms, endovascular treatment was superior to neurosurgical treatment with respect to dependency or death at 1 year.
Reference
Andrew Molyneux, Richard Kerr, Irene Stratton et al. International Subarachnoid Aneurysm Trial (ISAT) of neurosurgical clipping versus endovascular coiling in 2143 patients with ruptured intracranial aneurysms: a randomised trial. Lancet. 2002 Oct 26;360(9342):1267-74.
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