ISAT and ISUIA: the impact on informed consent

Area of Science:

• Neurosurgery
• Interventional Radiology
• Neurology

Background:

• Subarachnoid hemorrhage due to ruptured brain aneurysms is a critical neurological emergency.
• Treatment options historically included surgical clipping and, more recently, endovascular coiling.
• Patient selection for optimal treatment modality was a significant clinical challenge.

Purpose of the Study:

• To compare the safety and efficacy of endovascular coil treatment versus surgical clipping for ruptured brain aneurysms.
• To evaluate outcomes in patients deemed equally suitable for both treatment options (clinical equipoise).

Main Methods:

• Multicenter randomized trial design.
• Inclusion criteria required patients to be candidates for both coiling and clipping.
• Comparison of clinical outcomes between the two treatment groups.

Main Results:

• Endovascular coiling demonstrated superior safety and efficacy compared to surgical clipping.
• The trial established a new standard of care for eligible patients.

Conclusions:

• Endovascular coiling is the preferred treatment for ruptured brain aneurysms in patients suitable for both coiling and clipping.
• The ISAT trial significantly influenced the landscape of neurovascular interventions and interventional radiology/endovascular neurosurgery.
• Clinical equipoise is crucial for conducting definitive comparative trials in neurosurgery.