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ISAT Study
International Subarachnoid Aneurysm Trial (ISAT) of neurosurgical clipping versus endovascular coiling in 2143 patients with ruptured intracranial aneurysms: a randomized trial.
Molyneux A, Kerr R, Stratton I, Sandercock P, Clarke M, Shrimpton J, Holman R. Lancet. 2002: 360: 1267-74.
Purpose: Determine whether endovascular treatment compared with neurosurgical treatment reduced the proportion of patients dependent or dead, defined by a modified Rankin score of 3-6
Methods: 2143 patients randomly assigned endovascular coil treatment (n=1070) or neurosurgical clipping (n=1073). Most randomized patients had good-grade (88 percent in WFNS grades I and II), small anterior circulation aneurysms (92 percent less than 11 mm in size).
Results:
| Endovascular | Surgical | |
| Died or had mRS score 3-6 at 1 year | 23.7% (n= 801) | 30.6% (n=793) |
| - Relative risk reduction favoring coiling is 22.6%. Absolute risk reduction is 6.9%.* | ||
| - The risk of rebleeding during the first year was 2.4 percent for the endovascular group and 1.0 percent for the surgical group. Rebleeding after 1 year was 2 per 1276 follow-up years for coiling patients and 0 per 1081 follow-up years for surgical patients. | ||
Conclusions:
In ruptured brain aneurysm patients, equally suited for both treatment options, endovascular coil treatment produces substantially better patient outcomes than surgery in terms of survival free of disability at one year.
* All adverse events, retreatments, rebleeds included in 1 year data. One-year data on 1,888 patients demonstrated a relative risk reduction of 26.8% in favor of coiling, an absolute risk reduction of 8.7%. Reference: Kerr R. The International Subarachnoid Aneurysm Trial: What have we learned? Presentation at AANS Satellite Symposium: State of the Art Treatment for Acute Subarachnoid Hemorrhage. April 28, 2003.
1 Year Patient Outcome 1,594 Patients:
|
|
Treatment Allocation |
|
Modified Rankin Scale |
Endovascular (n=959) |
Neurosurgery (n=947) |
|
0 No symptoms |
207 (25.8%) |
152 (19.2%) |
|
1 Minor symptoms |
217 (27.1%) |
220 (27.7%) |
|
2 Some restriction in lifestyle (0-2 inclusive) |
187 (23.4%) 611 (76.3%) |
178 (22.4%) 550 (69.4%) |
|
3 Significant restriction in lifestyle |
80 (10%) |
106 (13.4%) |
|
4 Partly dependent |
24 (3%) |
32 (4%) |
|
5 Fully dependent |
21 (2.6%) |
25 (3.2%) |
|
6 Dead (3-6 inclusive) |
65 (8.1%) 190 (23.7%) |
80 (10.1%) 243 (30.6%) |
|
Data in italics are primary outcome |
||
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