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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