Modality of Intervention

Since the introduction of endovascular therapy for ruptured aneurysms, a controversial debate has ensued regarding the optimal approach for excluding aneurysms from the systemic circulation to prevent rebleeding. Numerous trials have been conducted to characterize the risks of both endovascular and surgical treatment of aneurysms, but only one randomized trial has been conducted and reported—that of the International Subarachnoid Aneurysm Trial (ISAT) (5).

The ISAT trial was an international, randomized trial that compared the safety and efficacy of endovascular and surgical management for ruptured cerebral aneurysms (5 ). A total of 2143 patients were enrolled, randomly assigned to surgery or endovascular management (with groups well matched for presentation and distribution of aneurysms), and followed for one year, ascertaining for functional outcomes (as assessed by the modified Rankin scale) and secondary endpoints (as described below). The trial was stopped early due to an increased rate of death and dependence in the surgically treated patients (30.6% vs. 23.7%). Although the rate of death and dependence was higher in the surgical cohort, endovascular management involved other complications, including a lower rate of successful initial treatment (92.5% vs. 97.8% in the surgical group), an increased rate of requiring a second procedure (12.6% vs. 3.2% in the surgical group), and a higher rate of bleeding after definitive intervention (68 cases in the endovascu-lar group vs. 43 in the surgical group). The reported rebleeding after endovascular treatment necessitates a closer examination of the rate of SAH after endovascular occlusion to gain a better understanding of the effectiveness of each intervention.

The ISAT trial has been extensively criticized for its design, including subjective enrollment criteria (of both patients and treating physicians), patients undergoing surgery before being enrolled in the trial, and the fact that it was largely conducted outside of the United States (its applicability to the North American population, therefore, questioned) (6). For example, the rate of rebleeding in the first year following surgery appears much higher than reported by North American centers with high caseloads. A review of the critiques of the ISAT trial provides great insight into the limitations of clinical trials and their implications. Most have concluded from this study that endovascular management offers an effective treatment modality for ruptured aneurysms but that such patients need to be selected carefully and advised appropriately. Further trials and long-term outcomes of the ISAT are expected.

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