A Pragmatic Randomized Trial Comparing Surgical Clipping and Endovascular Treatment of Unruptured Intracranial Aneurysms

Abstract

BACKGROUND AND PURPOSE: Surgical clipping and endovascular treatment are commonly used in patients with unruptured intracranial aneurysms. We compared the safety and efficacy of the 2 treatments in a randomized trial. MATERIALS AND METHODS:Clipping or endovascular treatments were randomly allocated to patients with one or more 3-to 25-mm unruptured intracranial aneurysms judged treatable both ways by participating physicians. The study hypothesized that clipping would decrease the incidence of treatment failure from 13% to 4%, a composite primary outcome defined as failure of aneurysm occlusion, intracranial hemorrhage during follow-up, or residual aneurysms at 1 year, as adjudicated by a core lab. Safety outcomes included new neurologic deficits following treatment, hospitalization of .5 days, and overall morbidity and mortality (mRS . 2) at 1 year. There was no blinding. RESULTS:Two hundred ninety-one patients were enrolled from 2010 to 2020 in 7 centers. The 1-year primary outcome, ascertainable in 290/291 (99%) patients, was reached in 13/142 (9%; 95% CI, 5%-15%) patients allocated to surgery and in 28/148 (19%; 95% CI, 13%-26%) patients allocated to endovascular treatments (relative risk: 2.07; 95% CI, 1.12-3.83; P ¼ .021). Morbidity and mortality (mRS .2) at 1 year occurred in 3/143 and 3/148 (2%; 95% CI, 1%-6%) patients allocated to surgery and endovascular treatments, respectively.

Microsurgical Clipping of Unruptured Anterior Circulation Aneurysms—A Global Multicenter Investigation of Perioperative Outcomes

“…By contrast, the rate of residual saccular aneurysms in the endovascularly treated group was 15%. 19 Furthermore, some studies suggest that clipping may be a more cost-effective method of treatment. [20][21][22] In addition, we confirmed several known patient-specific and aneurysm-specific risk factors.…”

“…The size of the aneurysms treated in our database was comparable with large prospective randomized trials on ruptured and unruptured aneurysms and considered representative. 19,28 In general, reports on complication rates vary in the literature. However, the rates in our study are comparable with those in large meta-analyses.…”

ARISE I Consensus Review on the Management of Intracranial Aneurysms

“…22 Most studies reporting the morbidity and mortality of surgical clipping are single-center retrospective reviews. Most recently, Darsaut et al 29 performed a pragmatic randomized trial comparing UIA clipping ligation to endovascular treatment in 7 centers over 10 years. Morbidity and mortality (modified Rankin Scale score >2) at 1 year occurred in 3/143 and 3/148 (2% [95% CI, 1%–6%]) patients allocated to surgery and endovascular treatments, respectively.…”

“…22 Most studies reporting the morbidity and mortality of surgical clipping are single-center retrospective reviews. Most recently, Darsaut et al 29 30 In 2019, Algra et al's systemic review and meta-analysis of 114 studies reported a complication risk of 4.9% and a case-fatality risk of 0.3%. 31 However, microsurgical techniques have evolved over the years, with improvement in microsurgical instruments, intraoperative diagnostic tools (catheter angiography, indocyanine-green, Doppler, ultrasound, and flow cytometry), and avoidance of fixed brain retractors causing cerebral contusions.…”

Management of wide-neck aneurysms in 2024: how does one make the best treatment decision when there are so many good options?

“…Both ISAT 4 and BRAT 5 1-year outcomes demonstrated improved clinical outcomes for patients who underwent ruptured aneurysm coiling compared with clipping, but these randomized controlled trials (RCTs) are becoming outdated (especially with regards to EVT) and also included all aneurysms, so that the results are not directly applicable to WNAs. More recently, the CURES trial 6 compared EVT and clipping for unruptured aneurysms and found better angiographic outcomes (primary outcome) with clipping with similar final clinical outcomes (secondary outcomes). There were, however, more new neurological deficits and longer hospitalizations with clipping.…”