Editor’s Choice
May 2014
(3 of 3)
This prospective, randomized, multicenter study compares the efficacy of the Matrix versus bare metal coils. A group of 626 patients were divided between the 2 coil types and aneurysm recurrence and hemorrhage were assessed 1 year after procedures. Recurrences were associated with initial incomplete obliterations and the bare metal coils were not inferior to Matrix coils. Thus, due to cost differences, utilization of Matrix coils may not be justified.
Abstract
BACKGROUND AND PURPOSE
The ability of polymer-modified coils to promote stable aneurysm occlusion after endovascular treatment is not well-documented. Angiographic aneurysm recurrence is widely used as a surrogate for treatment failure, but studies documenting the correlation of angiographic recurrence with clinical failure are limited. This trial compares the effectiveness of Matrix2 polyglycolic/polylactic acid biopolymer–modified coils with bare metal coils and correlates the angiographic findings with clinical failure (ie, target aneurysm recurrence), a composite end point that includes any incident of posttreatment aneurysm rupture, retreatment, or unexplained death.
MATERIALS AND METHODS
This was a multicenter randomized noninferiority trial with blinded end point adjudication. We enrolled 626 patients, divided between Matrix2 and bare metal coil groups. The primary outcome was target aneurysm recurrence at 12 ± 3 months.
RESULTS
At 455 days, at least 1 target aneurysm recurrence event had occurred in 14.6% of patients treated with bare metal coils and 13.3% of Matrix2 (P = .76, log-rank test) patients; 92.8% of target aneurysm recurrence events were re-interventions for aneurysms that had not bled after treatment, and 5.8% of target aneurysm recurrence events resulted from hemorrhage or rehemorrhage, with or without retreatment. Symptomatic re-intervention occurred in only 4 (0.6%) patients. At 455 days, 95.8% of patients with unruptured aneurysms and 90.4% of those with ruptured aneurysms were independent (mRS ≤ 2). Target aneurysm recurrence was associated with incomplete initial angiographic aneurysm obliteration, presentation with rupture, and a larger aneurysmal dome and neck size.
CONCLUSIONS
Tested Matrix2 coils were not inferior to bare metal coils. Endovascular coiling of intracranial aneurysms was safe, and the rate of technical success was high. Target aneurysm recurrence is a promising clinical outcome measure that correlates well with established angiographic measurements.