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 Matrix(2) 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 Matrix(2) 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 Matrix(2) (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 Matrix(2) 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.
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Authors | C G McDougall, S Claiborne Johnston, A Gholkar, S L Barnwell, J C Vazquez Suarez, J Massó Romero, J C Chaloupka, A Bonafe, A K Wakhloo, D Tampieri, C F Dowd, A J Fox, S J Imm, K Carroll, A S Turk, MAPS Investigators |
Journal | AJNR. American journal of neuroradiology
(AJNR Am J Neuroradiol)
Vol. 35
Issue 5
Pg. 935-42
(May 2014)
ISSN: 1936-959X [Electronic] United States |
PMID | 24481333
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | © 2014 by American Journal of Neuroradiology. |
Chemical References |
- Coated Materials, Biocompatible
- Platinum
|
Topics |
- Adolescent
- Adult
- Aged
- Aged, 80 and over
- Coated Materials, Biocompatible
(chemistry)
- Embolization, Therapeutic
(instrumentation, mortality)
- Equipment Failure Analysis
- Extracellular Matrix
(chemistry)
- Female
- Humans
- Incidence
- Internationality
- Intracranial Aneurysm
(diagnostic imaging, mortality, surgery)
- Male
- Middle Aged
- Platinum
(chemistry)
- Prosthesis Design
- Radiography
- Recurrence
- Risk Factors
- Single-Blind Method
- Stents
(statistics & numerical data)
- Survival Rate
- Treatment Outcome
- Young Adult
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