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Bioactive versus bare platinum coils in the treatment of intracranial aneurysms: the MAPS (Matrix and Platinum Science) trial
- Source :
- AJNR. American journal of neuroradiology, vol 35, iss 5
- Publication Year :
- 2014
- Publisher :
- eScholarship, University of California, 2014.
-
Abstract
- Background and purposeThe 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 methodsThis 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.ResultsAt 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.ConclusionsTested 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.
- Subjects :
- MAPS Investigators
Biocompatible
Adult
Male
Internationality
Adolescent
Clinical Trials and Supportive Activities
Clinical Sciences
Prosthesis Design
Cardiovascular
Embolization
Young Adult
Recurrence
Risk Factors
Clinical Research
80 and over
Humans
Single-Blind Method
Platinum
Aged
Incidence
Coated Materials
Neurosciences
Intracranial Aneurysm
Middle Aged
Extracellular Matrix
Radiography
Survival Rate
Equipment Failure Analysis
Stroke
Nuclear Medicine & Medical Imaging
Treatment Outcome
Stents
Female
Therapeutic
Subjects
Details
- Database :
- OpenAIRE
- Journal :
- AJNR. American journal of neuroradiology, vol 35, iss 5
- Accession number :
- edsair.od.......325..f5ccd3028cdf016214db39fa0e89ef37