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AJNR Am J Neuroradiol. 2014 May;35(5):935-42. doi: 10.3174/ajnr.A3857. Epub 2014 Jan 30.

Bioactive versus bare platinum coils in the treatment of intracranial aneurysms: the MAPS (Matrix and Platinum Science) trial.

Author information

1
From the Department of Neurosurgery (C.G.M.), Barrow Neurological Institute, St. Joseph's Hospital and Medical Center, Phoenix, Arizona neuropub@dignityhealth.org.
2
Clinical and Translational Science Institute (S.C.J.).
3
Department of Neuroradiology (A.G.), Regional Neurosciences Center, Royal Victoria Infirmary, Newcastle Upon Tyne, UK.
4
Departments of Neurological Surgery and Diagnostic Radiology (S.L.B.), Oregon Health and Science University, Portland, Oregon.
5
Therapeutic Neuroradiology Unit (J.C.V.S.), University General Hospital of Alicante, Alicante, Spain.
6
Department of Interventional Neuroradiology (J.M.R.), Hospital Donostia, San Sebastián, Spain.
7
Department of Neurosurgery and Radiology (J.C.C.), Mount Sinai Medical Center, Miami Beach, Florida.
8
Service de Neuroradiologie (A.B.), Hôspital Gui de Chauliac, Montpellier Cedex, France.
9
Division of Neuroimaging and Intervention (A.K.W.), Department of Radiology, University of Massachusetts Medical School, Worcester, Massachusetts.
10
Department of Diagnostic and Interventional Neuroradiology (D.T.), Montreal Neurological Institute, Montreal, Canada.
11
Department of Radiology (C.F.D.), University of California, San Francisco, San Francisco, California.
12
Department of Neuroradiology (A.J.F.), Sunnybrook Health Sciences Center, Toronto, Ontario, Canada.
13
Stryker Corporation (S.J.I., K.C.), Fremont, California.
14
Departments of Neurointerventional Surgery, Radiology, and Neurosurgery (A.S.T.), Medical University of South Carolina, Charleston, South Carolina.

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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00396981.

PMID:
24481333
DOI:
10.3174/ajnr.A3857
[Indexed for MEDLINE]
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