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Randomized Controlled Trial
. 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

C G McDougall  1 , S Claiborne Johnston  2 , A Gholkar  3 , S L Barnwell  4 , J C Vazquez Suarez  5 , J Massó Romero  6 , J C Chaloupka  7 , A Bonafe  8 , A K Wakhloo  9 , D Tampieri  10 , C F Dowd  11 , A J Fox  12 , S J Imm  13 , K Carroll  13 , A S Turk  14 ; MAPS Investigators
Affiliations
Randomized Controlled Trial

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

C G McDougall et al. AJNR Am J Neuroradiol. 2014 May.

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.

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Figures

Fig 1.
Fig 1.
Subject flow through 455 days.
Fig 2.
Fig 2.
Kaplan-Meier curve showing freedom from TAR to 455 days in the intent-to-treat population (n = 626).
See this image and copyright information in PMC

References

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