TY - JOUR
T1 - Bioactive versus bare platinum coils in the treatment of intracranial aneurysms
T2 - The MAPS (Matrix and Platinum Science) trial
AU - McDougall, Cameron G.
AU - Claiborne Johnston, S.
AU - Gholkar, A.
AU - Barnwell, S. L.
AU - Vazquez Suarez, J. C.
AU - Massó Romero, J.
AU - Chaloupka, J. C.
AU - Bonafe, A.
AU - Wakhloo, A. K.
AU - Tampieri, D.
AU - Dowd, C. F.
AU - Fox, A. J.
AU - Imm, S. J.
AU - Carroll, K.
AU - Turk, A. S.
PY - 2014/5
Y1 - 2014/5
N2 - 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. MATERIALSANDMETHODS: This was a multicenter randomized noninferiority trial with blinded end point adjudication.Weenrolled 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.
AB - 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. MATERIALSANDMETHODS: This was a multicenter randomized noninferiority trial with blinded end point adjudication.Weenrolled 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.
UR - http://www.scopus.com/inward/record.url?scp=84901004691&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84901004691&partnerID=8YFLogxK
U2 - 10.3174/ajnr.A3857
DO - 10.3174/ajnr.A3857
M3 - Article
C2 - 24481333
AN - SCOPUS:84901004691
SN - 0195-6108
VL - 39
SP - 935
EP - 942
JO - American Journal of Neuroradiology
JF - American Journal of Neuroradiology
IS - 5
ER -