TY - JOUR
T1 - Five-year results of randomized bioactive versus bare metal coils in the treatment of intracranial aneurysms
T2 - The Matrix and Platinum Science (MAPS) Trial
AU - McDougall, Cameron G.
AU - Johnston, S. Claiborne
AU - Hetts, Steven W.
AU - Gholkar, Anil
AU - Barnwell, Stanley L.
AU - Vazquez Suarez, Juan Carlos
AU - Massó Romero, Javier
AU - Chaloupka, John C.
AU - Bonafe, Alain
AU - Wakhloo, Ajay K.
AU - Tampieri, Donatella
AU - Dowd, Christopher F.
AU - Fox, Allan J.
AU - Turk, Aquilla S.
N1 - Funding Information:
This study was funded by Stryker (MAPS Trial).
Publisher Copyright:
© Author(s) (or their employer(s)) 2021.
PY - 2021
Y1 - 2021
N2 - Background No randomized trial of intracranial aneurysm coiling has compared long-term efficacy of polymer-modified coils to bare metal coils (BMCs). We report 5-year results comparing Matrix 2 coils to BMCs. The primary objective was to compare the rates of target aneurysm recurrence (TAR) at 12 months. Secondary objectives included angiographic outcomes at TAR or 12 months and TAR at 5 years. Methods A total of 626 patients were randomized to BMCs or Matrix 2 coils. Detailed methods and 1-year results have been published previously. Results Of 580 patients eligible for 5-year follow-up, 431 (74.3%) completed follow-up or reached TAR. Matrix 2 coils were non-inferior to BMCs (P=0.8) but did not confer any benefit. Core lab reported post-treatment residual aneurysm filling (Raymond III) correlated with TAR (P<0.0001) and with aneurysm hemorrhage after treatment (P<0.008). Repeat aneurysmal hemorrhage after treatment, but before hospital discharge, occurred in three patients treated for acutely ruptured aneurysms. Additionally, two patients treated for unruptured aneurysms experienced a first hemorrhage during follow-up. All five hemorrhages resulted from aneurysms with Raymond III residual aneurysm filling persisting after initial treatment. After 5 years follow-up, 2/626 (0.3%) patients are known to have had target aneurysm rupture following hospital discharge. The annualized rate of delayed hemorrhage after coiling was 2/398/5=0.001 (0.1%) per year for unruptured aneurysms and 0 for ruptured aneurysms. Conclusions After 5 years Matrix 2 coils were non-inferior to BMCs but no benefit was demonstrated. Post-treatment residual angiographic aneurysm filling (Raymond III) is strongly associated with TAR (P<0.0001) and post-treatment aneurysmal hemorrhage (P=0.008).
AB - Background No randomized trial of intracranial aneurysm coiling has compared long-term efficacy of polymer-modified coils to bare metal coils (BMCs). We report 5-year results comparing Matrix 2 coils to BMCs. The primary objective was to compare the rates of target aneurysm recurrence (TAR) at 12 months. Secondary objectives included angiographic outcomes at TAR or 12 months and TAR at 5 years. Methods A total of 626 patients were randomized to BMCs or Matrix 2 coils. Detailed methods and 1-year results have been published previously. Results Of 580 patients eligible for 5-year follow-up, 431 (74.3%) completed follow-up or reached TAR. Matrix 2 coils were non-inferior to BMCs (P=0.8) but did not confer any benefit. Core lab reported post-treatment residual aneurysm filling (Raymond III) correlated with TAR (P<0.0001) and with aneurysm hemorrhage after treatment (P<0.008). Repeat aneurysmal hemorrhage after treatment, but before hospital discharge, occurred in three patients treated for acutely ruptured aneurysms. Additionally, two patients treated for unruptured aneurysms experienced a first hemorrhage during follow-up. All five hemorrhages resulted from aneurysms with Raymond III residual aneurysm filling persisting after initial treatment. After 5 years follow-up, 2/626 (0.3%) patients are known to have had target aneurysm rupture following hospital discharge. The annualized rate of delayed hemorrhage after coiling was 2/398/5=0.001 (0.1%) per year for unruptured aneurysms and 0 for ruptured aneurysms. Conclusions After 5 years Matrix 2 coils were non-inferior to BMCs but no benefit was demonstrated. Post-treatment residual angiographic aneurysm filling (Raymond III) is strongly associated with TAR (P<0.0001) and post-treatment aneurysmal hemorrhage (P=0.008).
KW - aneurysm
KW - bioactive
KW - coil
KW - device
KW - subarachnoid
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U2 - 10.1136/neurintsurg-2020-016906
DO - 10.1136/neurintsurg-2020-016906
M3 - Article
C2 - 33298509
AN - SCOPUS:85097556933
VL - 13
SP - 930
EP - 934
JO - Journal of NeuroInterventional Surgery
JF - Journal of NeuroInterventional Surgery
SN - 1759-8478
IS - 10
ER -