Bioactive versus Bare Platinum Coils in the Treatment of Intracranial Aneurysms: The MAPS (Matrix and Platinum Science) Trial

被引:102
作者
McDougall, C. G. [1 ]
Johnston, S. Claiborne [2 ]
Gholkar, A. [4 ]
Barnwell, S. L. [5 ,6 ]
Vazquez Suarez, J. C. [7 ]
Masso Romero, J. [8 ]
Chaloupka, J. C. [9 ]
Bonafe, A. [10 ]
Wakhloo, A. K. [11 ]
Tampieri, D. [12 ]
Dowd, C. F. [3 ]
Fox, A. J. [13 ]
Imm, S. J. [14 ]
Carroll, K. [14 ]
Turk, A. S. [15 ,16 ,17 ]
机构
[1] St Josephs Hosp, Barrow Neurol Inst, Dept Neurosurg, Phoenix, AZ 85013 USA
[2] Univ Calif San Francisco, Clin & Translat Sci Inst, San Francisco, CA 94143 USA
[3] Univ Calif San Francisco, Dept Radiol, San Francisco, CA USA
[4] Royal Victoria Infirm, Dept Neuroradiol, Reg Neurosci Ctr, Newcastle Upon Tyne NE1 4LP, Tyne & Wear, England
[5] Oregon Hlth & Sci Univ, Dept Neurol Surg, Portland, OR 97201 USA
[6] Oregon Hlth & Sci Univ, Dept Diagnost Radiol, Portland, OR 97201 USA
[7] Univ Gen Hosp Alicante, Therapeut Neuroradiol Unit, Alicante, Spain
[8] Hosp Donostia, Dept Intervent Neuroradiol, San Sebastian, Spain
[9] Mt Sinai Med Ctr, Dept Neurosurg & Radiol, Miami Beach, FL 33140 USA
[10] Hosp Gui de Chauliac, Serv Neuroradiol, Montpellier, France
[11] Univ Massachusetts, Sch Med, Dept Radiol, Div Neuroimaging & Intervent, Worcester, MA USA
[12] McGill Univ, Montreal Neurol Inst, Dept Diagnost & Intervent Neuroradiol, Montreal, PQ, Canada
[13] Sunnybrook Hlth Sci Ctr, Dept Neuroradiol, Toronto, ON M4N 3M5, Canada
[14] Stryker Corp, Fremont, CA USA
[15] Med Univ S Carolina, Dept Neurointervent Surg, Charleston, SC 29425 USA
[16] Med Univ S Carolina, Dept Radiol, Charleston, SC 29425 USA
[17] Med Univ S Carolina, Dept Neurosurg, Charleston, SC 29425 USA
关键词
PROSPECTIVE MULTICENTER REGISTRY; SINGLE-CENTER EXPERIENCE; ENDOVASCULAR TREATMENT; DETACHABLE COILS; CEREBRAL ANEURYSMS; CLINICAL-OUTCOMES; COATED COILS; FOLLOW-UP; IMMEDIATE; EMBOLIZATION;
D O I
10.3174/ajnr.A3857
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
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.
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收藏
页码:935 / 942
页数:8
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