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July 27, 2011
Stryker's MAPS Trial Supports Neurovascular Aneurysm Coiling
July 27, 2011—Stryker Neurovascular, a division of Stryker Corporation (Kalamazoo, MI), announced that results of the MAPS (Matrix and Platinum Science) trial were presented at the Society of NeuroInterventional Surgery (SNIS) 8th Annual Meeting in Colorado Springs, Colorado. The MAPS trial was initiated in 2007 by Boston Scientific Corporation (Natick, MA), which sold its neurovascular interventions business to Stryker in late 2010, as reported in Endovascular Today.
According to Stryker, the MAPS trial establishes a standard for the measurement of aneurysm treatment success and target aneurysm recurrence (TAR) rate, and it supports coiling as a treatment for both ruptured and unruptured aneurysms. TAR is defined as aneurysm recurrence evidenced by a clinically relevant event of aneurysm bleeding/rebleeding, aneurysm reintervention, or death from an unknown cause.
The MAPS trial is a large, randomized controlled study of the clinical effectiveness of coils for treating both ruptured and unruptured aneurysms. The trial examined 626 patients worldwide. Each patient had a single aneurysm, ranging in size from 4 to 20 mm, and was treated with Stryker's Matrix2 detachable coils or its earlier generation GDC detachable coils. Principal Investigators S. Claiborne Johnston, MD, Cameron McDougall, MD, and Anil Gholkar, MBBS, designed and led the trial.
The trial investigators found that 96% of patients with unruptured aneurysms and 90% of patients with acutely ruptured aneurysms were alive and free of disability out to 15 months after treatment. Trial results also demonstrated that, overall, Matrix2 detachable coils are as effective as GDC detachable coils with TAR rates of 13.3% versus 14.6%, respectively. In aneurysms with good occlusion immediately postprocedure, Matrix2 detachable coils demonstrated a statistically significant, superior long-term TAR rate of 2.7% compared to the GDC detachable coils' rate of 9.6%.
“The MAPS trial shows that the field of neurointervention is now mature enough to successfully carry out a randomized, prospective trial that is rigorously overseen, assesses the performance of contemporary technology, and is applicable worldwide,” commented Dr. McDougall, who is the current president of SNIS. “While not comparing clipping to coiling, the trial shows better endovascular results than previous benchmark studies, specifically ISAT (International Subarachnoid Aneurysm Trial) and ISUIA (International Study of Unruptured Intracranial Aneurysms). In addition, the trial's clinical endpoint has been demonstrated to be clinically relevant and correlate with immediate posttreatment angiogram, making it reliable and easily adopted by future studies to ensure a consistent measure of treatment success.”
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