Steven William Hetts MD, Presenter: Consultant, Silk Road Medical Grant, Stryker Corporation

S. Claiborne Johnston, Abstract Co-Author: Consultant, Stryker Corporation

Anil Gholkar MD, Abstract Co-Author: Consultant, Stryker Corporation Consultant, Johnson & Johnson

Cameron McDougall MD, Abstract Co-Author: Nothing to Disclose

Joey D. English MD, PhD, Abstract Co-Author: Consultant, Silk Road Medical Research Grant, Stryker Corporation

Gary Nesbit MD, Abstract Co-Author: Nothing to Disclose

Sijian Grace Ge PhD, Abstract Co-Author: Employee, Stryker Corporation

Jinhua Nancy Jin PhD, Abstract Co-Author: Employee, Stryker Corporation

J. Mocco MD, Abstract Co-Author: Nothing to Disclose

Stanley Barnwell MD, PhD, Abstract Co-Author: Nothing to Disclose

Demetrius Lopes, Abstract Co-Author: Consultant, Stryker Corporation

Charles Prestigiacomo MD, Abstract Co-Author: Nothing to Disclose

To evaluate disability and mortality in patients treated with coil embolization for unruptured and ruptured intracranial aneurysms enrolled in the MAPS trial, a multicenter randomized trial that showed that Matrix2 biocompatible absorbable polymer-coated coils were noninferior to GDC bare-platinum coils.

We conducted a randomized trial with blinded outcome assessment at 43 centers worldwide. Eligible patients were 18-80 years old with a single untreated intracranial saccular aneurysm, 4-20 mm, ruptured or unruptured (Hunt and Hess score I-III, modified Rankin Scale [mRS] score 0-3) for which both Matrix2 and GDC coils were treatment options, and for which primary coiling treatment was planned to be completed during a single procedure. mRS was assessed at baseline and 1 year follow-up, and predictors of disability or mortality (mRS>3) and a worsening in the mRS were evaluated in univariate and multivariable logistic regression models.

Among 626 subjects, 570 had an mRS assessment at 1 year, of whom 208 initially presented with a ruptured aneurysm and 362 with an unruptured aneurysm. At 1 year follow-up, 24 had died (3.8%), of whom 7 (1.1%) were judged device or procedure related; another 11 were disabled (1.8%). Rates of death or disability were greater for ruptured aneurysms (9.6%) than for unruptured aneurysms (4.1%, p=0.009); however, rates of worsening in mRS were similar (ruptured 11.7% vs. 10.2%, p=0.583). Rates of death and disability were similar for those randomized to GDC compared to Matrix (p=0.601), as were rates of worsening of mRS (p=0.489). Independent predictors of death or disability were older age (per decade, OR 2.1, 95% CI 1.3-3.4, p=0.001), current smoker (OR 5.5, 1.9-15.5, p=0.0014), diabetes (OR 4.5, 1.4-14.6, P=0.012) and current use of illicit drugs or alcohol (OR 3.5, 1.0-11.9, p=0.042). Coil type (GDC vs. Matrix), other clinical characteristics, aneurysm characteristics, and retreatment were not predictors of death or disability.

Coil embolization of intracranial aneurysms is rarely associated with death or disability, with overall rates generally lower than previously reported. Although older age and initial rupture are known to be associated with worse outcomes, current smoking status, diabetes, and current use of illicit drugs or alcohol were also baseline predictors.

The safety of coil embolization of aneurysms continues to improve.

Hetts, S, Johnston, S, Gholkar, A, McDougall, C, English, J, Nesbit, G, Ge, S, Jin, J, Mocco, J, Barnwell, S, Lopes, D, Prestigiacomo, C, Death and Disability after Coil Embolization of Ruptured and Unruptured Aneurysms in the Matrix and Platinum Science (MAPS) Trial.  Radiological Society of North America 2012 Scientific Assembly and Annual Meeting, November 25 - November 30, 2012 ,Chicago IL. http://archive.rsna.org/2012/12037285.html