Trial puts coiling on the MAP(S) for aneurysm treatment
Performing coiling in patients who suffer from both ruptured and unruptured aneurysm is safe and effective and showed high rates of post-procedure survival, according to the results of the MAPS trial presented at this year’s Society of NeuroInterventional Surgery meeting July 27 in Colorado Springs, Colo.
The MAPS (Matrix and Platinum Science) trial enrolled 626 patients between the ages of 18 and 80 who had documented, untreated, ruptured or unruptured, intracranial saccular aneurysm (2-20 mm in size). Primary coiling treatment was planned to be completed during a single procedure and patients were treated with either the Matrix2 detachable coils or GDC detachable coils.
Trial objectives included:
S. Claiborne Johnston, MD, PhD, of the University of California, San Francisco’s neurocritical care and stroke department, and colleagues reported that the trial met its primary endpoints and that the Matrix2 was not inferior to GDC coils. Additionally, the authors reported that patients treated with the Matrix device had a lower incidence rate of TAR compared to patients treated with GDC.
Ninety-six percent of patients with unruptured aneurysms and 90 percent of patients with acutely ruptured aneurysms survived and were free of disability up to 15 months post-treatment. Johnston et al also found that the reintervention rates between the Matrix and GDC devices at 12 months were similar (10.3 percent vs. 11.1 percent). Matrix2 detachable coils were as effective as GDC detachable coils, the authors reported. The TAR rates were 13.3 percent versus 14.6 percent for Matrix and GDC coils, respectively.
The results also showed that in patients with aneurysms with good occlusion post-procedure, Matrix2 demonstrated a superior long-term TAR rate of 2.7 percent compared to the 9.6 percent reported with GDC coils.
The researchers reported that coiling is a safe and effective treatment option for ruptured and unruptured aneurysms.
“TAR is a meaningful and measurable outcome for assessment of clinical outcomes in aneurysm coiling,” the authors concluded. Additionally, they wrote that the clinical endpoint, TAR, will establish an industry baseline for the evaluation of aneurysm treatment in practice.
“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,” Cameron McDougall, MD, current president of the Society of NeuroInterventional Surgery said in a statement.
“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 post-treatment angiogram, making it reliable and easily adopted by future studies to ensure a consistent measure of treatment success.”
The neurovascular division of Boston Scientific (now Stryker Neurovascular) initiated the MAPS trial in 2005.
The MAPS (Matrix and Platinum Science) trial enrolled 626 patients between the ages of 18 and 80 who had documented, untreated, ruptured or unruptured, intracranial saccular aneurysm (2-20 mm in size). Primary coiling treatment was planned to be completed during a single procedure and patients were treated with either the Matrix2 detachable coils or GDC detachable coils.
Trial objectives included:
- Establishing target aneurysm recurrence (TAR) rates, a clinically relevant recurrence resulting in target aneurysm reintervention, rupture/re-rupture and/or neurologic death for Matrix2 coils and GDC coils that are indicated to treat ruptured or unruptured intracranial saccular aneurysms; and
- Correlating defined angiographic endpoints with TAR rates and assess their predictive value, providing a framework to establish relevant clinical endpoints for future studies.
S. Claiborne Johnston, MD, PhD, of the University of California, San Francisco’s neurocritical care and stroke department, and colleagues reported that the trial met its primary endpoints and that the Matrix2 was not inferior to GDC coils. Additionally, the authors reported that patients treated with the Matrix device had a lower incidence rate of TAR compared to patients treated with GDC.
Ninety-six percent of patients with unruptured aneurysms and 90 percent of patients with acutely ruptured aneurysms survived and were free of disability up to 15 months post-treatment. Johnston et al also found that the reintervention rates between the Matrix and GDC devices at 12 months were similar (10.3 percent vs. 11.1 percent). Matrix2 detachable coils were as effective as GDC detachable coils, the authors reported. The TAR rates were 13.3 percent versus 14.6 percent for Matrix and GDC coils, respectively.
The results also showed that in patients with aneurysms with good occlusion post-procedure, Matrix2 demonstrated a superior long-term TAR rate of 2.7 percent compared to the 9.6 percent reported with GDC coils.
The researchers reported that coiling is a safe and effective treatment option for ruptured and unruptured aneurysms.
“TAR is a meaningful and measurable outcome for assessment of clinical outcomes in aneurysm coiling,” the authors concluded. Additionally, they wrote that the clinical endpoint, TAR, will establish an industry baseline for the evaluation of aneurysm treatment in practice.
“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,” Cameron McDougall, MD, current president of the Society of NeuroInterventional Surgery said in a statement.
“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 post-treatment angiogram, making it reliable and easily adopted by future studies to ensure a consistent measure of treatment success.”
The neurovascular division of Boston Scientific (now Stryker Neurovascular) initiated the MAPS trial in 2005.