TARGET® Intracranial Aneurysm Coiling Prospective Multicenter Registry: Final Analysis of Peri-Procedural and Long-Term Safety and Efficacy Results

Abstract

Background and Purpose: To describe the final results of the TARGET Registry, a multicenter, real-world study of patients with intracranial aneurysms treated with new generation TARGET Coils. Methods: The TARGET Registry is a prospective, single-arm study with independent medical event monitoring and core-lab adjudication. Patients with de novo intracranial aneurysms were embolized with either TARGET-360° or helical coils in 12 US centers. The primary outcome was aneurysm packing density (PD), which was assessed immediately post-procedure. The secondary outcomes were immediate and long-term aneurysm occlusion rate using the Raymond Scale, and independent functional outcome using the modified Rankin Scale (mRS). A secondary analysis investigated the influence of the use of 100% 360-complex coils on clinical and angiographic outcomes. Results: 148 patients with 157 aneurysms met the inclusion and exclusion criteria. 58 (39.2%) patients with ruptured and 90 (61.8%) with unruptured aneurysms were treated using TARGET 360°, helical Coils, or both. Median age was 58.3 (IQR 48.1–67.4), 73% female, and 71.6% were Caucasian. Median follow-up time was 5.9 (IQR 4.0–6.9) months. The majority were treated with TARGET 360-coils (63.7%), followed by mixed and helical coils only. Peri-procedural morbidity and mortality was seen in 2.7% of patients. A good outcome at discharge (mRS 0–2) was seen in 89.9% of the full cohort, and in 84.5 and 93.3% in the ruptured and unruptured patients, respectively. The median packing density was 28.8% (IQR 20.3–41.1). Long-term complete and near complete occlusion rate was seen in 90.4% of aneurysms and complete obliteration was seen in 66.2% of the aneurysms. No significant difference in clinical and angiographic outcomes were noted between the pure 360-complex coiling vs. mixed 360-complex/Helical coiling strategies. In a multivariate analysis, predictors for long-term aneurysm occlusion were aneurysm location, immediate occlusion grade, and aneurysm size. The long-term independent functional outcome was achieved in 128/135 (94.8%) patients and all-cause mortality was seen in 3/148 (2%) patients. Conclusion: In the multicenter TARGET Registry, two-thirds of aneurysms achieved long-term complete occlusion and 91.0% achieved complete or near complete occlusion with excellent independent functional outcome. Clinical Trial Registration: www.ClinicalTrials.gov , identifier: NCT01748903

Basilar Artery Bifurcation Aneurysm: Small Wide-Necked Incidental Basilar Artery Bifurcation Aneurysm, Treated with Staged pCONUS1 HPC Implantation and Coil Occlusion; Protrusion of a Coil Loop into the Basilar Artery Bifurcation, Which Prompted the Removal of That Coil Using an Alligator Device

“…The coil protrusion from the aneurysm sac into the basilar artery bifurcation occurred while the third coil was being prepared. The Target 360 coil is currently our preferred 3D coil product, and our good results are essentially in line with published data (Zaidat et al 2019). Both secondary spontaneous displacement of coil loops and coil migration through the petals of a pCONUS1 HPC are infrequently encountered issues.…”

The SMART Registry: Long-Term Results on the Utility of the Penumbra SMART COIL System for Treatment of Intracranial Aneurysms and Other Malformations

“…The SMART Registry outcomes are comparable to contemporary studies of other coils. The TARGET Registry was a prospective, single-arm registry that compared outcomes for patients with saccular (ruptured and unruptured) intracranial aneurysms treated exclusively with TARGET-360 • (Stryker Corp., Fremont, California) complex shape coils (designated for framing, filling, and finishing) vs. patients treated with both complex shape and helical coils (12). There were no significant differences between the groups for complete or near complete occlusion and in retreatment rates at 6 months, or for any other safety or efficacy outcomes.…”

“…Mortality within 24 h of the procedure in the overall population was low (0.2%) and none were procedural or device-related. In the TARGET real-world randomized trial that evaluated outcomes after coiling aneurysms, the periprocedural mortality rate was 0.7% (12). In the GREAT trial for aneurysms, the 14-day mortality was 2.1% in the bare platinum coil arm (13).…”

“…RROC III immediate post-procedure, aneurysm size, balloon-assisted coiling, and ruptured aneurysm were predictors for RROC III or retreatment (incomplete occlusion) at 1-year. The predictors for occlusion in the TARGET Registry were aneurysm location, size, and immediate occlusion grade (12).…”

Toward the Development of a Shape Memory Polymer for Individualized Endovascular Therapy of Intracranial Aneurysms Using a 3D‐Printing/Leaching Method

“…Despite the great advances in ICA endovascular technologies, the occlusion effectiveness of state‐of‐the‐art endovascular devices is far below optimal, especially when treating large ICAs with complex 3D geometries. For example, the GDCs have exhibited 50–66% complete occlusion rates, [ 12–15 ] while hydrogel‐coated coils showed complete occlusion rates of , [ 14 ] not significantly superior to the GDCs, according to meta‐analysis. [ 16 ] In addition, other endovascular devices, such as the the Woven EndoBridge and flow diverters, only reach complete occlusion rates of .…”