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

Osama O Zaidat,Mouhammed R Kabbani,Brittany L Nordhaus,Mary S Patterson,Ansaar T Rai,Asif M Taqi,Qaisar A Shah,Amer K Alshekhlee,Syed I Hussain,William J Mack,Ajit S Puri,Lucas Elijovich,Vallabh Janardhan,Ketan R Bulsara,Alicia C Castonguay,Aamir Badruddin

doi:10.3389/fneur.2019.00737

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

Highlights

The use of flow diverters and adjunctive devices has increased in recent years, detachable coils remain the mainstay approach in the endovascular treatment of intracranial aneurysms [1,2,3,4,5]
The prospective, multicenter TARGET Registry included ruptured or unruptured saccular intracranial aneurysms, which were treated with Target 360◦ coils only (360◦ group) or both Target 360◦ and Helical coils (Mixed group) (ClinicalTrials.gov Identifier: NCT01748903)
From January 2013 to May 2014, 150 patients with 159 ruptured or unruptured aneurysms were prospectively enrolled in the TARGET Registry

Summary

Introduction

The use of flow diverters and adjunctive devices has increased in recent years, detachable coils remain the mainstay approach in the endovascular treatment of intracranial aneurysms [1,2,3,4,5]. In a study of unruptured intracranial aneurysms, ∼60% of anterior circulation aneurysms were 6 mm or less, with 17% prevalence of aneurysms sizes between 1–3 mm and 43% in 4–6 mm in size range [6] These frequently encountered small intracranial aneurysms (≤6 mm) are primarily treated with aneurysm coiling with or without adjunctive devices. Complex coil shapes and 2D helical coils are routinely used to achieve high packing density, complete aneurysm occlusion, and enable the treatment of complexshaped aneurysms [7]. These coil types can be used together in a complementary approach to achieve greater aneurysm occlusion. 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

Results

Conclusion