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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.

SUBMITTER: Zaidat OO

PROVIDER: S-EPMC6629893 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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

Zaidat Osama O OO Castonguay Alicia C AC Rai Ansaar T AT Badruddin Aamir A Mack William J WJ Alshekhlee Amer K AK Shah Qaisar A QA Hussain Syed I SI Kabbani Mouhammed R MR Bulsara Ketan R KR Taqi Asif M AM Janardhan Vallabh V Patterson Mary S MS Nordhaus Brittany L BL Elijovich Lucas L Puri Ajit S AS

Frontiers in neurology 20190709

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 pa ...[more]

PMID: 31338061

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Project description:Background and purposeStent-assisted coiling was initially invented for wide-neck aneurysms, but is now used for smaller berry aneurysms. The aim of this study was to compare the safety and efficiency of stent-assisted coiling with conventional coiling in treatment of intracranial aneurysms.MethodsA meta-analysis of studies that compared stent-assisted coiling with coiling only was conducted by searching English literatures via Pubmed, Medline and Cochrane Library databases without restricting the publication year. The primary outcomes in this study were immediate occlusion, progressive thrombosis rate, all-complication rate and angiographic recurrence. The secondary outcomes examined were packing density, mortality, permanent complication and thromboembolic complication rate.ResultsTen retrospective cohort studies were included. There is currently only one unfinished randomized study. Although the stent-assisted coiling group tended to show a lower initial occlusion rate than that of the coiling-only group (57.6% versus 68.7%; OR, 0.66; 95% CI, 0.30-1.44; P = 0.30), it achieved a significantly higher progressive thrombosis rate during follow up compared to that of the coiling only group (37.5% versus 19.4%; OR, 2.75; 95% CI, 1.95-3.86; P<0.00001) and a significantly lower recurrence rate (16.2% versus 34.4%; OR, 0.35; 95% CI, 0.25-0.49; P<0.00001). With respect to safety concerns, the all-complication rate (17.6% versus 15.9%; OR, 1.12; 95% CI, 0.77-1.62; P = 0.56), mortality rate (9.1% versus 2.6%; OR, 2.31; 95% CI, 0.68-7.82; P = 0.18), permanent complication rate (5.6% versus 3.9%; OR, 1.52; 95% CI, 0.96-2.41; P = 0.08) and thromboembolic complication rate (4.2% versus 4.9%; OR, 0.99; 95% CI, 0.41-2.38; P = 0.97) did not show significant difference between the two groups.ConclusionsStent-assisted coiling has a lower recurrence rate than conventional coiling. Analysis of complication events did not show any significant difference between the two methods. Despite the findings reported herein, further validation by well-designed prospective studies is needed.

Project description:BackgroundUnruptured intracranial aneurysms (UIA) are increasingly being treated by endovascular coiling as opposed to open surgical clipping. Unfortunately, endovascular coiling imparts an approximate 25% recanalization rate, leading to additional procedures and increased rupture risk. While a new health technology innovation (HTI) that reduces this recanalization rate would benefit patients, few advancements have been made. We aim to determine whether cost-effectiveness has been a barrier to HTI.MethodsA probabilistic Markov model was constructed from the healthcare payer perspective to compare standard endovascular treatment of UIA to standard treatment plus the addition of a HTI adjunct. Costs were measured in 2018 USD and health outcomes were measured in quality-adjusted life-years (QALY). In the base case, the HTI was a theoretical mesenchymal stem cell therapy which reduced the aneurysm recanalization rate by 50% and cost $10,000 per procedure. All other model inputs were derived from the published scientific literature.ResultsBased on the model results, we found that for a given HTI price (y) and relative risk reduction of aneurysm recanalization (x), the HTI was always cost-effective if the following equation was satisfied: y ≤ 20268 ∙ x, using a willingness-to-pay threshold of $50,000 per QALY. The uncertainty surrounding whether an aneurysm would recanalize was a significant driver within the model. When the uncertainty around the risk of aneurysm recanalization was eliminated, the 10-year projected additional benefit to the United States healthcare system was calculated to be $113,336,994.ConclusionCost-effectiveness does not appear to be a barrier to innovation in reducing the recanalization rate of UIA treated by endovascular coil embolization. Our model can now be utilized by academia and industry to accentuate economically feasible HTI and by healthcare payers to calculate their maximum willingness-to-pay for a new technology. Our results also indicate that predicting a patient's baseline risk of aneurysm recanalization is a critical area of future research.

Project description:BackgroundOne limitation of the endovascular treatment of intracranial aneurysms is aneurysm recanalization. The Analysis of Recanalization after Endovascular Treatment of intracranial Aneurysm (ARETA) study is a prospective multicenter cohort study evaluating the factors associated with recanalization after endovascular treatment.MethodsThe current analysis is focused on patients treated by coiling or balloon-assisted coiling (BAC). Postoperative, mid-term vascular imaging, and evolution of aneurysm occlusion were independently evaluated by two neuroradiologists. A 3-grade scale was used for aneurysm occlusion (complete occlusion, neck remnant, and aneurysm remnant) and for occlusion evolution (improved, stable, and worsened). Recanalization was defined as any worsening of aneurysm occlusion.ResultsBetween December 2013 and May 2015, 16 French neurointerventional departments enrolled 1289 patients. A total of 945 aneurysms in 908 patients were treated with coiling or BAC. The overall rate of aneurysm recanalization at mid-term follow-up was 29.5% (95% CI 26.6% to 32.4%): 28.9% and 30.3% in the coiling and BAC groups, respectively. In multivariate analyses factors independently associated with recanalization were current smoking (36.6% in current smokers vs 24.5% in current non-smokers (OR 1.8 (95% CI 1.3 to 2.4); p=0.0001), ruptured status (31.9% in ruptured aneurysms vs 25.1% in unruptured (OR 1.5 (95% CI 1.1 to 2.1); p=0.006), aneurysm size ≥10 mm (48.8% vs 26.5% in aneurysms <10 mm (OR 2.6 (95% CI 1.8 to 3.9); p<0.0001), wide neck (32.1% vs 25.8% in narrow neck (OR 1.5 (95% CI 1.1 to 2.1); p=0.02), and MCA location (34.3% vs 28.3% in other locations (OR 1.5 (95% CI 1.0 to 2.1); p=0.04).ConclusionsSeveral factors are identified by the ARETA study as playing a role in aneurysm recanalization after coiling: current smoking, aneurysm status (ruptured), aneurysm size (≥10 mm), neck size (wide neck), and aneurysm location (middle cerebral artery). This finding has important consequences in clinical practice.Trial registration numberURL: http://www.Clinicaltrialsgov; Unique Identifier: NCT01942512.

Dataset Information

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

Publications

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

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