Comparison of Thromboembolic Events Between Pipeline Embolization Device (PED) Shield and PED/PED Flex: A Propensity Score-Matched Analysis.
Journal
Neurosurgery
ISSN: 1524-4040
Titre abrégé: Neurosurgery
Pays: United States
ID NLM: 7802914
Informations de publication
Date de publication:
23 Feb 2024
23 Feb 2024
Historique:
received:
20
11
2023
accepted:
04
01
2024
medline:
23
2
2024
pubmed:
23
2
2024
entrez:
23
2
2024
Statut:
aheadofprint
Résumé
The pipeline embolization device (PED) Flex with Shield technology is a third-generation flow diverter used for intracranial aneurysm treatment designed to decrease thrombogenicity through a phosphorylcholine coating. Herein, we aim to compare the rate of thromboembolic events in PED with Shield technology and PED without it through propensity score matching. We conducted a retrospective analysis of aneurysms treated with PED first-generation/PED Flex and PED with Shield between 2013 and 2023 at a single academic institution. Patients were matched through propensity score by controlling for confounding factors including age, smoking history, diabetes, previous subarachnoid hemorrhage, modified Rankin Scale pretreatment, location, aneurysm size, previous treatment, and clopidogrel or aspirin resistance. After matching, we evaluated for periprocedural and postoperative thromboembolic events. Data analysis was performed using Stata 14. A total of 543 patients with 707 aneurysms treated in 605 procedures were included in the analysis. From these, 156 aneurysms were treated with PED with Shield (22.07%) and 551 (77.93%) without Shield technology. Propensity score matching resulted in 84 matched pairs. The rate of thromboembolic events was 3.57% for PED Shield and 10.71% for PED first-generation/PED Flex (P = .07), while retreatment rates were 2.38% for PED Shield and 8.32% for PED Flex (P = .09). Complete occlusion at first (P = .41) and last imaging follow-up (P = .71), in-stent stenosis (P = .95), hemorrhagic complications (P = .31), and functional outcomes (P = .66) were comparable for both groups. This is the first study in the literature performing a propensity scored-matched analysis comparing PED with PED with Shield technology. Our study suggests a trend toward lower thromboembolic events for PED Shield, even after controlling for aspirin and clopidogrel resistance, and a trend toward lower aneurysm retreatment rates with PED Shield, without reaching statistical significance.
Sections du résumé
BACKGROUND AND OBJECTIVES
OBJECTIVE
The pipeline embolization device (PED) Flex with Shield technology is a third-generation flow diverter used for intracranial aneurysm treatment designed to decrease thrombogenicity through a phosphorylcholine coating. Herein, we aim to compare the rate of thromboembolic events in PED with Shield technology and PED without it through propensity score matching.
METHODS
METHODS
We conducted a retrospective analysis of aneurysms treated with PED first-generation/PED Flex and PED with Shield between 2013 and 2023 at a single academic institution. Patients were matched through propensity score by controlling for confounding factors including age, smoking history, diabetes, previous subarachnoid hemorrhage, modified Rankin Scale pretreatment, location, aneurysm size, previous treatment, and clopidogrel or aspirin resistance. After matching, we evaluated for periprocedural and postoperative thromboembolic events. Data analysis was performed using Stata 14.
RESULTS
RESULTS
A total of 543 patients with 707 aneurysms treated in 605 procedures were included in the analysis. From these, 156 aneurysms were treated with PED with Shield (22.07%) and 551 (77.93%) without Shield technology. Propensity score matching resulted in 84 matched pairs. The rate of thromboembolic events was 3.57% for PED Shield and 10.71% for PED first-generation/PED Flex (P = .07), while retreatment rates were 2.38% for PED Shield and 8.32% for PED Flex (P = .09). Complete occlusion at first (P = .41) and last imaging follow-up (P = .71), in-stent stenosis (P = .95), hemorrhagic complications (P = .31), and functional outcomes (P = .66) were comparable for both groups.
CONCLUSION
CONCLUSIONS
This is the first study in the literature performing a propensity scored-matched analysis comparing PED with PED with Shield technology. Our study suggests a trend toward lower thromboembolic events for PED Shield, even after controlling for aspirin and clopidogrel resistance, and a trend toward lower aneurysm retreatment rates with PED Shield, without reaching statistical significance.
Identifiants
pubmed: 38391195
doi: 10.1227/neu.0000000000002883
pii: 00006123-990000000-01068
doi:
Banques de données
ClinicalTrials.gov
['NCT04870047']
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
Copyright © Congress of Neurological Surgeons 2024. All rights reserved.
Références
Enriquez-Marulanda A, Young MM, Taussky P. Flow diversion: a disruptive technology coming of age. Lessons learned and challenges for the future. J Neurosurg. 2023;139(5):1317-1327.
Ravindran K, Casabella AM, Cebral J, Brinjikji W, Kallmes DF, Kadirvel R. Mechanism of action and biology of flow diverters in the treatment of intracranial aneurysms. Neurosurgery. 2020;86(Suppl 1):S13-S19.
Brasiliense LBC, Stanley MA, Grewal SS, et al. Silent ischemic events after Pipeline embolization device: a prospective evaluation with MR diffusion-weighted imaging. J Neurointerv Surg. 2016;8(11):1136-1139.
Briganti F, Napoli M, Tortora F, et al. Italian multicenter experience with flow-diverter devices for intracranial unruptured aneurysm treatment with periprocedural complications—a retrospective data analysis. Neuroradiology. 2012;54(10):1145-1152.
Burrows AM, Cloft H, Kallmes DF, Lanzino G. Periprocedural and mid-term technical and clinical events after flow diversion for intracranial aneurysms. J Neurointerv Surg. 2015;7(9):646-651.
Zoppo CT, Mocco J, Manning NW, Bogdanov AAJ, Gounis MJ. Surface modification of neurovascular stents: from bench to patient. J Neurointerventional Surg. Published online October 4, 2023. doi: 10.1136/jnis-2023-020620.
doi: 10.1136/jnis-2023-020620
Girdhar G, Li J, Kostousov L, Wainwright J, Chandler WL. In-vitro thrombogenicity assessment of flow diversion and aneurysm bridging devices. J Thromb Thrombolysis. 2015;40(4):437-443.
Starke RM, Thompson J, Pagani A, et al. Preclinical safety and efficacy evaluation of the pipeline vantage embolization device with shield technology. J Neurointerv Surg. 2020;12(10):981-986.
Bounajem MT, Joyce E, Scoville JP, et al. Safety and efficacy of the Pipeline Flex embolization device with Shield Technology for the acute treatment of ruptured internal carotid artery pseudoaneurysms: a multi-institution case series. Neurosurg Focus. 2023;54(5):E4.
Yeomans J, Sandu L, Sastry A. Pipeline Flex embolisation device with Shield Technology for the treatment of patients with intracranial aneurysms: periprocedural and 6 month outcomes. Neuroradiol J. 2020;33(6):471-478.
Chia GS, De Villiers L, Carraro do Nascimento V, et al. Safety and clinical effectiveness of pipeline shield device for intracranial aneurysms in an Australian cohort (SCOPE-AUS). Stroke: Vasc Interv Neurol. 2022;2(5):e000292.
Martínez-Galdámez M, Lamin SM, Lagios KG, et al. Treatment of intracranial aneurysms using the pipeline flex embolization device with shield technology: angiographic and safety outcomes at 1-year follow-up. J Neurointerv Surg. 2019;11(4):396-399.
Manning NW, Cheung A, Phillips TJ, Wenderoth JD. Pipeline shield with single antiplatelet therapy in aneurysmal subarachnoid haemorrhage: multicentre experience. J Neurointerv Surg. 2019;11(7):694-698.
El Naamani K, Mastorakos P, Yudkoff CJ, et al. Comparison of PED/PED Flex and PED Shield in the treatment of unruptured intracerebral aneurysms. J Neurosurg. 2023;140(2):436-440.
Lordkipanidzé M, Pharand C, Schampaert E, Turgeon J, Palisaitis DA, Diodati JG. A comparison of six major platelet function tests to determine the prevalence of aspirin resistance in patients with stable coronary artery disease. Eur Heart J. 2007;28(14):1702-1708.
Leung GKK, Tsang ACO, Lui WM. Pipeline embolization device for intracranial aneurysm: a systematic review. Clin Neuroradiol. 2012;22(4):295-303.
Bhatia KD, Kortman H, Orru E, Klostranec JM, Pereira VM, Krings T. Periprocedural complications of second-generation flow diverter treatment using pipeline flex for unruptured intracranial aneurysms: a systematic review and meta-analysis. J Neurointerv Surg. 2019;11(8):817-824.
Hanel RA, Aguilar-Salinas P, Brasiliense LB, Sauvageau E. First US experience with Pipeline Flex with Shield Technology using aspirin as antiplatelet monotherapy. BMJ Case Rep. 2017;2017:bcr2017219406.
Trivelato FP, Wajnberg E, Rezende MTS, et al. Safety and effectiveness of the pipeline flex embolization device with shield technology for the treatment of intracranial aneurysms: midterm results from a multicenter study. Neurosurgery. 2020;87(1):104-111.
Rice H, Martínez Galdámez M, Holtmannspötter M, et al. Periprocedural to 1-year safety and efficacy outcomes with the pipeline embolization device with shield technology for intracranial aneurysms: a prospective, post-market, multi-center study. J Neurointerv Surg. 2020;12(11):1107-1112.
Hanel RA, Kallmes DF, Lopes DK, et al. Prospective study on embolization of intracranial aneurysms with the pipeline device: the PREMIER study 1 year results. J Neurointerv Surg. 2020;12(1):62-66.
Grandhi R, Ravindra VM, Kallmes DF, Lopes D, Hanel RA, Lylyk P. Treatment of giant intracranial aneurysms using the pipeline flow-diverting stent: long-term results from the International Retrospective Study of the Pipeline Embolization Device (IntrePED) study. Interv Neuroradiol. Published online September 27, 2022. doi: 10.1177/15910199221123282.
doi: 10.1177/15910199221123282
Arai S, Fujii T, Teranishi K, et al. Pipeline flex with shield technology placement for small- and medium-sized aneurysms achieves early complete occlusion. Neurol Med Chir. 2023;63(2):58-64.
White TG, Santhumayor BA, Turpin J, et al. Flow diverter surface modifications for aneurysm treatment: a review of the mechanisms and data behind existing technologies. Interv Neuroradiol. Published online October 29, 2023. doi: 10.1177/15910199231207550.
doi: 10.1177/15910199231207550
Luo C, Jin L, Dong J, et al. Clinical outcomes of pipeline embolization devices with shield technology for treating intracranial aneurysms. Front Neurol. 2022;13:971664.
Li YL, Roalfe A, Chu EYL, Lee R, Tsang ACO. Outcome of flow diverters with surface modifications in treatment of cerebral aneurysms: systematic review and meta-analysis. AJNR Am J Neuroradiol. 2021;42(2):327-333.
Pikis S, Mantziaris G, Mamalis V, et al. Diffusion weighted image documented cerebral ischemia in the postprocedural period following pipeline embolization device with shield technology treatment of unruptured intracranial aneurysms: a prospective, single center study. J Neurointerv Surg. 2020;12(4):407-411.
Cortez GM, Benalia VHC, Sauvageau E, Aghaebrahim A, Pederson JM, Hanel RA. Diffusion-weighted imaging lesions after intracranial aneurysm treatment with Pipeline Flex and Pipeline Flex with Shield technology: a retrospective cohort analysis. J Neurointerv Surg. Published online May 17, 2023. doi: 10.1136/jnis-2023-020250.
doi: 10.1136/jnis-2023-020250
Bond KM, Brinjikji W, Murad MH, Kallmes DF, Cloft HJ, Lanzino G. Diffusion-weighted imaging-detected ischemic lesions following endovascular treatment of cerebral aneurysms: a systematic review and meta-analysis. AJNR Am J Neuroradiol. 2017;38(2):304-309.
Ikizceli T, Donmez H, Kahveci S, Kahriman G. Ischaemic brain changes associated with catheter-based diagnostic cerebral angiography: a diffusion-weighted imaging study. Pol J Radiol. 2021;86:e481-e486.
Lim J, Monteiro A, Cortez GM, et al. Early termination versus standard regimen duration of dual antiplatelet therapy in intracranial aneurysm patients treated with pipeline embolization device flex with shield technology: preliminary experience of 3 U.S. Centers. World Neurosurg. 2023;178:e465-e471.
Döring K, Aburub A, Krauss JK, et al. Early clinical experience with the new generation Pipeline Vantage flow diverter in the treatment of unruptured saccular aneurysms using short-term dual antiplatelet therapy. Interv Neuroradiol. Published online October 5, 2023. doi: 10.1177/15910199231205047.
doi: 10.1177/15910199231205047
Gawlitza M, Klisch J, Kaiser DPO, Linn J, Pierot L, Lobsien D. A systematic literature review and meta-analysis of the treatment of ruptured intracranial aneurysms with hydrophilic polymer and phosphorylcholine-coated flow diverters under single antiplatelet therapy. World Neurosurg. 2023;170:e791-e800.