J Raymond1, R Klink2, M Chagnon3, S L Barnwell4, A J Evans5, J Mocco6, B H Hoh7, A S Turk8, R D Turner8, H Desal9, D Fiorella10, S Bracard11, A Weill12, F Guilbert12, S Lanthier13, A J Fox14, T E Darsaut15, P M White16, D Roy12. 1. From the Departments of Radiology (J.R., A.W., F.G., D.R.) jean.raymond@umontreal.ca. 2. Laboratory of Interventional Neuroradiology (R.K.), Research Centre of the Centre Hospitalier de l'Université de Montreal, Quebec, Canada. 3. Department of Mathematics and Statistics (M.C.), Université de Montréal, Montreal, Quebec, Canada. 4. Department of Neurological Surgery (S.L.B.), Oregon Health and Science University, Portland, Oregon. 5. Department of Radiology and Medical Imaging (A.J.E.), University of Virginia, Charlottesville, Virginia. 6. Department of Neurosurgery (J.M.), Mount Sinai Health System, New York, New York. 7. Department of Neurosurgery (B.H.H.), University of Florida, Gainesville, Florida. 8. Department of Neurosurgery (A.S.T., R.D.T.), Medical University of South Carolina, Charleston, South Carolina. 9. Service de Neuroradiologie Diagnostique et Interventionnelle (H.D.), Centre Hospitalier Universitaire de Nantes, Nantes, France. 10. Cerebrovascular Center (D.F.), Stony Brook University Medical Center, Stony Brook, New York. 11. Département de Neuroradiologie Diagnostique et Interventionnelle (S.B.), Centre Hospitalier Universitaire de Nancy, Nancy, France. 12. From the Departments of Radiology (J.R., A.W., F.G., D.R.). 13. Neurosciences (S.L.), Centre Hospitalier de l'Université de Montreal, Montreal, Quebec, Canada. 14. Department of Medical Imaging (A.J.F.), University of Toronto, Toronto, Ontario, Canada. 15. Department of Surgery (T.E.D.), Division of Neurosurgery, University of Alberta Hospital, Edmonton, Alberta, Canada. 16. Stroke Research Group (P.M.W.), Institute of Neuroscience, Newcastle Upon Tyne, UK.
Abstract
BACKGROUND AND PURPOSE: Some patients are at high risk of aneurysm recurrence after endovascular treatment: patients with large aneurysms (Patients Prone to Recurrence After Endovascular Treatment PRET-1) or with aneurysms that have previously recurred after coiling (PRET-2). We aimed to establish whether the use of hydrogel coils improved efficacy outcomes compared with bare platinum coils. MATERIALS AND METHODS: PRET was an investigator-led, pragmatic, multicenter, parallel, randomized (1:1) trial. Randomized allocation was performed separately for patients in PRET-1 and PRET-2, by using a Web-based platform ensuring concealed allocation. The primary outcome was a composite of a residual/recurrent aneurysm, adjudicated by a blinded core laboratory, or retreatment, intracranial bleeding, or mass effect during the 18-month follow-up. Secondary outcomes included adverse events, mortality, and morbidity (mRS > 2). The hypothesis was that hydrogel would decrease the primary outcome from 50% to 30% at 18 months, necessitating 125 patients per group (500 for PRET-1 and PRET-2). RESULTS: The trial was stopped once 250 patients in PRET-1 and 197 in PRET-2 had been recruited because of slow accrual. A poor primary outcome occurred in 44.4% (95% CI, 35.5%-53.2%) of those in PRET-1 allocated to platinum compared with 52.5% (95% CI, 43.4%-61.6%) of patients allocated to hydrogel (OR, 1.387; 95% CI, 0.838-2.295; P = .20) and in 49.0% (95% CI, 38.8%-59.1%) in PRET-2 allocated to platinum compared with 42.1% (95% CI, 32.0%-52.2%) allocated to hydrogel (OR, 0.959; 95% CI, 0.428-1.342; P = .34). Adverse events and morbidity were similar. There were 3.6% deaths (1.4% platinum, 5.9% hydrogel; P = .011). CONCLUSIONS: Coiling of large and recurrent aneurysms is safe but often poorly effective according to angiographic results. Hydrogel coiling was not shown to be better than platinum.
RCT Entities:
BACKGROUND AND PURPOSE: Some patients are at high risk of aneurysm recurrence after endovascular treatment: patients with large aneurysms (Patients Prone to Recurrence After Endovascular Treatment PRET-1) or with aneurysms that have previously recurred after coiling (PRET-2). We aimed to establish whether the use of hydrogel coils improved efficacy outcomes compared with bare platinum coils. MATERIALS AND METHODS: PRET was an investigator-led, pragmatic, multicenter, parallel, randomized (1:1) trial. Randomized allocation was performed separately for patients in PRET-1 and PRET-2, by using a Web-based platform ensuring concealed allocation. The primary outcome was a composite of a residual/recurrent aneurysm, adjudicated by a blinded core laboratory, or retreatment, intracranial bleeding, or mass effect during the 18-month follow-up. Secondary outcomes included adverse events, mortality, and morbidity (mRS > 2). The hypothesis was that hydrogel would decrease the primary outcome from 50% to 30% at 18 months, necessitating 125 patients per group (500 for PRET-1 and PRET-2). RESULTS: The trial was stopped once 250 patients in PRET-1 and 197 in PRET-2 had been recruited because of slow accrual. A poor primary outcome occurred in 44.4% (95% CI, 35.5%-53.2%) of those in PRET-1 allocated to platinum compared with 52.5% (95% CI, 43.4%-61.6%) of patients allocated to hydrogel (OR, 1.387; 95% CI, 0.838-2.295; P = .20) and in 49.0% (95% CI, 38.8%-59.1%) in PRET-2 allocated to platinum compared with 42.1% (95% CI, 32.0%-52.2%) allocated to hydrogel (OR, 0.959; 95% CI, 0.428-1.342; P = .34). Adverse events and morbidity were similar. There were 3.6% deaths (1.4% platinum, 5.9% hydrogel; P = .011). CONCLUSIONS: Coiling of large and recurrent aneurysms is safe but often poorly effective according to angiographic results. Hydrogel coiling was not shown to be better than platinum.
Authors: Joris A Broeders; Usama Ahmed Ali; Andrew J Molyneux; Wojciech Poncyljusz; Jean Raymond; Phillip M White; Brendan Steinfort Journal: J Neurointerv Surg Date: 2015-09-10 Impact factor: 5.836
Authors: Jean Raymond; François Guilbert; Alain Weill; Stavros A Georganos; Louis Juravsky; Anick Lambert; Julie Lamoureux; Miguel Chagnon; Daniel Roy Journal: Stroke Date: 2003-05-29 Impact factor: 7.914
Authors: J Raymond; R Klink; M Chagnon; S L Barnwell; A J Evans; J Mocco; B L Hoh; A S Turk; R D Turner; H Desal; D Fiorella; S Bracard; A Weill; F Guilbert; D Roy Journal: AJNR Am J Neuroradiol Date: 2014-06-19 Impact factor: 3.825
Authors: Andrew J Molyneux; Richard S C Kerr; Ly-Mee Yu; Mike Clarke; Mary Sneade; Julia A Yarnold; Peter Sandercock Journal: Lancet Date: 2005 Sep 3-9 Impact factor: 79.321
Authors: Jingjie Hu; Hassan Albadawi; Brian W Chong; Amy R Deipolyi; Rahul A Sheth; Ali Khademhosseini; Rahmi Oklu Journal: Adv Mater Date: 2019-06-06 Impact factor: 30.849
Authors: Zefu Zhang; Hassan Albadawi; Richard J Fowl; Izzet Altun; Marcela A Salomao; Jama Jahanyar; Brian W Chong; Joseph L Mayer; Rahmi Oklu Journal: Adv Mater Date: 2022-01-21 Impact factor: 30.849
Authors: Sarah M Chau; Scott M Herting; Dillon A Noltensmeyer; Hamzah Ahmed; Duncan J Maitland; Shreya Raghavan Journal: J Biomed Mater Res B Appl Biomater Date: 2022-01-28 Impact factor: 3.405
Authors: Bernard R Bendok; Karl R Abi-Aad; Jennifer D Ward; Jason F Kniss; Mary J Kwasny; Rudy J Rahme; Salah G Aoun; Tarek Y El Ahmadieh; Najib E El Tecle; Samer G Zammar; Rami James N Aoun; Devi P Patra; Sameer A Ansari; Jean Raymond; Henry H Woo; David Fiorella; Guilherme Dabus; Genevieve Milot; Josser E Delgado Almandoz; John A Scott; Andrew J DeNardo; Shervin R Dashti Journal: Neurosurgery Date: 2020-05-01 Impact factor: 4.654
Authors: A Benomar; B Farzin; G Gevry; W Boisseau; D Roy; A Weill; D Iancu; F Guilbert; L Létourneau-Guillon; G Jacquin; C Chaalala; M W Bojanowski; M Labidi; R Fahed; D Volders; T N Nguyen; J-C Gentric; E Magro; G Boulouis; G Forestier; J-F Hak; J S Ghostine; Z Kaderali; J J Shankar; M Kotowski; T E Darsaut; J Raymond Journal: AJNR Am J Neuroradiol Date: 2021-07-29 Impact factor: 4.966
Authors: Siham Hourani; Kartik Motwani; Daisuke Wajima; Hanain Fazal; Chad H Jones; Sylvain Doré; Koji Hosaka; Brian L Hoh Journal: Front Neurol Date: 2018-03-19 Impact factor: 4.003