J Raymond1, J Ghostine2, B A van Adel3, J J S Shankar4, D Iancu5, A P Mitha6, P Kvamme7, R D Turner8, A Turk8, V Mendes-Pereira9, J S Carpenter10, S Boo10, A Evans11, H H Woo12, D Fiorella12, A Alaraj13, D Roy2, A Weill2, P Lavoie14, M Chagnon15, T N Nguyen16, J L Rempel17, T E Darsaut18. 1. From the Department of Radiology (J.R., J.G., D.R., A.W.), Service of Interventional Neuroradiology, Centre Hospitalier de l'Université de Montréal, Montreal, Quebec, Canada jean.raymond@Umontreal.ca. 2. From the Department of Radiology (J.R., J.G., D.R., A.W.), Service of Interventional Neuroradiology, Centre Hospitalier de l'Université de Montréal, Montreal, Quebec, Canada. 3. Department of Surgery/Medicine (B.A.v.A), McMaster University, Hamilton, Ontario, Canada. 4. Department of Radiology (J.J.S.S.), University of Manitoba, Winnipeg, Manitoba, Canada. 5. Department of Radiology, Service of Interventional Neuroradiology (D.I.), University of Ottawa Hospitals, Civic Campus, Ottawa, Ontario, Canada. 6. Department of Clinical Neurosciences (A.P.M.), University of Calgary, Calgary, Alberta, Canada. 7. Department of Radiology (P.K.), University of Tennessee Medical Center, Knoxville, Tennessee. 8. Department of Neurosurgery (R.D.T., A.T.), Prisma Health-Upstate, Greenville, South Carolina. 9. Division of Neuroradiology (V.M.-P.), Department of Medical Imaging, Toronto Western Hospital, University Health Network, Toronto, Ontario, Canada. 10. Department of Neuroradiology (J.S.C., S.B.), West Virginia University, Rockefeller Neuroscience Institute, Morgantown, West Virginia. 11. Department of Interventional Neuroradiology (A.E.), University of Virginia Medical Center, Charlottesville, Virginia. 12. Departments of Neurosurgery and Radiology, Northwell Health System (H.H.W., D.F.), Manhasset, New York. 13. Department of Neurosurgery (A.A.), University of Illinois Hospital and Health Sciences System, Chicago, Illinois. 14. Department of Neurosurgery (P.L.), Hôpital Enfant-Jésus, Quebec City, Quebec, Canada. 15. Department of Mathematics and Statistics (M.C.), University of Montreal, Montreal, Quebec, Canada. 16. Departments of Neurology, Neurosurgery, and Radiology (T.N.N.), Boston Medical Center, Boston, Massachusetts. 17. Department of Radiology and Diagnostic Imaging (J.L.R.). 18. Division of Neurosurgery (T.E.D.), Department of Surgery, Mackenzie Health Sciences Centre, University of Alberta Hospital, Edmonton, Alberta, Canada.
Abstract
BACKGROUND AND PURPOSE: The impact of increased aneurysm packing density on angiographic outcomes has not been studied in a randomized trial. We sought to determine the potential for larger caliber coils to achieve higher packing densities and to improve the angiographic results of embolization of intracranial aneurysms at 1 year. MATERIALS AND METHODS: Does Embolization with Larger Coils Lead to Better Treatment of Aneurysms (DELTA) was an investigator-initiated multicenter prospective, parallel, randomized, controlled clinical trial. Patients had 4- to 12-mm unruptured aneurysms. Treatment allocation to either 15- (experimental) or 10-caliber coils (control group) was randomized 1:1 using a Web-based platform. The primary efficacy outcome was a major recurrence or a residual aneurysm at follow-up angiography at 12 ± 2 months adjudicated by an independent core lab blinded to the treatment allocation. Secondary outcomes included indices of treatment success and standard safety outcomes. Recruitment of 564 patients was judged necessary to show a decrease in poor outcomes from 33% to 20% with 15-caliber coils. RESULTS: Funding was interrupted and the trial was stopped after 210 patients were recruited between November 2013 and June 2017. On an intent-to-treat analysis, the primary outcome was reached in 37 patients allocated to 15-caliber coils and 36 patients allocated to 10-caliber coils (OR = 0.931; 95% CI, 0.528-1.644; P = .885). Safety and other clinical outcomes were similar. The 15-caliber coil group had a higher mean packing density (37.0% versus 26.9%, P = .0001). Packing density had no effect on the primary outcome when adjusted for initial angiographic results (OR = 1.001; 95% CI, 0.981-1.022; P = .879). CONCLUSIONS: Coiling of aneurysms randomized to 15-caliber coils achieved higher packing densities compared with 10-caliber coils, but this had no impact on the angiographic outcomes at 1 year, which were primarily driven by aneurysm size and initial angiographic results.
RCT Entities:
BACKGROUND AND PURPOSE: The impact of increased aneurysm packing density on angiographic outcomes has not been studied in a randomized trial. We sought to determine the potential for larger caliber coils to achieve higher packing densities and to improve the angiographic results of embolization of intracranial aneurysms at 1 year. MATERIALS AND METHODS: Does Embolization with Larger Coils Lead to Better Treatment of Aneurysms (DELTA) was an investigator-initiated multicenter prospective, parallel, randomized, controlled clinical trial. Patients had 4- to 12-mm unruptured aneurysms. Treatment allocation to either 15- (experimental) or 10-caliber coils (control group) was randomized 1:1 using a Web-based platform. The primary efficacy outcome was a major recurrence or a residual aneurysm at follow-up angiography at 12 ± 2 months adjudicated by an independent core lab blinded to the treatment allocation. Secondary outcomes included indices of treatment success and standard safety outcomes. Recruitment of 564 patients was judged necessary to show a decrease in poor outcomes from 33% to 20% with 15-caliber coils. RESULTS: Funding was interrupted and the trial was stopped after 210 patients were recruited between November 2013 and June 2017. On an intent-to-treat analysis, the primary outcome was reached in 37 patients allocated to 15-caliber coils and 36 patients allocated to 10-caliber coils (OR = 0.931; 95% CI, 0.528-1.644; P = .885). Safety and other clinical outcomes were similar. The 15-caliber coil group had a higher mean packing density (37.0% versus 26.9%, P = .0001). Packing density had no effect on the primary outcome when adjusted for initial angiographic results (OR = 1.001; 95% CI, 0.981-1.022; P = .879). CONCLUSIONS: Coiling of aneurysms randomized to 15-caliber coils achieved higher packing densities compared with 10-caliber coils, but this had no impact on the angiographic outcomes at 1 year, which were primarily driven by aneurysm size and initial angiographic results.
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