W Brinjikji1, P M White2, H Nahser3, J Wardlaw4, R Sellar4, H J Cloft5, D F Kallmes5. 1. From the Department of Radiology (W.B., H.J.C., D.F.K.), Mayo Clinic, Rochester, Minnesota brinjikji.waleed@mayo.edu. 2. Institute for Ageing and Health (P.M.W.), Newcastle University, Newcastle-upon-Tyne, United Kingdom. 3. Department of Clinical Neuroscience (H.N.), University of Edinburgh, Edinburgh, United Kingdom. 4. Walton Centre (J.W., R.S.), Liverpool, United Kingdom. 5. From the Department of Radiology (W.B., H.J.C., D.F.K.), Mayo Clinic, Rochester, Minnesota.
Abstract
BACKGROUND AND PURPOSE: The HydroCoil Endovascular Aneurysm Occlusion and Packing Study (HELPS) was a randomized, controlled trial comparing HydroCoils with bare-platinum coils. The purpose of this study was to perform a subgroup analysis of angiographic and clinical outcomes of medium-sized aneurysms in the HELPS trial. MATERIALS AND METHODS:Patients with medium-sized aneurysms (5-9.9 mm) were selected from the HELPS trial. Outcomes compared between the HydroCoil and bare-platinum groups included the following: 1) any recurrence, 2) major recurrence, 3) retreatment, and 4) mRS score of ≤2. Subgroup analysis by rupture status was performed. Multivariate logistic regression analysis adjusting for aneurysm neck size, shape, use of adjunctive device, and rupture status was performed. RESULTS:Two hundred eighty-eight patients with medium-sized aneurysms were randomized (144 in each group). At 15-18 months posttreatment, the major recurrence rate was significantly lower in the HydroCoil group than in controls (18.6% versus 30.8%, P = .03, respectively). For patients with recently ruptured aneurysms, the major recurrence rate was significantly lower for the HydroCoil group than for controls (20.3% versus 47.5%, P = .003), while rates were similar between groups for unruptured aneurysms (16.7% versus 14.8%, P = .80). Multivariate analysis of patients with recently ruptured aneurysms demonstrated a lower odds of major recurrence with HydroCoils (OR = 0.27; 95% CI, 0.12-0.58; P = .0007). No difference in retreatment rates or mRS of ≤2 was seen between groups. CONCLUSIONS: HydroCoils were associated with statistically significant and clinically relevant lower rates of major recurrence for recently ruptured, medium-sized aneurysms in the HELPS trial. Because this was not a prespecified subgroup analysis, these results should not alter clinical practice but, rather, provide insight into the design of future clinical trials comparing bare platinum with second-generation coils.
RCT Entities:
BACKGROUND AND PURPOSE: The HydroCoil Endovascular Aneurysm Occlusion and Packing Study (HELPS) was a randomized, controlled trial comparing HydroCoils with bare-platinum coils. The purpose of this study was to perform a subgroup analysis of angiographic and clinical outcomes of medium-sized aneurysms in the HELPS trial. MATERIALS AND METHODS:Patients with medium-sized aneurysms (5-9.9 mm) were selected from the HELPS trial. Outcomes compared between the HydroCoil and bare-platinum groups included the following: 1) any recurrence, 2) major recurrence, 3) retreatment, and 4) mRS score of ≤2. Subgroup analysis by rupture status was performed. Multivariate logistic regression analysis adjusting for aneurysm neck size, shape, use of adjunctive device, and rupture status was performed. RESULTS: Two hundred eighty-eight patients with medium-sized aneurysms were randomized (144 in each group). At 15-18 months posttreatment, the major recurrence rate was significantly lower in the HydroCoil group than in controls (18.6% versus 30.8%, P = .03, respectively). For patients with recently ruptured aneurysms, the major recurrence rate was significantly lower for the HydroCoil group than for controls (20.3% versus 47.5%, P = .003), while rates were similar between groups for unruptured aneurysms (16.7% versus 14.8%, P = .80). Multivariate analysis of patients with recently ruptured aneurysms demonstrated a lower odds of major recurrence with HydroCoils (OR = 0.27; 95% CI, 0.12-0.58; P = .0007). No difference in retreatment rates or mRS of ≤2 was seen between groups. CONCLUSIONS:HydroCoils were associated with statistically significant and clinically relevant lower rates of major recurrence for recently ruptured, medium-sized aneurysms in the HELPS trial. Because this was not a prespecified subgroup analysis, these results should not alter clinical practice but, rather, provide insight into the design of future clinical trials comparing bare platinum with second-generation coils.
Authors: A Berenstein; J K Song; Y Niimi; K Namba; N S Heran; J L Brisman; M C Nahoum; M Madrid; D J Langer; M J Kupersmith Journal: AJNR Am J Neuroradiol Date: 2006-10 Impact factor: 3.825
Authors: Ron C Gaba; Sameer A Ansari; Soma Sinha Roy; Franklin A Marden; Marlos A G Viana; Tim W Malisch Journal: Stroke Date: 2006-05-04 Impact factor: 7.914
Authors: Andrew J Ringer; Rafael Rodriguez-Mercado; Erol Veznedaroglu; Elad I Levy; Ricardo A Hanel; Robert A Mericle; Demetrius K Lopes; Giuseppe Lanzino; Alan S Boulos Journal: Neurosurgery Date: 2009-08 Impact factor: 4.654
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: Waleed Brinjikji; Giuseppe Lanzino; Harry J Cloft; Alejandro Rabinstein; David F Kallmes Journal: Stroke Date: 2009-11-19 Impact factor: 7.914