Surgical clipping or endovascular coiling for unruptured intracranial aneurysms: a pragmatic randomised trial

被引:121
作者
Darsaut, Tim E. [1 ]
Findlay, J. Max [1 ]
Magro, Elsa [2 ]
Kotowski, Marc [3 ]
Roy, Daniel [3 ]
Weill, Alain [3 ]
Bojanowski, Michel W. [4 ]
Chaalala, Chiraz [4 ]
Iancu, Daniela [5 ]
Lesiuk, Howard [6 ]
Sinclair, John [6 ]
Scholtes, Felix [7 ]
Martin, Didier [7 ]
Chow, Michael M. [1 ]
O'Kelly, Cian J. [1 ]
Wong, John H. [8 ]
Butcher, Ken [9 ]
Fox, Allan J. [10 ]
Arthur, Adam S. [11 ]
Guilbert, Francois [3 ]
Tian, Lu [12 ]
Chagnon, Miguel [13 ]
Nolet, Suzanne [14 ]
Gevry, Guylaine [14 ]
Raymond, Jean [3 ]
机构
[1] Univ Alberta, Div Neurosurg, Dept Surg, Edmonton, AB, Canada
[2] CHU Cavale Blanche, Serv Neurochirurg, INSERM, UMR 1101,LaTIM, Brest, France
[3] Notre Dame Hosp, CHUM, Dept Radiol, Serv Neuroradiol, Montreal, PQ, Canada
[4] Notre Dame Hosp, CHUM, Dept Surg, Serv Neurosurg, Montreal, PQ, Canada
[5] Univ Ottawa, Ottawa Hosp, Neuroradiol Sect, Dept Med Imaging, Ottawa, ON, Canada
[6] Univ Ottawa, Ottawa Hosp, Sect Neurosurg, Dept Surg, Ottawa, ON, Canada
[7] Ctr Hosp Univ Liege, Dept Neurosurg, Liege, Belgium
[8] Univ Calgary, Hotchkiss Brain Inst, Div Neurosurg, Dept Clin Neurosci, Calgary, AB, Canada
[9] Univ Alberta, Div Neurol, Dept Med, Edmonton, AB, Canada
[10] Univ Toronto, Sunnybrook Hlth Sci Ctr, Dept Med Imaging, Toronto, ON, Canada
[11] Univ Tennessee, Dept Neurosurg, Semmes Murphey Neurol & Spine Inst, Memphis, TN USA
[12] Stanford Univ, Dept Biomed Data Sci, Sch Med, Stanford, CA 94305 USA
[13] Univ Montreal, Dept Math & Stat, Montreal, PQ, Canada
[14] Notre Dame Hosp, CHUM, Res Ctr, Montreal, PQ, Canada
关键词
BARE PLATINUM COILS; CEREBRAL ANEURYSMS; UNITED-STATES; OUTCOMES; MANAGEMENT; SAFETY; METAANALYSIS; OCCLUSION; HYDROGEL; IMPACT;
D O I
10.1136/jnnp-2016-315433
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
Background Unruptured intracranial aneurysms (UIAs) are increasingly diagnosed and are commonly treated using endovascular treatment or microsurgical clipping. The safety and efficacy of treatments have not been compared in a randomised trial. How to treat patients with UIAs suitable for both options remains unknown. Methods We randomly allocated clipping or coiling to patients with one or more 3-25 mm UIAs judged treatable both ways. The primary outcome was treatment failure, defined as: initial failure of aneurysm treatment, intracranial haemorrhage or residual aneurysm on 1-year imaging. Secondary outcomes included neurological deficits following treatment, hospitalisation >5 days, overall morbidity and mortality and angiographic results at 1 year. Results The trial was designed to include 260 patients. An analysis was performed for slow accrual: 136 patients were enrolled from 2010 through 2016 and 134 patients were treated. The 1-year primary outcome, available for 104 patients, was reached in 5/48 (10.4% (4.5%-22.2%)) patients allocated surgical clipping, and 10/56 (17.9% (10.0%-29.8%)) patients allocated endovascular coiling (OR: 0.54 (0.13-1.90), p=0.40). Morbidity and mortality (modified Rankin Scale>2) at 1 year occurred in 2/48 (4.2% (1.2%-14.0%)) and 2/56 (3.6% (1.0%-12.1%)) patients allocated clipping and coiling, respectively. New neurological deficits (15/65 vs 6/69; OR: 3.12 (1.05-10.57), p=0.031), and hospitalisations beyond 5 days (30/65 vs 6/69; OR: 8.85 (3.22-28.59), p=0.0001) were more frequent after clipping. Conclusion Surgical clipping or endovascular coiling of UIAs did not show differences in morbidity at 1 year. Trial continuation and additional randomised evidence will be necessary to establish the supposed superior efficacy of clipping.
引用
收藏
页码:663 / 668
页数:6
相关论文
共 36 条
[1]   Hospital Mortality and Complications of Electively Clipped or Coiled Unruptured Intracranial Aneurysm [J].
Alshekhlee, Amer ;
Mehta, Sonal ;
Edgell, Randall C. ;
Vora, Nirav ;
Feen, Eli ;
Mohammadi, Afshin ;
Kale, Sushant P. ;
Cruz-Flores, Salvador .
STROKE, 2010, 41 (07) :1471-1476
[2]  
[Anonymous], 2006, Cochrane Handbook for Systematic Reviews of Interventions
[3]   Patient Outcomes Are Better for Unruptured Cerebral Aneurysms Treated at Centers That Preferentially Treat with Endovascular Coiling: A Study of the National Inpatient Sample 2001-2007 [J].
Brinjikji, W. ;
Rabinstein, A. A. ;
Lanzino, G. ;
Kallmes, D. F. ;
Cloft, H. J. .
AMERICAN JOURNAL OF NEURORADIOLOGY, 2011, 32 (06) :1065-1070
[4]   Better Outcomes with Treatment by Coiling Relative to Clipping of Unruptured Intracranial Aneurysms in the United States, 2001-2008 [J].
Brinjikji, W. ;
Rabinstein, A. A. ;
Nasr, D. M. ;
Lanzino, G. ;
Kallmes, D. F. ;
Cloft, H. J. .
AMERICAN JOURNAL OF NEURORADIOLOGY, 2011, 32 (06) :1071-1075
[5]   Effect of Age on Outcomes of Treatment of Unruptured Cerebral Aneurysms A Study of the National Inpatient Sample 2001-2008 [J].
Brinjikji, Waleed ;
Rabinstein, Alejandro A. ;
Lanzino, Giuseppe ;
Kallmes, David F. ;
Cloft, Harry J. .
STROKE, 2011, 42 (05) :1320-1324
[6]   A long-term study of durability and risk factors for aneurysm recurrence after microsurgical clip ligation [J].
Brown, Mason A. ;
Parish, Jonathan ;
Guandique, Cristian F. ;
Payner, Troy D. ;
Homer, Terry ;
Leipzig, Thomas ;
Rupani, Karishma V. ;
Kim, Richard ;
Bohnstedt, Bradley N. ;
Cohen-Gadol, Aaron A. .
JOURNAL OF NEUROSURGERY, 2017, 126 (03) :819-824
[7]   Clipping of previously coiled cerebral aneurysms: efficacy, safety, and predictors in a cohort of 111 patients [J].
Daou, Badih ;
Chalouhi, Nohra ;
Starke, Robert M. ;
Barros, Guilherme ;
Ya'qoub, Lina ;
Do, John ;
Tjoumakaris, Stavropoula ;
Rosenwasser, Robert H. ;
Jabbour, Pascal .
JOURNAL OF NEUROSURGERY, 2016, 125 (06) :1337-1343
[8]   How to choose clipping versus coiling in treating intracranial aneurysms [J].
Darsaut, T. E. ;
Kotowski, M. ;
Raymond, J. .
NEUROCHIRURGIE, 2012, 58 (2-3) :61-67
[9]   Uncertainty and agreement in the management of unruptured intracranial aneurysms [J].
Darsaut, Tim E. ;
Estrade, Laurent ;
Jamali, Sara ;
Bojanowski, Michel W. ;
Chagnon, Miguel ;
Raymond, Jean .
JOURNAL OF NEUROSURGERY, 2014, 120 (03) :618-623
[10]   The Design of the Canadian UnRuptured Endovascular versus Surgery (CURES) Trial [J].
Darsaut, Tim E. ;
Findlay, J. Max ;
Raymond, Jean .
CANADIAN JOURNAL OF NEUROLOGICAL SCIENCES, 2011, 38 (02) :236-241