T E Darsaut1, D Roy2, A Weill2, M W Bojanowski3, C Chaalala3, A Bilocq4, J M Findlay1, J L Rempel5, M M Chow1, C O'Kelly1, R A Ashforth5, M Kotowski2, E Magro6, M Lemus2, R Fahed7, F Arikan8, I Arrese9, R Sarabia9, D J Altschul10, M Chagnon11, F Guilbert2, J J S Shankar12, F Proust13, S Nolet14, G Gevry14, J Raymond15. 1. University of Alberta Hospital, Mackenzie Health Sciences Centre, Department of Surgery, Division of Neurosurgery, Edmonton, Alberta, Canada. 2. Centre Hospitalier de l'Université de Montréal (CHUM), Department of Radiology, Service of Neuroradiology, Montreal, Quebec, Canada. 3. Centre Hospitalier de l'Université de Montréal (CHUM), Department of Surgery, Service of Neurosurgery, Montreal, Quebec, Canada. 4. Centre Hospitalier Régional de Trois-Rivières, Service of Neurosurgery, Trois-Rivières, Québec, Canada. 5. University of Alberta Hospital, Mackenzie Health Sciences Centre, Department of Radiology and Diagnostic Imaging, Edmonton, Alberta, Canada. 6. Inserm UMR 1101 LaTIM, service de neurochirurgie, CHU Cavale Blanche, 29200 Brest, France. 7. Fondation Rothschild Hospital, Department of Interventional Neuroradiology, 75019 Paris, France. 8. Vall d'Hebron University Hospital, Department of Neurological Surgery, Barcelona, Spain. 9. Hospital Universitario Río Hortega de Valladolid, Unit of Vascular Neurosurgery UNVRH, Valladolid, Spain. 10. Albert Einstein College of Medicine, Montefiore Medical Centre, Department of Neurological Surgery, New York, NY, USA. 11. Université de Montréal, Department of Mathematics and Statistics, Montreal, Quebec, Canada. 12. QEII Health Sciences Centre, Department of Diagnostic Radiology, Halifax, Nova Scotia, Canada. 13. Service de neurochirurgie, CHRU de Rouen, 76000 Rouen, France. 14. Centre Hospitalier de l'Université de Montréal (CHUM), Research Centre, Interventional Neuroradiology Laboratory, Montreal, Quebec, Canada. 15. Centre Hospitalier de l'Université de Montréal (CHUM), Department of Radiology, Service of Neuroradiology, Montreal, Quebec, Canada. Electronic address: jean.raymond@umontreal.ca.
Abstract
BACKGROUND AND PURPOSE: Appropriate management of ruptured intracranial aneurysm (RIA) in patients eligible for surgical clipping but under-represented in or excluded from previous randomized trials remains undetermined. METHODS: The International Subarachnoid Aneurysm Trial-2 (ISAT-2) is a randomized care trial comparing surgical versus endovascular treatment (EVT) of RIA. All patients considered for surgical clipping but eligible for endovascular treatment can be included. The primary endpoint is death or dependency on modified Rankin score (mRS>2) at 1 year. Secondary endpoints are 1 year angiographic results and length of hospital stay. RESULTS: An interim analysis was performed after 103 patients were treated from November 2012 to July 2017 in 4 active centers. Fifty-two of the 55 patients allocated to surgery were treated by clipping, and 45 of the 48 allocated toEVT were treated by coiling, with 3 crossovers in each arm. The main endpoint (1 year mRS>2), available for 76 patients, was reached in 16/42 patients allocated to clipping (38%; 95%CI: 25%-53%), and 10/34 patients allocated to coiling (29%; 17%-46%). One year imaging results were available in 54 patients: complete aneurysm occlusion was found in 23/27 patients allocated to clipping (85%; 67%-94%), and 18/27 patients allocated to coiling (67%; 47%-81%). Hospital stay exceeding 20 days was more frequent in surgery (26/55 [47%; 34%-60%]) than EVT (9/48 [19%; 10%-31%]). CONCLUSION: Ruptured aneurysm patients for whom surgical clipping may still be best can be managed in a randomized care trial, which is feasible in some centers. More participating centers are needed.
RCT Entities:
BACKGROUND AND PURPOSE: Appropriate management of ruptured intracranial aneurysm (RIA) in patients eligible for surgical clipping but under-represented in or excluded from previous randomized trials remains undetermined. METHODS: The International Subarachnoid Aneurysm Trial-2 (ISAT-2) is a randomized care trial comparing surgical versus endovascular treatment (EVT) of RIA. All patients considered for surgical clipping but eligible for endovascular treatment can be included. The primary endpoint is death or dependency on modified Rankin score (mRS>2) at 1 year. Secondary endpoints are 1 year angiographic results and length of hospital stay. RESULTS: An interim analysis was performed after 103 patients were treated from November 2012 to July 2017 in 4 active centers. Fifty-two of the 55 patients allocated to surgery were treated by clipping, and 45 of the 48 allocated to EVT were treated by coiling, with 3 crossovers in each arm. The main endpoint (1 year mRS>2), available for 76 patients, was reached in 16/42 patients allocated to clipping (38%; 95%CI: 25%-53%), and 10/34 patients allocated to coiling (29%; 17%-46%). One year imaging results were available in 54 patients: complete aneurysm occlusion was found in 23/27 patients allocated to clipping (85%; 67%-94%), and 18/27 patients allocated to coiling (67%; 47%-81%). Hospital stay exceeding 20 days was more frequent in surgery (26/55 [47%; 34%-60%]) than EVT (9/48 [19%; 10%-31%]). CONCLUSION: Ruptured aneurysmpatients for whom surgical clipping may still be best can be managed in a randomized care trial, which is feasible in some centers. More participating centers are needed.