Ruptured aneurysms and the International Subarachnoid Aneurysm Trial (ISAT): What is known and what remains to be questioned

Neurochirurgie

Volumn 58, Issue 2-3, 2012, Pages 103-108

  Raymond, J ^a   Kotowski, M ^b   Darsaut, T E ^a,c   Molyneux, A J ^d   Kerr, R S ^d  

^a NOTRE DAME HOSPITAL   (Canada)

^b LAUSANNE UNIVERSITY HOSPITAL   (Switzerland)

^c UNIVERSITY OF ALBERTA   (Canada)

^d UNIVERSITY OF OXFORD   (United Kingdom)

Author keywords

Intracranial aneurysm

Indexed keywords

BRAIN ANGIOGRAPHY; BRAIN ARTERY ANEURYSM RUPTURE; CLINICAL STUDY; CLIPPING; COILING; ENDOVASCULAR SURGERY; HUMAN; INTERNATIONAL SUBARACHNOID ANEURYSM TRIAL; MEDICAL ETHICS; MEDICAL LITERATURE; PATIENT CARE; QUESTIONNAIRE; SHORT SURVEY; SURVIVAL; ANEURYSM RUPTURE; BRAIN ARTERY ANEURYSM;

ANEURYSM, RUPTURED; CLINICAL TRIALS AS TOPIC; EMBOLIZATION, THERAPEUTIC; HUMANS; INTRACRANIAL ANEURYSM; OUTCOME ASSESSMENT (HEALTH CARE);

EID: 84860270005     PISSN: 00283770     EISSN: 17730619     Source Type: Journal    
DOI: 10.1016/j.neuchi.2012.02.020     Document Type: Short Survey

References (54)

1. Altman D.G., Bland J.M. Absence of evidence is not evidence of absence. BMJ 1995, 311(7003):485.
2. Ashcroft R. Giving medicine a fair trial. Trials should not second guess what patients want. BMJ 2000, 320(7251):1686.
3. Ausman J.I. ISAT study: is coiling better than clipping?. Surg Neurol 2003, 59(3):162-165. [discussion 165-173; author reply 173-185].
4. Ausman J.I. The International Subarachnoid Aneurysm Trial II: comparison of clipping vs coiling: key questions. Are the results of the study generalizable? Should clipping be done for patients less than 40years of age?. Surg Neurol 2008, 70(1):104-107.
5. Bakker N.A., Metzemaekers J.D., et al. International subarachnoid aneurysm trial 2009: endovascular coiling of ruptured intracranial aneurysms has no significant advantage over neurosurgical clipping. Neurosurgery 2010, 66(5):961-962.
6. Barrow D.L. Bad science ISAT: the impact on neurosurgical practice. Clin Neurosurg 2004, 51:126-131.
7. Batjer H.H. Surg Neurol 2003, 59(3):168-169.
8. Britz G.W. ISAT trial: coiling or clipping for intracranial aneurysms?. Lancet 2005, 366(9488):783-785.
9. Britz G.W., Newell D.W., et al. The ISAT trial. Lancet 2003, 361(9355):431-432.
10. Brookes S.T., Whitley E., et al. Subgroup analyses in randomised controlled trials: quantifying the risks of false-positives and false-negatives. Health Technol Assess 2001, 5(33):1-56.
11. Carter B.S. ISAT subgroups: is aneurysm clipping better for some patients?. Neurosurgery 2008, 63(6):14.
12. Casasco A.E., Aymard A., et al. Selective endovascular treatment of 71intracranial aneurysms with platinum coils. J Neurosurg 1993, 79(1):3-10.
13. Collins R., MacMahon S. Reliable assessment of the effects of treatment on mortality and major morbidity, I: clinical trials. Lancet 2001, 357(9253):373-380.
14. Cowan J., Ziewacz, et al. Use of endovascular coil embolization and surgical clip occlusion for cerebral artery aneurysms. J Neurosurg 2007, 107(3):530-535.
15. Debrun G. Commentary. Surg Neurol 2003, 59(3):168.
16. Derdeyn C.P., Barr J.D., et al. The International Subarachnoid Aneurysm Trial (ISAT): a position statement from the Executive Committee of the American Society of Interventional and Therapeutic Neuroradiology and the American Society of Neuroradiology. AJNR Am J Neuroradiol 2003, 24(7):1404-1408.
17. Figueiredo E.G. The ISAT. Again. World Neurosurg 2010, 73(6):601-603.
18. Gnanalingham K.K., Apostolopoulos V., et al. The impact of the international subarachnoid aneurysm trial (ISAT) on the management of aneurysmal subarachnoid haemorrhage in a neurosurgical unit in the UK. Clin Neurol Neurosurg 2006, 108(2):117-123.
19. Harbaugh R.E. Surg Neurol 2003, 59(3):165-167.
20. Harbaugh R.E., Heros R.C., et al. More on ISAT. Lancet 2003, 361(9359):783-784.
21. Hernesniemi J., Koivisto T. Comments on The impact of the International Subarachnoid Aneurysm Treatment Trial (ISAT) on neurosurgical practice. Acta Neurochir (Wien) 2004, 146(2):203-208.
22. Heros R.C., Hadley M.N., Harbaugh R.E. Position statement by the AANS, CNS and AANS/CNS section on cerebrovascular surgery. AANS Bull 2002, 11(4.).
23. Heros R.C. International Subarachnoid Aneurysm Trial analysis. J Neurosurg 2008, 108(3):433-435.
24. Heros R.C. Vascular neurosurgery since the International Subarachnoid Aneurysm Trial. J Neurosurg 2008, 109(6):989-991. [author reply 990-991].
25. Higashida R.T., Halbach V.V., et al. Treatment of intracranial aneurysms with preservation of the parent vessel: results of percutaneous balloon embolization in 84 patients. AJNR Am J Neuroradiol 1990, 11(4):633-640.
26. Javadpour M. ISAT: Will the results stand the test of time?. Br J Neurosurg 2007, 21(1):7-8.
27. Kirkpatrick P.J., Kirollos R.W., et al. Lessons to be learnt from the International Subarachnoid Haemorrhage Trial (ISAT). Br J Neurosurg 2003, 17(1):5-7.
28. Kobayashi S. Commentary. Surg Neurol 2003, 59(3):167-168.
29. Laitt R.D. How much can be concluded from ISAT?. Br J Neurosurg 2007, 21(1):9-10.
30. Leung C.H., Poon W.S., et al. The ISAT trial. Lancet 2003, 361(9355):430-431. [author reply 432].
31. Lindsay K.W. The impact of the International Subarachnoid Aneurysm Treatment Trial (ISAT) on neurosurgical practice. Acta Neurochir (Wien) 2003, 145(2):97-99.
32. Maurice-Williams R.S. Aneurysm surgery after the International Subarachnoid Aneurysm Trial (ISAT). J Neurol Neurosurg Psychiatry 2004, 75(6):807-808.
33. Mitchell P., Kerr R., et al. Could late rebleeding overturn the superiority of cranial aneurysm coil embolization over clip ligation seen in the International Subarachnoid Aneurysm Trial?. J Neurosurg 2008, 108(3):437-442.
34. Mitha A.P., Ogilvy C.S. ISAT: coiling or clipping for ruptured intracranial aneurysms?. Lancet Neurol 2005, 4(12):791-792.
35. Mocco J., Hopkins L.N. International Subarachnoid Aneurysm Trial analysis. J Neurosurg 2008, 108(3):436.
36. Mohr J.P. The ISAT trial. Lancet 2003, 361(9355):431. [author reply 432].
37. Molyneux A., Kerr R., et al. International Subarachnoid Aneurysm Trial (ISAT) of neurosurgical clipping versus endovascular coiling in 2143patients with ruptured intracranial aneurysms: a randomised trial. Lancet 2002, 360(9342):1267-1274.
38. Molyneux A.J., Kerr R.S., et al. Risk of recurrent subarachnoid haemorrhage, death, or dependence and standardised mortality ratios after clipping or coiling of an intracranial aneurysm in the International Subarachnoid Aneurysm Trial (ISAT): long-term follow-up. Lancet Neurol 2009, 8(5):427-433.
39. Molyneux A.J., Kerr R.S., et al. International subarachnoid aneurysm trial (ISAT) of neurosurgical clipping versus endovascular coiling in 2143patients with ruptured intracranial aneurysms: a randomised comparison of effects on survival, dependency, seizures, rebleeding, subgroups, and aneurysm occlusion. Lancet 2005, 366(9488):809-817.
40. Naggara O., Raymond J., et al. The problem of subgroup analyses: an example from a trial on ruptured intracranial aneurysms. AJNR Am J Neuroradiol 2011, 32(4):633-636.
41. Nguyen T.N., Raymond J., et al. Association of endovascular therapy of very small ruptured aneurysms with higher rates of procedure-related rupture. J Neurosurg 2008, 108(6):1088-1092.
42. Nishioka H. Report on the cooperative study of intracranial aneurysms and subarachnoid hemorrhage. Section VII. I. Evaluation of the conservative management of ruptured intracranial aneurysms. J Neurosurg 1966, 25(5):574-592.
43. Piotin M., Blanc R., et al. Stent-assisted coiling of intracranial aneurysms: clinical and angiographic results in 216consecutive aneurysms. Stroke 2010, 41(1):110-115.
44. Raabe A., Schmiedek P., et al. German Society of Neurosurgery Section on Vascular Neurosurgery: Position Statement on the International Subarachnoid Hemorrhage Trial (ISAT). Zentralblatt fur Neurochirurgie 2003, 64(3):99-103.
45. Raymond J., Darsaut T.E., et al. A trial on unruptured intracranial aneurysms (the TEAM trial): results, lessons from a failure and the necessity for clinical care trials. Trials 2011, 12:64.
46. Raymond J., Guilbert F., et al. Long-term angiographic recurrences after selective endovascular treatment of aneurysms with detachable coils. Stroke 2003, 34(6):1398-1403.
47. Ryttlefors M., Enblad P., et al. International subarachnoid aneurysm trial of neurosurgical clipping versus endovascular coiling: subgroup analysis of 278elderly patients. Stroke 2008, 39(10):2720-2726.
48. Sackett, D. (2006). The Tactics of performing therapeutic trials. Cilical epidemiology: How to do clinical practice research. R. Haynes, Sackett, DR, Guyatt, GH, Tugwell, P. Philadelphia, Lippincott, Williams & Wilkins: p. 66-172.
49. Sade B., Mohr G. Critical appraisal of the International Subarachnoid Aneurysm Trial (ISAT). Neurol India 2004, 52(1):32-35.
50. Schulz K.F., Grimes D.A. Multiplicity in randomised trials II: subgroup and interim analyses. Lancet 2005, 365(9471):1657-1661.
51. Solomon R. Commentary. Surg Neurol 2003, 59(3):173.
52. Tait M.J., Critchley G.R., et al. How much can be concluded from the International Subarachnoid Aneurysm Trial (ISAT)?. Br J Neurosurg 2007, 21(1):3-6.
53. ter Brugge K.G. Commentary. Surg Neurol 2003, 59(3):172-173.
54. Zacharia B.E., Ducruet A.F., et al. Technological advances in the management of unruptured intracranial aneurysms fail to improve outcome in New York state. Stroke 2011, 42(10):2844-2849.