학술논문
Individual-patient meta-analysis of three randomized trials comparing endovascular versus open repair for ruptured abdominal aortic aneurysm
Document Type
Report
Author
Sweeting, M. J.; Balm, R.; Desgranges, P.; Ulug, P.; Powell, J. T.; Koelemay, M. J. W.; Idu, M. M.; Kox, C.; Legemate, D. A.; Huisman, L. C.; Willems, M. C. M.; Reekers, J. A.; van Delden, O. M.; van Lienden, K. P.; Hoornweg, L. L.; Reimerink, J. J.; van Beek, S. C.; Vahl, A. C.; Leijdekkers, V. J.; Bosma, J.; Montauban van Swijndregt, A. D.; de Vries, C.; van der Hulst, V. P. M.; Peringa, J.; Blomjous, J. G. A. M.; Visser, M. J. T.; van der Heijden, F. H. W. M.; Wisselink, W.; Hoksbergen, A. W. J.; Blankensteijn, J. D.; Visser, M. T. J.; Coveliers, H. M. E.; Nederhoed, J. H.; van den Berg, F. G.; van der Meijs, B. B.; van den Oever, M. L. P.; Lely, R. J.; Meijerink, M. R.; Voorwinde, A.; Ultee, J. M.; van Nieuwenhuizen, R. C.; Dwars, B. J.; Nagy, T. O. M.; Tolenaar, P.; Wiersema, A. M.; Lawson, J. A.; van Aken, P. J.; Stigter, A. A.; van den Broek, T. A. A.; Vos, G. A.; Mulder, W.; Strating, R. P.; Nio, D.; Akkersdijk, G. J. M.; van der Elst, A.; Exter, P.van; Becquemin, J.-P.; Allaire, E.; Cochennec, F.; Marzelle, J.; Louis, N.; Schneider, J.; Majewski, M.; Castier, Y.; Leseche, G.; Francis, F.; Steinmetz, E.; Berne, J.-P.; Favier, C.; Haulon, S.; Koussa, M.; Azzaoui, R.; Piervito, D.; Alimi, Y.; Boufi, M.; Hartung, O.; Cerquetta, P.; Amabile, P.; Piquet, P.; Penard, J.; Demasi, M.; Alric, P.; Canaud, L.; Berthet, J.-P.; Julia, P.; Fabiani, J.-N.; Alsac, J. M.; Gouny, P.; Badra, A.; Braesco, J.; Favre, J.-P.; Albertini, J.-N.; Martinez, R.; Hassen-Khodja, R.; Batt, M.; Jean, E.; Sosa, M.; Declemy, S.; Destrieux-Garnier, L.; Lermusiaux, P.; Feugier, P.; Ashleigh, R.; Gomes, M.; Greenhalgh, R. M.; Grieve, R.; Hinchliffe, R.; Sweeting, M.; Thompson, M. M.; Thompson, S. G.; Cheshire, N. J.; Boyle, J. R.; Serracino-Inglott, F.; Smyth, J. V.; Hinchliffe, R. J.; Bell, R.; Wilson, N.; Bown, M.; Dennis, M.; Davis, M.; Howell, S.; Wyatt, M. G.; Valenti, D.; Bachoo, P.; Walker, P.; MacSweeney, S.; Davies, J. N.; Rittoo, D.; Parvin, S. D.; Yusuf, W.; Nice, C.; Chetter, I.; Howard, A.; Chong, P.; Bhat, R.; McLain, D.; Gordon, A.; Lane, I.; Hobbs, S.; Pillay, W.; Rowlands, T.; El-Tahir, A.; Asquith, J.; Cavanagh, S.; Dubois, L.; Forbes, T. L.
Source
British Journal of Surgery. Sept, 2015, Vol. 102 Issue 10, p1229, 11 p.
Subject
Language
English
ISSN
0007-1323
Abstract
Byline: M. J. Sweeting, R. Balm, P. Desgranges, P. Ulug, J. T. Powell, Ruptured Aneurysm Trialists, R. Balm, M. J. W. Koelemay, M. M. Idu, C. Kox, D. A. Legemate, L. C. Huisman, M. C. M. Willems, J. A. Reekers, O. M. van Delden, K. P. van Lienden, L. L. Hoornweg, J. J. Reimerink, S. C. van Beek, A. C. Vahl, V. J. Leijdekkers, J. Bosma, A. D. Montauban van Swijndregt, C. de Vries, V. P. M. van der Hulst, J. Peringa, J. G. A. M. Blomjous, M. J. T. Visser, F. H. W. M. van der Heijden, W. Wisselink, A. W. J. Hoksbergen, J. D. Blankensteijn, M. T. J. Visser, H. M. E. Coveliers, J. H. Nederhoed, F. G. van den Berg, B. B. van der Meijs, M. L. P. van den Oever, R. J. Lely, M. R. Meijerink, A. Voorwinde, J. M. Ultee, R. C. van Nieuwenhuizen, B. J. Dwars, T. O. M. Nagy, P. Tolenaar, A. M. Wiersema, J. A. Lawson, P. J. van Aken, A. A. Stigter, T. A. A. van den Broek, G. A. Vos, W. Mulder, R. P. Strating, D. Nio, G. J. M. Akkersdijk, A. van der Elst, P.van Exter, P. Desgranges, J.-P. Becquemin, E. Allaire, F. Cochennec, J. Marzelle, N. Louis, J. Schneider, M. Majewski, Y. Castier, G. Leseche, F. Francis, E. Steinmetz, J.-P. Berne, C. Favier, S. Haulon, M. Koussa, R. Azzaoui, D. Piervito, Y. Alimi, M. Boufi, O. Hartung, P. Cerquetta, P. Amabile, P. Piquet, J. Penard, M. Demasi, P. Alric, L. Canaud, J.-P. Berthet, P. Julia, J.-N. Fabiani, J. M. Alsac, P. Gouny, A. Badra, J. Braesco, J.-P. Favre, J.-N. Albertini, R. Martinez, R. Hassen-Khodja, M. Batt, E. Jean, M. Sosa, S. Declemy, L. Destrieux-Garnier, P. Lermusiaux, P. Feugier, J. T. Powell, R. Ashleigh, M. Gomes, R. M. Greenhalgh, R. Grieve, R. Hinchliffe, M. Sweeting, M. M. Thompson, S. G. Thompson, P. Ulug, N. J. Cheshire, J. R. Boyle, F. Serracino-Inglott, J. V. Smyth, M. M. Thompson, R. J. Hinchliffe, R. Bell, N. Wilson, M. Bown, M. Dennis, M. Davis, R. Ashleigh, S. Howell, M. G. Wyatt, D. Valenti, P. Bachoo, P. Walker, S. MacSweeney, J. N. Davies, D. Rittoo, S. D. Parvin, W. Yusuf, C. Nice, I. Chetter, A. Howard, P. Chong, R. Bhat, D. McLain, A. Gordon, I. Lane, S. Hobbs, W. Pillay, T. Rowlands, A. El-Tahir, J. Asquith, S. Cavanagh, L. Dubois, T. L. Forbes Background The benefits of endovascular repair of ruptured abdominal aortic aneurysm remain controversial, without any strong evidence about advantages in specific subgroups. Methods An individual-patient data meta-analysis of three recent randomized trials of endovascular versus open repair of abdominal aortic aneurysm was conducted according to a prespecified analysis plan, reporting on results to 90 days after the index event. Results The trials included a total of 836 patients. The mortality rate across the three trials was 31ae3 per cent for patients randomized to endovascular repair/strategy and 34ae0 per cent for those randomized to open repair at 30 days (pooled odds ratio 0ae88, 95 per cent c.i. 0ae66 to 1ae18), and 34ae3 and 38ae0 per cent respectively at 90 days (pooled odds ratio 0ae85, 0ae64 to 1ae13). There was no evidence of significant heterogeneity in the odds ratios between trials. Mean(s.d.) aneurysm diameter was 8ae2(1ae9) cm and the overall in-hospital mortality rate was 34ae8 per cent. There was no significant effect modification with age or Hardman index, but there was indication of an early benefit from an endovascular strategy for women. Discharge from the primary hospital was faster after endovascular repair (hazard ratio 1ae24, 95 per cent c.i. 1ae04 to 1ae47). For open repair, 30-day mortality diminished with increasing aneurysm neck length (adjusted odds ratio 0ae69 (95 per cent c.i. 0ae53 to 0ae89) per 15mm), but aortic diameter was not associated with mortality for either type of repair. Conclusion Survival to 90 days following an endovascular or open repair strategy is similar for all patients and for the restricted population anatomically suitable for endovascular repair. Women may benefit more from an endovascular strategy than men and patients are, on average, discharged sooner after endovascular repair. CAPTION(S): Appendix S1 Multiple imputation models TableS1 Variables considered for multiple imputations and imputation model considered FigS1 Thirty-day mortality by randomized group: a for 834 patients, b restricted to 525 patients with ruptured abdominal aortic aneurysm eligible for both endovascular (EVAR) and open aneurysm repair FigS2 Thirty-day mortality by randomized group with subgroup analyses for age, sex and Hardman index. Multiple imputation was used for Hardman index. With small numbers in the ECAR trial (0 of 10 deaths within 30 days in women), the trial-specific subgroup effect for sex was calculated by adding a continuity correction of 0.5 to all cells in the contingency table. EVAR, endovascular aneurysm repair FigS3 Cumulative incidence of time to primary hospital discharge by trial and randomized group, and restricting IMPROVE data to ruptured abdominal aortic aneurysm (AAA) suitable for endovascular aneurysm repair (EVAR) FigS4 Aortic neck length by trial, and restricting IMPROVE data to ruptured abdominal aortic aneurysm suitable for endovascular repair (EVAR). All patients with rupture in the common iliac arteries of an aortoiliac aneurysm were excluded FigS5 Effect of abdominal aortic aneurysm (AAA) diameter on 30-day mortality, by treatment commenced. The analysis was restricted to patients with ruptured AAA who underwent CT, commenced treatment and did not have a common iliac aneurysm. All analyses were adjusted for age, sex, Hardman index, admission mean arterial BP, treatment commenced and randomized group. Multiple imputation used to account for missing data FigS6 Effect of aortic neck diameter on 30-day mortality, by treatment commenced. The analysis was restricted to ruptured patients with ruptured abdominal aortic aneurysm who underwent CT, commenced treatment and did not have a common iliac aneurysm. All analyses were adjusted for age, sex, Hardman index, admission mean arterial BP, treatment commenced and randomized group. Multiple imputation was used to account for missing data FigS7 Effect of proximal neck angulation on 30-day mortality, by treatment commenced. The analysis was restricted to ruptured patients with ruptured abdominal aortic aneurysm who underwent CT, commenced treatment and did not have a common iliac aneurysm. All analyses were adjusted for age, sex, Hardman index, admission mean arterial BP, treatment commenced and randomized group. Multiple imputation was used to account for missing data