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Meta-analysis of individual-patient data from EVAR-1, DREAM, OVER and ACE trials comparing outcomes of endovascular or open repair for abdominal aortic aneurysm over 5 years.

ABSTRACT: BACKGROUND:The erosion of the early mortality advantage of elective endovascular aneurysm repair (EVAR) compared with open repair of abdominal aortic aneurysm remains without a satisfactory explanation. METHODS:An individual-patient data meta-analysis of four multicentre randomized trials of EVAR versus open repair was conducted to a prespecified analysis plan, reporting on mortality, aneurysm-related mortality and reintervention. RESULTS:The analysis included 2783 patients, with 14?245 person-years of follow-up (median 5·5?years). Early (0-6 months after randomization) mortality was lower in the EVAR groups (46 of 1393 versus 73 of 1390 deaths; pooled hazard ratio 0·61, 95 per cent c.i. 0·42 to 0·89; P = 0·010), primarily because 30-day operative mortality was lower in the EVAR groups (16 deaths versus 40 for open repair; pooled odds ratio 0·40, 95 per cent c.i. 0·22 to 0·74). Later (within 3 years) the survival curves converged, remaining converged to 8 years. Beyond 3 years, aneurysm-related mortality was significantly higher in the EVAR groups (19 deaths versus 3 for open repair; pooled hazard ratio 5·16, 1·49 to 17·89; P = 0·010). Patients with moderate renal dysfunction or previous coronary artery disease had no early survival advantage under EVAR. Those with peripheral artery disease had lower mortality under open repair (39 deaths versus 62 for EVAR; P?=?0·022) in the period from 6 months to 4 years after randomization. CONCLUSION:The early survival advantage in the EVAR group, and its subsequent erosion, were confirmed. Over 5?years, patients of marginal fitness had no early survival advantage from EVAR compared with open repair. Aneurysm-related mortality and patients with low ankle?:?brachial pressure index contributed to the erosion of the early survival advantage for the EVAR group. Trial registration numbers: EVAR-1, ISRCTN55703451; DREAM?(Dutch Randomized Endovascular Aneurysm Management), NCT00421330; ACE (Anévrysme de l'aorte abdominale, Chirurgie versus Endoprothèse), NCT00224718; OVER (Open Versus Endovascular Repair Trial for Abdominal Aortic Aneurysms), NCT00094575.

SUBMITTER: Powell JT

PROVIDER: S-EPMC5299468 | biostudies-literature | 2017 Feb

REPOSITORIES: biostudies-literature

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Meta-analysis of individual-patient data from EVAR-1, DREAM, OVER and ACE trials comparing outcomes of endovascular or open repair for abdominal aortic aneurysm over 5 years.

Powell J T JT Sweeting M J MJ Ulug P P Blankensteijn J D JD Lederle F A FA Becquemin J-P JP Greenhalgh R M RM

The British journal of surgery 20170201 3

<h4>Background</h4>The erosion of the early mortality advantage of elective endovascular aneurysm repair (EVAR) compared with open repair of abdominal aortic aneurysm remains without a satisfactory explanation.<h4>Methods</h4>An individual-patient data meta-analysis of four multicentre randomized trials of EVAR versus open repair was conducted to a prespecified analysis plan, reporting on mortality, aneurysm-related mortality and reintervention.<h4>Results</h4>The analysis included 2783 patients ...[more]

PMID: 28160528

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Project description:Background Abdominal aortic aneurysms (AAA) are far more common in male than female gender, although they appear to have a more aggressive pathophysiology in females. Given the lower incidence of AAA in females, it has been difficult to assess the impact of graft selection for endovascular aortic aneurysm repair (EVAR) in this cohort. Purpose To identify whether graft selection influences outcomes following AAA endoluminal repair in female patients. Methodology A retrospective analysis of published data for 711 female patients was conducted, collating data from three cohorts - Endurant Stent Graft Natural Selection Global post-market registry (ENGAGE), Global Registry for Endovascular Aortic Treatment (GREAT) and U.S. Zenith multicenter trial in combination with the Zenith female registry. Patients were recruited into the ENGAGE registry between 2009 and 2011, the GREAT registry between August 2010 and October 2016, and into the Zenith registry between 2000 and 2003. Patients from ENGAGE received the Medtronic Endurant stent graft for infrarenal AAA repair, patients analysed in GREAT received the Gore Excluder stent graft and the Zenith group received the Cook Zenith stent graft. Analyses were performed to evaluate all-cause mortality, aorta-related mortality, endoleak occurrence and surgical reintervention rates between the three cohorts. Results Of the 711 females, 133 were from ENGAGE (mean age 76 years), 538 were from GREAT (mean age 75 years) and 40 were from Zenith (mean age 74 years). The rates of co-morbidities between the three groups were broadly similar except for atherosclerotic disease which was more commonly observed in those treated with the GORE Excluder. The rate of endoleaks was lower when the Excluder stent was utilised as compared to the other two stents (Excluder 6.7% vs. Zenith 12.5% vs. Endurant 35.3%) even considering the limited follow-up of the Zenith group to two years as compared to five years for both ENGAGE and GREAT. All-cause mortality was similar in all three groups across the period examined while aorta-related mortality was uncommon. Reintervention rate was 15% at two years following the utilisation of the Zenith aortic graft while the rate of intervention at five years was broadly similar between ENGAGE and GREAT. Conclusion The newer generation, lower profile aortic endografts appear to have provided a safe and successful tool in the management of AAA in female patients, despite more complex aortic anatomy with shorter infrarenal neck length and larger aortic neck angulation.

Project description:Background Endovascular aneurysm repair (EVAR) has become the treatment modality of choice in patients with abdominal aortic aneurysms. This has resulted in endograft utilization within instructions for use (IFU) and in cases with proximal neck anatomy outside of IFU. Purpose To identify whether graft selection influences outcomes following EVAR outside of IFU. Methodology A retrospective analysis was conducted from previously published data for 636 patients, collated from the Endurant Stent Graft Natural Selection Global Post-Market Registry (ENGAGE) and the Global Registry for Endovascular Aortic Treatment (GREAT). Patients were recruited into the ENGAGE registry between 2009 and 2011 and into the GREAT registry between August 2010 and October 2016. In ENGAGE, they received the Medtronic Endurant stent graft (Medtronic Vascular Inc, Dublin, Ireland) for infrarenal AAA repair while patients analyzed in GREAT received the Gore Excluder stent-graft (W. L. Gore & Associates, Flagstaff, Arizona). Analyses were performed to evaluate all-cause mortality, aneurysm-related mortality, endoleak occurrence, and surgical reintervention rates between the two cohorts. Results Of the 636 patients, 225 were from ENGAGE (mean age 73 years) and 411 were from GREAT (mean age 75 years). 17.8% were treated outside of IFU in the ENGAGE registry, while 12.4% were treated outside IFU in the GREAT cohort. Five-year freedom from all-cause mortality was similar in both cohorts (65.6% vs. 63.8%). The rate of type IA endoleak development was lower in the Excluder cohort, although this may have been impacted by the fact that only endoleaks that underwent reintervention were recorded within GREAT analysis (Endurant 10.6% vs. Excluder 7.0%). The reintervention rate was 16% at five years following the Endurant aortic graft while it was 13.3% at five years with the Excluder. Conclusion Treatment outside of IFU, be it with a suprarenal or an infrarenal fixation device, is associated with worse outcomes. This analysis reinforces the importance of the consideration of either fenestrated or open repair in those aneurysms that fail to satisfy IFU while endovascular repair in such a setting should be reserved as a last resort strategy.

Dataset Information

Meta-analysis of individual-patient data from EVAR-1, DREAM, OVER and ACE trials comparing outcomes of endovascular or open repair for abdominal aortic aneurysm over 5 years.

Publications

Meta-analysis of individual-patient data from EVAR-1, DREAM, OVER and ACE trials comparing outcomes of endovascular or open repair for abdominal aortic aneurysm over 5 years.

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