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Individual-patient meta-analysis of three randomized trials comparing endovascular versus open repair for ruptured abdominal aortic aneurysm.

ABSTRACT:

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 31.3 per cent for patients randomized to endovascular repair/strategy and 34.0 per cent for those randomized to open repair at 30 days (pooled odds ratio 0.88, 95 per cent c.i. 0.66 to 1.18), and 34.3 and 38.0 per cent respectively at 90 days (pooled odds ratio 0.85, 0.64 to 1.13). There was no evidence of significant heterogeneity in the odds ratios between trials. Mean(s.d.) aneurysm diameter was 8.2(1.9) cm and the overall in-hospital mortality rate was 34.8 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 1.24, 95 per cent c.i. 1.04 to 1.47). For open repair, 30-day mortality diminished with increasing aneurysm neck length (adjusted odds ratio 0.69 (95 per cent c.i. 0.53 to 0.89) per 15 mm), 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.

SUBMITTER: Sweeting MJ

PROVIDER: S-EPMC4744980 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description: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.

Project description:BackgroundAbdominal aortic aneurysm (AAA) repair has been performed by various surgical specialties for many years. Endovascular aneurysm repair (EVAR) may be a disruptive technology, having an impact on which specialties care for patients with AAA. Therefore, we examined the proportion of AAA repairs performed by various specialties over time in the United States and evaluated the impact of the introduction of EVAR.MethodsThe Nationwide Inpatient Sample (2001-2009) was queried for intact and ruptured AAA and for open repair and EVAR. Specific procedures were used to identify vascular surgeons (VSs), cardiac surgeons (CSs), and general surgeons (GSs) as well as interventional cardiologists and interventional radiologists for states that reported unique treating physician identifiers. Annual procedure volumes were subsequently calculated for each specialty.ResultsWe identified 108,587 EVARs and 85,080 open AAA repairs (3011 EVARs and 12,811 open repairs for ruptured AAA). VSs performed an increasing proportion of AAA repairs during the study period (52% in 2001 to 66% in 2009; P < .001). GSs and CSs performed fewer repairs during the same period (25% to 17% [P < .001] and 19% to 13% [P < .001], respectively). EVAR was increasingly used for intact (33% to 78% of annual cases; P < .001) as well as ruptured AAA repair (5% to 28%; P < .001). The proportion of intact open repairs performed by VSs increased from 52% to 65% (P < .001), whereas for EVAR, the proportion went from 60% to 67% (P < .001). The proportion performed by VSs increased for ruptured open repairs from 37% to 53% (P < .001) and for ruptured EVARs from 28% to 73% (P < .001). Compared with treatment by VSs, treatment by a CS (0.55 [0.53-0.56]) and GS (0.66 [0.64-0.68]) was associated with a decreased likelihood of undergoing endovascular rather than open AAA repair.ConclusionsVSs are performing an increasing majority of AAA repairs, in large part driven by the increased utilization of EVAR for both intact and ruptured AAA repair. However, GSs and CSs still perform AAA repair. Further studies should examine the implications of these national trends on the outcome of AAA repair.