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NEW YORK -- The early promise of endovascular repair of abdominal aortic aneurysms may not be borne out over the long term, according to the ongoing follow-up of a randomized Dutch trial. The results suggest that mortality may be higher at 4 years after endovascular repair than after open surgical repair.

Initial experience in the study demonstrated that there was a survival advantage apparent during the first month after endovascular repair (EVAR) of abdominal aortic aneurysms compared with open repair. In the Dutch Randomized Endovascular Aneurysm Management (DREAM) trial, which included 345 patients, the combined rate of operative mortality and severe complications was 10% in the open repair group and 5% in the EVAR group.

In their first report the investigators wrote, "The findings of this randomized trial comparing open and endovascular aneurysm repair suggest that in patients who qualify for either procedure, endovascular repair is preferable to open repair over the first 30 days after the procedure" (N. Engl. J. Med. 2004;351:1607-18).

However, that advantage was seen to be lost at 2 years, when the survival curves for the two groups finally converged, according to lead investigator Dr. Jan D. Blankensteijn, who is chief of vascular surgery at Radboud University Nijmegen (the Netherlands) Medical Centre.

At that 2-year point the cumulative survival rate was at 90% in both the endovascular and the open surgical groups, leading the authors to caution, "Our 2-year data do not exclude the possibility that these curves will eventually cross, resulting in a higher rate of death for endovascular repair than for open repair after 24 months," (N. Engl. J. Med. 2005;352:2398-405).

"Four years after discharge, with 62% of patients remaining alive and only 10% having been censored, overall survival shows a clear and highly significant difference between the groups, with a higher mortality rate as of discharge in the endovascular group," Dr. Blankensteijn said at the Veith symposium on vascular medicine sponsored by the Cleveland Clinic.

However, Dr. Blankensteijn declined to provide any further specific data or interpretation in his report. "The data are preliminary and incompletely analyzed, and in particular, the causes of death need further analysis before any interpretation can be given," he explained in an interview.

"For instance, were there more aneurysm ruptures in the EVAR group? Was there greater mortality associated with reinterventions? We don't know," he said

All patients will continue to be followed for 5 years, which should allow time to collect the necessary data.

"For now, the message is that there might be a differential long-term death rate for the two groups after discharge. We need to figure out if the apparent trend holds up in the long-term analysis of all randomized trials, why it is so, and whether this accounts for all patients or just particular subgroups," he said.

"This may be conceived as a disappointment to some, and in the long term it may jeopardize the perioperative survival advantage of EVAR," he concluded.

DREAM has been supported by a grant from the Netherlands National Health Insurance Council. Dr. Blankensteijn declared no conflicts of interest with regard to the study.

When asked to comment on this story, Dr. Ron Fairman, professor of surgery and chief, division of vascular surgery and endovascular therapy, Hospital of the University of Pennsylvania, Philadelphia, stated: "We have known for quite some time that the mortality following abdominal aortic aneurysm repair is not insignificant and is attributed largely to cardiovascular demise.

"Clearly, it will be essential to learn why the DREAM mortality profile following EVAR changes over time and if it is due to technology failure and aneurysm-related death. If so, this data will impact our algorithms for long-term follow-up of EVAR patients," Dr. Fairman concluded.