Stenting, Open Repair Trials: No Clear Winner

NICE, FRANCE — Advocates of endovascular aneurysm repair had high hopes that three large randomized, controlled trials conducted in Europe—EVAR I, EVAR II, and DREAM—would establish the procedure's superiority over open repair. Recently published results have been equivocal, however, and the closest an expert speakers' panel could come to consensus was that informed patient preference should be the deciding factor for the time being.

“I think today it's too close to call,” Jim A. Reekers, M.D., Ph.D., concluded after presentations by the principal investigators and a heated audience discussion at the annual meeting of the Cardiovascular and Interventional Radiological Society of Europe.

“The patient can make up his own mind because we don't have a definite answer yet,” said Dr. Reekers, a radiology professor at the University of Amsterdam, who discussed implications at the special session.

The three multicenter studies focused on abdominal aortic aneurysm repair.

British investigators led by Roger Greenhalgh, M.D., conducted the Endovascular Aneurysm Repair (EVAR) I trial at 34 centers in the United Kingdom. They enrolled patients who had aneurysms at least 5.5 cm in diameter and were fit for either endovascular or open repair.

EVAR I randomized 543 patients to stenting and 539 to open repair. Early results favored stenting, as its 30-day mortality rate of 1.7% was two-thirds less than the 4.7% reported for patients who had open repair (Lancet 2004;364:843–8).

By 4 years, however, all-cause mortality had leveled off at about 28% for both groups. The stenting cohort had fewer aneurysm-related deaths (4% vs. 7%), but more postoperative complications (41% vs. 9%).

The Dutch Randomized Endovascular Aneurysm Management (DREAM) trial group led by Jan D. Blankensteijn, M.D., enrolled patients with aneurysms at least 5 cm in length at 28 centers in the Netherlands and Belgium. It randomized 171 to stenting and 174 to open repair.

Again the early results favored stenting, which had an operative mortality rate of 1.2% vs. 4.6% in the open-repair group. Severe complications were fewer (N. Engl. J. Med. 2004;351:1607–18).

Once more, the results were not sustained. Two years after randomization, both cohorts had cumulative survival rates approaching 90%. Though open repair had more aneurysm-related deaths (5.7% vs. 2.1% for stenting), the investigators attributed the difference to the perioperative period. Aneurysm-related mortality was similar after the first 30 days. About two-thirds of both groups were free of moderate to severe complications (N. Engl. J. Med. 2005;352:2398–405).

Only unfit patients who were not candidates for surgery entered the EVAR II trial at 31 hospitals in the United Kingdom. The investigators assigned 166 to stenting and 172 to no intervention.

All told, 197 patients (including 47 who had been assigned to no intervention) underwent some form of aneurysm repair. During the follow-up period, 142 patients died; in 42 cases the deaths were related to aneurysms.

There were no significant differences in overall mortality or aneurysm-related survival (Lancet 2005;365:2187–92).

All three studies reported higher costs with stenting. The investigators attributed this, in part, to mandates for intensive follow-up in patients undergoing a new procedure.

The Dutch investigators similarly found costs to be about 4,500 euros higher with stenting, according to Dr. Blankensteijn, a professor of vascular surgery at the Radboud University Nijmegen (the Netherlands) Medical Center.

Dr. Greenhalgh, head of the department of vascular surgery at the Imperial College School of Medicine and Charing Cross Hospital in London, rejected a suggestion from the audience that the results favored open repair. “If open repair were clearly superior I would say EVAR is dead. If EVAR and open repair are neck and neck, then it is possible that EVAR is ahead,” he said. “At the 4-year point, there is a small but significant benefit of EVAR. Therefore EVAR is close to open repair or better.”

From a patient's perspective, he added, improved short-term risk with EVAR could be the deciding factor. For a man who is going to become a grandfather in 6 months, the early advantage could be more important than comparable survival at 4 years or the higher cost to society.

“But you have to say it comes at a cost, that [the patient] will be chained to your institution for period of time and might need repeat interventions,” Dr. Greenhalgh advised, adding that increased complications with stenting did not increase mortality. Most of the complications were minor.

NICE, FRANCE — Advocates of endovascular aneurysm repair had high hopes that three large randomized, controlled trials conducted in Europe—EVAR I, EVAR II, and DREAM—would establish the procedure's superiority over open repair. Recently published results have been equivocal, however, and the closest an expert speakers' panel could come to consensus was that informed patient preference should be the deciding factor for the time being.

“I think today it's too close to call,” Jim A. Reekers, M.D., Ph.D., concluded after presentations by the principal investigators and a heated audience discussion at the annual meeting of the Cardiovascular and Interventional Radiological Society of Europe.

“The patient can make up his own mind because we don't have a definite answer yet,” said Dr. Reekers, a radiology professor at the University of Amsterdam, who discussed implications at the special session.

The three multicenter studies focused on abdominal aortic aneurysm repair.

British investigators led by Roger Greenhalgh, M.D., conducted the Endovascular Aneurysm Repair (EVAR) I trial at 34 centers in the United Kingdom. They enrolled patients who had aneurysms at least 5.5 cm in diameter and were fit for either endovascular or open repair.

EVAR I randomized 543 patients to stenting and 539 to open repair. Early results favored stenting, as its 30-day mortality rate of 1.7% was two-thirds less than the 4.7% reported for patients who had open repair (Lancet 2004;364:843–8).

By 4 years, however, all-cause mortality had leveled off at about 28% for both groups. The stenting cohort had fewer aneurysm-related deaths (4% vs. 7%), but more postoperative complications (41% vs. 9%).

The Dutch Randomized Endovascular Aneurysm Management (DREAM) trial group led by Jan D. Blankensteijn, M.D., enrolled patients with aneurysms at least 5 cm in length at 28 centers in the Netherlands and Belgium. It randomized 171 to stenting and 174 to open repair.

Again the early results favored stenting, which had an operative mortality rate of 1.2% vs. 4.6% in the open-repair group. Severe complications were fewer (N. Engl. J. Med. 2004;351:1607–18).

Once more, the results were not sustained. Two years after randomization, both cohorts had cumulative survival rates approaching 90%. Though open repair had more aneurysm-related deaths (5.7% vs. 2.1% for stenting), the investigators attributed the difference to the perioperative period. Aneurysm-related mortality was similar after the first 30 days. About two-thirds of both groups were free of moderate to severe complications (N. Engl. J. Med. 2005;352:2398–405).

Only unfit patients who were not candidates for surgery entered the EVAR II trial at 31 hospitals in the United Kingdom. The investigators assigned 166 to stenting and 172 to no intervention.

All told, 197 patients (including 47 who had been assigned to no intervention) underwent some form of aneurysm repair. During the follow-up period, 142 patients died; in 42 cases the deaths were related to aneurysms.

There were no significant differences in overall mortality or aneurysm-related survival (Lancet 2005;365:2187–92).

All three studies reported higher costs with stenting. The investigators attributed this, in part, to mandates for intensive follow-up in patients undergoing a new procedure.

The Dutch investigators similarly found costs to be about 4,500 euros higher with stenting, according to Dr. Blankensteijn, a professor of vascular surgery at the Radboud University Nijmegen (the Netherlands) Medical Center.

Dr. Greenhalgh, head of the department of vascular surgery at the Imperial College School of Medicine and Charing Cross Hospital in London, rejected a suggestion from the audience that the results favored open repair. “If open repair were clearly superior I would say EVAR is dead. If EVAR and open repair are neck and neck, then it is possible that EVAR is ahead,” he said. “At the 4-year point, there is a small but significant benefit of EVAR. Therefore EVAR is close to open repair or better.”

From a patient's perspective, he added, improved short-term risk with EVAR could be the deciding factor. For a man who is going to become a grandfather in 6 months, the early advantage could be more important than comparable survival at 4 years or the higher cost to society.

“But you have to say it comes at a cost, that [the patient] will be chained to your institution for period of time and might need repeat interventions,” Dr. Greenhalgh advised, adding that increased complications with stenting did not increase mortality. Most of the complications were minor.

NICE, FRANCE — Advocates of endovascular aneurysm repair had high hopes that three large randomized, controlled trials conducted in Europe—EVAR I, EVAR II, and DREAM—would establish the procedure's superiority over open repair. Recently published results have been equivocal, however, and the closest an expert speakers' panel could come to consensus was that informed patient preference should be the deciding factor for the time being.

“I think today it's too close to call,” Jim A. Reekers, M.D., Ph.D., concluded after presentations by the principal investigators and a heated audience discussion at the annual meeting of the Cardiovascular and Interventional Radiological Society of Europe.

“The patient can make up his own mind because we don't have a definite answer yet,” said Dr. Reekers, a radiology professor at the University of Amsterdam, who discussed implications at the special session.

The three multicenter studies focused on abdominal aortic aneurysm repair.

British investigators led by Roger Greenhalgh, M.D., conducted the Endovascular Aneurysm Repair (EVAR) I trial at 34 centers in the United Kingdom. They enrolled patients who had aneurysms at least 5.5 cm in diameter and were fit for either endovascular or open repair.

EVAR I randomized 543 patients to stenting and 539 to open repair. Early results favored stenting, as its 30-day mortality rate of 1.7% was two-thirds less than the 4.7% reported for patients who had open repair (Lancet 2004;364:843–8).

By 4 years, however, all-cause mortality had leveled off at about 28% for both groups. The stenting cohort had fewer aneurysm-related deaths (4% vs. 7%), but more postoperative complications (41% vs. 9%).

The Dutch Randomized Endovascular Aneurysm Management (DREAM) trial group led by Jan D. Blankensteijn, M.D., enrolled patients with aneurysms at least 5 cm in length at 28 centers in the Netherlands and Belgium. It randomized 171 to stenting and 174 to open repair.

Again the early results favored stenting, which had an operative mortality rate of 1.2% vs. 4.6% in the open-repair group. Severe complications were fewer (N. Engl. J. Med. 2004;351:1607–18).

Once more, the results were not sustained. Two years after randomization, both cohorts had cumulative survival rates approaching 90%. Though open repair had more aneurysm-related deaths (5.7% vs. 2.1% for stenting), the investigators attributed the difference to the perioperative period. Aneurysm-related mortality was similar after the first 30 days. About two-thirds of both groups were free of moderate to severe complications (N. Engl. J. Med. 2005;352:2398–405).

Only unfit patients who were not candidates for surgery entered the EVAR II trial at 31 hospitals in the United Kingdom. The investigators assigned 166 to stenting and 172 to no intervention.

All told, 197 patients (including 47 who had been assigned to no intervention) underwent some form of aneurysm repair. During the follow-up period, 142 patients died; in 42 cases the deaths were related to aneurysms.

There were no significant differences in overall mortality or aneurysm-related survival (Lancet 2005;365:2187–92).

All three studies reported higher costs with stenting. The investigators attributed this, in part, to mandates for intensive follow-up in patients undergoing a new procedure.

The Dutch investigators similarly found costs to be about 4,500 euros higher with stenting, according to Dr. Blankensteijn, a professor of vascular surgery at the Radboud University Nijmegen (the Netherlands) Medical Center.

Dr. Greenhalgh, head of the department of vascular surgery at the Imperial College School of Medicine and Charing Cross Hospital in London, rejected a suggestion from the audience that the results favored open repair. “If open repair were clearly superior I would say EVAR is dead. If EVAR and open repair are neck and neck, then it is possible that EVAR is ahead,” he said. “At the 4-year point, there is a small but significant benefit of EVAR. Therefore EVAR is close to open repair or better.”

From a patient's perspective, he added, improved short-term risk with EVAR could be the deciding factor. For a man who is going to become a grandfather in 6 months, the early advantage could be more important than comparable survival at 4 years or the higher cost to society.

“But you have to say it comes at a cost, that [the patient] will be chained to your institution for period of time and might need repeat interventions,” Dr. Greenhalgh advised, adding that increased complications with stenting did not increase mortality. Most of the complications were minor.