The latest results from the largest study to date comparing open and endovascular surgery for abdominal aortic aneurysm repair found no difference in long-term survival between the procedures.
The findings called into question the benefit of offering endovascular AAA repair to patients who are too sick to undergo open surgery.
"The
dream of improving long-term survival and expanding the population that will benefit from AAA repair is seemingly over," Brigham & Women’s Hospital’s Dr. Joshua Beckman wrote in an editorial accompanying the results from the Open Versus Endovascular Repair study.
That could be bad news for the medtech giants working on endovascular AAA repair systems, including Medtronic (NYSE:MDT) with its Endurant AAA stent graft and Johnson & Johnson (NYSE:JNJ) subsidiary Cordis with its Incraft AAA system.
The 881-patient OVER study is the largest yet to directly compare open and endovascular AAA repair, and the results largely confirmed what researchers had found in prior studies – endovascular repair offers reduced pain and suffering and confers some mortality benefit in the short term, but that benefit fades away after 3 years.
"Most studies have shown a perioperative benefit in mortality for endovascular repair, and in the previous trials that had gone away in about a year and a half," study researcher Dr. Frank Lederle told heartwire. "It persisted quite a bit longer in our study, so there was some benefit seen at up to 5 years, and it was a significant benefit for endovascular repair up to 3 years, but nevertheless in the end, the long-term mortality was the same."
The most important conclusions of the study, according to Lederle, are that patient preference should play a larger role in selecting endovascular versus open surgery and that older patients who are not candidates for open surgery should not be considered eligible for endovascular surgery either.
"Endovascular repair should not be taken to a new group of patients who are older and sicker because it looks like that’s not where this procedure is likely to have its advantages," Lederle said. "You may get away with the repair, but in the mid-term and long-term, results are going to be no better. If you can’t do open repair, it’s not a group that you should repair."