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DENVER -- Early endovascular repair provided no advantages over ultrasound surveillance for patients with small abdominal aortic aneurysms in the 4- to 5-cm range, according to an interim analysis of a large trial.

Patients had the same risk of rupture or aneurysm-related death at 20 months' follow-up regardless of whether they were randomized to repair or surveillance in the ongoing Positive Impact of Endovascular Options for Treating Aneurysms Early (PIVOTAL) trial.

"The risk of rupture is low with careful follow-up and selective intervention," Dr. Kenneth Ouriel reported at the Vascular Annual Meeting.

PIVOTAL is a multicenter trial involving 728 patients with abdominal aortic aneurysms 4-5 cm in diameter who were randomized to endovascular repair or ultrasound surveillance every 6 months with intervention in the event of aneurysm enlargement or development of symptoms.

The risk of small abdominal aortic aneurysm rupture is low with careful follow-up and selective intervention.
DR. OURIE

Standard practice has been to watch aneurysms of that size. The PIVOTAL hypothesis was that endovascular repair of such aneurysms might be more beneficial. Even though prior clinical trials have failed to show an advantage for open surgical repair over surveillance of small aneurysms, endovascular repair has proved safer than open surgery in the case of large aneurysms, thus providing a rationale for PIVOTAL, explained Dr. Ouriel, a vascular surgeon who serves as senior vice president and chief of international operations at New York-Presbyterian Hospital.

The primary composite PIVOTAL end point is rupture or aneurysm-related death, which by 20 months' follow-up had occurred in two patients (0.6%) in each study arm. The secondary end point, all-cause mortality, occurred in 15 patients in each group (4.1%).

The PIVOTAL trial was originally planned for 1,050 patients, but enrollment was slow. A statistical futility analysis performed at the 728-patient mark indicated a less than a 1% likelihood of finding a different overall study outcome with the addition of a further 250 patients, so enrollment in the study was terminated late last year.

By a mean 20 months of follow-up, 112 patients in the surveillance arm had undergone aneurysm repair, a rate some audience members considered high. Dr. Ouriel responded that this rate was in line with those reported in other studies reflective of real-world clinical practice. Although a 0.5-cm increase in aneurysm size in a 6-month period or enlargement to 5.5 cm are often considered indications for intervention, some patients who don't meet those standards request repair because they've grown uncomfortable in waiting.

Dr. Ouriel stressed that although early endovascular repair and surveillance are neck and neck in terms of key outcomes at this point, the final answer is not in. PIVOTAL follow-up will continue out to a mean of 4 years.

The study is sponsored by Medtronic Vascular. Dr. Ouriel disclosed that he has no financial conflicts of interest, as he is participating in the trial without compensation.