PIVOTAL Study of EVAR Presented at TCT

September 24, 2009—When compared to surveillance, there was no apparent benefit to endovascular repair (EVAR) of small abdominal aortic aneurysms (AAAs) measuring between 4 and 5 cm, according to results from the PIVOTAL (Positive Impact of Endovascular Options for Treating Aneurysms Early) trial. Kenneth Ouriel, MD, presented the findings at the 2009 Transcatheter Cardiovascular Therapeutics (TCT) scientific sessions in San Francisco, as reported in the conference newspaper, TCT Daily. PIVOTAL is sponsored by Medtronic, Inc. (Minneapolis, MN) to determine whether repair of small aneurysms is superior to surveillance with respect to the frequency of rupture or aneurysm-related deaths using the company's AneuRx AAA and Talent AAA stent grafts.

According to the TCT Daily, patients in PIVOTAL randomized to early EVAR had a significantly higher overall rate of repair at 3 years versus surveillance patients who subsequently crossed over, but there was no difference in the primary endpoint of aneurysm-related mortality or rupture. There was also no difference in survival or cumulative rate of secondary interventions. PIVOTAL was originally designed to enroll 1,050 patients to receive either early repair or surveillance. The study was stopped at the interim analysis after it was determined that further enrollment would not change the results.

A total of 728 patients were enrolled and analyzed. Of these patients, 326 underwent EVAR. At 3 years, over 90% of EVAR patients had successful repair of their aneurysm compared to just over 40% in the surveillance group. In the surveillance group, a large proportion of patients' aneurysms grew to more than 5 cm. However, there were only two aneurysm-related mortalities in each group out to 3 years.

"The risk of rupture was lower than we predicted in either group," Dr. Ouriel said. Rates of all-cause mortality were also similar, with a total of 15 deaths in each group. At 3 years, five patients in the surveillance group and 12 patients in the EVAR group required a secondary intervention. Acute procedural outcomes did not differ.

Dr. Ouriel concluded, "In patients with a small aneurysm, either strategy can be safe. Some people will say, 'Don't do anything,' but I would say that should be based on the individual patient characteristics." He added that if surveillance is preferred, the patient must be willing to submit to serial screening with CT imaging and have no contraindications for CT imaging.