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Home > Press Center > U.S. Researchers Believe Endovascular Abdominal Aortic Repair Safe

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Emily Kalata
Communications Manager
312.334.2309

Endovascular aortic aneurysm repair (EVAR) is safe for patients at high risk for open surgery and provides lasting protection from abdominal aortic aneurysm (AAA) related mortality, according to study published in the August 2006 issue of the Journal of Vascular Surgery.

Gregorio A. Sicard, MD, chief of the section for vascular surgery at Washington University School of Medicine in St. Louis, Mo., and chair of the Society for Vascular Surgery (SVS) Outcomes Committee, along with the SVS Outcomes Committee, analyzed high risk patients in the Lifeline Registry. To be considered, high risk patients had to be 60 years or older with an aneurysm size of 5.5 cm or greater, and had to have at least one cardiac, pulmonary or renal comorbidity. The inclusion criteria were similar to those published from a recent European randomized trial (EVAR2).

Of the 2,216 patients from five multicenters FDA IDE trials, 565 patients treated with EVAR and 61 treated with open surgery met the high risk criteria.

The 30-day operative mortality was 2.9 percent with EVAR compared to 5.1 percent for open surgery. AAA-related death rate for EVAR was 3.0 percent and 4.2 percent for one and four years respectively; compared to 5.1 percent for open surgery at both time points. EVAR prevented AAA rupture in 99.5 percent at one year and 97.2 percent at four years.

“Researchers for EVAR2 reviewed their outcomes and believed that EVAR should not be used on high risk patients,” added Dr. Sicard. “They compared patients who were deemed unfit for surgery using a pragmatic approach by their surgeon, radiologist, anesthesiologist and or cardiologist. These patients were then randomized to EVAR or no treatment (surveillance). In our study, we evaluated independently audited, high compliance, chart verified data sets of high risk patients and compared their results of EVAR to open surgery.”  Dr. Sicard said that the U.S. data showed a 30-day mortality of 2.9 percent compared to EVAR2’s nine percent. At four years, our AAA-related mortality was markedly lower (four percent compared to 14 percent in EVAR2). Another marked difference was the four-year patient survival rate of 56 percent compared to 34 percent in EVAR2.  The difference, he said, could be due to the possibility that the EVAR2 trial may have randomized sicker patients.

Nine of the 20 deaths (45 percent) in the treatment arm of EVAR2 occurred during a 57-day interval between randomization and treatment. “Many deaths may not have occurred with a shorter interval before repair,” noted Dr. Sicard. “Also, 22 percent of the patients randomized to EVAR or no treatment (surveillance) with a low (2 percent) mortality. This reduced the aneurysm-related death rate in the control arm and biased results against EVAR in the intent to treat analysis.”

Dr. Sicard added that all-cause mortality at four years was 44 percent in the U.S. study, compared to 66 percent in EVAR2. “The mortality for EVAR in our study remained comparable to open surgery up to four years,” he said. “We believe endovascular repair of large infrarenal AAAs in anatomically-suited high risk surgical patients using FDA-approved devices in the United States is safe. However, the decision to treat AAAs in patients with advanced age and significant comorbidities must be individualized and carefully considered.”