Stent graft system safe, effective at 4 years in patients with AAA

LAS VEGAS — A low-profile abdominal stent graft system for the treatment of abdominal aortic aneurysms was associated with a low rate of major adverse events and no ruptures, conversions, type I/III endoleaks or migration at 4 years, according to follow-up data from the Ovation clinical study.

The Ovation Abdominal Stent Graft System (TriVascular Inc.) was studied in the prospective, single-arm Ovation study, the regulatory trial for U.S. approval. In total, 161 patients with abdominal aortic aneurysm (AAA) were treated with the stent graft during endovascular aneurysm repair (EVAR) from November 2009 to May 2011 at 36 centers in Chile, Germany and the United States. The mean age of the cohort was 73 years, 88% were men and the mean AAA diameter was 54 mm. Forty-one percent of patients had access vessels < 6 mm, aortic neck length < 10 mm or both.

Manish Mehta, MD, MPH, FACS, director of Vascular Health Partners and professor of surgery at Albany Medical College in New York, reported 4-year results of the pivotal study at VIVA 15.

The stent graft was implanted successfully in all patients. The rate of major adverse events was 2.5% at 30 days (primary endpoint) and 3.8% between 30 days and 1 year. The 1-year rate of AAA-related mortality was 0.6% and all-cause mortality was 2.5%. Through 4-year follow-up, Mehta said no ruptures, conversions, type I/III endoleaks or migration occurred. Limb occlusion was reported in 1.2% of patients. Only 6.2% of patients required reinterventions during follow-up.

Aneurysm diameter that has been stable or decreasing was noted in the vast majority of patients at 3 and 4 years, Mehta said during a presentation. Patients in the study had an aneurysm enlargement rate of 10% at 4 years, which he said is comparable to previous EVAR studies that included only U.S. participants.

Percutaneous access was used in 43% of patients and a cut-down strategy in the remainder. Those patients who received percutaneous access achieved similar clinical outcomes, with lower anesthesia time, procedure time and hospitalization.

“To date, over 8,000 patients worldwide have been treated with the Ovation Abdominal Stent Graft platform, with over 1,000 subjects in a tightly controlled study or registry. Patient demographics, anatomical characteristics and procedural characteristics indicate a challenging patient cohort,” Mehta said. “… These data provide compelling evidence that the Ovation system can expand EVAR access to more patients and improve EVAR outcomes for all patients.” – by Katie Kalvaitis

Reference:

Mehta M. Late-Breaking Clinical Trials. Presented at: VIVA 15; Nov. 2-5, 2015; Las Vegas.

Disclosure: Mehta reports receiving honoraria and research/clinical trial/drug study funds from TriVascular Inc.