Aortic Trial Update: TEVAR and STABLE Trial Series With Cook Petticoat System

Hollywood, FL (January 24, 2020) – In a presentation at the International Symposium on Endovascular Therapy (ISET), Joseph Lombardi, MD, described the results of a systematic review addressing whether thoracic endovascular aortic repair (TEVAR) prevents aortic growth. He also reviewed the STABLE I and STABLE II trials that compared TEVAR alone versus TEVAR and the Petticoat system (Cook Medical).

TEVAR for complicated type B aortic dissection has known benefits, including reduced mortality compared to open surgery. Rupture and malperfusion are effectively initially managed with TEVAR, and long-term positive thoracic aortic remodeling is possible with longer coverage of the thoracic aorta.

However, in the long term, aortic growth occurs in 30% to 40% of patients after TEVAR, and secondary interventions are needed in over 20% of patients. The visceral aorta is the most frequent area of growth and the most difficult area to treat.

To investigate whether TEVAR affects aortic growth, Dr. Lombardi and his colleagues conducted a systematic review of articles that examined age or growth, or at least measured early growth in long-term follow-up aortic measurements. Of 84 publications identified, 17 met inclusion criteria and “compared apples to apples,” said Dr. Lombardi.

The review found that 1108 patients had a 33.8% growth rate of the thoracic aorta after TEVAR for the treatment of type B aortic dissection. The authors also found that the abdominal aorta was much less described in the literature, with 397 patients who had a 34.5% growth rate.

“Clearly it seemed that based on this data, TEVAR did not prevent aortic growth, based on the literature available to us today,” said Dr. Lombardi.

As a result, “we’re rethinking our approach,” he said. TEVAR is now seen as the first stage of complicated type B aortic dissection management, and frequent follow-up and patient surveillance for growth is important.

Initial available management strategies, he said, are TEVAR alone or TEVAR and Petticoat (Cook Medical), a bare-metal stent that is the subject of the STABLE I and STABLE II trials. STABLE I was a feasibility trial with broad inclusion criteria that included high-risk parameters such as persistent pain and persistent hypertension despite maximum medical therapy. STABLE II was a pivotal trial that included patients with rupture and malperfusion.

Mortality rate was a key outcome at 30 days. “Mortality was 5.5% in STABLE I, which is the best reported data for mortality for aortic dissection,” said Dr. Lombardi.

He also covered data comparing TEVAR alone with the Petticoat system. “We’ve found that the Petticoat system really did have significantly greater remodeling influence in type B dissections. And we also looked at TEVAR alone in a setting of malperfusion versus Petticoat, and we found there was a significant survival advantage when matched head to head with patients with TEVAR alone when you use Petticoat,” he said.

He concluded that neither standard TEVAR nor Petticoat eliminate the risk of aneurysmal degeneration. However, early and late failures can be remedied by detailed imaging and entry flow management. “The Petticoat concept provides early decreased morbidity and mortality and long-term management options,” he said.