STABLE II: Endovascular device favorable to patients with complicated type B aortic dissection

A composite endovascular device was associated with short-term positive outcomes for most members of a cohort with complicated type B aortic dissection, according to data from the STABLE II trial.

Researchers evaluated the safety and efficacy of the device, a covered stent graft plus a bare-metal stent (Zenith Dissection Endovascular System, Cook Medical), in 73 patients (mean age, 61 years; 66% men) with acute complicated type B aortic dissection who presented with aortic rupture (22%), branch vessel malperfusion (73%) or both (5.5%).

The primary safety endpoint was freedom from major adverse events at 30 days. The primary efficacy endpoint was 30-day survival.

Joseph V. Lombardi, MD, professor and chief of the division of vascular surgery at Cooper University Hospital in Camden, New Jersey, presented 30-day (97% of cohort) and 1-year (85% of cohort) results at the Society for Vascular Surgery 2016 Vascular Annual Meeting.

Joseph V. Lombardi

The 30-day mortality rate was 6.8% (n = 5). The five deaths were caused by aortic dissection, ischemic bowel, multiple organ failure, stroke and aortic rupture, according to the researchers.

Major adverse events at 30 days included 10 cases of prolonged ventilator support, seven cases of chronic renal insufficiency or renal failure requiring dialysis, five strokes, four cases of paraplegia or paraparesis, one MI and one case of bowel ischemia, according to Lombardi and colleagues.

After 30 days but before 1 year, there were nine deaths (one related to dissection repair) and three major adverse events (two cases of chronic renal insufficiency or renal failure requiring dialysis and one case of stroke and bowel ischemia), according to the researchers.

There were nine patients who required a secondary intervention at 1 year, but none were converted to open surgery.

At 1 year, mean true lumen diameter in the descending thoracic aorta increased from 22.3 mm to 33.8 mm and mean true lumen diameter in the abdominal aorta increased from 18.4 mm to 25.8 mm, whereas mean false lumen diameter decreased from 18.4 mm to 8.6 mm in the descending thoracic aorta and from 15.3 mm to 12.3 mm in the abdominal aorta, Lombardi and colleagues found.

“These initial results from the STABLE II study appeared favorable in terms of clinical and anatomical outcomes for the treatment of rupture and malperfusion in the setting of [complicated type B aortic dissection],” Lombardi and colleagues wrote in an abstract. “Five-year follow-up is ongoing.” – by Erik Swain

Reference:

Lombardi JV, et al. Plenary Session 6: RS17. Presented at: Society for Vascular Surgery 2016 Vascular Annual Meeting; June 8-11, 2016; National Harbor, Md.

Disclosure: Lombardi reports receiving consulting fees and research funding from Cook Medical.