Aortic remodeling after endovascular treatment of complicated type B aortic dissection with the use of a composite device design

Objective: The purpose of this study is to report updated clinical and aortic remodeling results from the Study for the Treatment of complicated Type B Aortic Dissection using Endoluminal repair (STABLE) trial, a prospective, multicenter study evaluating safety and effectiveness of a pathology-specific endovascular system (proximal stent graft and distal bare metal stent) for the treatment of complicated type B aortic dissection. Methods: All 86 enrolled patients (mean age, 59 years; 73.3% men) were treated within 90 days of symptom onset (55 with acute dissections and 31 with nonacute dissections). Inclusion criteria were branch vessel obstruction/compromise, impending rupture as evidenced by periaortic effusion/hematoma, resistant hypertension, persistent pain/symptoms, or aortic growth >= 5 mm within 3 months (or transaortic diameter >= 40 mm). Remodeling of the dissected aorta, including thrombosis of the false lumen and changes in the true lumen, false lumen, and transaortic diameter, were assessed in patients with available computed tomographic imaging through 2 years. Results: The 30-day mortality rate was 4.7% (4/86) in the overall patient group (5.5% in acute patients and 3.2% in nonacute patients). Freedom from all-cause mortality was 88.3% at 1 year and 84.7% at 2 years (no significant difference between acute and nonacute patients). From baseline to 2 years, the true lumen diameter increased significantly in the descending thoracic aorta and the more distal abdominal aorta, along with a decrease in the false lumen diameter in both aortic segments. A majority of patients had either a stable or shrinking transaortic diameter in the thoracic (80.3% at 1 year and 73.9% at 2 years) or abdominal aorta (79.1% at 1 year and 66.7% at 2 years). Transaortic growth (>5 mm) occurred predominantly in acute dissections. Consistently, a shorter time from symptom onset to treatment was found to predict transaortic growth in the abdominal aorta (P = .03). Conclusions: Endovascular repair of complicated type B aortic dissection with the use of a composite construct demonstrates favorable early clinical outcomes and aortic remodeling. However, patients treated in the acute setting may be prone to aortic growth and may require close observation. Follow-up through 5 years is ongoing.