Five-year results from the Study of Thoracic Aortic Type B Dissection Using Endoluminal Repair (STABLE I) study of endovascular treatment of complicated type B aortic dissection using a composite device design

Abstract

Objective: We report the final 5-year results from the Study of Thoracic Aortic Type B Dissection Using Endoluminal Repair (STABLE I) study, a prospective, single-arm, multicenter study of the Zenith Dissection Endovascular System (William Cook Europe, Aps, Bjaeverskov, Denmark), a pathology-specific device comprising a proximal stent graft with barbs and a distal bare stainless steel stent for the treatment of patients with complicated type B aortic dissection. Methods:The study prospectively enrolled 86 patients (mean age, 59 years; 73% male) at sites in the United States, Europe, and Australia from 2007 to 2012. Treatment occurred during the acute phase (#14 days after symptom onset) in 55 patients and during the nonacute phase (>14 days; all treated #90 days) in 31 patients. Five-year clinical and imaging follow-up was available for 88.5% of eligible patients. Results:The 30-day all-cause mortality rate was 5.5% (3 of 55) for acute and 3.2% (1 of 31) for nonacute patients (P > .99). The 5-year freedom from all-cause mortality was 79.9% 6 6.2% for acute and 70.1% 6 8.4% for nonacute patients (log-rank test, P ¼ .40). The 5-year freedom from dissection-related mortality (including deaths of indeterminate relatedness to dissection repair) was 83.9% 6 5.9% for acute and 90.1% 6 5.9% for nonacute patients (log-rank test, P ¼ .55). Complete false lumen thrombosis in the thoracic aorta increased over time and was observed in 74.1% of acute and in 58.8% of nonacute patients at 5 years. From preprocedure through 5 years, there was an overall increase in true lumen diameter and a concomitant decrease in false lumen diameter in both acute and nonacute patients at the level of the largest diameter in both the thoracic and abdominal aortas. At 5 years, 65.5% of acute and 81.3% of nonacute patients exhibited a stable or shrinking transaortic diameter in the thoracic aorta, and 48.3% of acute and 76.5% of nonacute patients had a stable or shrinking transaortic diameter in the abdominal aorta. Freedom from secondary intervention at 5 years was 65.5% 6 7.5% for acute and 71.2% 6 9.0% for nonacute patients (log-rank test, P ¼ .71).Conclusions: Endovascular repair of complicated type B aortic dissection with a composite device design demonstrated low all-cause mortality at 30 days, as well as low dissection-related mortality throughout follow-up. Overall, the acute and nonacute cohorts appeared to respond similarly to treatment involving use of the stent-graft and bare metal stent, demonstrating similar clinical outcomes and favorable improvement in aortic remodeling in the thoracic and abdominal aortas.

Satisfactory Long-term Outcomes of Thoracic Endovascular Aortic Repair With a Bare Stent for Acute Complicated Type B Aortic Dissections

“…6–8 In the prospective, multicenter STABLE study, 9 a stent-graft combined with a bare stent to treat cATBAD reduced the incidence of 30-day mortality to 5% and 1-year mortality to 10%. Additionally, beneficial aortic remodeling was observed at 2-year 10 and 5-year 11 follow-up. In China, a recent study showed that TEVAR with a distal bare stent reduced complications and improved favorable aortic remodeling by increasing FL thrombosis and preventing TL collapse.…”

Endovascular strategies for post-dissection aortic aneurysm (PDAA)

“…This strategy provided diffuse mechanical aorto-iliac support and led to complications necessitating re-intervention when treating extensive TBAD. Based on the concept of PETTICOAT, Lombardi JV et al proposed a composite device design to treat complicated type B aortic dissection [ 17 ]. The device comprised a pathology-specific device comprising a proximal stent graft with barbs and a distal bare stainless steel stent.…”

Acute complicated type B aortic dissection during the New York City COVID‐19 surge

“…5,7 In contrast, in the Study of Thoracic Aortic Type B Dissection Using Endoluminal Repair (STABLE I), favorable results were found with the Zenith Dissection Endovascular System (Cook Medical) with a 30-day paraplegia rate of 1.8%. 6 Less disruption of spinal cord perfusion with the use of bare metal stent, continued FL compression to encourage thrombosis and remodeling. 9 There is limited data on TEVAR/EVAR for patients with MFS and only a few case reports presented PETTICOAT technique for patients with MFS.…”

“…[2][3][4] Use of the provisional extension to induce complete attachment (PETTICOAT) technique has been demonstrated to decrease the risk of spinal cord ischemia in comparison to use of covered stent grafts in similar settings. [5][6][7][8]…”