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TEVAR plus OMT promising for stable type B aortic dissections
Results from the INSTEAD-XL trial have shown that thoracic endovascular aortic repair plus optimal medical treatment improves 5-year aorta-specific survival and delayed disease progression in patients with stable type B aortic dissection compared with optimal medical treatment alone, and may potentially lead to a paradigm shift in the management of these patients.
With previous research indicating short-term outcomes for patients with complicated type B dissection improve with endovascular management, Christoph A. Nienaber, MD, PhD, and fellow researchers of the INSTEAD-XL trial set out to determine whether the same approach could benefit patients with an uncomplicated — initially stable — form of the condition.
They enrolled 140 patients with stable type B aortic dissection who were previously randomized to optimal medical treatment (OMT) and thoracic endovascular aortic repair (TEVAR; n=72) or OMT alone (n=68). Patients were analyzed retrospectively for aorta-specific, all-cause outcomes and disease progression using landmark statistical analysis of years 2 to 5 following index procedure.
At 5 years, the risk of aorta-specific mortality (6.9% vs. 19.3%; P=.04) and progression (27% vs. 46.1%; P=.04) were lower with TEVAR compared with OMT, and there was a trend favoring TEVAR in all-cause mortality (11.1% vs. 19.3%; P=.13).
Christoph A. Nienaber
In landmark analysis, researchers observed a benefit with TEVAR for all endpoints between 2 and 5 years, including all-cause mortality (0% vs. 16.9%; P=.0003), aorta-specific mortality (0% vs. 16.9%; P=.0005) and progression (4.1% vs. 28.1%; P=.004); results remained consistent regardless of whether landmarking was at 1 year or 1 month.
In other data, improved survival and less progression of disease after elective TEVAR were linked with stent graft induced false lumen thrombosis in 90.6% of cases (P<.0001).
“Although in ‘complicated’ dissection TEVAR is already accepted as first choice option for successful management, the community wasn’t clear about ‘uncomplicated’ cases that are usually managed only with drugs. With INSTEAD-XL, it became clear that the benefits of timely TEVAR are there but only emerge later,” Nienaber told Cardiology Today’s Intervention. “The mission now for ‘stable’ patients is to use TEVAR to preempt late aortic rupture and to avoid late complications that are more difficult to treat. One could postulate that the term ‘uncomplicated dissection’ is in fact a misnomer, since there are either early complications (malperfusion, imminent rupture) or late complications (sudden rupture or late malperfusion), but never no complications; as a result, uncomplicated dissection does not exist.”
Disclosure: The study was partially funded by Medtronic. Nienaber has received lecture and consulting fees from Boston Scientific, Cook Medical and Medtronic.