Dissection
Strategies for subacute/chronic type B aortic dissection: The Investigation of Stent Grafts in Patients with Type B Aortic Dissection (INSTEAD) trial 1-year outcome

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Objective

Endovascular stent grafting represents a novel concept for type B aortic dissection both in the acute and subacute/chronic setting, with an unknown effect on outcomes.

Methods

In a prospective trial 140 patients with stable type B dissection were randomly subjected to elective stent-graft placement in addition to optimal medical therapy (n = 72) or to optimal medical therapy (n = 68) with surveillance (arterial pressure according to World Health Organization guidelines ≤120/80 mm Hg). The primary end point was 1-year all-cause mortality, whereas aorta-related mortality, progression (with need for conversion or additional endovascular or open surgical intervention), and aortic remodeling were secondary end points.

Results

There was no difference in all-cause mortality: cumulative survival was 97.0% ± 3.4% with optimal medical therapy versus 91.3% ± 2.1% with thoracic endovascular aortic repair (P = .16). Moreover, aorta-related mortality was not different (P = .42), and the risk for the combined end point of aorta-related death (rupture) and progression (including conversion or additional endovascular or open surgical intervention) was similar (P = .86). Three neurologic adverse events occurred in the thoracic endovascular aortic repair group (1 paraplegia, 1 stroke, and 1 transient paraparesis) versus 1 episode of paraparesis with medical treatment. Finally, aortic remodeling (with true-lumen recovery and thoracic false-lumen thrombosis) occurred in 91.3% with thoracic endovascular aortic repair versus 19.4% with medical treatment (P < .001), which is suggestive of continued remodeling.

Conclusions

In survivors of uncomplicated type B aortic dissection, elective stent-graft placement does not improve 1-year survival and adverse events, despite favorable aortic remodeling.

CTSNet classification

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Supported by an unrestricted research grant from Medtronic Bakken Research Institute, Maastricht, Belgium. Supplemental support was from the Institutional Research Unit at Rostock University (minor funding for statistical support).

Disclosures: Christoph A. Nienaber receives grant/research support from Medtronic, Inc; and is a member of the speakers bureau for Boston Science, Inc, and Cook, Inc. Stephan Kische receives lecture and consulting fees from Medtronic. Hervé Rousseau is a consultant for Medtronic, Gore, and Bolton and receives lecture fees from Medtronic and Bolton. Holger Eggebrecht receives lecture fees from Medtronic and Edwards Lifesciences. Rossella Fattori receives lecture fees from Medtronic. Tim C. Rehders reports lecture fees from Medtronic. Burkhart Zipfel reports lecture fees from Medtronic. Louis Labrousse receives lecture fees from Gore. Hüseyin Ince receives honoraria from Medtronic. Ibrahim Akin, Guenther Kundt, Dierk Scheinert, Martin Czerny, and Tilo Kleinfeldt have nothing to disclose with regard to commercial support.