INSTEAD-XL

Investigation of Stent Grafts in Aortic Dissection — eXtended Long-term follow-up

Patient / Population Intervention / Exposition Comparaison Critère de jugement

In 140 patients with stable uncomplicated type B aortic dissection, thoracic endovascular aortic repair added to optimal medical therapy reduced 5-year aorta-specific mortality and disease progression compared with optimal medical therapy alone.

140

Schéma

Open-label RCT with 5-year extended follow-up

Critère

All-cause mortality, aorta-specific mortality and disease progression at 5 years

Pertinence

RésultatAll-cause mortality 11.1 % vs 19.3 % (p=0.13); aorta-specific mortality 6.9 % vs 19.3 % (p=0.04); disease progression 27.0 % vs 46.1 % (p=0.04). False-lumen thrombosis in 90.6 %.

Nienaber CA, Kische S, et al. Circ Cardiovasc Interv. 2013;6(4):407-416. 10.1161/CIRCINTERVENTIONS.113.000463

Discussion et critique

Tiny, underpowered for all-cause mortality — which was not significant — and the striking late divergence comes from a post-hoc landmark analysis of survivors. It is the only randomised evidence for pre-emptive TEVAR in uncomplicated type B dissection and underpins the conditional recommendation in anatomically suitable, high-risk patients.