One-Year Results with a Low-Profile Endograft in Subjects with Thoracic Aortic Aneurysm and Ulcer Pathologies

Abstract

Objective Evaluate safety and effectiveness of the second generation, low-profile RelayPro thoracic endograft for the treatment of descending thoracic aortic aneurysm or penetrating atherosclerotic ulcer (PAU). Method A prospective, international, non-blinded, non-randomized, pivotal trial analyzed a primary safety endpoint of major adverse events (MAE) at 30 days (death, myocardial infarction, stroke, renal/respiratory failure, paralysis, bowel ischemia, procedural blood loss), and a primary effectiveness endpoint of treatment success at one year (technical success, patency, absence of aneurysm rupture, type I/III endoleaks, stent fractures, reinterventions, aneurysm expansion, and migration) compared to performance goals from the previous generation Relay pivotal study. The study was conducted in 36 centers in the US and Japan and enrolled between 2017 and 2019. Results The study population of 110 patients had a median (IQR) age of 76 (70 – 81) years, n=69 (62.7%) were male, n=43 (39.1%) were Asian, and were treated for 76 fusiform aneurysms (69%), 24 saccular aneurysms (22%), and 10 PAUs (9%). Most patients (82.7%) were treated with a non-bare stent (NBS) configuration. Technical success was 100%: median (IQR) procedure time was 91 (64 – 131) min, deployment time was 16 (10 – 25) min; 50 patients (73.5%) of the US cohort had percutaneous access, while centers in Japan used only surgical cutdown. The 30-day composite MAE rate was 6.4% (95% upper CI 11.6%, p=.0002): 2 strokes, 2 procedural blood losses >1000 mL requiring transfusion, 2 paralysis events, and 1 renal failure. Primary effectiveness was 89.2% (lower 95% CI 81.8%, p=.0185): 9 subjects experienced 11 events (1 aneurysm expansion, 6 secondary interventions, 4 type I endoleaks). There was no loss of stent-graft patency, no rupture, no fractures, and no migration. Conclusions The low-profile RelayPro thoracic endograft met the study primary endpoints and demonstrated satisfactory 30-day safety and 1-year effectiveness for the treatment of patients with aneurysms of the descending thoracic aorta or PAUs. Follow-up is ongoing to evaluate longer term outcomes and durability.