Background: The Flow diversion in the treatment of Intracranial Aneurysm (FIAT) trial was designed to guide the clinical use of flow diversion. Methods: FIAT proposed randomized allocation flow diversion or standard management (observation, coiling, parent vessel occlusion, or clipping), and a registry of non-randomized patients treated with flow diversion. Primary safety outcome was death or dependency (mRS > 2) at 3 months. Primary efficacy outcome was angiographic occlusion at 3-12 months combined with independent clinical outcome. Results: Of 112 participating patients recruited, 78 were randomized, and 34 received flow diversion within the registry. The study was halted for safety concerns. Twelve of 73 patients (16.4%; CI [9.7% -26.7%]) who were allocated or received flow diversion at any time were dead (n=8) or dependent (n=4) at 3 months or more, crossing a predefined safety boundary. Death or dependency occurred in 5 of 36 patients randomly allocated flow diversion and in 5 of 36 patients allocated standard treatment (13.9%; [6.1%-28.7%]). Efficacy was below hypothesized expectations: 15 of 36 patients (41.7%; [27.1%-57.8%]) randomly allocated flow diversion failed to reach the primary outcome, as compared to 11 of 36 patients allocated standard treatment (30.1%; [18.0%-46.9%]). Conclusions: Flow diversion was not as safe and effective as hypothesized. More randomized trials are needed.
DEFINITION OF «SAFETY BOUNDARY» IN CASE OF TERRORIST ATTACK WITH CHEMICAL AGENTS
