Flow diversion in the treatment of aneurysms: a randomized care trial and registry.
OBJECTIVE The Flow Diversion in the Treatment of Intracranial Aneurysm Trial (FIAT) was designed to guide the clinical use of flow diversion, an innovative method to treat intracranial aneurysms, within a care trial and to study safety and efficacy. METHODS FIAT, conducted in 3 Canadian hospitals, proposed randomized allocation to flow diversion or standard management options (observation, coil embolization, parent vessel occlusion, or clip placement), and a registry of non-randomized patients treated with flow diversion. The primary safety outcome was death or dependency (modified Rankin Scale score > 2) at 3 months, to be determined for all patients who received flow diversion at any time. The primary efficacy outcome was angiographic occlusion at 3-12 months combined with an independent clinical outcome. RESULTS Of 112 participating patients recruited between May 2, 2011, and February 25, 2015, 78 were randomized (39 in each arm), and 34 received flow diversion within the registry. The study was halted due to safety concerns. Twelve (16%) of 75 patients (95% CI 8.9%-26.7%) who were allocated to 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 (13.2%) of 38 patients randomly allocated and treated by flow diversion (95% CI 5.0%-28.9%) and in 5 (12.8%) of 39 patients allocated to standard treatment (95% CI 4.8%-28.2%). Efficacy was below expectations of the trial hypothesis: 16 (42.1%) of 38 patients (95% CI 26.7%-59.1%) randomly allocated to flow diversion failed to reach the primary outcome, as compared with 14 (35.9%) of 39 patients allocated to standard treatment (95% CI 21.7%-52.9%). CONCLUSIONS Flow diversion was not as safe and effective as hypothesized. More randomized trials are needed to determine the role of flow diversion in the management of aneurysms. Clinical trial registration no.: NCT01349582 (clinicaltrials.gov).
Department of Radiology, Centre Hospitalier de l'Université de Montréal, Notre-Dame Hospital, Montreal, Quebec, Canada.
Jean
J
Raymond
Department of Radiology, Centre Hospitalier de l'Université de Montréal, Notre-Dame Hospital, Montreal, Quebec, Canada.|Groupe d'Étude de la Thrombose en Bretagne Occidentale, Brest, France.
Jean-Christophe
JC
Gentric
Division of Neurosurgery, Department of Surgery, University of Alberta Hospital, Mackenzie Health Sciences Centre, Edmonton, Alberta, Canada.
Tim E
TE
Darsaut
Department of Radiology, Ottawa Hospital, Civic Campus, Ottawa, Ontario, Canada; and.
Daniela
D
Iancu
Department of Mathematics and Statistics, Université de Montréal, Quebec, Canada.
Miguel
M
Chagnon
Department of Radiology, Centre Hospitalier de l'Université de Montréal, Notre-Dame Hospital, Montreal, Quebec, Canada.
Alain
A
Weill
Department of Radiology, Centre Hospitalier de l'Université de Montréal, Notre-Dame Hospital, Montreal, Quebec, Canada.
Daniel
D
Roy
D000293:Adolescent; D000368:Aged; D000369:Aged, 80 and over; D002170:Canada; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods*; D005260:Female; D006801:Humans; D002532:Intracranial Aneurysm / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D012042:Registries; D016896:Treatment Outcome
BSO = best standard option; CI = confidence interval; DSMC = Data Safety and Monitoring Committee; FIAT = Flow Diversion in the Treatment of Intracranial Aneurysm Trial; PVO = parent vessel occlusion; aneurysm; clinical trial; flow diversion; flow diverter; mRS = modified Rankin Scale; vascular disorders