Final results of the multicenter, prospective Axium MicroFX for Endovascular Repair of IntraCranial Aneurysm Study (AMERICA).

Abstract

BACKGROUND:

We previously performed a multicenter prospective single-arm trial of 100 patients treated with Axium MicroFX Coils (ev3; Plymouth, Minnesota, USA), AMERICA: Axium MicroFX for Endovascular Repair of IntraCranial Aneurysm study. Initial angiographic and clinical outcomes were excellent. The final results are presented herein.

METHODS:

AMERICA is a multicenter, prospective single-arm trial evaluating the safety and efficacy of the ev3 Axium MicroFX coil system in 100 separate aneurysms between April 2010 and October 2012. Trial endpoints were 3-6 month angiographic occlusion and clinical status, as reported by treatment center.

RESULTS:

Mean follow-up was 157.9 days (median 153.5, range 1-445, SEM 9.3 days). At last follow-up imaging, 90.6% of all aneurysms, 90% of unruptured aneurysms, and 93.3% of ruptured aneurysms had Raymond grade I or II occlusion. Progression to further occlusion (lower Raymond occlusion grade) occurred in 29/85 aneurysms (34.1%). Aneurysm recurrence occurred in 11/85 aneurysms (12.9%). Ninety-nine per cent of patients treated electively and 68.7% of ruptured patients had a modified Rankin score of 0-2. Delayed adverse events (AEs), occurring after discharge and during the follow-up period, occurred in 10% of patients. In total, two AEs (one severe and one moderate) were potentially related to the device, thereby providing a 2% device-related AE rate.

CONCLUSIONS:

In this prospective, multicenter series of 100 aneurysms treated with Axium MicroFX PGLA (polyglycolic/polylactic acid) coils, 3-6 month angiographic occlusion and clinical outcomes were excellent. This study suggests that Axium MicroFX PGLA coils are safe and effective in the treatment of intracranial aneurysms.

• Authors: Kyle M Fargen, Spiros Blackburn, Eric M Deshaies, Jeffrey S Carpenter, Pascal Jabbour, William J Mack, Ansaar T Rai, Adnan H Siddiqui, Raymond D Turner, J Mocco
• Journal: Journal of neurointerventional surgery (J Neurointerv Surg) Vol. 7 Issue 1 Pg. 40-3 (Jan 2015) ISSN: 1759-8486 [Electronic] England
• PMID: 24394153 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
• Copyright: Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Chemical References

• Coated Materials, Biocompatible
• Polyesters
• Polymers
• Polyglycolic Acid
• Lactic Acid
• poly(lactide)

Topics

• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Coated Materials, Biocompatible (adverse effects, therapeutic use)
• Embolization, Therapeutic (adverse effects, instrumentation, methods)
• Endovascular Procedures (adverse effects, instrumentation, methods)
• Female
• Follow-Up Studies
• Humans
• Intracranial Aneurysm (diagnostic imaging, therapy)
• Lactic Acid
• Male
• Middle Aged
• Outcome Assessment, Health Care
• Polyesters
• Polyglycolic Acid
• Polymers
• Radiography
• Young Adult