N-butyl cyanoacrylate embolization of cerebral arteriovenous malformations: results of a prospective, randomized, multi-center trial.
OBJECTIVE
Liquid N-butyl cyanoacrylate (n-BCA) use for the treatment of arteriovenous malformations (AVM) in the brain has become part of medical practice. However, no study has led to the Food and Drug Administration's approval of n-BCA for intravascular use. The purpose of this study was to verify the effectiveness and safety of an n-BCA/Tantalum Powder/Ethiodized Oil mixture, compared with conventional treatment (Trufill polyvinyl alcohol [PVA]) for preoperative embolization of cerebral AVM.


METHODS
Between October 15, 1996, and March 24, 1999, 104 patients at 13 centers were prospectively randomized to undergo embolization using an n-BCA/Tantalum Powder/Ethiodol mixture or Trufill PVA. The pre-embolization therapy goals were determined in terms of the number of pedicles to be embolized and the percent of nidus reduction expected. Embolization results were evaluated by a central laboratory. Subsequent surgical resection data were recorded. Safety evaluation data included recording device complications, procedure complications, and intracranial events/overall neurologic outcomes, which could be either device-related, procedure-related, or both.


RESULTS
The reduction of AVM dimensions (79.4% in the n-BCA group and 86.9% in the PVA group) and the mean number of vessels embolized (2.2 in the n-BCA group and 2.1 in the PVA group) was similar in the two groups. Coils were used more commonly with PVA embolization (P<.0001). No differences were detected in surgical resection time, number of patients who required transfusion, volume and number of transfusion units, or type and volume of fluid replacement. Glasgow Outcome Scale scores were not significantly different between the two groups before treatment, after embolization, or after resection. Two of 42 patients who underwent resection and had been treated with n-BCA experienced post-resection hematoma, compared with eight of 45 patients who underwent resection and had been treated with PVA (P<.05).


CONCLUSIONS
This prospective, randomized trial showed that n-BCA is equivalent to PVA as a preoperative embolic agent for treatment of cerebral AVM as determined by percent of nidus reduction and number of feeding pedicles embolized.
D000328:Adult; D004621:Embolization, Therapeutic; D004659:Enbucrilate / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006406:Hematoma / Q000139:chemically induced / Q000209:etiology; D006801:Humans; D002538:Intracranial Arteriovenous Malformations / Q000628:therapy*; D008297:Male; D011142:Polyvinyl Alcohol / Q000009:adverse effects / Q000627:therapeutic use*; D011183:Postoperative Complications; D011300:Preoperative Care; D011446:Prospective Studies; D012449:Safety; D016037:Single-Blind Method; D016896:Treatment Outcome
D011142:Polyvinyl Alcohol; D004659:Enbucrilate