PMID- 20433277
OWN - NLM
STAT- MEDLINE
DCOM- 20101028
LR  - 20131121
IS  - 1933-0693 (Electronic)
IS  - 0022-3085 (Linking)
VI  - 113
IP  - 4
DP  - 2010 Oct
TI  - A prospective, multicenter, randomized trial of the Onyx liquid embolic system 
      and N-butyl cyanoacrylate embolization of cerebral arteriovenous malformations. 
      Clinical article.
PG  - 733-41
LID - 10.3171/2010.3.JNS09370 [doi]
AB  - OBJECT: The Onyx liquid embolic system (Onyx) was approved in the European Union 
      in 1999 for embolization of lesions in the intracranial and peripheral 
      vasculature, including brain arteriovenous malformations (AVMs) and hypervascular 
      tumors. In 2001 a prospective, equivalence, multicenter, randomized controlled 
      trial was initiated to support a submission for FDA approval. The objective of 
      this study was to verify the safety and efficacy of Onyx compared with N-butyl 
      cyanoacrylate (NBCA) for the presurgical treatment of brain AVMs. METHODS: One 
      hundred seventeen patients with brain AVMs were treated with either Onyx (54 
      patients) or NBCA (63 patients) for presurgical endovascular embolization between 
      May 2001 and April 2003. The primary end point was technical success in achieving 
      >/= 50% reduction in AVM volume. Secondary end points were operative blood loss and 
      resection time. All adverse events (AEs) were reported and assigned a 
      relationship to the Onyx or NBCA system, treatment, disease, surgery, or 
      other/unknown. The Data Safety Monitoring Board adjudicated AEs, and a blinded, 
      independent core lab assessed volume measurements. Patients were monitored 
      through discharge after the final surgery or through a 3- and/or 12-month 
      follow-up if resection had not been performed or was incomplete. RESULTS: The use 
      of Onyx led to >/= 50% AVM volume reduction in 96% of cases versus 85% for NBCA (p 
      = not significant). The secondary end points of resection time and blood loss 
      were similar. Serious AEs were also similar between the 2 treatment groups. 
      CONCLUSIONS: Onyx is equivalent to NBCA in safety and efficacy as a preoperative 
      embolic agent in reducing brain AVM volume by at least 50%.
FAU - Loh, Yince
AU  - Loh Y
AD  - Department of Medicine, Neurovascular Service, Madigan Army Medical Center, 
      Tacoma, Washington 98431, USA. yincer@yahoo.com
FAU - Duckwiler, Gary R
AU  - Duckwiler GR
CN  - Onyx Trial Investigators
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - United States
TA  - J Neurosurg
JT  - Journal of neurosurgery
JID - 0253357
RN  - 0 (Onyx HD 500)
RN  - 0 (Polyvinyls)
RN  - F8CEP82QNP (Enbucrilate)
RN  - YOW8V9698H (Dimethyl Sulfoxide)
SB  - IM
CIN - J Neurosurg. 2010 Oct;113(4):731-2; discussion 732. PMID: 20433274
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Blood Loss, Surgical/statistics & numerical data
MH  - Brain/pathology
MH  - Child
MH  - Combined Modality Therapy
MH  - *Dimethyl Sulfoxide
MH  - Double-Blind Method
MH  - Embolization, Therapeutic/adverse effects/*methods
MH  - Enbucrilate/*therapeutic use
MH  - Endpoint Determination
MH  - Female
MH  - Follow-Up Studies
MH  - Glasgow Coma Scale
MH  - Humans
MH  - Intracranial Arteriovenous Malformations/pathology/surgery/*therapy
MH  - Male
MH  - Middle Aged
MH  - Neurosurgical Procedures
MH  - *Polyvinyls
MH  - Prospective Studies
MH  - Treatment Outcome
MH  - Young Adult
FIR - Mericle, R
IR  - Mericle R
FIR - Firment, C
IR  - Firment C
FIR - Pryor, J
IR  - Pryor J
FIR - Rabinov, J
IR  - Rabinov J
FIR - Watson, V
IR  - Watson V
FIR - Barnwell, S
IR  - Barnwell S
FIR - Nesbit, G
IR  - Nesbit G
FIR - Clark, W
IR  - Clark W
FIR - Delashaw, J
IR  - Delashaw J
FIR - Lutsep, H
IR  - Lutsep H
FIR - Kuether, T
IR  - Kuether T
FIR - Vaishnav, A
IR  - Vaishnav A
FIR - Rasmussen, P
IR  - Rasmussen P
FIR - Masaryk, T
IR  - Masaryk T
FIR - Woo, H
IR  - Woo H
FIR - Purdy, P
IR  - Purdy P
FIR - Pride, G L
IR  - Pride GL
FIR - DeNardo, A
IR  - DeNardo A
FIR - Scott, J
IR  - Scott J
FIR - Berenstein, A
IR  - Berenstein A
FIR - Setton, A
IR  - Setton A
FIR - Mawad, M
IR  - Mawad M
FIR - Klucznik, R
IR  - Klucznik R
FIR - Duckwiler, G
IR  - Duckwiler G
FIR - Jahan, R
IR  - Jahan R
FIR - Sanders, W
IR  - Sanders W
FIR - Kazmierczak, C
IR  - Kazmierczak C
FIR - Rosenwasser, R
IR  - Rosenwasser R
FIR - Benitez, R
IR  - Benitez R
FIR - Rodriguez-Mercado, R
IR  - Rodriguez-Mercado R
FIR - Malisch, T
IR  - Malisch T
FIR - Marks, M
IR  - Marks M
FIR - Do, H
IR  - Do H
FIR - Dion, J
IR  - Dion J
FIR - McDougall, C
IR  - McDougall C
FIR - Fessler, R
IR  - Fessler R
FIR - Chaloupka, J
IR  - Chaloupka J
FIR - Solander, S
IR  - Solander S
FIR - Larsen, Donald
IR  - Larsen D
FIR - Gress, Daryl
IR  - Gress D
FIR - Giannotta, Steven
IR  - Giannotta S
FIR - Sayre, Jim
IR  - Sayre J
EDAT- 2010/05/04 06:00
MHDA- 2010/10/29 06:00
CRDT- 2010/05/04 06:00
PHST- 2010/05/04 06:00 [entrez]
PHST- 2010/05/04 06:00 [pubmed]
PHST- 2010/10/29 06:00 [medline]
AID - 10.3171/2010.3.JNS09370 [doi]
PST - ppublish
SO  - J Neurosurg. 2010 Oct;113(4):733-41. doi: 10.3171/2010.3.JNS09370.