Sunday, June 20, 2010

Sunday June 20, 2010
Vernakalant - The AVRO Trial

Summary: A Phase III Prospective Randomized Double-Blind Active Controlled, Multicenter Superiority Study of Vernakalant Injection versus Intravenous Amiodarone in Subjects with Recent Onset Atrial Fibrillation. The AVRO Trial.

Study Design: The investigators randomized patients (n= 254) with recent onset sustained (3 -48 hours) atrial fibrillation in a double blind, active controlled, double blind manner to two serial doses of vernakalant (3 mg/kg followed by an additional 2 mg/kg dose if the patient remained in atrial fibrillation) or serial doses of amiodarone (5 mg/kg followed by a 50 mg dose if the patient remained in atrial fibrillation) . The primary endpoint was proportion of patients with conversion to sinus rhythm in 90 minutes. and secondary endpoints included: Time to conversion, proportion of patients without symptoms due to atrial fibrillation at 90 minutes, and change in quality of life.

Results and Conclusions

  • Vernakalant was significantly more effective than amiodarone for converting atrial fibrillation to sinus rhythm within 90 minutes (vernakalant: 51.7% vs. amiodaone: 5.2%).
  • Vernakalant was also more effective than amiodaone for eliminating symptoms due to atrial fibrillation within 90 minutes (vernakalant: 53.4 % vs. amiodarone: 32.8%).
  • Vernakalant was safe and generally well tolerated although patients complained of transient symptoms such as dysgeusia (6.9%), cough (3.4%) and nausea (2.6%). One patient developed nonsustained V.Tach. but no episodes of Torsades de Pointes or sustained ventricular arrhythmias were observed.

* Presented by Dr A John Camm (St George's University, London, UK) during the late-breaking clinical-trials session at the Heart Rhythm Society 2010 Scientific Sessions.

* It is still not approved in the US.




A Phase III Superiority Study of Vernakalant vs Amiodarone in Subjects With Recent Onset Atrial Fibrillation (AVRO) - clinicaltrials.gov