Journal club 11 April 2012


Closure or Medical Therapy for Cryptogenic Stroke with Patent Foramen Ovale





patients between 18 and
60 years of age who presented with a cryptogenic stroke or transient ischemic attack
(TIA) and had a patent foramen ovale


StarFlex PFO closure device


Medical therapy: aspirin alone, warfarin alone, aspirin and warfarin (at discretion of investigator)


The primary end point was a composite of
stroke or transient ischemic attack during 2 years of follow-up, death from any
cause during the first 30 days, or death from neurologic causes between 31 days
and 2 years
A total of 909 patients were enrolled in the trial. The cumulative incidence (Kaplan–
Meier estimate) of the primary end point was 5.5% in the closure group (447 patients)
as compared with 6.8% in the medical-therapy group (462 patients) (adjusted hazard
ratio, 0.78; 95% confidence interval, 0.45 to 1.35; P = 0.37). The respective rates were
2.9% and 3.1% for stroke (P = 0.79) and 3.1% and 4.1% for TIA (P = 0.44). No deaths
occurred by 30 days in either group, and there were no deaths from neurologic
causes during the 2-year follow-up period. A cause other than paradoxical embolism
was usually apparent in patients with recurrent neurologic events.

Discussion Summary 

  • This was a negative trial.
  • The issues of being under-powered.
  • The high frequency of alternative explanations for stroke were noted/
  • The increased frequency of atrial fibrillation in the device group compared with medical therapy and the transesophageal echocardiographic’device associated thrombus’ are concerning and suggest that medical therapy is in general the preferred initial strategy.



See also previous post.
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