Closure or Medical Therapy for Cryptogenic Stroke With Patent Foramen Ovale

Study Questions:

In patients with cryptogenic stroke, does percutaneous closure of patent foramen ovale (PFO) reduce the risk of recurrent stroke?

Methods:

A multicenter, randomized, open-label trial of PFO closure with the STARFlex device was performed. Patients between the ages of 18 and 60 with a history of stroke or transient ischemic attack (TIA) and a PFO were enrolled. The primary endpoint was a composite of stroke or TIA during 2 years of follow-up, all-cause mortality during the first 30 days, or death due to neurologic causes between 31 days and 2 years.

Results:

A total of 909 patients were enrolled, of which 447 underwent device closure and 462 received medical therapy. The effective closure rate for patients undergoing device closure was 86.1% at 6 months. The cumulative incidence of the primary endpoint was 5.5% in the closure group and 6.8% in the medical therapy group (adjusted hazard ratio, 0.78; 95% confidence interval, 0.45-1.35; p = 0.37). Stroke rate was 2.9% in the closure group and 3.1% in the medical therapy group (p = 0.79), whereas TIA rate was 3.1% in the closure group and 4.1% in the medical therapy group (p = 0.44). Atrial fibrillation was more common in patients following device closure, occurring in 5.7% of patients in the closure group, as compared with 0.7% of patients in the medical therapy group (p < 0.001). Three of the 12 strokes in the closure group were attributed to atrial fibrillation.

Conclusions:

The authors concluded that in patients with cryptogenic stroke or TIA, device closure did not offer a greater benefit than medical therapy alone for the prevention of recurrent stroke or TIA.

Perspective:

This paper reports results of the much-awaited CLOSURE I (Evaluation of the STARFlex Septal Closure System in Patients With a Stroke and/or Transient Ischemic Attack Due to a Presumed Paradoxical Embolism Through a Patent Foramen Ovale) trial. In short, the rate of recurrent stroke or TIA was not decreased after device closure, as compared with medical therapy. A specific concern for the patient population is that higher-risk patients may have pursued off-label closure, as opposed to risking randomization to the control group if they enrolled in this study. While it will continue to be argued that perhaps a different device, longer follow-up, larger sample size, or different patient population might result in a different study outcome, this study provides the best evidence available at this time to guide clinical decisions. Device closure is not a completely benign procedure, as demonstrated by the increased rate of atrial fibrillation, which may have resulted in neurologic events in the closure group. Off-label closure outside of clinical trials does not appear appropriate for the vast majority of adults with stroke or TIA and PFO.

Clinical Topics: Arrhythmias and Clinical EP, Congenital Heart Disease and Pediatric Cardiology, Atrial Fibrillation/Supraventricular Arrhythmias, Congenital Heart Disease, CHD and Pediatrics and Arrhythmias, CHD and Pediatrics and Quality Improvement

Keywords: Outcome Assessment (Health Care), Stroke, Follow-Up Studies, Ischemic Attack, Transient, Psychotherapy, Group, Atrial Fibrillation, Foramen Ovale, Patent, Confidence Intervals, Embolism, Paradoxical


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