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Published on: July 21, 2013
Closure or medical therapy for cryptogenic stroke with patent foramen ovale
Anthony J Furlan1, Mark Reisman, Joseph Massaro
1Department of Neurology, University Hospitals Case Medical Center, Cleveland, Ohio 44106, USA. anthony.furlan@uhhospitals.org
Insights
Patent foramen ovale closure with a device did not reduce recurrent stroke or TIA risk compared to medical therapy alone in cryptogenic stroke patients. This finding suggests medical management is as effective as device closure for preventing future events.
Area of Science:
- Cardiology
- Neurology
- Medical Devices
Background:
- Patent foramen ovale (PFO) is more common in cryptogenic stroke patients.
- PFO closure is frequently recommended, but its efficacy in preventing recurrent stroke is unproven.
Purpose of the Study:
- To compare the effectiveness of percutaneous PFO closure versus medical therapy alone in preventing recurrent stroke or TIA.
Main Methods:
- A multicenter, randomized, open-label trial involving 909 patients aged 18-60 with cryptogenic stroke/TIA and PFO.
- Primary endpoint: composite of stroke/TIA, death within 30 days, or neurologic death within 2 years.
- Comparison between percutaneous device closure and medical therapy alone.
Main Results:
- No significant difference in the primary endpoint between the closure (5.5%) and medical therapy (6.8%) groups (P=0.37).
- Recurrent stroke rates were 2.9% (closure) vs. 3.1% (medical therapy) (P=0.79).
- Recurrent TIA rates were 3.1% (closure) vs. 4.1% (medical therapy) (P=0.44).
Conclusions:
- Percutaneous PFO closure does not provide greater benefit than medical therapy alone for preventing recurrent stroke or TIA in patients with cryptogenic stroke.
- Alternative causes were typically identified for recurrent neurological events.
Background:
The prevalence of patent foramen ovale among patients with cryptogenic stroke is higher than that in the general population. Closure with a percutaneous device is often recommended in such patients, but it is not known whether this intervention reduces the risk of recurrent stroke.
Methods:
We conducted a multicenter, randomized, open-label trial of closure with a percutaneous device, as compared with medical therapy alone, in 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. 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.
Results:
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.
Conclusions:
In patients with cryptogenic stroke or TIA who had a patent foramen ovale, closure with a device did not offer a greater benefit than medical therapy alone for the prevention of recurrent stroke or TIA. (Funded by NMT Medical; ClinicalTrials.gov number, NCT00201461.).
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