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Percutaneous closure of patent foramen ovale in cryptogenic embolism
Bernhard Meier1, Bindu Kalesan, Heinrich P Mattle
1Department of Cardiology, Bern University Hospital, Bern, Switzerland. bernhard.meier@insel.ch
Insights
Patent foramen ovale closure did not significantly reduce recurrent embolic events or death compared to medical therapy for secondary prevention. This study compared PFO closure with antithrombotic medication in patients with cryptogenic embolism.
Area of Science:
- Cardiovascular Medicine
- Neurology
- Interventional Cardiology
Background:
- Patent foramen ovale (PFO) is associated with cryptogenic embolism.
- Treatment options include antithrombotic medications or percutaneous PFO closure.
- The superiority of PFO closure over medical therapy for secondary prevention remains under investigation.
Purpose of the Study:
- To compare the efficacy of percutaneous PFO closure versus medical therapy in preventing recurrent embolic events.
- To determine if PFO closure is superior to medical therapy for secondary prevention in patients with cryptogenic embolism.
Main Methods:
- A multicenter, superiority trial involving 29 centers across Europe, Canada, Brazil, and Australia.
- Patients with PFO and ischemic stroke, TIA, or peripheral thromboembolic event were randomized.
- Intervention groups: Amplatzer PFO Occluder closure vs. medical therapy. Primary endpoint: composite of death, nonfatal stroke, TIA, or peripheral embolism.
Main Results:
- Follow-up averaged 4.0-4.1 years.
- The primary endpoint occurred in 3.4% of the closure group vs. 5.2% of the medical therapy group (HR, 0.63; P=0.34).
- Nonfatal stroke rates were 0.5% (closure) vs. 2.4% (medical therapy) (HR, 0.20; P=0.14). TIA rates were 2.5% vs. 3.3% respectively.
Conclusions:
- Percutaneous closure of patent foramen ovale did not significantly reduce the risk of recurrent embolic events or death compared to medical therapy.
- The study did not demonstrate superiority of PFO closure over medical management for secondary prevention of cryptogenic embolism.
Background:
The options for secondary prevention of cryptogenic embolism in patients with patent foramen ovale are administration of antithrombotic medications or percutaneous closure of the patent foramen ovale. We investigated whether closure is superior to medical therapy.
Methods:
We performed a multicenter, superiority trial in 29 centers in Europe, Canada, Brazil, and Australia in which the assessors of end points were unaware of the study-group assignments. Patients with a patent foramen ovale and ischemic stroke, transient ischemic attack (TIA), or a peripheral thromboembolic event were randomly assigned to undergo closure of the patent foramen ovale with the Amplatzer PFO Occluder or to receive medical therapy. The primary end point was a composite of death, nonfatal stroke, TIA, or peripheral embolism. Analysis was performed on data for the intention-to-treat population.
Results:
The mean duration of follow-up was 4.1 years in the closure group and 4.0 years in the medical-therapy group. The primary end point occurred in 7 of the 204 patients (3.4%) in the closure group and in 11 of the 210 patients (5.2%) in the medical-therapy group (hazard ratio for closure vs. medical therapy, 0.63; 95% confidence interval [CI], 0.24 to 1.62; P=0.34). Nonfatal stroke occurred in 1 patient (0.5%) in the closure group and 5 patients (2.4%) in the medical-therapy group (hazard ratio, 0.20; 95% CI, 0.02 to 1.72; P=0.14), and TIA occurred in 5 patients (2.5%) and 7 patients (3.3%), respectively (hazard ratio, 0.71; 95% CI, 0.23 to 2.24; P=0.56).
Conclusions:
Closure of a patent foramen ovale for secondary prevention of cryptogenic embolism did not result in a significant reduction in the risk of recurrent embolic events or death as compared with medical therapy. (Funded by St. Jude Medical; ClinicalTrials.gov number, NCT00166257.).
