Long-Term Propensity-Score Matched Comparison of Percutaneous Closure of Patent Foramen Ovale with Medical Treatment after Paradoxical Embolism
Background—Patients with ischemic stroke or transient ischemic attack (TIA) presumably related to patent foramen ovale (PFO) are at risk for recurrent cerebrovascular events. Differences in long-term clinical outcome were investigated among patients with percutaneous PFO closure as compared with medical treatment.
Methods and Results—Between 1994 and 2000, 308 consecutive patients with cerebrovascular events presumably related to PFO underwent either percutaneous PFO closure (150 patients) or medical treatment (158 patients). Patients were prospectively followed for up to 15 years. Seven patients were lost during follow-up. The primary outcome was a composite of stroke, TIA, or peripheral embolism. We analyzed 103 propensity score matched pairs of patients who underwent percutaneous PFO closure or medical treatment. At a median follow-up of 9 years, the primary composite outcome occurred in 11 patients slated to PFO closure (11%) and 22 patients slated to medical treatment (21%): HR=0.43, 95% CI 0.20-0.94, P=0.033. The treatment effect was driven by a decrease in the risk of TIA of 5% versus 14%, respectively: HR 0.31, 95% CI 0.10 to 0.94, P=0.039. The risk of all-cause (6% in both groups) and cardiovascular mortality (3% in both groups) appeared identical.
Conclusions—In this long-term observational, propensity score matched study, percutaneous PFO closure was more effective than medical treatment for secondary prevention of recurrent cerebrovascular events among patients with PFO related TIA or stroke.
- Received March 9, 2011.
- Accepted December 30, 2011.
- Copyright © 2012, American Heart Association, Inc. All rights reserved. Unauthorized use prohibited