Long-Term Propensity-Score Matched Comparison of Percutaneous Closure of Patent Foramen Ovale With Medical Treatment After Paradoxical Embolism

Study Questions:

What are the differences in long-term clinical outcomes in patients with ischemic stroke or transient ischemic attack (TIA) related to patent foramen ovale (PFO) who undergo device closure, as compared with medical therapy?

Methods:

A total of 308 consecutive patients with cerebrovascular events presumably related to PFO underwent either percutaneous PFO closure with a variety of devices, or medical therapy. Choice of therapy was dependent on consensus between the treating neurologist and the patient. Analysis of 103 propensity-score matched pairs of patients was performed. The primary outcome was a composite of stroke, TIA, or peripheral embolism.

Results:

At a median follow-up period of 9 years, the primary composite outcome occurred in 11 (11%) patients in the PFO closure group and 22 (21%) patients in the medical therapy group (hazard ratio [HR], 0.43; 95% confidence interval [CI], 0.2-0.94; p = 0.33). Most of this benefit was due to a decreased risk of TIA of 5% in the PFO group, as compared with 14% in the medical therapy group (HR, 0.31; 95% CI, 0.1-0.94; p = 0.039). There was no difference in all-cause or cardiovascular mortality. There was no difference in stroke, with a stroke occurring in six (6%) patients in the PFO closure group and eight (8%) patients in the medical therapy group (p = 0.59).

Conclusions:

The authors concluded that over the course of a median follow-up period of 9 years, PFO closure appears to reduce the rate of recurrent TIA, but not of stroke.

Perspective:

This study will renew the debate over PFO closure for prevention of recurrent TIA or stroke. The as yet unpublished CLOSURE I study (presented at the American Heart Association Scientific Sessions, Chicago, 2010) was a randomized trial, which enrolled a similar patient population. The CLOSURE I trial used the STARFlex device, and followed patients for 2 years. No difference was seen in the composite endpoint, or the rate of TIA or stroke. The strength of the current study is the relatively long follow-up (median 9 years). The weakness is lack of randomization. Although the definitive answer to the question of efficacy of device closure for PFO may not be known, clinicians have a much more robust body of data with which to counsel patients.

Clinical Topics: Congenital Heart Disease and Pediatric Cardiology, Congenital Heart Disease, CHD & Pediatrics and Quality Improvement

Keywords: Risk, Follow-Up Studies, Ischemic Attack, Transient, Heart Septal Defects, Atrial, Chicago, Psychotherapy, Group, Foramen Ovale, Patent, Embolism, Paradoxical, United States


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