Surgical vs. drug therapy in patients with patent foramen ovale and cryptogenic stroke.

OBJECTIVE

This study aimed to investigate the effectiveness of risk scoring for predicting stroke recurrence after percutaneous patent foramen ovale (PFO) closure or medication therapy in patients with PFO and a history of cryptogenic stroke.

METHODS

This study included 559 patients with PFO and cryptogenic stroke who were treated in our hospital from January 2013 to January 2018 and were followed up for 15-72 months. After calculating the risk scores for stroke recurrence, we randomly divided the patients into two groups (ratio, 1:1): Patients in one group underwent PFO closure and those in the other received drug therapy.

RESULTS

Patients in the PFO closure group had a lower risk of recurrent stroke than those in the drug therapy group (1.1% vs. 4.2%). Moreover, serious bleeding was less frequent in the PFO closure group than in the drug therapy group (0% vs. 3.2%), although the incidence of atrial fibrillation or flutter did not significantly differ between the groups (p = 0.67). Interestingly, a subgroup analysis revealed no inter-treatment group difference in the rate of cryptogenic stroke recurrence among patients with risk scores of 0-1. By contrast, PFO closure yielded superior outcomes among patients with risk scores of ≥2.

CONCLUSION

Compared with drug therapy, PFO closure reduced the risk of recurrent stroke among patients with a risk score of ≥2 and reduced the incidence of serious bleeding without increasing the risk of new-onset atrial fibrillation or atrial flutter.