Abstract: Abstract: Objective To investigate the effects of interventional therapy and rivaroxaban anticoagulant therapy on the prognosis of patients with cryptogenic stroke and patent foramen ovale (PFO). Methods A total of 49 PFO patients with cryptogenic stroke were enrolled. They were randomized into an interventional group (n=24) and a rivaroxaban treatment group (n=25). Patients in interventional group received percutaneous PFO closure, and the patients in rivaroxaban treatment group received rivaroxaban treatment (10 mg / d). The primary endpoints included recurrent nonfatal ischemic stroke (including transient ischemic attack) or fatal stroke, early death (within 30 days after placement of the instrument or within45 days after randomization), and the secondary endpoints included all-cause death, peripheral vascular embolism, newly occurring arrhythmias (such as atrial fibrillation), myocardial infarction and bleeding. Results The mean follow-up time was (3.5±0.5) years for the two groups of patients. During the follow-up period, the loss of follow-up rates were 8.3% (2/25) and 16.6% (4/24) in the rivaroxaban group and the intervention group, respectively. The difference was not statistically significant between the two groups (P＞0.05). There was one patient showed a nonfatal ischemic stroke (transient ischemic attack) in the interventional group and 3 patients in the rivaroxaban group. There were no fatal strokes or early deaths in either group. There was no significant difference in the cumulative survival rate between the interventional group and the rivaroxaban group (P＞0.05). In the interventional group, there were one case of new atrial fibrillation, two cases of atrial premature beats combined with short-term atrial tachycardia, but spontaneously recovered to sinus rhythm within 24 hours after surgery. No cardiovascular death, peripheral vascular embolism, myocardial infarction and bleeding events were found. The incidences of combined endpoints were 16.7% (4/24) and 44% (11/25) in the interventional and rivaroxaban groups,respectively. There was significant difference in the cumulative survival rate between the two groups (P＜0.05). There were no significant differences in NIHSS scores and mRS scores at each time point between the two groups. Conclusion Interventional closure is more effective than rivaroxaban inimproving theprognosis ofpatients with cryptogenic stroke and PFO.

Key words: foramen ovale, patent, stroke, Rivaroxaban, prognosis, idiopathic, interventional therapy