4.1
A randomised controlled trial (RCT) of 980 patients treated by percutaneous patent foramen ovale closure or medical therapy reported rates of stroke of 0.7 and 1.4 per 100 patient-years respectively in the intention-to-treat population (p=0.08). An RCT of 909 patients reported that the cumulative incidence of a composite end point of stroke or transient ischaemic attack during 2 years of follow-up, death from any cause during the first 30 days, or death from neurological causes between 31 days and 2 years, was 6% in the percutaneous patent foramen ovale closure group and 7% in the medical therapy group (p=0.37). An RCT of 414 patients reported a composite end point of death, non-fatal stroke, transient ischaemic attack or peripheral embolism in 3% (7 out of 204) of patients treated by percutaneous patent foramen ovale closure and 5% (11 out of 210) of patients treated by medical therapy, with a mean follow-up of 4 years (p=0.34). A meta-analysis of 58 observational studies (8,185 patients treated by percutaneous patent foramen ovale closure and 2,142 patients treated by medical therapy) reported a pooled incidence of recurrent neurological events of 0.8 (95% confidence interval [CI] 0.5 to 1.1) per 100 person-years for percutaneous patent foramen ovale closure and 4.4 (95% CI 3.2 to 5.6) per 100 person-years for medical therapy.