Percutaneous closure of patent foramen ovale to prevent recurrent cerebral embolic events

4 Efficacy

This section describes efficacy outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the overview.

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% (7/204) of patients treated by percutaneous patent foramen ovale closure and 5% (11/210) of patients treated by medical therapy, with a mean follow-up of 4 years (p=0.34). A meta-analysis of 58 observational studies (8185 patients treated by percutaneous patent foramen ovale closure and 2142 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.

4.2 The RCT of 909 patients treated by percutaneous patent foramen ovale closure or medical therapy reported successful closure at 2‑year follow-up in 87% (320/369) of patients who had the procedure. The meta-analysis of 58 observational studies reported a residual shunt immediately after the procedure in 25% (95% CI 17 to 34) of patients; 6% (95% CI 0 to 18) of patients had a residual shunt for more than 12 months.

4.3 A UK register reported that 98% (4133/4202) of patients treated by percutaneous patent foramen ovale closure were alive and 2% (69/4202) of patients were dead at a median follow-up of 3.8 years. Actuarial 5‑year and 10‑year survival were 98% and 97% respectively.

4.4 The specialist advisers listed key efficacy outcomes as reduction in the rate of stroke and systemic emboli, and complete functional closure of the patent foramen ovale.