Ahmad Y, Howard JP, Arnold A, et al. Patent foramen ovale closure vs. medical therapy for cryptogenic stroke: a meta-analysis of randomized controlled trials. Eur Heart J. 2018 Mar 24. pii: 4944510. doi: 10.1093/eurheartj/ehy121.
Area Score
Surgery - Cardiac
Internal Medicine
Hemostasis and Thrombosis

Aims: The efficacy of patent foramen ovale (PFO) closure for cryptogenic stroke has been controversial. We undertook a meta-analysis of randomized controlled trials (RCTs) comparing device closure with medical therapy to prevent recurrent stroke for patients with PFO.

Methods and results: We systematically identified all RCTs comparing device closure to medical therapy for cryptogenic stroke in patients with PFO. The primary efficacy endpoint was recurrent stroke, analysed on an intention-to-treat basis. The primary safety endpoint was new onset atrial fibrillation (AF). Five studies (3440 patients) were included. In all, 1829 patients were randomized to device closure and 1611 to medical therapy. Across all patients, PFO closure was superior to medical therapy for prevention of stroke [hazard ratio (HR) 0.32, 95% confidence interval (95% CI) 0.13-0.82; P = 0.018, I2 = 73.4%]. The risk of AF was significantly increased with device closure [risk ratio (RR) 4.68, 95% CI 2.19-10.00, P<0.001, heterogeneity I2 = 27.5%)]. In patients with large shunts, PFO closure was associated with a significant reduction in stroke (HR 0.33, 95% CI 0.16-0.72; P = 0.005), whilst there was no significant reduction in stroke in patients with a small shunt (HR 0.90, 95% CI 0.50-1.60; P = 0.712). There was no effect from the presence or absence of an atrial septal aneurysm on outcomes (P = 0.994).

Conclusion: In selected patients with cryptogenic stroke, PFO closure is superior to medical therapy for the prevention of further stroke: this is particularly true for patients with moderate-to-large shunts. Guidelines should be updated to reflect this.

Comments from MORE raters

Hematology rater

This meta-analysis suggests that in patients with large shunts, the device closure reduces the risk for cryptogenetic strokes. On the basis of these results, current guideline recommendations should be updated to reflect this.

Internal Medicine rater

The subgroup analysis is probably the most important part of this. Medical therapy wasn't well standardized in all the trials, so we honestly don't know that closure is better than full anticoagulation (at least I don't think so).

Surgery - Cardiac rater

This is a well-written and conducted meta-analysis with important implications that run contrary to current guidelines. It is useful in offering patients the correct management where the current guidance is apparently recently outdated.