Ahmad Y, et al. - In view of the controversial efficacy of patent foramen ovale (PFO) closure for cryptogenic stroke, researchers analyzed evidence from randomized controlled trials (RCTs) comparing device closure with medical therapy to prevent recurrent stroke for patients with PFO. They noted that PFO closure was superior to medical therapy for the prevention of further stroke in selected patients with cryptogenic stroke. This was particularly observed for patients with moderate-to-large shunts. Updating guidelines is recommended to reflect this.

Methods

• All RCTs comparing device closure to medical therapy for cryptogenic stroke in patients with PFO were identified.
• Recurrent stroke, analysed on an intention-to-treat basis, was the primary efficacy endpoint.
• New onset atrial fibrillation (AF) was the primary safety endpoint.

Results

• Researchers included 5 studies (3,440 patients).
• Device closure was performed on 1,829 patients and 1611 underwent 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%].
• Significantly increased risk of AF was observed with device closure [risk ratio (RR) 4.68, 95% CI 2.19–10.00, P<0.001, heterogeneity I² = 27.5%)].
• PFO closure was associated with a significant reduction in stroke among patients with large shunts (HR 0.33, 95% CI 0.16–0.72; P=0.005).
• However, no significant reduction in stroke was evident in patients with a small shunt (HR 0.90, 95% CI 0.50–1.60; P=0.712).
• The presence or absence of an atrial septal aneurysm had no effect on outcomes (P=0.994).