Patent foramen ovale closure versus medical therapy for cryptogenic stroke: An updated meta-analysis.

BACKGROUND: The efficacy of patent foramen ovale (PFO) closure for secondary stroke prevention in cryptogenic stroke (CS) patients with PFO is uncertain. This meta-analysis aims to assess whether PFO closure is superior to medical therapy.

METHODS: Pooled estimates were calculated using Revman 5.3. The two primary endpoints were stroke and transient ischemic attack (TIA). Secondary outcomes included all-cause mortality, new-onset atrial fibrillation or flutter, major bleeding and any adverse event.

RESULTS: Five randomized controlled trials were included. A total of 3440 patients were randomized to either PFO closure (n = 1829) or medical therapy group (n = 1611) and followed for average 2.0-5.9 years. PFO closure reduced the incidence of recurrent stroke in CS patients with PFO compared to medical therapy (Risk ratio (RR) 0.42, 95% confidence intervals (CI) 0.20-0.91, P = 0.03; hazard ratio (HR) 0.34, 95% CI 0.15-0.78, p = 0.01). There were no significant differences between the two groups in TIA (RR 0.78, 95% CI 0.53-1.15, P = 0.21; HR 0.73, 95% CI 0.49-1.09, p = 0.12), all-cause mortality (RR 0.76, 95% CI 0.35-1.63, P = 0.48), major bleeding (RR 0.96, 95% CI 0.42-2.20, P = 0.93) and any adverse event (RR 1.06, 95% CI 0.95-1.18, P = 0.29). Higher risk of new-onset atrial fibrillation or flutter was found in closure group (RR 4.69, 95% CI 2.17-10.12, P < 0.0001).

CONCLUSIONS: PFO closure combined with medical therapy showed superiority over medical therapy alone for stroke prevention in carefully selected CS patients with PFO, but increased the risk of atrial fibrillation or flutter.