Closure Vs. Medical Therapy for Preventing Recurrent Stroke in Patients with Patent Foramen Ovale and a History of Cryptogenic Stroke or Tia

Summary

A Cochrane review [Abstract] 1 included 3 RCTs with a total of 2303 subjects. The patients were aged 60 years or younger with a cryptogenic stroke or TIA and had a patent foramen ovale (PFO) by means of transesophageal echocardiography. A total of 1150 patients were randomized to transcatheter device closure (TDC) and 1153 patients to medical therapy. The medical therapy in the control groups was at the discretion of the principal investigator (antiplatelet therapy or oral anticoagulation). The mean follow-up of all 3 trials was less than 5 years. Intention-to-treat analyses did not show a statistically significant risk reduction in the composite endpoint of recurrent stroke or TIA in the TDC group when compared with medical therapy (RR 0.73, 95% CI 0.45 to 1.17; 2 studies, n=1323). A time-to-event analysis combining the results of two RCTs also failed to show a significant risk reduction with TDC (HR 0.69, 95% CI 0.43 to 1.13). When assessing stroke prevention alone, TDC still did not show a statistically significant benefit (RR 0.61, 95% CI 0.29 to 1.27; 2 studies, n=2303) (HR 0.55, 95% CI 0.26 to 1.18; 2 studies, n=2303). In a sensitivity analysis including the two studies using the Amplatzer PFO occluder, TDC showed a possible protective effect on recurrent stroke compared with medical therapy (HR 0.38, 95% CI 0.14 to 1.02); however, it did not reach statistical significance. Safety analysis found that the overall risks for all-cause mortality and adverse events were similar in both the TDC and medical therapy groups. However, TDC increased the risk of new-onset atrial fibrillation (RR 3.50, 95% CI 1.47 to 8.35) and may be associated with the type of device used.