Patients with cryptogenic stroke who were treated with patent foramen ovale closure and medical therapy had a decreased risk for recurrent stroke and an increased risk for atrial fibrillation vs. those treated with medical therapy alone, according to a meta-analysis published in The American Journal of Cardiology.
Tomo Ando, MD, fellow in the division of cardiology at Wayne State University School of Medicine in Detroit, and colleagues analyzed data from 3,440 patients (mean age range, 43 to 50 years) with cryptogenic stroke from five randomized controlled trials who were treated with PFO closure and medical therapy (n = 1,829) or medical therapy alone (n = 1,611). Patients were followed up for a mean of 4.1 years.
The primary efficacy endpoint of interest was recurrent stroke during follow-up. Secondary efficacy endpoints of interest included overall survival and transient ischemic attack. Safety endpoints of interest included newly detected AF and major bleeding.
Patients treated with PFO closure and medical therapy had reduced their risk for recurrent stroke by 58% vs. medical therapy alone (RR = 0.42; 95% CI, 0.2-0.91). The number needed to treat to prevent one recurrent stroke via PFO closure was 38. There was adequate evidence that showed that PFO closure with medical therapy decreased the rate of recurrent stroke by at least 60% compared with medical therapy alone, as shown by the cumulative z score that crossed the trial sequential boundary (P = .05).
The risk for mortality (RR = 0.74; 95% CI, 0.35-1.6), TIA (RR = 0.78; 95% CI, 0.53-1.15) and major bleeding (RR = 0.96; 95% CI, 0.42-2.2) did not decrease in patients who were treated with PFO closure and medical therapy compared with medical therapy alone. Patients who received PFO closure and medical therapy had an increased risk for newly detected AF vs. those who received medical therapy alone (RR = 4.69; 95% CI, 2.17-10.12). The number needed to harm was 29.
“The guidelines for PFO closure in cryptogenic stroke should be revisited and further study should focus on revealing the mechanism behind the increased rates of AF after PFO closure, determine whether it is transient, paroxysmal or persistent AF, and what is its effect on recurrent stroke risk,” Ando and colleagues wrote. – by Darlene Dobkowski
The authors report no relevant financial disclosures.