BACKGROUND:

Cryptogenic strokes, accounting for 40% of acute ischemic strokes, are linked to patent foramen ovale (PFO). Despite research efforts, uncertainties remain about optimal prevention strategies.

OBJECTIVES:

Therefore, we aimed to review RCTs and Propensity Score Matching (PSM) Studies comparing percutaneous transcatheter closure (PTC) versus drug treatment in patients with PFO.

METHODS:

We searched PubMed, Embase and Cochrane.

Outcomes:

stroke, transient ischemic attack (TIA), all-cause-mortality, AF and major bleeding. We performed subgroup analyses according to the shunt size and age for stroke endpoint. Statistical analysis was performed using the R program (version 4.3.2). Heterogeneity was assessed with I2 statistics.

RESULTS:

We included 6 RCTs and 7 PSM studies with 13072, of whom 56% underwent PTC. Mean follow-up ranged from 2 to 9 years. In PTC group there was a significant decreased stroke (HR 0.59; 95% CI 0.37-0.95; p<0.0001; I²=72%), major bleeding (OR 0.66; 95% CI 0.49-0.90; p=0.007; I²=28%) and all-cause mortality (OR 0.51; 95% CI 0.39-0.66; p<0.01; I²=0%). The PTC approach was associated with fewer stroke events in patient subgroups with moderate to large shunt size (HR 0.30; 95% CI 0.18-0.50; p<0.001 ; I²=0%) and patients aged between 18 and 45 years old (HR 0.29; 95% CI 0.15-0.56; p<0.001 ; I²=0%). There was an increase of AF (OR 3.16; 95% CI 1.58-6.33; p=0.001; I²=65%). No statistical significance was found in TIA (HR 0.77;95% CI 0.54-1.11; p=0.16; I²=54%).

CONCLUSION:

In this meta-analysis of RCTs and PSM observational studies of patients with PFO, PTC was associated with lower risk of all-cause mortality and stroke and increased risk of onset AF.