Transcatheter closure versus antithrombotic therapy for cryptogenic stroke in elderly patients with patent foramen ovale: a systematic review and meta-analysis of non-randomized studies

Background There is lacking of robust clinical evidence comparing transcatheter closure with antithrombotic therapy in elderly patent foramen ovale (PFO) patients with cryptogenic stroke. Methods The Pubmed, Embase, Web of Science, clinicaltrials.gov and Cochrane Library databases were systematically searched. Studies comparing transcatheter closure therapy with antithrombotic drug therapy in PFO patients in older age (≥55 years old) were included. The number of patients with and without events in both experimental group and control group were extracted. There were three study endpoints: composite endpoint of recurrent ischemic stroke and transient ischemic attack (TIA); all-cause death; new-onset atrial fibrillation. A random-effect model was performed. Heterogeneity among selected publications was assessed using Q-test based on a χ² test. I 2 >50% was defined as high heterogeneity. P < 0.05 was considered statistically significant. Results Nine studies of 7275 elderly PFO patients with cryptogenic stroke were included. Patients undergoing PFO closure had significantly lower risk of a composite endpoint of recurrent stroke and TIA (4.74% versus 8.08%, OR=0.517, 95% CI:0.325-0.821) and all-cause death (1.17% versus 1.24%, OR=0.531, 95% CI: 0.317-0.891). There was no significant different occurrence of new-onset atrial fibrillation between the two groups (3.81% versus 2.82%, OR=1.218, 95% CI: 0.826-1.798). None of the studies measuring the three endpoints manifested high heterogeneity. Conclusions PFO closure might reduce the risk of composite endpoint of recurrent stroke and TIA and all-cause death, while not increase the risk of new-onset atrial fibrillation comparing with medication therapy in elderly PFO patients with cryptogenic stroke. PFO closure should be considered part of a comprehensive secondary prevention strategy in elderly patients.