PFO closure reduced the risk of recurrent stroke by 40% (HR=0.60) and mortality by 59% (HR=0.41) compared to antithrombotic therapy in patients ≥60 years with cryptogenic stroke.
Does transcatheter PFO closure reduce the risk of recurrent stroke compared to antithrombotic therapy in patients ≥60 years with cryptogenic stroke?
In patients ≥60 years with cryptogenic stroke, PFO closure reduces recurrent stroke and mortality compared to antithrombotic therapy, extending the evidence base to an older population typically excluded from randomized trials.
Absolute Event Rate: 0% vs 0%
Background: In younger patients (<60 years) with cryptogenic stroke presumed to be patent foramen ovale (PFO)-related, the standard approach involves transcatheter PFO closure combined with antithrombotic therapy (ATA). However, due to their exclusion from randomized clinical trials, no formal recommendations exist for patients ≥60 years. This study investigates whether PFO closure benefits patients ≥60 years with prior cryptogenic stroke or if ATA remains the preferred option. Methods: We searched the PubMed, Embase, Web of Science, and ScienceDirect databases to obtain articles in all languages from January 2004 until July 2025. The primary outcome was a risk of recurrent stroke during follow-up and secondary outcomes were risk of new-onset atrial fibrillation (AF), all-cause mortality and in-hospital complications. PROSPERO registration ID: CRD420250652870. Results: One post hoc evaluation of the DEFENSE-PFO trial and eleven observational studies were included. Compared to ATA, PFO closure was associated with a reduced risk of recurrent stroke (HR=0.60; 95% CI: 0.45 to 0.80, p<.001) and mortality (HR=0.41; 95% CI: 0.19 to 0.90, p=.02; I2 = 43.8%) with no difference in risk of new-onset AF (HR=1.13, 95%CI: 0.53 to 2.44, p=.74). When compared with patients <60 years, individuals ≥60 years had a higher risk of recurrent stroke (HR = 2.68; 95% CI 1.40–5.13; p=.002), new-onset AF (HR = 4.12; 95% CI 1.90–8.95; p<0.001) and mortality during follow-up (HR = 8.24; 95% CI 3.49–19.46; p<.0001). In-hospital complications after PFO closure were comparable between two age groups. Conclusion: While PFO closure may reduce ischemic stroke risk in older patients with cryptogenic stroke, this benefit is offset by higher absolute risks for recurrent stroke, new-onset AF, and mortality. Therefore, highly individualized patient selection and age-specific risk tools are crucial. Further long-term randomized trials are essential to optimize PFO closure in this population.
Phan et al. (Thu,) reported a other. PFO closure reduced the risk of recurrent stroke by 40% (HR=0.60) and mortality by 59% (HR=0.41) compared to antithrombotic therapy in patients ≥60 years with cryptogenic stroke.