Key result
In high-risk PFO patients over 60 years of age, PFO-closure resulted in a similar rate of recurrent ischemic stroke compared to medical therapy alone (7% vs 4%, RR 1.95).
Why the study?
Randomized controlled trials do not provide definite guidance for secondary prevention after cryptogenic IS/TIA attributed to PFO, with no recommendations established for patients >60 years.
Does PFO-closure compared to medical therapy alone reduce recurrent ischemic stroke or intracranial hemorrhage in patients with cryptogenic stroke and PFO?
Observational (n=236)
Single-blind
No
Does PFO-closure compared to medical therapy alone reduce recurrent ischemic stroke or intracranial hemorrhage in patients with cryptogenic stroke and PFO?
In a real-world setting, PFO closure in high-risk patients ≤60 years showed low stroke recurrence comparable to RCTs, while medical therapy alone appeared appropriate for low-risk PFO and had similar recurrence rates to closure in patients >60 years.
PFO closure yielded similar recurrent stroke rates to medical therapy in high-risk patients >60 years; leaves open benefit in this age group pending randomized data.
BACKGROUND: Results of randomized controlled trials (RCT) do not provide definite guidance for secondary prevention after ischemic stroke (IS)/transient ischemic attack (TIA) attributed to patent foramen ovale (PFO). No recommendations can be made for patients > 60 years. We aimed to compare interventional and medical PFO-management in cryptogenic IS/TIA patients, including patients > 60 years. METHODS: Prospective case series including consecutive cryptogenic IS/TIA patients with PFO at Tuebingen university stroke unit, Germany. 'PFO-closure' was recommended in patients ≤70 years when featuring high-risk PFO (i.e., with atrial septal aneurysm, spontaneous, or high-grade right-to-left shunt during Valsalva). Primary (recurrent IS/intracranial hemorrhage) and secondary endpoints (e.g., disability) were assessed during ≥1-year follow-up; planned subgroup analyses of patients ≤60/> 60 years. RESULTS: Among 236 patients with median age of 58 (range 18-88) years, 38.6% were females and median presenting National Institutes of Health Stroke Scale score was 1 (IQR 0-4). Mean follow-up was 2.8 ± 1.3 years. No intracranial hemorrhage was observed. Recurrent IS rate after 'PFO-closure' was 2.9% (95%CI 0-6.8%) and 7% (4-16.4) in high-risk PFO patients ≤60 (n = 103) and > 60 years (n = 43), respectively, versus 4% (0-11.5) during 'medical therapy alone' MTA (n = 28). 42 low-risk PFO patients treated with MTA experienced no recurrent IS/TIA. CONCLUSIONS: In our real-world study, IS recurrence rate in 'PFO-closure' high-risk PFO patients ≤60 years was comparable to that observed in recent RCT. High-risk PFO patients > 60 years who underwent PFO-closure had similar IS recurrence rates than those who received MTA. MTA seems the appropriate treatment for low-risk PFO. TRIAL REGISTRATION: ClinicalTrials.gov, registration number: NCT04352790 , registered on: April 20, 2020 - retrospectively registered.
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Poli et al. (2021) conducted an observational in Cryptogenic ischemic stroke or transient ischemic attack with patent foramen ovale (n=236). PFO-closure vs. Medical therapy alone was evaluated on Recurrent ischemic stroke or intracranial hemorrhage (RR 1.95, 95% CI 0.21-17.85, p=0.36). In high-risk PFO patients over 60 years of age, PFO-closure resulted in a similar rate of recurrent ischemic stroke compared to medical therapy alone (7% vs 4%, RR 1.95).
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