Aims A long standing debate about the optimal approach for the management of patients with PFO after a cryptogenic stroke exists with conflicting results among multiple observational studies. The combined results of the first 3 randomised controlled trials (Closure-1, PC and RESPECT) concluded the non-superiority of PFO closure over medical therapy alone. However, the short-term follow-up and low statistical power due to the small number of included subjects remains a major limitation of prior meta-analyses. Recently, the results of 2 new RCT (GORE REDUCE and CLOSE) and long term follow up from the RESPECT trial have been published. Therefore, we aimed to examine the long-term clinical outcomes with transcatheter patent foramen ovale (PFO) closure vs medical therapy alone in patients with cryptogenic stroke.
Methods An electronic database search was performed for randomised clinical trials (RCTs) reporting clinical outcomes with PFO closure vs medical therapy alone after stroke. Random effects DerSimonian-Laird risk ratios (RR) were calculated. The main outcome was recurrence of stroke. Other outcomes included transient ischaemic attack (TIA), new-onset atrial fibrillation/flutter (AF/AFL), major bleeding, serious adverse events, and device-related complications. All-cause death was also examined.
Results Five RCTs with a total of 3440 patients were included. At a mean follow-up of 4.02±1.57 years, PFO closure was associated with less recurrence of stroke (RR=0.43; 95% CI 0.19–0.91; p=0.027) compared with medical therapy alone. No difference was observed between both strategies for TIA (p=0.21), major bleeding (p=0.69), serious adverse events (p=0.35) and all-cause death (p=0.48). PFO closure, however, was associated with increased new-onset AF/AFL (p<0.001), pulmonary embolism (p=0.04), and device-related complications (p<0.001). On a subgroup analysis, the stroke recurrence rate remained lower in PFO closure arm regardless of the type of closure device used (P-interaction=0.50), or the presence of substantial shunt in the majority of the study population (P-interaction=0.13).
Conclusions Transcatheter PFO closure reduces the recurrence of stroke compared with medical therapy alone, with no significant safety concerns. Close follow-up of patients after PFO closure is recommended to detect new-onset atrial arrhythmias.
Summary forest plot of the outcome of stroke recurrence with PFO closure versusmedical therapy alone, with subgroup analysis according to the type of device used and the presence of substantial inter-atrial shunt. The relative size of the data markers indicates the weight of the sample size from each study.
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