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- W2970933977 abstract "Based on observational studies, there was a 2–3 times increased frequency of patent foramen ovale (PFO) in patients with cryptogenic stroke, which suggested that PFO could be the pathway for a paradoxical embolus as the mechanism of these strokes. A meta-analysis of 48 observational studies showed that patients with cerebrovascular events who received only medical therapy in the presence of a PFO had a 6.3-fold increased rate of recurrent neurological events compared with patients who underwent percutaneous PFO closure. The release of these reports preceded the publication of randomized clinical trials that attempted to determine the efficacy and safety of PFO closure versus standard of care medical therapy for secondary prevention of PFO-associated stroke. CLOSURE I, PC, and the early follow-up data from RESPECT (patients were followed for a median of 2.1 years), the first 3 randomized trials, could not demonstrate a statistically significant benefit of PFO closure for secondary stroke prevention in an intention-to-treat analysis. Subsequent meta-analyses of these trials, and the long-term follow-up data from RESPECT, enhanced the individual results of these early studies and confirmed that PFO closure decreases the risk of recurrent stroke over medical therapy alone. This chapter describes the first 3 randomized trials of PFO closure for stroke along with their meta-analyses, and discusses how the Food and Drug Administration utilized these data to assess the role of percutaneous PFO device closure for secondary stroke prevention." @default.
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- W2970933977 date "2020-01-01" @default.
- W2970933977 modified "2023-09-26" @default.
- W2970933977 title "Early Randomized Trials of PFO Closure for Stroke (CLOSURE I, PC and RESPECT)" @default.
- W2970933977 doi "https://doi.org/10.1016/b978-0-12-816966-7.00006-3" @default.
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