In patients over 60 with a PFO, is there any benefit to treating with full anticoagulation over antiplatelet therapy alone?
Probably not. Truthfully there’s not good randomized data outside of the PFO closure trials, and none that looks specifically at this population of interest. I’m attaching two papers with prespecified subgroup analysis that looked at rivaroxaban and dabigatran, respectively, compared to aspirin. The rivaroxaban study found a lower likelihood of recurrent stroke, but it did not reach statistical significance.
Figure 1. Kaplan-Meier curve for time to recurrent ischaemic stroke by treatment assingment and PFO status
And the dabigatran study did not find a difference between the two groups.
Figure 1. Outcomes by patent foramen ovale (PFO) subgroup in RE-SPECT ESUS (randomized set).
Interestingly, when you put it all together, there is a suggestion of benefit:
Figure 2. Ischemic stroke in random comparisons of anticoagulation vs antiplatelet therapy in patients with embolic stroke of undetermined source (ESUS) and patent foramen ovale (PFO).
However, none of these studies were designed to answer this specific question, and there’s probably too much variability to draw any meaningful conclusions. Here’s a link to the Up To Date summary. I do think my reading is practice changing in the sense that I’ll be more aggressive about looking for VTE in these patients (e.g. looking at lower extremities AND pelvic veins), as such a diagnosis would change management. I’ll also start counseling more about VTE preventive measures in patients with known PFO. But given the multitude of risk factors in these older patients, at this point it still seems like aspirin is adequate, or perhaps more accurately, that a DOAC is not clearly superior.
Diener HC, Chutinet A, Easton JD, et al. Dabigatran or Aspirin After Embolic Stroke of Undetermined Source in Patients With Patent Foramen Ovale. Stroke. 2021;52(3):1065-1068.
Kasner SE, Swaminathan B, Lavados P, et al. Rivaroxaban or aspirin for patent foramen ovale and embolic stroke of undetermined source: a prespecified subgroup analysis from the NAVIGATE ESUS trial. The Lancet Neurology. 2018;17(12):1053-1060.
