The PC Trial: PFO Closure Not Statistically Superior to Medical Therapy for Stroke Prevention

Percutaneous patent foramen ovale (PFO) closure using the Amplatzer PFO Occluder for the secondary prevention of stroke and other thromboembolic events was not statistically superior to medical therapy with antiplatelet agents or Vitamin K antagonists, according to results of the PC trial presented Oct. 25 at TCT 2012 in Miami, Fl.

The study looked at a total of 414 patients, of whom 204 were randomized to percutaneous PFO closure and 210 to medical therapy. The primary endpoint was a composite of all-cause mortality, non-fatal stroke, transient ischemic attack and peripheral embolism. After five years of follow-up, there was a nonsignificant 37 percent relative risk reduction in the incidence of the primary composite endpoint favoring PFO closure (hazard ratio [HR] 0.63 [0.24-1.62, p=0.34]). There were no significant differences in the incidence of secondary endpoints or bleeding complications between treatments.

The study did find an 80 percent relative risk reduction in the incidence of stroke favoring PFO closure (HR 0.20 [0.20-1.72, p=0.14]). According to the study investigators, this finding may be clinically relevant if confirmed by future trials.

To date, the superiority of percutaneous PFO closure to medical treatment among patients with stroke of unknown origin remains controversial for a number of reasons. Not only have observational studies suggested a lower risk of recurrence with PFO closure compared with medical treatment, the CLOSURE I trial failed to show superiority of PFO closure over medical treatment. In addition, outcomes may be influenced by device-type in terms of closure success and thrombus formation. The investigators noted that the data from the PC trial is an important step toward providing greater clarity on this issue.

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