Published PRIMA Trial Results Evaluate PFO Closure to Reduce Migraine

July 18, 2016—Findings from the PRIMA trial of percutaneous closure of patent foramen ovale (PFO) in patients with migraine with aura were published by Heinrich P. Mattle, MD, et al in the European Heart Journal (EHJ. 2016;37:2029–2036). The investigators concluded that in patients with refractory migraine with aura and PFO, overall monthly migraine days were not reduced by PFO closure.

According to the investigators, the background of the study is that migraine with aura and PFO are associated. The multicenter, randomized PRIMA trial sought to investigate the effect of percutaneous PFO closure in patients refractory to medical treatment. 

As summarized in EHJ, migraine-with-aura patients with PFO who were unresponsive to preventive medications were randomized to PFO closure or medical treatment. Both groups were given acetylsalicylic acid 75–100 mg/day for 6 months and clopidogrel 75 mg/day for 3 months. The primary endpoint was reduction in monthly migraine days during months 9 to 12 after randomization, compared with a 3-month baseline phase before randomization. The committee reviewing the headache diaries were blinded to treatment assignment.

The investigators reported that 107 patients were randomly allocated to treatment with an Amplatzer PFO Occluder (St. Jude Medical, Inc.; n = 53) or control with medical management (n = 54). The trial was terminated prematurely because of slow enrollment. 

There were 83 patients (40 occluder, 43 control) who completed 12-month follow-up. Mean migraine days at baseline were 8 (± 4.7 standard deviation) in the closure group and 8.3 (± 2.4) in controls. The primary endpoint was negative with −2.9 days after PFO closure versus −1.7 days in the control group (P = .17). PFO closure caused five adverse events without permanent sequelae, reported the investigators in EHJ.