There were 4 device-related complications: 1 fatigue, 2 with non-sustained atrial fibrillation, and 1 with syncope. Procedural complication rates were Complete cessation rate overall was 9% with device versus 0.7 in the control arm (p 50% of attacks) had significant reductions in all 4 endpoints.Mean reduction in monthly migraine attacks was -2.0 with device versus 1.4 in the control arm (p = 0.01).Responder rate was 38% with device versus 29% in the control arm (p = 0.13).Mean reduction in monthly migraine days was 3.1 with PFO closure versus 1.9 with medical therapy alone (p = 0.02).No significant differences were observed in patient characteristics in the 2 treatment arms.This analysis was performed "as-treated." Safety outcomes were reported for procedural complications for all subjects who received devices (both randomized subjects as well subjects from PREMIUM who had PFO closed after blinding was removed). Sub-group analyses were performed looking at age, gender, history of head trauma, mood disorder, palpitations, snoring, steroid use, migraine with aura, and Migraine Disability Assessment and Beck Depression Inventory scores. An intention-to-treat analysis was used for the efficacy outcomes. Patient characteristics were compared between the two trials. Responder rate (≥50% reduction in migraine attacks) Transcranial Doppler at 12 months, grade 2 or less Transesophageal echocardiography at 6 and 12 months if grade 2 or higher shunting remained Neurologist- and patient-blinded, sham-control procedure Transcranial Doppler bubble study with grade 4 or 5 right to left shunt, confirmed by wire crossing during procedure PFO on transesophageal echocardiography with bubble study The 4 endpoints were given the same importance. The endpoints were mean reduction in migraine days, responder rate (≥50 reduction in monthly migraine attacks), mean reduction in migraine attacks, and complete migraine cessation. This study was a pooled subject-level data analysis of two randomized trials. This study's cohort comprised patients who were enrolled in either PRIMA (Percutaneous Closure of Patent Foramen Ovale In Migraine With Aura - A Randomized Prospective Study) or PREMIUM (Prospective, Randomized Investigation to Evaluate Incidence of Headache Reduction in Subjects With Migraine and PFO Using the AMPLATZER PFO Occluder to Medical Management). ![]() It was felt by pooling the two studies, there may be sufficient power to demonstrate efficacy. These studies did not meet their primary endpoints but did meet secondary endpoints. Two randomized trials were conducted that specifically examined PFO closure for migraine. ![]() Multiple studies of PFO closure for stroke showed a high rate of migraine sufferers among participants, many of whom experienced a reduction of migraine days. PFOs are present in a higher proportion of patients with migraines than in the general population.
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