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. 2021 Feb 16;77(6):667-676.
doi: 10.1016/j.jacc.2020.11.068.

Pooled Analysis of PFO Occluder Device Trials in Patients With PFO and Migraine

Mohammad K Mojadidi  1 , Preetham Kumar  2 , Ahmed N Mahmoud  3 , Islam Y Elgendy  4 , Hilary Shapiro  2 , Brian West  5 , Andrew C Charles  6 , Heinrich P Mattle  7 , Sherman Sorensen  8 , Bernhard Meier  9 , Stephen D Silberstein  10 , Jonathan M Tobis  2
Affiliations
Free article

Pooled Analysis of PFO Occluder Device Trials in Patients With PFO and Migraine

Mohammad K Mojadidi et al. J Am Coll Cardiol. .
Free article

Abstract

Background: Although observational studies have shown percutaneous patent foramen ovale (PFO) closure to be a safe means of reducing the frequency and duration of migraine, randomized clinical trials have not met their primary efficacy endpoints.

Objectives: The authors report the results of a pooled analysis of individual participant data from the 2 randomized trials using the Amplatzer PFO Occluder to assess the efficacy and safety of percutaneous device closure as a therapy for episodic migraine with or without aura.

Methods: The authors analyzed individual patient-level data from 2 randomized migraine trials (the PRIMA [Percutaneous Closure of Patent Foramen Ovale in Migraine With Aura] and PREMIUM [Prospective Randomized Investigation to Evaluate Incidence of Headache Reduction in Subjects with Migraine and PFO Using the Amplatzer PFO Occluder Compared to Medical Management] studies). Efficacy endpoints were mean reduction in monthly migraine days, responder rate (defined as ≥50% reduction in monthly migraine attacks), mean reduction in monthly migraine attacks, and percentage of patients who experienced complete cessation of migraine. The safety endpoint was major procedure- and device-related adverse events.

Results: Among 337 subjects, 176 were randomized by blocks to device closure and 161 to medical treatment only. At 12-month follow-up, the analysis met 3 of the 4 efficacy endpoints: mean reduction of monthly migraine days (-3.1 days vs. -1.9 days; p = 0.02), mean reduction of monthly migraine attacks (-2.0 vs. -1.4; p = 0.01), and number of subjects who experienced complete cessation of migraine (14 [9%] vs. 1 [0.7%]; p < 0.001). For the safety analysis, 9 procedure-related and 4 device-related adverse events occurred in 245 subjects who eventually received devices. All events were transient and resolved.

Conclusions: This pooled analysis of patient-level data demonstrates that PFO closure was safe and significantly reduced the mean number of monthly migraine days and monthly migraine attacks, and resulted in a greater number of subjects who experienced complete migraine cessation.

Keywords: PFO occluder; PREMIUM trial; PRIMA trial; migraine headache with aura; patent foramen ovale.

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Conflict of interest statement

Funding Support and Author Disclosures Dr. West was funded in part by National Institutes of Health grant 5T32HL007895-19. The participant-level data were provided by Abbott. No funding was provided to conduct this study. Dr. Charles was on the steering committee for the PREMIUM trial. Dr. Mattle was on the steering committee for the PRIMA trial. Dr. Sorensen was on the steering committee for the PREMIUM trial. Dr. Meier has served on the speakers bureau for and received speaker fees from Abbott; and was on the steering committee for the PRIMA trial. Dr. Silberstein was on the steering committee for the PREMIUM trial. Dr. Tobis has served as a consultant for St. Jude Medical (now Abbott) and W.L. Gore; has served as a proctor for Cardiac Dimensions; was a coinvestigator of the RESPECT trial; and was on the steering committee for the PREMIUM trial. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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