Abstract
Background Migraine is a prevalent and disabling disorder. Patent foramen ovale (PFO) has been associated with migraine, but its role in the disorder remains poorly understood. Objectives This study examined the efficacy of percutaneous PFO closure as a therapy for migraine with or without aura. Methods The PREMIUM (Prospective, Randomized Investigation to Evaluate Incidence of Headache Reduction in Subjects With Migraine and PFO Using the AMPLATZER PFO Occluder to Medical Management) was a double-blind study investigating migraine characteristics over 1 year in subjects randomized to medical therapy with a sham procedure (right heart catheterization) versus medical therapy and PFO closure with the Amplatzer PFO Occluder device (St. Jude Medical, St. Paul, Minnesota). Subjects had 6 to 14 days of migraine per month, had failed at least 3 migraine preventive medications, and had significant right-to-left shunt defined by transcranial Doppler. Primary endpoints were responder rate defined as 50% reduction in migraine attacks and adverse events. Secondary endpoints included reduction in migraine days and efficacy in patients with versus without aura. Results Of 1,653 subjects consented, 230 were enrolled. There was no difference in responder rate in the PFO closure (45 of 117) versus control (33 of 103) groups. One serious adverse event (transient atrial fibrillation) occurred in 205 subjects who underwent PFO closure. Subjects in the PFO closure group had a significantly greater reduction in headache days (–3.4 vs. –2.0 days/month, p = 0.025). Complete migraine remission for 1 year occurred in 10 patients (8.5%) in the treatment group versus 1 (1%) in the control group (p = 0.01). Conclusions PFO closure did not meet the primary endpoint of reduction in responder rate in patients with frequent migraine. (Prospective, Randomized Investigation to Evaluate Incidence of Headache Reduction in Subjects With Migraine and PFO Using the AMPLATZER PFO Occluder to Medical Management [PREMIUM]; NCT00355056)
| Original language | English |
|---|---|
| Pages (from-to) | 2766-2774 |
| Number of pages | 9 |
| Journal | Journal of the American College of Cardiology |
| Volume | 70 |
| Issue number | 22 |
| DOIs | |
| State | Published - Dec 5 2017 |
Bibliographical note
Funding Information:This research was funded by St. Jude Medical Incorporated, Minneapolis, Minnesota. Drs. Tobis and Sorenson served on the PREMIUM Steering Committee. Dr. Charles has served on the PREMIUM Steering Committee; and has served as a consultant for Alder, Amgen, Biohaven, Eli Lilly, and eNeura. Dr. Silberstein has served on the PREMIUM Steering Committee; and has served as a consultant to Alder Biopharmaceuticals, Allergan, Amgen, Avanir Pharmaceuticals, Curelator, Dr. Reddy’s Laboratories, eNeura, electroCore Medical, Lilly USA, Medscape, National Institute of Neurological Disorders and Stroke, Supernus Pharmaceuticals, Teva Pharmaceuticals, Theranica, and Trigemina. Dr. Maini has served on the speakers bureaus and advisory boards of, contracted research for, and received proctorship honoraria from Medtronic, Abbott Vascular, Boston Scientific, Abiomed, St. Jude Medical, and Siemens. Dr. Horwitz has received research grant support from St. Jude Medical, Edwards Lifesciences, Biotronik, Sanofi, Bristol-Myers Squibb, AstraZeneca, Teva/Cephalon, and Keystone Heart. Dr. Gurley has reported that he has no relationships relevant to the contents of this paper to disclose.
Publisher Copyright:
© 2017 American College of Cardiology Foundation
Keywords
- Amplatzer PFO Occluder device
- aura
- double-blind randomized clinical trial
- migraine
- patent foramen ovale
ASJC Scopus subject areas
- Cardiology and Cardiovascular Medicine