Percutaneous Closure of Patent Foramen Ovale in Patients With Migraine: The PREMIUM Trial

Jonathan M Tobis; Phillip A Horwitz; Andrew Charles; Stephen D Silberstein; Sherman Sorensen; Brijeshwar Maini; John C Gurley

doi:10.1016/j.jacc.2017.09.1105

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Percutaneous Closure of Patent Foramen Ovale in Patients With Migraine: The PREMIUM Trial

Journal article

Open access

Peer reviewed

Percutaneous Closure of Patent Foramen Ovale in Patients With Migraine: The PREMIUM Trial

Jonathan M Tobis, Phillip A Horwitz, Andrew Charles, Stephen D Silberstein, Sherman Sorensen, Brijeshwar Maini and John C Gurley

Journal of the American College of Cardiology, Vol.70(22), pp.2766-2774

12/05/2017

DOI: 10.1016/j.jacc.2017.09.1105

PMID: 29191325

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Abstract

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. This study examined the efficacy of percutaneous PFO closure as a therapy for migraine with or without aura. 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. 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). 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).

Severity of Illness Index

Double-Blind Method

Humans

Middle Aged

Migraine Disorders - diagnosis

Pain Management - methods

Prosthesis Implantation - instrumentation

Male

Treatment Outcome

Pain Measurement - methods

Migraine Disorders - therapy

Septal Occluder Device

Foramen Ovale, Patent - surgery

Foramen Ovale, Patent - diagnosis

Prosthesis Implantation - adverse effects

Cardiac Catheterization - methods

Migraine Disorders - complications

Migraine Disorders - physiopathology

Adult

Echocardiography, Doppler - methods

Female

Foramen Ovale, Patent - complications

Prosthesis Implantation - methods

Details

Title: Subtitle: Percutaneous Closure of Patent Foramen Ovale in Patients With Migraine: The PREMIUM Trial
Creators: Jonathan M Tobis - David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, California. Electronic address: jtobis@mednet.ucla.edu
Phillip A Horwitz - University of Iowa Carver College of Medicine, Iowa City, Iowa
Andrew Charles - David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, California
Stephen D Silberstein - Jefferson Headache Center, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, Pennsylvania
Sherman Sorensen - Intermountain Medical Center, Salt Lake City, Utah
Brijeshwar Maini - Tenet Healthcare Corporation, Boca Raton, Florida
John C Gurley - University of Kentucky College of Medicine, Lexington, Kentucky
Resource Type: Journal article
Publication Details: Journal of the American College of Cardiology, Vol.70(22), pp.2766-2774
DOI: 10.1016/j.jacc.2017.09.1105
PMID: 29191325
NLM abbreviation: J Am Coll Cardiol
ISSN: 0735-1097
eISSN: 1558-3597
Language: English
Date published: 12/05/2017
Academic Unit: Cardiovascular Medicine; Internal Medicine
Record Identifier: 9984094370502771

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