Josep Rodes-Cabau, M.D., of Laval University, Quebec City, Canada, and colleagues randomly assigned 171 patients with an indication for atrial septal defect (ASD) closure and no history of migraine to receive dual antiplatelet therapy (aspirin + clopidogrel [the clopidogrel group], n = 84) or single antiplatelet therapy (aspirin + placebo [the placebo group], n = 87) for 3 months following transcatheter ASD closure. This JAMA study is being released to coincide with its presentation at the American Heart Association's Scientific Sessions 2015.
An atrial septal defect is a hole in the part of the septum (wall) that separates the upper chambers of the heart. Occurrence of new-onset migraine attacks has been reported in approximately 15 percent of patients following transcatheter ASD closure, with the majority of initial episodes occurring within the days to weeks following the procedure. Aspirin is often prescribed for 6 months following the procedure. Preliminary studies have suggested an association with a lower incidence and severity of migraine headaches following ASD closure when ticlopidine or clopidogrel is added to aspirin treatment.
The researchers found that patients in the clopidogrel group had a reduced average number of monthly migraine days within the 3 months following the procedure (0.4 days) vs the placebo group (1.4 days) and a lower incidence of migraine attacks (9.5 percent for the clopidogrel group vs 22 percent for the placebo group). Among patients with migraines, those in the clopidogrel group had less-severe migraine attacks (zero patients with moderately or severely disabling migraine attacks vs 37 percent [7 patients] in the placebo group). No significant increase in adverse events was observed with the use of dual vs single antiplatelet therapy.
"Further studies are needed to assess generalizability and durability of this effect," the authors write.
(doi:10.1001/jama.2015.13919; Available pre-embargo to the media at http://media.jamanetwork.com)
Editor's Note: This study was funded by unrestricted grants from Sanofi and St. Jude Medical and a grant from the Foundation of the Quebec Heart and Lung Institute. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, etc.