RTI uses cookies to offer you the best experience online. By clicking “accept” on this website, you opt in and you agree to the use of cookies. If you would like to know more about how RTI uses cookies and how to manage them please view our Privacy Policy here. You can “opt out” or change your mind by visiting: http://optout.aboutads.info/. Click “accept” to agree.
Effect of clopidogrel and aspirin vs aspirin alone on migraine headaches after transcatheter atrial septal defect closure
One-year results of the CANOA randomized clinical trial
Wintzer-wehekind, J., Horlick, E., Ibrahim, R., Cheema, A. N., Labinaz, M., Nadeem, N., Osten, M., Côté, M., Marsal, J. R., Rivest, D., Marrero, A., Houde, C., & Rodés-cabau, J. (2021). Effect of clopidogrel and aspirin vs aspirin alone on migraine headaches after transcatheter atrial septal defect closure: One-year results of the CANOA randomized clinical trial. JAMA Cardiology, 6(2), 209-213. https://doi.org/10.1001/jamacardio.2020.4297
IMPORTANCE Adding clopidogrel to aspirin for 3 months after transcatheter atrial septal defect (ASD) closure results in a lower incidence of new-onset migraine attacks. However, the outcomes at 6- to 12-month follow-up (after clopidogrel cessation at 3 months) remain largely unknown.
OBJECTIVE To assess the incidence of migraine attacks at 6- and 12-month follow-up after transcatheter ASD closure.
DESIGN, SETTING, AND PARTICIPANTS This prespecified analysis of a randomized, double-blind clinical trial included patients with no prior history of migraine undergoing ASD closure from 6 university hospitals in Canada from December 2008 to November 2014. Patients were followed up at 3, 6, and 12 months, and a migraine headache questionnaire was administered at each time. Analysis began June 2019.
INTERVENTIONS Patients were randomized (1:1) to receive dual antiplatelet therapy (aspirin plus clopidogrel; n = 84) vs single antiplatelet therapy (aspirin plus placebo; n = 87) for 3 months following transcatheter ASD closure. After 3 months, only single antiplatelet therapy (aspirin) was pursued.
MAIN OUTCOMES AND MEASURES Incidence and severity of migraine attacks at 6- and 12-month follow-up.
RESULTS The mean (SD) age of the study population was 38 (12) years, with 106 women (62%). A total of 27 patients (15.8%) had new-onset migraine attacks within the 3 months following ASD closure (8 of 84 [9.5%] vs 19 of 87 [21.8%] in the initial clopidogrel and placebo groups, respectively; P =.03). After cessation of clopidogrel and aspirin monotherapy, the percentage of patients with migraine attacks decreased over time, with 8 (4.7%) and 4 patients (2.3%) continuing to have migraine attacks at 6 and 12 months, respectively (vs 3 months: P
CONCLUSIONS AND RELEVANCE New-onset migraine attacks after ASD closure improved or resolved spontaneously within 6 to 12 months in most patients. No significant rebound effect was observed after clopidogrel cessation at 3 months. These results demonstrate a low rate of migraine events beyond 3 months following transcatheter ASD closure and support the early discontinuation of clopidogrel therapy if administered.