A study compared six- and 12-month outcomes among patients who received aspirin plus clopidogrel versus aspirin alone following transcatheter atrial septal defect (ASD) closure to prevent migraines. The researchers concluded that clopidogrel can be safely discontinued after three months without significantly increasing the risk for migraine attacks.
“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,” the researchers wrote in their reasoning for undertaking the study.
The double-blinded clinical trial took place between December 2008 and November 2014 at six Canadian university hospitals. ASD closure patients with no history of migraines were randomized 1:1 to receive aspirin plus clopidogrel (n=84) or aspirin plus placebo (n=87) for three months after the procedure; after the first three months, only aspirin was used. Patients were followed up at three, six, and 12 months via a migraine headache questionnaire. The primary outcome was incidence and severity of migraine attacks at six and 12 months.
The cohort was primary female (n=106; 62%), with a mean overall age of 38 years. During the first three months, 27 patients (15.8%) had new-onset migraine attacks: eight in the initial aspirin plus clopidogrel group (9.5%) and 19 in the initial aspirin plus placebo group (21.8%) (P=0.03). The incidence of migraine attacks decreased after termination of clopidogrel and aspirin monotherapy: at six months, eight patients (4.7%) still had migraine attacks, and by 12 months, this decreased to four patients (2.3%) (vs. three months: P<0.001). There were no moderate or severe attacks at six or 12 months (vs. three months: P<0.001). At six and 12 months, the initial clopidogrel plus aspirin and initial aspirin plus placebo groups did not largely differ in terms of migraine attack rates (six months, 2.4% [n=2] vs. 6.9% [n=6], respectively; P=0.28; 12 months, 3.6% [n=3] vs. 1.1% [n=1], respectively; P=0.36). After three months, one patient in each group experienced new-onset migraine attacks.
The study was published in JAMA Cardiology.
The researchers summarized, “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.”