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Patients undergoing transcatheter atrial septal defect (ASD) closure did not have worsening migraines after completing a course of dual antiplatelet therapy, the CANOA investigators found.

Overall, there was a 15.8% incidence of migraines in the first 3 months following the procedure among people randomized to clopidogrel (Plavix) plus aspirin or aspirin alone. After this initial period, all participants went on aspirin alone and 4.7% reported migraines at 6 months and 2.3% at 12 months, both significant improvements from 3 months.

Whether initially assigned DAPT or aspirin alone, migraines occurred at similar rates at both 6 months (2.4% vs 6.9%, P=0.28) and 12 months (3.6% vs 1.1%, P=0.36), according to Josep Rodés-Cabau, MD, PhD, of Quebec Heart & Lung Institute, Laval University in Quebec City, and colleagues. Their manuscript was published online in .

Among people who had migraines, the severity of migraine attacks progressively decreased over time: there were no moderate or severe attacks at 6 or 12 months compared with 26% at 3 months (P<0.001).

Previous studies indicated that about 15% of patients undergoing ASD closure develop new-onset migraine, Rodés-Cabau and colleagues noted.

"The results of this study provide further reassurance for patients (usually young adults in working age) receiving transcatheter ASD closure by demonstrating a low rate of migraine events beyond 3 months following transcatheter ASD closure and supporting the early discontinuation of clopidogrel therapy if administered," the investigators wrote.

"Importantly, only 1% of patients had new-onset migraine attacks after clopidogrel cessation. Thus, these data support a limited duration (no longer than 3 months) of clopidogrel therapy following ASD closure. However, further studies with a longer follow-up are needed to further evaluate the outcomes of patients with persistent migraine headaches at 1 year after the procedure."

CANOA investigators had previously reported the efficacy of clopidogrel in in the 3 months following transcatheter ASD closure. This finding may be due to clopidogrel's antiplatelet, antioxidant, anti-inflammatory, and vasoprotective effects, Rodés-Cabau and colleagues suggested.

Their trial included patients with no prior history of migraine who underwent ASD closure at six Canadian hospitals.

The present prespecified analysis included people who remained on aspirin up to 12 months: 84 patients initially randomized to aspirin plus clopidogrel and 87 assigned to aspirin plus placebo in the first 3 months after ASD closure.

Patients had a mean age of 38 years, and 62% were women.

Incidence and severity of migraine attacks were assessed using a migraine headache questionnaire.

"The pathophysiology linking transcatheter ASD closure and migraine attacks remains unclear. Nickel allergy, increased platelet aggregation, and the presence of microthrombus on the ASD closure device have been proposed as potential mechanisms," Rodés-Cabau's group said.

Limitations of CANOA included the lack of platelet reactivity testing for clopidogrel responders vs non-responders. Investigators also used just one ASD closure device for the study, and the results could have been affected by the loss to follow-up of 7.6% patients at 12 months.

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