Antithrombotic agents may be effective in preventing migraine in patients with patent foramen ovale

1. The antithrombotic agents aspirin, clopidogrel, and rivaroxaban were non-inferior to metoprolol for responder rate in participants with patent foramen ovale and migraine.

Evidence Rating Level: 1 (Excellent)

Patent foramen ovale (PFO) has been associated with migraine and has been suggested to involve a microembolic mechanism. Antithrombotic treatment has been proposed for migraine prevention by suppressing thrombus formation and microemboli. However, the efficacy of antithrombotic agents in preventing migraine among patients with PFO is unclear. This study thus examined the efficacy and safety of antithrombotic treatment for migraine prevention in patients with PFO. This randomised clinical trial included adults in China aged 18-64 years between October 2022 and December 2024 who were diagnosed with migraine for >1 year, experiencing at least four migraine days per month, and with PFO. Participants were randomised 1:1:1:1 to receive aspirin (300 mg once daily), clopidogrel (75 mg once daily), or rivaroxaban (20 mg once daily), or the first-line preventive agent metoprolol (25 mg twice daily; active control) for 12 weeks. The primary outcome was the proportion of participants achieving a ≥50% reduction in monthly migraine days or attacks from baseline to weeks 9-12 after randomisation. Safety outcomes included bleeding and other adverse events. Among the 984 participants analyzed (mean [IQR] age =38.5 [31.0-47.3], female [%] = 739 [75.1%]), 247 were in the aspirin group, 244 in the clopidogrel group, 245 in the rivaroxaban group, and 248 in the metoprolol group. All three antithrombotic agents were non-inferior to metoprolol, with responder rates of 61.7% with aspirin, 66.8% with clopidogrel, 78.4% with rivaroxaban, and 61.8% with metoprolol. Only rivaroxaban showed a higher responder rate than metoprolol, with an absolute difference of 16.2% (98.33% CI 6.0 to 26.4). Overall, the antithrombotic agents aspirin, clopidogrel, and rivaroxaban were non-inferior to metoprolol for responder rate in patients with PFO and migraine. These findings support a potential microembolic mechanism contributing to migraine in patients with PFO.

Click here to read this study in the BMJ (British Medical Journal)

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