Clopidogrel for the Prevention of New-Onset Migraine Headache Following Transcatheter Closure of Atrial Septal Defects - CANOA

Nov 09, 2015
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Sanofi, St Jude Medical, and Foundation of the Quebec Heart and Lung Institute
Date Presented:
11/09/2015
Date Published:
11/09/2015
Original Posted Date:
11/09/2015
References

Contribution To Literature:

The CANOA trial showed that aspirin plus clopidogrel was superior to aspirin alone at reducing the occurrence of new-onset migraine headache after ASD closure.

Description:

The goal of the trial was to evaluate treatment with aspirin plus clopidogrel compared with aspirin alone among patients undergoing percutaneous closure of an atrial septal defect (ASD) and no history of migraine headache.

Study Design

  • Randomized
  • Parallel
  • Blinded
  • Placebo

Patients undergoing percutaneous closure of an ASD with the Amplatzer Septal Occluder were randomized to aspirin 80 mg plus clopidogrel 75 mg for 3 months (n = 84) versus aspirin 80 mg plus placebo for 3 months (n = 87).

  • Total number of enrollees: 220
  • Duration of follow-up: 3 months
  • Mean patient age: 49 years
  • Percentage female: 62%
  • Percentage diabetics: 5.9%
  • Mean ASD size: 16 mm

Inclusion criteria:

  • Patients ≥18 years of age undergoing transcatheter ASD closure

Exclusion criteria:

  • Intolerance to aspirin or clopidogrel
  • Need for anticoagulation
  • Use of ASD closure device other than the Amplatzer Septal Occluder
  • History of migraine headache
  • Pregnancy or ability to become pregnant
  • Previous stroke

Principal Findings:

The primary outcome, mean number of monthly migraine days per patient within 3 the months following ASD closure, was 0.4 in the aspirin plus clopidogrel group versus 1.4 in the aspirin plus placebo group (p = 0.035).

Secondary outcomes:

  • Mild residual shunt at 3 months: 12.7% in the aspirin plus clopidogrel group vs. 9.2% in the aspirin plus placebo group
  • New-onset migraine attacks: 9.5% in the aspirin plus clopidogrel group vs. 21.8% in the aspirin plus placebo group (p = 0.031)
  • Total migraine days at 3 months: 1.0 in the aspirin plus clopidogrel group vs. 3.8 in the aspirin plus placebo group (p < 0.001)

Interpretation:

Among individuals undergoing percutaneous closure of an ASD, aspirin plus clopidogrel was effective at preventing new-onset migraine headache compared with aspirin alone. This study confirms the occurrence of new-onset migraine headaches following ASD closure. It is unknown why ASD closure would be associated with an increased risk of new-onset migraine headaches. The pathophysiology of this disease is likely different from chronic migraine associated with patent foramen ovale (PFO).

The MIST trial, which treated all patients with dual antiplatelet therapy for 3 months, failed to demonstrate a reduction in migraine headaches from PFO closure. Future studies will need to address the optimal duration of dual antiplatelet therapy after percutaneous ASD closure.

References:

Wintzer-Wehekind J, Horlick E, Ibrahim R, et al. 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 Cardiol 2020;Sep 23:[Epub ahead of print]

Rodés-Cabau J, Horlick E, Ibrahim R, et al. Effect of clopidogrel and aspirin vs aspirin alone on migraine headaches after transcatheter atrial septal defect closure: The CANOA randomized clinical trial. JAMA 2015;Nov 9:[Epub ahead of print].

Presented by Dr. Josep Rodés-Cabau at the American Heart Association Scientific Sessions, Orlando, FL, November 9, 2015.

Keywords: Anticoagulants, Aspirin, Heart Defects, Congenital, Heart Septal Defects, Atrial, Migraine Disorders, Platelet Aggregation Inhibitors, Primary Prevention, Risk, Septal Occluder Device, Ticlopidine, AHA Annual Scientific Sessions


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