Do You Stop Stroke Secondary Prophylaxis After PFO Closure?
No, you should not completely stop antithrombotic therapy after PFO closure—continue single antiplatelet therapy (SAPT) for up to 5 years, with consideration for lifelong treatment based on individual stroke and bleeding risk. 1
Post-PFO Closure Antithrombotic Protocol
The most recent consensus guidelines provide a clear algorithmic approach:
Initial Phase (1-6 months post-closure)
- Dual antiplatelet therapy (DAPT) for 1-6 months following PFO closure 1
- This period allows for device endothelialization and addresses the risk of residual shunts 1
Maintenance Phase (6 months to 5 years)
- Transition to single antiplatelet therapy (SAPT) and continue for up to 5 years 1
- The choice of specific antiplatelet agent is empirical (aspirin or clopidogrel) 1
Long-Term Considerations (Beyond 5 years)
- Prolongation beyond 5 years should be determined by the patient's stroke and bleeding risks 1
- Data suggest all patients with a history of ischemic stroke might be candidates for lifelong antithrombotic treatment, regardless of PFO closure 1
Critical Evidence Supporting Continued Therapy
The rationale for not stopping prophylaxis entirely is based on:
- An observational study of 660 patients showed thromboembolic events occurred in 3.8% within 5 years post-closure, with the latest stroke occurring 56 months (nearly 5 years) after the procedure 1
- Real-world data demonstrates a recurrence rate of 0.38 per 100 patient-years over 10-year follow-up, with freedom from stroke/TIA/death at 96.2% at 10 years 2
- Bleeding events occurred in approximately 6% of patients over median 8-year follow-up, including major bleeding in 1.3% (all under aspirin therapy) 3
When Discontinuation May Be Considered
While guidelines recommend up to 5 years of therapy, real-world evidence suggests some flexibility:
- In one cohort, 18% of patients discontinued antithrombotic therapy at median 7 months post-closure, and none experienced ischemic events during median 7-year follow-up without therapy 3
- Propensity-matched analysis showed no difference in ischemic events between patients who discontinued therapy within 1 year versus those continuing therapy 3
- However, this applies only to young patients without other comorbidities increasing stroke risk 3
Common Pitfalls to Avoid
Do Not Assume PFO Closure Eliminates All Stroke Risk
- PFO closure addresses paradoxical embolism but doesn't eliminate other stroke mechanisms 1
- Patients may have unrecognized traditional vascular risk factors 1
Do Not Use Dual Antiplatelet Therapy Long-Term
- DAPT is only for the initial 1-6 month period 1
- Long-term secondary prevention uses single antiplatelet therapy 4
Do Not Apply These Recommendations to Patients >60 Years
- Guidelines specifically apply to patients 18-60 years old 1
- Older patients have different stroke mechanisms and risk-benefit profiles 1
Special Circumstances
If Patient Already on Anticoagulation
- For patients requiring long-term anticoagulation for other indications (e.g., atrial fibrillation), the decision regarding additional antiplatelet therapy remains unclear 1
- Continue the anticoagulation as indicated for the primary condition 1
If Recurrent Events Occur Despite Closure
- Consider switching from antiplatelet to anticoagulation therapy 4
- Re-evaluate for other stroke etiologies including hypercoagulable states or venous thromboembolism 4
Bottom Line Algorithm
- Months 0-6: DAPT (aspirin + clopidogrel) 1
- Months 6-60 (5 years): SAPT (aspirin or clopidogrel) 1
- Beyond 5 years: Individualize based on stroke risk factors and bleeding risk, but consider lifelong therapy in patients with history of ischemic stroke 1
- Early discontinuation (<5 years): May be reasonable only in young patients without other stroke risk factors and no bleeding complications, but this is not the guideline-recommended approach 3