Preventing stroke recurrence in patients with patent foramen ovale: antithrombotic therapy, foramen closure, or therapeutic abstention? A decision analytic perspective
Related Experiment Video
Updated: Oct 30, 2026
Closure of a Patent Foramen Ovale (PFO): An Intervention Sequence
Published on: December 23, 2022
M R Nendaz1, F P Sarasin, A F Junod
1Department of Medicine, Hôpital Cantonal Universitaire, Genève, Switzerland.
Insights
Patent foramen ovale closure is superior for preventing recurrent paradoxical strokes when recurrence risk exceeds 0.8% annually. For lower risks, anticoagulation or antiplatelet therapy may be preferred over watchful waiting.
Area of Science:
- Cardiology
- Neurology
- Medical Decision Making
Background:
- Patent foramen ovale (PFO) is increasingly recognized as a risk factor for paradoxical embolism leading to ischemic stroke.
- Current secondary stroke prevention strategies for PFO include antithrombotic therapies and device closure, but optimal indications remain unclear.
- Evaluating the comparative effectiveness and risks of different PFO closure strategies is crucial for patient management.
Purpose of the Study:
- To develop a decision analysis model comparing PFO closure, anticoagulation, antiplatelet therapy, and therapeutic abstention for secondary stroke prevention.
- To assess the risks of stroke recurrence, treatment complications, and mortality, alongside quality-adjusted life-years over a 5-year period.
- To identify optimal therapeutic strategies based on varying stroke recurrence risks.
Main Methods:
- A Markov-based decision analysis model was created for a hypothetical cohort of 55-year-old patients with presumed paradoxical embolism.
- The model simulated outcomes for PFO closure, anticoagulation, antiplatelet therapy, and therapeutic abstention.
- Sensitivity analyses were performed to identify key parameters influencing therapeutic choices, including stroke recurrence rates, bleeding risks, and case fatality rates.
Main Results:
- PFO closure demonstrated superior benefits over other strategies across a wide range of stroke recurrence risks (0.8% to 7% per year).
- Anticoagulation and antiplatelet therapies were favored over therapeutic abstention when stroke recurrence risk exceeded 0.8% and 1.4% per year, respectively.
- Therapeutic abstention was the preferred strategy only when the annual stroke recurrence risk was below 0.8%.
Conclusions:
- For patients with a presumed paradoxical embolism and a PFO, therapeutic abstention is the least favorable strategy if the estimated stroke recurrence risk exceeds 0.8% per year.
- Secondary stroke prevention strategies, including anticoagulation or PFO closure, are preferred above this threshold.
- Individualized therapeutic decisions should be guided by a comprehensive assessment of both stroke recurrence risk and the risks associated with each treatment option.
Abstract:
Emphasis on the role of patent foramen ovale as a potential risk factor for ischemic paradoxical stroke has recently increased. Current therapeutic options for secondary stroke prevention include long-term antithrombotic therapies and invasive closure of the defect, but selective indications have not been evaluated. Therefore we developed a Markov-based decision analysis model for a hypothetical cohort of patients 55 years of age with presumed paradoxical embolism, measuring for each therapy the risks of stroke recurrence, treatment-related complications, and death after 5 years and the quality-adjusted life-years. Over a wide range of stroke risk recurrence (0.8% per year to 7% per year), the gain provided by closure of the defect exceeded the one obtained by other therapeutic options. When the risk exceeded 0.8% per year and 1.4% per year, respectively, this was also verified for anticoagulation and antiplatelet therapies compared with therapeutic abstention. Therapeutic abstention was the preferred strategy under 0.8% per year. Sensitivity analyses identified key parameters influencing the choice of therapy. These included estimates of stroke recurrence, bleeding rates, surgery-related case fatality rates, and age. Considering the risks of treatment and the devastating consequences of a recurrent stroke, our model suggests that if the estimated risk of paradoxical stroke recurrence is > 0.8% per year, therapeutic abstention becomes the worst option. Above this threshold secondary stroke prevention with anticoagulation therapy or surgical closure of the defect is the preferred strategy, and assessment of both the risk of stroke recurrence and the risk related to therapeutic options should guide individual therapeutic decision making.
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