Younger patients with a patent foramen ovale who have had a cryptogenic ischemic stroke should undergo PFO closure followed by antiplatelet therapy to reduce risk for future stroke, according to clinical practice guideline published in The BMJ.
The expert panel drafting the guideline based its recommendations on a linked systematic review of three large randomized trials published in September 2017 suggesting that PFO closure may be more effective in reducing risk for stroke compared with medical therapy alone.
In addition to its recommendation that PFO closure plus antiplatelet therapy is preferable to antiplatelet therapy alone, the panel also recommended PFO closure plus antiplatelet therapy over anticoagulants. For patients in whom PFO closure is contraindicated or who prefer not to undergo the procedure, the panel recommended anticoagulants over antiplatelet therapy. The latter two recommendations, however, were weaker due to lower-quality evidence.
The guideline applies only to patients with a PFO aged younger than 60 years who have had a cryptogenic ischemic stroke when extensive workup of other stroke etiologies is negative, the panel noted.
The guideline was drafted as part of The BMJ’s “Rapid Recommendations” initiative, which is intended to produce rapid and trustworthy new guidelines based on new evidence.
In creating their recommendations, the panel used the GRADE approach comparing the three treatment options for patients with PFO who have had cryptogenic stroke, including PFO closure plus antiplatelet therapy, antiplatelet therapy alone and anticoagulation alone.
After reviewing the available evidence, experts agreed that PFO closure followed by antiplatelet therapy vs. antiplatelet therapy alone is associated with an 8.7% absolute risk reduction in ischemic stroke, with little or no difference in death, major bleeding, pulmonary embolism, transient ischemic attack or systemic embolism at 5 years.
They also noted that PFO closure plus antiplatelet therapy, compared with anticoagulation, results in only a 1.6% absolute risk reduction in ischemic stroke and likely decreases major bleeding with little or no difference in death, PE, TIA or systemic embolism at 5 years.
However, PFO closure plus antiplatelet therapy is associated with a 3.6% absolute risk for device- or procedure-related events as well as increased risks for persistent or transient atrial fibrillation or flutter at 1 year.
The experts also agreed that anticoagulation, compared with antiplatelet therapy, may decrease ischemic stroke risk, probably increases major bleeding and probably confers little or no difference in death, PE, TIA or systemic embolism at 5 years.
Despite their recommendations, the expert panel noted that PFO closure is associated with higher costs and implementation would likely have an important impact on costs for the health care system in the short term. Nevertheless, the panel pointed out that PFO closure may reduce costs over the long term by decreasing stroke rates and the associated costs of stroke.
Further research is also necessary to inform future guidelines, including more investigation into the benefits and harms of PFO closure vs. anticoagulants, the specific patient groups who are more likely to benefit from PFO closure vs. medical therapy, the best device for PFO closure and the longevity of the PFO closure device and ongoing need for monitoring of device performance, according to the panel.
Importantly, the guideline emphasized the need to consider patient preference and engage in shared decision making, and when drafting the recommendations, the panel sought patient input.
“PFO patients suffering cryptogenic stroke have experienced confusion when navigating the treatment decision making process and reported receiving recommendations based on physician’s preference rather than an unbiased assessment of available clinical trial data,” panel member Bray Patrick-Lake, MFS, founding director of the not-for-profit PFO Research Foundation, said in a press release.
“The BMJ working group included patient representatives in the critical assessment of PFO research and thoughtfully produced evidence that can help patients understand what their outcomes are likely to be with available therapies so they can work with their physicians to make an informed treatment decision which incorporates their values and preferences.” – by Melissa Foster
Disclosure: The authors report no relevant financial disclosures.