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Clinical Question

PFO closure for cryptogenic stroke?

Synthesises 3 trialsthree NEJM 2017 trials resolved a decade of ambiguity; AF excess is the trade-off

Clinical Synthesis

For selected patients <60 with cryptogenic ischemic stroke and a PFO carrying high-risk morphology, transcatheter closure plus antiplatelet therapy reduces recurrent stroke compared with antiplatelet alone; atrial fibrillation excess is the central trade-off.

Bottom line

In selected non-lacunar cryptogenic-stroke patients <60 with PFO carrying high-risk morphology and no other apparent etiology, percutaneous PFO closure plus long-term antiplatelet is reasonable (Class IIa, Level B-R). Confirm cryptogenic status with vessel imaging + prolonged cardiac monitoring + echocardiography with bubble study before applying.

Sources

Patent Foramen Ovale Closure or Anticoagulation vs. Antiplatelets after Stroke· 2017Patent Foramen Ovale Closure or Antiplatelet Therapy for Cryptogenic Stroke· 2017Long-Term Outcomes of Patent Foramen Ovale Closure or Medical Therapy after Stroke· 2017§5.2.2 Patent Foramen Ovale· 2021

Trials in this question· 3

CLOSE2017
In cryptogenic stroke <60 with PFO + ASA or large shunt, PFO closure abolished recurrent stroke vs antiplatelet alone.
NNT 20HR 0.03 (0.00–0.26)
RESPECT (long-term)2017
In cryptogenic stroke 18–60 with PFO, Amplatzer Occluder beat medical therapy on recurrent stroke over a median 5.9-year follow-up.
NNT 42HR 0.55 (0.31–0.999)
REDUCE2017
In cryptogenic stroke 18–59 with PFO and clean antiplatelet comparator, Gore HELEX/Cardioform closure beat antiplatelet alone on clinical stroke.
NNT 28HR 0.23 (0.09–0.62)

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