Patent foramen ovale medical therapy

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editors-In-Chief: Ifeoma Odukwe, M.D. [2], Priyamvada Singh, M.B.B.S. [3], Kristin Feeney, B.S. [4]

Overview

Medical therapy with antiplatelet therapy (aspirin) or anticoagulant therapy (warfarin) can be considered in patients with recurrent strokes a of cryptogenic stroke. However, the relative effectiveness of aspirin or warfarin in these patients has not been proven. Recommendations have been made on the use of antiplatelets and anticoagulants by the American Academy of Neurologists and American Heart Association.

Medical Therapy

  • Antiplatelets or anticoagulants may be used in preventing recurrent cryptogenic stroke in patients with patent foramen ovale. There is a lack of consensus on the medical therapy of choice.
  • The incidence of recurrent strokes in patients with index episode of cryptogenic stroke and treated with aspirin or warfarin has been found to be similar in the presence or absence of a patent foramen ovale[1].
  • Warfarin is associated with greater hemorrhagic risk and requires more complex monitoring and therapeutic adjustments.

Supportive Trial Data

A large randomized multicenter trial (42 centers) was done to compare the relative efficacy of aspirin and warfarin to prevent recurrent strokes in patients with patent foramen ovale. The study found an increased incidence of patent foramen ovale with cryptogenic stroke. This was similar to the results found in previous small scale trials. Also, it was found in the study that cryptogenic strokes were more common in larger patent foramen ovale compared to the smaller. Nevertheless, the rate of recurrent stroke or death, in medically treated patients after index episode of cryptogenic stroke, was found to be similar between patients with and without patent foramen ovale. Also, the rate of adverse events after medical therapy was found to be the same in patent foramen ovale of different sizes.[1][2][3][4].

International Guidelines for Prevention of Recurrent Cerebral Embolism in Patent Foramen Ovale

American Academy of Neurology Guidelines for Prevention of Recurrent Cerebral Embolism in Patent Foramen Ovale (DO NOT EDIT)[5][6]

Practice Recommendations

1) In the absence of another indication for anticoagulation, clinicians may routinely offer antiplatelet medications instead of anticoagulation to patients with cryptogenic stroke and PFO (Level C).

2) In rare circumstances, such as stroke that recurs while a patient is undergoing antiplatelet therapy, clinicians may offer anticoagulation to patients with cryptogenic stroke and PFO (Level C).

  • There is insufficient evidence to determine the efficacy of anticoagulants compared with antiplateles in preventing reccurent strokes in patients with crptogenic stroke and patent foramen ovale.
  • Among patients with a cryptogenic stroke and atrial septal abnormalities, there is insufficient evidence to determine the superiority of aspirin or warfarin for prevention of recurrent stroke or death (Level U), but the risks of minor bleeding are possibly greater with warfarin (Level C)

Rating of Recommendations

A = Established as effective, ineffective, or harmful for the given condition in the specified population.

B = Probably effective, ineffective, or harmful for the given condition in the specified population.

C = Possibly effective, ineffective, or harmful for the given condition in the specified population.

U = Data inadequate or conflicting. Given current knowledge, treatment (test, predictor) is unproven.

American Academy of Chest Physicians Guidelines for Prevention of Recurrent Cerebral Embolism in Patent Foramen Ovale (DO NOT EDIT) [7]

1) In patients with cryptogenic ischemic stroke and a PFO, we recommend antiplatelet therapy over no therapy (Grade 1A) and suggest antiplatelet therapy over warfarin (Grade 2A).

2) For patients with evidence of a DVT, anticoagulation therapy is recommended.

American Heart Association/American Stroke Association Guidelines for Prevention of Recurrent Cerebral Embolism in Patent Foramen Ovale (DO NOT EDIT)[8][9]

1) For patients with an ischaemic stroke or transient ischaemic attack and a PFO who are not undergoing anticoagulation therapy, antiplatelet therapy is recommended (Class I; Level of Evidence B).

2) For patients with an ischaemic stroke or transient ischaemic attack and both a PFO and a venous source of embolism, anticoagulation is indicated depending on stroke characteristics (Class I; Level of Evidence A). When anticoagulation is contraindicated, an inferior vena cava filter is reasonable (Class IIa; Level of Evidence C).

Class I = Conditions for which there is evidence for and/ or general agreement that the procedure or treatment is useful and effective.

Class II = Conditions for which there is conflicting evidence and/or a divergence of opinion about the usefulness/efficacy of a procedure or treatment.

Class IIa = The weight of evidence or opinion is in favor of the procedure or treatment.

Class IIb = Usefulness/efficacy is less well established by evidence or opinion.

Class III = Conditions for which there is evidence and/ or general agreement that the procedure or treatment is not useful/effective and in some cases may be harmful.

Therapeutic recommendations:

Level of Evidence A = Derived from multiple randomized clinical trials or meta-analyses.

Level of Evidence B = Data derived from a single randomized trial or nonrandomized studies.

Level of Evidence C = Consensus opinion of experts, case studies, or standard of care.

Diagnostic recommendations:

Level of Evidence A = Data derived from multiple prospective cohort studies using a reference standard applied by a masked evaluator.

Level of Evidence B = Data derived from a single grade A study or one or more case-control studies, or studies using a reference standard applied by an unmasked evaluator.

Level of Evidence C = Consensus opinion of experts.

European Stroke Organisation Guidelines for Prevention of Recurrent Cerebral Embolism in Patent Foramen Ovale (DO NOT EDIT)[10]

1) Patients with cardioembolic stroke unrelated to atrial fibrillation should receive warfarin if the risk of recurrence is high.

References

  1. 1.0 1.1 Homma S, Sacco RL, Di Tullio MR, Sciacca RR, Mohr JP, PFO in Cryptographic Stroke Study (PICSS) Investigators (2002). "Effect of medical treatment in stroke patients with patent foramen ovale: patent foramen ovale in Cryptogenic Stroke Study". Circulation. 105 (22): 2625–31. PMID 12045168.
  2. Lechat P, Mas JL, Lascault G, Loron P, Theard M, Klimczac M; et al. (1988). "Prevalence of patent foramen ovale in patients with stroke". N Engl J Med. 318 (18): 1148–52. doi:10.1056/NEJM198805053181802. PMID 3362165.
  3. Webster MW, Chancellor AM, Smith HJ, Swift DL, Sharpe DN, Bass NM; et al. (1988). "Patent foramen ovale in young stroke patients". Lancet. 2 (8601): 11–2. PMID 2898621.
  4. Di Tullio M, Sacco RL, Gopal A, Mohr JP, Homma S (1992). "Patent foramen ovale as a risk factor for cryptogenic stroke". Ann Intern Med. 117 (6): 461–5. PMID 1503349.
  5. Messé SR, Silverman IE, Kizer JR, Homma S, Zahn C, Gronseth G; et al. (2004). "Practice parameter: recurrent stroke with patent foramen ovale and atrial septal aneurysm: report of the Quality Standards Subcommittee of the American Academy of Neurology". Neurology. 62 (7): 1042–50. PMID 15078999.
  6. Messé, Steven R.; Gronseth, Gary; Kent, David M.; Kizer, Jorge R.; Homma, Shunichi; Rosterman, Lee; Kasner, Scott E. (2016). "Practice advisory: Recurrent stroke with patent foramen ovale (update of practice parameter)". Neurology. 87 (8): 815–821. doi:10.1212/WNL.0000000000002961. ISSN 0028-3878.
  7. Albers GW, Amarenco P, Easton JD, Sacco RL, Teal P (2004). "Antithrombotic and thrombolytic therapy for ischemic stroke: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy". Chest. 126 (3 Suppl): 483S–512S. doi:10.1378/chest.126.3_suppl.483S. PMID 15383482.
  8. Furie KL, Kasner SE, Adams RJ, Albers GW, Bush RL, Fagan SC; et al. (2011). "Guidelines for the prevention of stroke in patients with stroke or transient ischemic attack: a guideline for healthcare professionals from the american heart association/american stroke association". Stroke. 42 (1): 227–76. doi:10.1161/STR.0b013e3181f7d043. PMID 20966421.
  9. Kernan, Walter N.; Ovbiagele, Bruce; Black, Henry R.; Bravata, Dawn M.; Chimowitz, Marc I.; Ezekowitz, Michael D.; Fang, Margaret C.; Fisher, Marc; Furie, Karen L.; Heck, Donald V.; Johnston, S. Claiborne (Clay); Kasner, Scott E.; Kittner, Steven J.; Mitchell, Pamela H.; Rich, Michael W.; Richardson, DeJuran; Schwamm, Lee H.; Wilson, John A. (2014). "Guidelines for the Prevention of Stroke in Patients With Stroke and Transient Ischemic Attack". Stroke. 45 (7): 2160–2236. doi:10.1161/STR.0000000000000024. ISSN 0039-2499.
  10. European Stroke Organisation (ESO) Executive Committee. ESO Writing Committee (2008). "Guidelines for management of ischaemic stroke and transient ischaemic attack 2008". Cerebrovasc Dis. 25 (5): 457–507. doi:10.1159/000131083. PMID 18477843.

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