Data from: Patent foramen ovale closure, antiplatelet therapy or anticoagulation in patients with patent foramen ovale and cryptogenic stroke: a systematic review and network meta-analysis incorporating complementary external evidence

Mir, Hassan, Department of Health Research Methods, Evidence, and Impact

Siemieniuk, Reed A.C., Department of Health Research Methods, Evidence, and Impact

Ge, Long C.

Foroutan, Farid, Department of Clinical Epidemiology and Biostatistics

Fralick, Michael, Eliot Phillipson Clinician Scientist Training Program, Department of Medicine

Syed, Talha, Department of Health Research Methods, Evidence, and Impact

Lopes, Luciane, Pharmaceutical Sciences Graduate Course

Kuijpers, Ton, Department of Guideline Development and Research

Mas, Jean-Louis, Department of Neurology

Vandvik, Per O., Norwegian Institute of Public Health

Agoritsas, Thomas, Department of Health Research Methods, Evidence, and Impact

Guyatt, Gordon H., Department of Health Research Methods, Evidence, and Impact

Published Jul 03, 2018 on Dryad. https://doi.org/10.5061/dryad.ng017rc

Cite this dataset

Mir, Hassan et al. (2018). Data from: Patent foramen ovale closure, antiplatelet therapy or anticoagulation in patients with patent foramen ovale and cryptogenic stroke: a systematic review and network meta-analysis incorporating complementary external evidence [Dataset]. Dryad. https://doi.org/10.5061/dryad.ng017rc

Abstract

Objective: To examine the relative impact of three management options in patients less than 60 years old with cryptogenic stroke and a patent foramen ovale (PFO): PFO closure plus antiplatelet therapy, antiplatelet therapy alone, and anticoagulation alone. Design: Systematic review and network meta-analysis (NMA) supported by complementary external evidence Data sources: Medline, EMBASE, and Cochrane CENTRAL. Study selection: Randomised controlled trials (RCTs) addressing PFO closure and/or medical therapies in patients with PFO and cryptogenic stroke. Review methods: We conducted an NMA complemented with external evidence and rated certainty of evidence using the GRADE system. Results: Ten RCTs in eight studies proved eligible (n=4416). PFO closure versus antiplatelet therapy probably results in substantial reduction in ischaemic stroke recurrence (risk difference per 1000 patients over 5 years [RD]: -87, 95% credible interval [CrI] -100 to -33; moderate certainty). Compared with anticoagulation, PFO closure may confer little or no difference in ischaemic stroke recurrence (low certainty) but probably has a lower risk of major bleeding (RD -20, 95% Crl -27 to -2, moderate certainty). Relative to either medical therapy, PFO closure probably increases the risk of persistent atrial fibrillation (RD 18, CI +5 to +56, moderate certainty) and device-related adverse events (RD +36, 95% CI +23 to +50, high certainty). Anticoagulation, compared to antiplatelet therapy, may reduce the risk of ischaemic stroke recurrence (RD -71, 95% CrI -100 to +17, low certainty), but probably increases the risk of major bleeding (RD +12, CrI -5 to +65, moderate certainty). Conclusions: In patients less than 60 years old, PFO closure probably confers an important reduction in ischaemic stroke recurrence compared to antiplatelet therapy alone but may make no difference compared to anticoagulation. PFO closure incurs a risk of persistent atrial fibrillation and device-related adverse events. Compared to alternatives, anticoagulation probably increases major bleeding.

Usage notes

PFO and Cryptogenic Stroke Data File

This file contains 4 sheet. PFO vs Medical Therapy, PFO vs Antiplatelet, PFO vs Anticoagulation, and Anticoagulation vs Antiplatelet