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; Siemieniuk, Reed Alexander C.; Ge, Long Cruz; Foroutan, Farid; Fralick, Michael; Syed, Talha; Lopes, Luciane Cruz; Kuijpers, Ton; Mas, Jean-Louis; Vandvik, Per Olav; Agoritsas, Thomas; Guyatt, Gordon H
Journal article, Peer reviewed
Published version
Permanent lenke
http://hdl.handle.net/11250/2574113Utgivelsesdato
2018Metadata
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Originalversjon
Mir H, Siemieniuk RAC, Ge LC, et al. Patent foramen ovale closure, antiplatelet therapy or anticoagulation in patients with patent foramen ovale and cryptogenicstroke: a systematic review and network meta-analysis incorporating complementary external evidence. BMJ Open 2018;8:e023761. doi:10.1136/bmjopen-2018-023761 10.1136/bmjopen-2018-023761Sammendrag
OBJECTIVE:
To examine the relative impact of three management options in patients aged <60 years 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 Grading of Recommendations Assessment, Development and Evaluation (GRADE) system.
RESULTS:
Ten RCTs in eight studies proved eligible (n=4416). Seven RCTs (n=3913) addressed PFO closure versus medical therapy. Of these, three (n=1257) addressed PFO closure versus antiplatelet therapy, three (n=2303) addressed PFO closure versus mixed antiplatelet and anticoagulation therapies and one (n=353) addressed PFO closure versus anticoagulation. The remaining three RCTs (n=503) addressed anticoagulant versus antiplatelet therapy. 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% CrI -27 to -2, moderate certainty). Relative to either medical therapy, PFO closure probably increases the risk of persistent atrial fibrillation (RD 18, 95% CI +5 to +56, moderate certainty) and device-related adverse events (RD +36, 95% CI +23 to +50, high certainty). Anticoagulation, compared with 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, 95% CrI -5 to +65, moderate certainty).
CONCLUSIONS:
In patients aged <60 years, PFO closure probably confers an important reduction in ischaemic stroke recurrence compared with antiplatelet therapy alone but may make no difference compared with anticoagulation. PFO closure incurs a risk of persistent atrial fibrillation and device-related adverse events. Compared with alternatives, anticoagulation probably increases major bleeding.
PROSPERO REGISTRATION NUMBER: CRD42017081567.