TY - JOUR
T1 - Closure, anticoagulation, or antiplatelet therapy for cryptogenic stroke with patent foramen ovale
T2 - Systematic review of randomized trials, sequential meta-analysis, and new insights from the CLOSE study
AU - On behalf of the CLOSE Investigators
AU - Turc, Guillaume
AU - Calvet, David
AU - Guérin, Patrice
AU - Sroussi, Marjorie
AU - Chatellier, Gilles
AU - Mas, Jean Louis
AU - Mas, J. L.
AU - Turc, G.
AU - Domigo, V.
AU - Guiraud, V.
AU - Touzé, E.
AU - Calvet, D.
AU - Lamy, C.
AU - Teiger, E.
AU - Juliard, J. M.
AU - Dubois-Randé, J. L.
AU - Aubry, P.
AU - Varenne, O.
AU - Menacer, S.
AU - Sroussi, M.
AU - Nana, A.
AU - Cabanes, L.
AU - Guillon, B.
AU - Schunck, A.
AU - Herisson, F.
AU - De Gaalon, S.
AU - Sevin, M.
AU - Langlard, J. M.
AU - Piriou, N.
AU - Jaafar, P.
AU - Massardier, E.
AU - Juliard, J. M.
AU - Aubry, P.
AU - d'Héré, B.
AU - Stepowski, D.
AU - Bauer, F.
AU - Hosseini, H.
AU - Dubois-Randé, J. L.
AU - Teiger, E.
AU - Duval, A. M.
AU - Lim, P.
AU - Mechtouff, L.
AU - Nighoghossian, N.
AU - Derex, L.
AU - Cho, T.
AU - Rossi, R.
AU - Rioufol, G.
AU - Derumeaux, G.
AU - Thibaut, H.
AU - Hammoudi, N.
N1 - Publisher Copyright:
© 2018 The Authors.
PY - 2018/6/1
Y1 - 2018/6/1
N2 - Background--We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) comparing patent foramen ovale (PFO) closure, anticoagulation, and antiplatelet therapy to prevent stroke recurrence in patients with PFO-associated cryptogenic stroke. Methods and Results--We searched Medline, Cochrane Library, and EMBASE through March 2018. The primary outcome was stroke recurrence. Pooled incidences, hazard ratios, and risk ratios (RRs) were calculated in random-effects meta-analyses. PFO closure was associated with a lower risk of recurrent stroke compared with antithrombotic therapy (antiplatelet therapy or anticoagulation: 3560 patients from 6 RCTs; RR=0.36, 95% CI: 0.17-0.79; I2=59%). The effect of PFO closure on stroke recurrence was larger in patients with atrial septal aneurysm or large shunt (RR=0.27, 95% CI, 0.11-0.70; I2=42%) compared with patients without these anatomical features (RR=0.80, 95% CI, 0.43-1.47; I2=12%). Major complications occurred in 2.40% (95% CI, 1.03-4.25; I2=77%) of procedures. New-onset atrial fibrillation was more frequent in patients randomized to PFO closure versus antithrombotic therapy (RR=4.33, 95% CI, 2.37-7.89; I2=14%). One RCT compared PFO closure versus anticoagulation (353 patients; hazard ratio=0.14, 95% CI, 0.00-1.45) and 2 RCTs compared PFO closure versus antiplatelet therapy (1137 patients; hazard ratio=0.18, 95% CI, 0.05-0.63; I2=12%). Three RCTs compared anticoagulation versus antiplatelet therapy, with none showing a significant difference. Conclusions--PFO closure is superior to antithrombotic therapy to prevent stroke recurrence after cryptogenic stroke. The annual absolute risk reduction of stroke was low, but it has to be tempered by a substantial time at risk (at least 5 years) in young and middle-aged patients. PFO closure was associated with an increased risk of atrial fibrillation.
AB - Background--We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) comparing patent foramen ovale (PFO) closure, anticoagulation, and antiplatelet therapy to prevent stroke recurrence in patients with PFO-associated cryptogenic stroke. Methods and Results--We searched Medline, Cochrane Library, and EMBASE through March 2018. The primary outcome was stroke recurrence. Pooled incidences, hazard ratios, and risk ratios (RRs) were calculated in random-effects meta-analyses. PFO closure was associated with a lower risk of recurrent stroke compared with antithrombotic therapy (antiplatelet therapy or anticoagulation: 3560 patients from 6 RCTs; RR=0.36, 95% CI: 0.17-0.79; I2=59%). The effect of PFO closure on stroke recurrence was larger in patients with atrial septal aneurysm or large shunt (RR=0.27, 95% CI, 0.11-0.70; I2=42%) compared with patients without these anatomical features (RR=0.80, 95% CI, 0.43-1.47; I2=12%). Major complications occurred in 2.40% (95% CI, 1.03-4.25; I2=77%) of procedures. New-onset atrial fibrillation was more frequent in patients randomized to PFO closure versus antithrombotic therapy (RR=4.33, 95% CI, 2.37-7.89; I2=14%). One RCT compared PFO closure versus anticoagulation (353 patients; hazard ratio=0.14, 95% CI, 0.00-1.45) and 2 RCTs compared PFO closure versus antiplatelet therapy (1137 patients; hazard ratio=0.18, 95% CI, 0.05-0.63; I2=12%). Three RCTs compared anticoagulation versus antiplatelet therapy, with none showing a significant difference. Conclusions--PFO closure is superior to antithrombotic therapy to prevent stroke recurrence after cryptogenic stroke. The annual absolute risk reduction of stroke was low, but it has to be tempered by a substantial time at risk (at least 5 years) in young and middle-aged patients. PFO closure was associated with an increased risk of atrial fibrillation.
KW - Anticoagulation
KW - Patent foramen ovale
KW - Patent foramen ovale closure
KW - Stroke
UR - https://www.scopus.com/pages/publications/85049153044
U2 - 10.1161/JAHA.117.008356
DO - 10.1161/JAHA.117.008356
M3 - Article
C2 - 29910193
AN - SCOPUS:85049153044
SN - 2047-9980
VL - 7
JO - Journal of the American Heart Association
JF - Journal of the American Heart Association
IS - 12
M1 - e008356
ER -