Premium
Patent foramen ovale (PFO) closure versus medical therapy for prevention of recurrent stroke in patients with prior cryptogenic stroke: A systematic review and meta‐analysis of randomized controlled trials
Author(s) -
Akobeng Anthony K.,
Abdelgadir Ibtihal,
Boudjemline Younes,
Hijazi Ziyad M.
Publication year - 2018
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.27615
Subject(s) - medicine , randomized controlled trial , patent foramen ovale , stroke (engine) , meta analysis , relative risk , subgroup analysis , surgery , percutaneous , confidence interval , mechanical engineering , engineering
Objectives We performed a systematic review and meta‐analysis of randomized controlled trials to assess the effect of closure of a patent foramen ovale (PFO) compared with medical therapy for the prevention of stroke in patients with prior cryptogenic stroke. Background The role of PFO closure in reducing risk of stroke in patients with prior cryptogenic stroke has been controversial. Methods We searched PubMed, Embase, CINAHL, and CENTRAL for randomized trials investigating PFO closure versus medical therapy. We assessed trial bias and the quality of evidence for main outcomes was rated using GRADE. The primary outcome of interest was the occurrence of stroke. Estimates of effect were pooled with a random‐effects model. This study is registered with PROSPERO (CRD42017081579). Results We included five trials, comprising data for 3,440 adults randomized to receive PFO closure ( n = 1,829) or medical therapy ( n = 1,611). Mean follow‐up ranged from 2 years to 5.4 years across the trials. Patients treated with PFO closure had a lower risk of stroke (RR 0.39, 95% CI 0.18–0.88, I 2 = 57%, P = 0.02) compared with those treated with medical therapy. Subgroup analyses showed that the beneficial effect of PFO closure on a composite outcome of cerebrovascular events is more pronounced in patients with a large PFO shunt (RR 0.25, 95% CI 0.12–0.54, I 2 = 0%, P = 0.0004), male patients (RR 0.34, 95% CI 0.15–0.75, I 2 = 36%, P = 0.07), and those aged ≤45 years (RR 0.35, 95% CI 0.15–0.79, I 2 = 0%, P = 0.01). Conclusions PFO closure reduced risk of stroke compared with medical therapy. PFO closure is a therapeutic option that should be offered to adults with cryptogenic stroke.