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.

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, I2  = 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, I2  = 0%, P = 0.0004), male patients (RR 0.34, 95% CI 0.15-0.75, I2  = 36%, P = 0.07), and those aged ≤45 years (RR 0.35, 95% CI 0.15-0.79, I2  = 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.