Published online Apr 26, 2019. doi: 10.4330/wjc.v11.i4.126
Peer-review started: January 8, 2019
First decision: January 21, 2019
Revised: February 11, 2019
Accepted: March 27, 2019
Article in press: March 28, 2019
Published online: April 26, 2019
Processing time: 112 Days and 0 Hours
A few randomized clinical trials (RCT) and their meta-analyses have found patent foramen ovale closure (PFOC) to be beneficial in prevention of stroke compared to medical therapy. Whether the benefit is extended across all groups of patients remains unclear.
To evaluate the efficacy and safety of PFOC vs medical therapy in different groups of patients presenting with stroke, we performed this meta-analysis of RCTs.
Electronic search of PubMed, EMBASE, Cochrane Central, CINAHL and ProQuest Central and manual search were performed from inception through September 2018 for RCTs. Ischemic stroke (IS), transient ischemic attack (TIA), a composite of IS, TIA and systemic embolism (SE), mortality, major bleeding, atrial fibrillation (AF) and procedural complications were the major outcomes. Random-effects model was used to perform analyses.
Meta-analysis of 6 RCTs including 3560 patients showed that the PFOC, compared to medical therapy reduced the risk of IS [odds ratio: 0.34; 95% confidence interval: 0.15-0.78; P = 0.01] and the composite of IS, TIA and SE [0.55 (0.32-0.93); P = 0.02] and increased the AF risk [4.79 (2.35-9.77); P < 0.0001]. No statistical difference was observed in the risk of TIA [0.86 (0.54-1.38); P = 0.54], mortality [0.74 (0.28-1.93); P = 0.53] and major bleeding [0.81 (0.42-1.56); P = 0.53] between two strategies. Subgroup analyses showed that compared to medical therapy, PFOC reduced the risk of stroke in persons who were males, ≤ 45 years of age and had large shunt or atrial septal aneurysm.
In certain groups of patients presenting with stroke, PFOC is beneficial in preventing future stroke compared to medical therapy.
Core tip: Closure of patent foramen ovale closure (PFOC) is a treatment modality for patients with stroke. To evaluate the efficacy and safety of PFOC vs medical therapy in different groups of patients presenting with stroke, we performed this meta-analysis of randomized trials following standard techniques. It showed that PFOC, compared to medical therapy reduced the risk of ischemic stroke and the composite outcome of stroke, transient ischemic attack (TIA) and systemic thromboembolism but no difference was observed in the risk of TIA, mortality and major bleeding. PFOC increased the risk of atrial fibrillation. Subgroup analyses showed that PFOC reduced the risk of stroke in males.