Patent foramen ovale closure versus medical therapy for stroke prevention: A systematic review and meta-analysis of randomized controlled trials [version 2; referees: 2 approved]

• Main Authors: Jenny Chi Ling Lai, Gary Tse, William K.K. Wu, Mengqi Gong, George Bazoukis, Wing Tak Wong, Sunny Hei Wong, Konstantinos Lampropoulos, Adrian Baranchuk, Lap Ah Tse, Yunlong Xia, Guangping Li, Martin C.S. Wong, Yat Sun Chan, Nan Mu, Mei Dong, Tong Liu, International Health Informatics Study (IHIS) Network
• Format: Article
• Language: English
• Published: F1000 Research Ltd 2018-09-01
• Series: F1000Research
• Subjects: Cerebrovascular Disease; Congenital Heart Disease
• Online Access: https://f1000research.com/articles/6-2178/v2

Background: Previous randomized trials on patent foramen ovale (PFO) closure versus medical therapy for stroke prevention were inconclusive. Recently, two new randomized trials and new findings from an extended follow-up of a previous trial have been published on this topic. We conducted a systematic review and meta-analysis of randomized trials comparing PFO closure with medical therapy for stroke prevention. Methods: PubMed and Cochrane Library were searched until 16th September 2017.  The following search terms were used for PubMed: "patent foramen ovale" AND (stroke OR embolism) and "randomized" AND "Trial". For Cochrane Library, the following terms were used: "patent foramen ovale" AND "closure" AND (stroke OR embolism). Results: A total of 91 and 55 entries were retrieved from each database using our search strategy respectively, of which six studies on five trials met the inclusion criteria. This meta-analysis included 1829 patients in the PFO closure arm (mean age: 45.3 years; 54% male) and 1972 patients in the medical therapy arm (mean age: 45.1 years; 51% male). The median follow-up duration was 50 ± 30 months. When compared to medical therapy, PFO closure significantly reduced primary endpoint events with a risk ratio [RR] of 0.60 (95% CI: 0.44-0.83, P < 0.0001; I2: 15%). It also reduced stroke (RR: 0.50, 95% CI: 0.35-0.73, P < 0.0001; I2: 32%) despite increasing the risk of atrial fibrillation/flutter (RR: 1.90, 95% CI: 1.23-2.93, P < 0.01; I2: 43%). However, it did not reduce transient ischemic accident events (0.75; 95% CI: 0.51-1.10, P = 0.14; I2: 0%), all-cause bleeding (RR: 0.89; 95% CI: 0.44-1.78, P = 0.74; I2: 51%) or gastrointestinal complications (RR: 0.92; 95% CI: 0.32-2.70, P = 0.88; I2: 0%). Conclusions: PFO closure significantly reduces risk of stroke when compared to medical treatment and should therefore be considered for stroke prevention in PFO patients.