Transcatheter patent foramen ovale closure versus medical therapy for cryptogenic stroke: a meta-analysis of randomized clinical trials

BMC Cardiovascular Disorders

Kwan S Lee¹  Kapildeo Lotun¹  Justin Z Lee²  Muhammad Husnain¹  Chiu-Hsieh Hsu³  Ahmad Mizyed¹  Abhijeet Dhoble¹  Irbaz Bin Riaz² 

[1] Department of Cardiovascular Diseases, University of Arizona, 3950 S Country Club Road, Suite 200, Tucson, AZ 85714, USA;Department of Internal Medicine, University of Arizona, Tucson, AZ 85714, USA;Department of Biostatistics, University of Arizona, Tucson, AZ 85714, USA

关键词: Cryptogenic stroke;    Transcatheter closure;    Inter atrial shunt;    Patent foramen ovale;   

Others  :  855947
DOI  :  10.1186/1471-2261-13-116

 received in 2013-09-09, accepted in 2013-12-06,  发布年份 2013

【 摘 要 】

Background

There is an association between cryptogenic stroke and patent foramen ovale (PFO). The optimal treatment strategy for secondary prevention remains unclear. The purpose of this study was to analyze aggregate data examining the safety and efficacy of transcatheter device closure versus standard medical therapy in patients with PFO and cryptogenic stroke.

Methods

A search of published data identified 3 randomized clinical trials for inclusion. The primary outcome was a composite end-point of death, stroke and transient-ischemic attack (TIA). Pre-defined subgroup analysis was performed with respect to baseline characteristics including age, sex, atrial septal aneurysm and shunt size. Data was synthesized using a random effects model and results presented as hazard ratios (HRs) with 95% confidence intervals (CIs).

Results

A cohort of 2,303 patients with a history of cryptogenic stroke and PFO were randomized to device closure (n = 1150) and medical therapy (n = 1153). Mean follow-up was 2.5 years. Transcatheter closure was not superior to medical therapy in the secondary prevention of stroke or TIA in intention-to-treat analysis (HR: 0.66, 95% CI: 0.43 to 1.01; p = 0.056). However, the results were statistically significant using per-protocol analysis (HR: 0.64, 95% CI: 0.41 to 0.98; p = 0.043). Males had significant benefit with device closure (HR: 0.48, 95% CI: 0.24 to 0.96; p = 0.038).

Conclusions

In this meta-analysis, using intention-to-treat analysis, transcatheter device closure of PFO was not superior to standard medical therapy in the secondary prevention of cryptogenic stroke. Transcatheter closure was superior using per-protocol analysis.

【 授权许可】

   
2013 Riaz et al.; licensee BioMed Central Ltd.

【 图 表 】

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