Meta-Analysis Comparing Patent Foramen Ovale Closure Versus Medical Therapy to Prevent Recurrent Cryptogenic Stroke
| Autor: | Tomo Ando, Anthony A. Holmes, Luis Afonso, Alenxandros Briasoulis, Theodore Schreiber, Tesfaye Telila, Hisato Takagi, Arshad Javed, Sripal Bangalore, Cindy L. Grines, Mohit Pahuja |
|---|---|
| Rok vydání: | 2018 |
| Předmět: |
medicine.medical_specialty
Foramen Ovale Patent 030204 cardiovascular system & hematology law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial Recurrence law Internal medicine medicine Humans 030212 general & internal medicine Cardiac Surgical Procedures Foramen ovale (heart) business.industry Anticoagulants Atrial fibrillation medicine.disease Stroke medicine.anatomical_structure Meta-analysis Relative risk Cardiology Patent foramen ovale Number needed to treat Cardiology and Cardiovascular Medicine business Medical therapy Platelet Aggregation Inhibitors |
| Zdroj: | The American Journal of Cardiology. 121:649-655 |
| ISSN: | 0002-9149 |
| DOI: | 10.1016/j.amjcard.2017.11.037 |
| Popis: | New evidence suggests that closure of a patent foramen ovale (PFO) plus medical therapy (MT; antiplatelet or anticoagulation) is superior to MT alone to prevent recurrent cryptogenic stroke. We performed a meta-analysis of randomized controlled trials that compared PFO closure plus MT with MT alone in patients with cryptogenic stroke. The efficacy end points were recurrent stroke, transient ischemia attack, and death. The safety end points were major bleeding and newly detected atrial fibrillation. Trials were pooled using random effects and fixed effects models. A trial sequential analysis was performed to assess if the current evidence is sufficient. Risk ratios (RR) were calculated for pooled estimates of risk. Five randomized controlled trials (3,440 patients) were included. Mean follow-up was 4.1 years. PFO closure reduced the risk of recurrent stroke by 58% (RR 0.42, 95% CI 0.20 to 0.91, p = 0.03). The number needed to treat was 38. The cumulative Z-line crossed the trial sequential boundary, suggesting there is adequate evidence to conclude that PFO closure reduces the risk of recurrent stroke by 60%. PFO closure did not reduce the risk of transient ischemia attack (RR 0.78, 95% CI 0.53 to 1.15, p = 0.21), mortality (RR 0.74, 95% CI 0.35 to 1.60, p = 0.45), or major bleeding (RR 0.96, 95% CI 0.42 to 2.20, p = 0.93); it did increase the risk of atrial fibrillation (RR 4.69, 95% CI 2.17 to 10.12, p0.0001). |
| Databáze: | OpenAIRE |
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